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Evidence based medicine in complicated and uncomplicated gallstone disease

van Dijk, A.H.

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Citation for published version (APA):van Dijk, A. H. (2018). Evidence based medicine in complicated and uncomplicated gallstone disease.

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Assessment of available evidence in the management of gallbladder and bile duct stones: a systematic

review of international guidelines.

A.H. van Dijk P.R. de Reuver M.G.H. Besselink C.J.H.M. van Laarhoven E.M. Harrison S.J. Wigmore T.J. Hugh M.A. Boermeester

HPB (Oxford). 2017;19(4)

CHAPTER 1

ABSTRACT

Background Gallstone disease is a frequent disorder in the Western world with a prevalence of 10-20%. Recommendations for the assessment and management of gallstones vary internationally. The aim of this systematic review was to assess quality of guideline recommendations for treatment of gallstones.

MethodsPubMed, EMBASE and websites of relevant associations were systematically searched. Guidelines without a critical appraisal of literature were excluded. Quality of guidelines was determined using the AGREE II instrument. Recommendations without consensus or with low level of evidence were considered to define problem areas and clinical research gaps.

ResultsFourteen guidelines were included. Overall quality of guidelines was low, with a mean score of 57/100 (standard deviation 19). Five of 14 guidelines were considered suitable for use in clinical practice without modifications. Ten recommendations from all included guidelines were based on low level of evidence and subject to controversy. These included major topics, such as definition of symptomatic gallstones, indications for cholecystectomy and intraop-erative cholangiography.

ConclusionOnly five guidelines on gallstones are evidence-based and of a high quality, but even in these controversy exists on important topics. High quality evidence is needed in specific areas before an international guideline can be developed and endorsed worldwide.

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Available evidence in the management of gallstones

INTRODUCTION

Gallstone disease is a common condition with an estimated prevalence of 10-20%, increas-ing to 15-24% in patients aged over seventy years [1,2]. Most patients with gallstones remain asymptomatic throughout their lifetime, but about 13-22% of patients will eventually become symptomatic [3].

Standard treatment of symptomatic gallstone disease is laparoscopic cholecystectomy (LC). Currently, over 700,000 cholecystectomies are performed in the United States each year with health care costs surpassing US$ 6.5 billion [4].

Various health comparison studies from Europe and the US have shown that the assessment and management of gallbladder and ductal stones varies between surgeons, hospitals and countries [5,6]. A Canadian study demonstrated that patients with similar severity of acute cholecystitis across hospitals in one health care system did not receive comparable care, showing significant practice variation [5]. Rates of cholecystectomy are increasing over the years and geographic variation exists between France, Britain and the US [6].

A good quality up-to-date internationally endorsed guideline might minimize practice variation through the use of the best available evidence. The Institute of Medicine in the US defines an adequate guideline as ”systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances” [7]. Creating clinically relevant and useful guidelines can be a long and arduous process with all recommendations needing to be supported by high quality evidence. Successful imple-mentation is also critically-dependent on the manner of distribution and promotion of the guideline, active involvement of clinicians, and the need for a mechanism to incorporate feedback and peer review [8,9].

Guidelines are important in clinical care, especially in a common problem such as gall-bladder and ductal stones. A guideline can provide important direction in all patients with gallstones, regardless of nationality, the hospital or physician. The aim of this study was to conduct a systematic review of available guidelines for the management of patients with gallbladder and ductal stones and to evaluate the quality of evidence.

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Chapter 1

METHODS

The PRISMA checklist (Preferred Reporting Items for Systematic Reviews and Meta-Analyses [10]) was used to perform this systematic review.

Literature searchNational and international guidelines on gallbladder and ductal stones were identified by a systemic search of PubMed, EMBASE and the Cochrane library in October 2015. We used the following search terms for Medline: laparoscopic cholecystectomy, cholecystolithiasis, gallstones, choledocholithiasis, ductal stones, biliary tract surgical procedures, guideline, consensus development conference. The EMBASE database and the Cochrane Library were searched with similar terms. The full search is described in detail in appendix 1. Websites of all international Gastroenterological and Surgical Associations were searched for additional relevant guidelines.

Eligibility criteriaGuidelines were eligible for inclusion when the following inclusion criteria were met; (a) de-scription of assessment and/or management of a topic associated with gallbladder or ductal stones; (b) full text available; (c) critical appraisal of the used literature. The most recent version of each guideline was used. No limits regarding language or design of the guideline were defined. Biliary and pancreatic malignancies, gallbladder polyps, gallbladder dyskine-sia, cholecystitis, cholangitis and pancreatitis were outside the scope of this review.

Selection of suitable guidelines and data extractionAfter removal of duplicates all available articles were reviewed for relevance by screening the title and abstract. The eligibility criteria were assessed in the full-text guidelines. Two authors (AhvD, PRdR) were involved in data extraction and checking the data for accuracy, which was done using a pre-defined pro forma. The data fields in the template included title, organisa-tion, group of authors, year of publication, development, multidisciplinary character, the use of figures and flowcharts, the rating systems used, the use of peer review, mode of distribu-tion and all recommendations.

Comparison of guidelines and recommendation assessmentIn order to make comparison of the guidelines possible, every individual critical appraisal of the literature was converted to levels of evidence (LoE), in line with the system devised by the Oxford Centre for Evidence-based Medicine, version 2011 [11] (see appendix 2). Recommenda-tions were arranged according to the GRADE approach [12] (see appendix 2) and were further organised depending on the consensus assigned in the guideline.

If a recommendation was given in two or more guidelines, and the authors of the original guideline agreed on the recommendation, it was classified as a ‘consensus’. Where only

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one guideline described the recommendation or the authors did not agree on the recom-mendation, it was ranked as ‘no consensus’. Only recommendations without consensus or with a low level of evidence were selected for further discussion if they were contentious or debatable issues in clinical practice.

Quality assessment of included guidelinesThe Appraisal of Guidelines for Research and Evaluation Instrument (AGREE II) was used to assess the quality of the included guidelines [13] by both reviewers (AhvD, PRdR). This instru-ment uses 23 key items organized in six domains with each item rated on a 7-point Likert scale. A scaled domain score was calculated per domain and was then displayed as a per-centage with a maximum of 100%. An overall assessment was then assigned regarding the quality of the guideline and recommended use of the guideline. An overall score of 50 or less is considered low quality and the guideline is not considered suitable for clinical practice. A score of 50 to 69 is considered moderate quality and the guideline can only be advised for clinical practice after considerable modifications. A score of 70 or higher represents a high quality guideline that is appropriate for use in clinical situations.

RESULTS

Literature search The systematic search (October 2015) identified 4270 articles (figure 1). Removal of dupli-cates and screening of the title and abstract resulted in 111 remaining articles. Further refine-ment of full texts retrieved 21 possible guidelines. Eleven additional guidelines were found by searching the websites of relevant associations and cross-referencing.

Excluded and included guidelinesAfter careful assessment of a total of 33 possible guidelines, 19 were excluded, due to a lack of a critical appraisal of the literature used (n=12), duplication (n=5) or absence of a full text version (n=2) (see table 1 and appendix 3). Only the most recent version of the guideline was included in this review. Of four of the included guidelines retrieved by the search, an earlier version was excluded (as indicated in appendix 3). Guideline content was developed by a committee or a writing group as a result of a consensus development conference or by an expert panel, as shown in table 2. Fourteen guidelines were included in the present review, in English, German and Dutch (table 2). Nine guide-lines covered all aspects of gallbladder and ductal stones [14–22]. One guideline specifically commented on the prevention and treatment of bile duct injuries [23] and the remaining four focussed on the diagnosis and management of choledocholithiasis [24–27]. Eleven guidelines were developed by a multidisciplinary team; nine use flowcharts or algo-rithms. The guidelines used various rating systems for grading the quality of the evidence, including instruments developed by guideline authors. Most guidelines were peer-reviewed

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Chapter 1

Search (n=4270)Pubmed = 1516EMBASE = 2725Cochrane = 34

Evaluation of full text (n=111)

Possible guidelines (n=33)

Website search and cross referencing (n=12)

Exclusion (n=90)Review = 14

Does not meet inclusion criteria = 51Guideline on other subject = 25

Exclusion (n=4165)Duplicates = 254

Irrelevant by screening title and abstract = 3911

Included guidelines (n=14)

Excluded guidelines (n=19)Previous version = 5

No critical appraisal of literature = 12

Full-text not available = 2

Figure 1. Flowchart of inclusion of guidelines (search 14-10-2015)

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and distributed by either a publication in a journal or on a website.

Guideline recommendations with consensus (table 3)High level of evidence consensus was reached for sixteen recommendations. The use of urso-deoxycholic acid in selected patients, safety of LC in patients with liver cirrhosis Child’s Pugh A/B, the use of prophylactic antibiotics in LC, the routine use of a drain in LC and evidence on the SILC procedure (single incision LC) and the three-port technique all gained evidence level 1 and are therefore of the highest quality.

Table 1. Included guidelines, ranked by year of publication

Organisation Guideline Abbreviation Year Language

European Association for the Study of the Liver

EASL Clinical Practice Guidelines on the Prevention, Diagnosis and Treatment ofGallstones[22]

EASL 2016 English

Dutch Association of Surgery Gallstone[29] DAS 2016 Dutch

European Association of Endoscopic Surgery and Italian Surgical Societies Working Group

Laparoscopic cholecystectomy: consensus conference-based guidelines[21]

EAES/ISS 1994, reviewed2015

English

American Academy of Family Physicians Surgical and Nonsurgical Management of Gallstones[18]

AAFP2 2014 English

National Institute of Health and Care Excellence

Gallstone disease; Diagnosis and manage-ment of cholelithiasis, cholecystitis and choledocholithiasis[19]

NICE 2014 English

University of Michigan Health System Evaluation and Management of Gallstone-Related Diseases in Non-Pregnant Adults[20]

UMH 2014 English

European Association of Endoscopic Surgery

Prevention and treatment of bile duct injuries during laparoscopic cholecystec-tomy[23]

EAES 2012 English

American Society for Gastrointestinal Endoscopy

The role of endoscopy in the management of choledocholithiasis[26]

ASGE2 2011 English

Society of American Gastrointestinal Endoscopic Surgeons

Guidelines for the clinical application of laparoscopic biliary tract surgery[16]

SAGES 1990, reviewed2010

English

American Society for Gastrointestinal Endoscopy

The role of endoscopy in the evaluation of suspected choledocholithiasis[24]

ASGE1 2010 English

British Society of Gastroenterology Guidelines on the management of common bile duct stones[25]

BSG 2008 English

German Society for Digestive and Metabolic Diseases / German Society for the Surgery of the Alimentary tract

S3 Guidelines for Diagnosis and treatment of Gallstones[15]

S3 2007 German

American Academy of Family Physicians Management of Gallstones[17] AAFP1 2005 English

Philippine society of general surgeons Evidence-based Clinical practice Guidelines on Bile Duct Stones[27]

PSGS 2005 English

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Chapter 1

Table 2. Content of included guidelines

Guideline Development MD Use of

flowchart/

algorithm

Rating quality

of evidence

References Peer

review

Distribution

AAFP1 Expert panel No No SORT 29 No Published in PRJ

PSGS Expert panel and committee

No No Oxford 19 Yes Published on website, presented on national con-ference

DAS Committee Yes Yes, one Own Not numbered separately

Yes Published on website, presented on national con-ference

S3 Committee Yes Yes, one Own 591 Yes Published on website and in PRJ and presented in educational meetings

BSG Writing group Yes Yes, two North of England evi-dence-based guideline project

247 Yes Published in PRJ and on website

SAGES Committee Yes No Own 177 Yes Published in PRJ and on website

ASGE1 Committee Yes Yes, one GRADE 106 Yes Published in PRJ and on website

EAES Expert panel Yes Yes, two Oxford 695 Yes Published on website and in PRJ, presented on national conference

ASGE2 Committee Yes No GRADE 224 Yes Published in PRJ and on website

EAES/ISS Consensus development conferences and committee

Yes Yes, one GRADE 300 Yes Published online and published in PRJ

AAFP2 Expert panel Yes Yes, one SORT 52 No Published in PRJ

NICE Guideline development group

Yes Yes, two GRADE Not numbered separately

Yes Published on website and in PRJ

UMH Guideline development team

Yes Yes, two Own 25 Yes Published online

EASL Guideline Panel Yes No GRADE 675 Yes Published online and on website

MD; developed by a multidisciplinary team, References; Total number of references used, SORT; Strength of Recommendation Taxonomy (a system of grading evidence)[63], PRJ; Peer reviewed journal, Oxford; Oxford Centre for Evidence-based Medicine Levels of Evidence[11], GRADE; GRADE system for rating the quality of evidence[64]

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Recommendation Guideline LoE/ grade

Expectant treatment is justified in patients with asymptomatic gallstone disease.

S3, EAES/ISS, AAFP1, DAS, AAFP2, NICE, EASL

LoE 2 / moderate

Transabdominal ultrasound is the diagnostic tool of choice for symptomatic gallstone disease.

S3, AAFP1, DAS, AAFP2, NICE, UMH, EASL

LoE 2 / moderate

Oral dissolution therapy is only recommended for selected patients.

S3, AAFP1 LoE 1 / high

Ursodeoxycholic acid can be used as a prevention in high risk patients.

S3, DAS, EASL LoE 2 / moderate

Shock wave lithotripsy is not recommended for gallbladder stones S3, EASL LoE 3/ moderate

The treatment of cholecystolithiasis in pregnancy is the same as in non-pregnant patients.

S3, EAES/ISS, DAS, AAFP2, EASL LoE 2 / moderate

LC is a safe procedure in patients with Child’s Pugh A or B SAGES, EAES/ISS, EASL LoE 1 / high

Prophylactic antibiotics in routine, elective LC are not necessary. SAGES, AAFP2, EASL LoE 1 / high

Routine use of a drain is not necessary after elective LC. SAGES, EAES/ISS, DAS LoE 1 / high

SILC has no proven advantages over LC. SAGES, EAES/ISS LoE 1 / high

The three-port technique is similar to the traditional four port technique.

SAGES, EAES/ISS, EAES LoE 1 / high

LC in day surgery is safe in carefully selected patients. EAES/ISS, NICE, SAGES, S3, DAS, EASL

LoE 2 / moderate

In patients with a low probability of CBDS no further evaluation is necessary.

ASGE1, DAS, UMH LoE 2-3 / moderate

In patients with suspected CBDS initial evaluation should consist of serum liver tests and a transabdominal ultrasound

S3, ASGE1, BSG, DAS, EASL LoE 1-3 / moderate

Following ultrasound, MRC or EUS can be used, depended on availability and experience.

ASGE1, DAS, NICE, EASL LoE 3 / moderate

ERC is not used solely as a diagnostic test, due to the associated complications.

SAGES, EAES/ISS, DAS LoE 2 / moderate

LC combined with LCBDE has a comparable mortality and morbidity with ERC followed by LC.

SAGES, EAES/ISS, AAFP1, BSG, DAS

LoE 1 / high

Table 3. Recommendations from included guidelines, with consensus and high to moderate level of evidence

LoE; Level of Evidence, LC; laparoscopic cholecystectomy, SILC; single incision laparoscopy, CBDS; common bile duct stones, MRC; mag-netic resonance cholangiography, EUS; endoscopic ultrasonography, ERC; endoscopic retrograde cholangiography, LCBDE; laparoscopic bile duct exploration

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Chapter 1

Guideline recommendations without consensusTen recommendations where no consensus was reached or where only a low level of evidence exists are further discussed (table 4).

1. Definition of uncomplicated symptomatic gallstone disease Biliary colic is usually described as the typical presentation of a patient with symptomatic gallstone disease. As defined by the Rome criteria, this is a steady pain, located in the epi-

Subject Reason for discussion Guideline LoE / grade Consensus

The definition of symptomatic gallstone disease

Ranges from a ‘steady increasing pain, which can last for 6 hours’ to ‘pain, lasting at least 30 minutes’

S3, AAFP1, DAS, EASL

LoE 4-5 / low-very low

No

The use of laboratory tests in preoperative assessment before LC

Some guidelines advise routinely performing laboratory tests, and other find them not useful

S3, DAS, NICE, UMH, EASL

LoE 5 / very low

No

Contraindications for LC Are only described in one guideline as ‘untre-ated coagulopathy, lack of surgical expertise or equipment, high chance of laparoscopic failure, advanced cirrhosis or liver disease and suspected malignancy’

SAGES LoE 4 / low No

The use of CVS during LC Limited evidence is available to recommend the use of the CVS in LC to prevent BDI

SAGES, EAES/ISS, EAES, DAS

LoE 4/ low Yes

The use of IOC during LC Little evidence exists to either recommend or discourage the routine or selective use of IOC during LC

SAGES, EAES/ISS, EAES, DAS, EASL

LoE 3-4 / low Yes

Subtotal cholecystectomy during LC

There is no consensus on the role of subtotal cholecystectomy as an alternative during LC

EAES/ISS LoE 2 / moderate

No

Lost stones and gall spill during LC

One guideline recommends a search for as much spilt gallstones as possible, while the other advises against an extensive search

EAES/ISS, DAS, EASL

LoE 2-5 / moderate-low

No

Persistent symptoms following LC

About 30-40 percent of patients seem to have persistent symptom after LC, but the quality of the evidence is low

S3, DAS, EASL

LoE 4-5 / low-very low

Yes

The standard treatment of CBDS

Some guidelines advise either ERC with sp-hincterotomy with stone extraction or LC with LCBDE and other guidelines have a preference for one of the techniques

S3, BSG, DAS, EASL

LoE 1 / high No

Timing of LC in patients with CBDS and concomitant sympto-matic gallstones following ERC

Timing of cholecystectomy after ERC varies from 24-72 hours to within two weeks.

S3, PSGS, ASGE2, DAS, NICE, EASL

LoE 4 / low No

LC; laparoscopic cholecystectomy, CVS; critical view of safety, BDI; bile duct injury, IOC; intra-operative cholangiography, CBDS; com-mon bile duct stones, ERC; endoscopic retrograde cholangiography, LCBDE; laparoscopic bile duct exploration

Table 4. Recommendations from included guidelines, without consensus or with a low level of evidence

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gastrium and/ or right upper quadrant, and lasting at least 30 minutes [28]. However, only three out of the 13 guidelines offer a description of ‘typical biliary symptoms’, and these de-scriptions are different. The Dutch ‘gallstones’ guideline (DAS, by the Dutch Association of Surgery) [29] describes two other symptoms that, in addition to biliary colic, can be associ-ated with gallstone disease: pain radiating to the back and a positive response to a simple analgesic (LoE 2). The S3 Guidelines for Diagnosis and treatment of Gallstones (S3, by the German Society for Digestive and Metabolic Diseases) [15] is in agreement with this definition, but adds that symptomatic gallstone disease is often associated with nausea and vomiting (LoE 4). In contrast, the guideline ‘Management of Gallstones’ (AAFP1, by the American Academy of Family Physicians) [17] defines typical biliary pain as ‘a steady pain which rapidly increases in intensity and reaches a plateau, can last for four to six hours and sometimes radiates to the right upper back’ (LoE 4).

2. Laboratory tests Four guidelines discuss the use of laboratory tests in the preoperative screening of LC [15,19,20,29]. DAS [29] state that laboratory tests is not useful in the assessment of symptomatic gallstone disease (LoE 5), whereas S3 [15] considers liver function tests, a full blood count and blood co-agulation tests mandatory (LoE 5). The guideline ‘Gallstone disease; Diagnosis and manage-ment of cholelithiasis, cholecystitis and choledocholithiasis’ (NICE, by the National Institute of Health and Care Excellence) [19] is in agreement that there is ‘sufficient evidence’ to advise the use of liver function tests to assist with identification of common bile duct stones (CBDS) (LoE 4) [19]. According to UMH, the guideline made by the University of Michigan Health System (Evaluation and Management of Gallstone-Related Diseases in Non-Pregnant Adults) the evaluation of gallstones routinely includes laboratory tests (LoE4) [20].

3. Contraindications for LCThe guidelines for the clinical application of laparoscopic biliary tract surgery (SAGES, by the Society of American Gastrointestinal Endoscopic Surgeons) [16] is the only guideline to describe ‘relative’ contra-indications for LC and these include untreated coagulopathy, lack of surgical expertise or equipment, high chance of laparoscopic failure, advanced cirrhosis or liver disease and suspected malignancy of the gallbladder (LoE 4).

4. The use of the Critical View of Safety during LCThe Critical View of Safety is a method used during laparoscopic cholecystectomy to help identify the biliary anatomy and was first described by Strasberg [30]. The use of the Critical View of Safety is mentioned in four guidelines ( [16,23,31,32]). All guidelines are in agreement that optimal exposure of the relevant anatomy is essential for a safe laparoscopic procedure (LoE 2). Specifically, the guideline ‘Laparoscopic cholecystectomy: consensus conference-based guidelines’ (EAES/ISS, by the Italian Surgical Societies Working Group) [21] recommends use of the Critical View of Safety, but with a footnote that there is limited evidence to support this approach (LoE 4).

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Chapter 1

5. The use of IOC during LCFour guidelines discuss the use of IOC during cholecystectomy [16,21,23,29]. The rationale for per-forming routine IOC is to identify choledocholithiasis and to clarify the biliary anatomy. In the absence of data about long-term complications in patients who do not undergo IOC, SAGES, DAS and EASL [21,22,29] suggest that routine use of IOC cannot be recommended (LoE3). In relation to this, a systematic review conducted by Ford et al [33] concluded that the available evidence is of low to moderate quality only and that no benefit of IOC has been shown.The selective use of IOC to help prevent BDI is a controversial topic. DAS, EAES, EASL and SAGES [16,22,23,29] state that IOC may decrease the risk of BDI (LoE 3-4). EAES/ISS [21] suggests that selective use of IOC can be useful, as it allows for therapeutic intervention and, consequently may reduce the risk of BDI (LoE 3-4). If BDI does occur, GS [29] suggests that IOC can identify this complication in 80% of cases (LoE 4). Furthermore, EAES [23] states that, if used correctly, IOC can provide early identification of a BDI (LoE 3).

6. Subtotal cholecystectomy Subtotal or partial cholecystectomy is practised by some as an alternative to conversion during a difficult dissection. Subtotal cholecystectomy is mentioned only in one guideline [21], where it is described as an option when the biliary anatomy is unclear (LoE 2). They do advise that closure of either the remnant of the gallbladder or the cystic duct (or both) ‘seems fa-vourable, without any definitive conclusion’, to prevent bile leaks and reduce the need for postoperative ERC (endoscopic retrograde cholangiography).

7. Gallstone spillage and lost stones during LCThree guidelines address iatrogenic gallbladder perforation during LC [21,22,29]. Overall, the reported incidence of lost stones is between 5 and 20% (LoE 3). EAES/ISS [21] advises retrieval of as many spilt stones as possible, particularly when they are larger than 15 mm, when there is a large number of stones, and whenever there are spilt pigment stones [34] (LoE 2). The type of stone seems to be a relevant in retrieving stones, as bacterial contamination is present in 83% of black, brown or mixed stones but only in 33% of cholesterol stones [35]. These authors also conclude that routine use of antibiotics following spillage of stones or bile is not necessary. DAS advises against an extensive search for intraperitoneal lost stones [29] (LoE 4). EASL comments that the intra-operative loss of gallstones is not a reason for conversion to an open procedure, but that ‘every attempt’ should be made to retrieve lost stones by lavage

[22] (LoE 5).

8. Persistent symptoms following LCThe occurrence of persistent symptoms following LC is only described in three guidelines ( [15,22,29]). DAS and EASL [22,29] comment that up to 40% percent of patients complain of persistent symptoms postoperatively, and consequently recommend to correctly and fully inform all patients about this possibility preoperatively (LoE 5). EASL goes on to advise en-doscopic ultrasound or MRCP (magnetic resonance cholangiopancreatography) in patients

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with persistent symptoms (LoE4-5). S3 [15] states that about 30% of patients will have lasting symptoms postoperatively (LoE 4).

9. Management of common bile duct stonesAccording to the British Society of Gastroenterology (Guidelines on the management of common bile duct stones, BSG), S3, EASL and DAS [15,22,25,29], the treatment for ductal stones can be either ERC with sphincterotomy followed by stone extraction using a basket or balloon catheter or LC combined with laparoscopic common bile duct exploration (if the necessary surgical expertise is available), as they are comparable in morbidity and mortality (LoE 1). DAS adds that experience in exploration of the common bile duct is declining fast, so it is now associated with an increase in morbidity. Therefore, they advise ERC with sphincterotomy and stone extraction as the first choice in the treatment of ductal stones in the Netherlands (LoE 3).NICE recommends ‘bile duct clearance‘ (surgical or with ERC) and LC in patients with both symptomatic and asymptomatic ductal stones (LoE4-5). EAES/ISS, BSG and S3 [15,21,25] also recommend balloon dilatation of the papilla as an alternative in patients with a high risk of bleeding after sphincterotomy (e.g. coagulopathy or cirrhosis, LoE 2).

10. Timing of LC in patients with ductal and concomitant gallbladder stonesAccording to GMC, GDD and CDL [19,21,25], cholecystectomy is recommended for all patients with ductal stones and concomitant symptomatic gallbladder stones (LoE 4). DAS, NICE, EAES/ISS and S3 [15,19,29] suggest that when ERC and sphincterotomy are performed following LC, this should not be on the same day (LoE 4).S3 advises removal of the gallbladder within six weeks of ERC and stone removal (LoE 2). In contrast, the guideline of the Philippine Society of general surgeons (Evidence-based Clinical practice Guidelines on Bile Duct Stones, PSGS) [27] recommends cholecystectomy within 24-48 hours of clearance of the bile duct (LoE 2-3), while ASGE2 [26] suggests that cholecystec-tomy should be performed within 2 weeks of ERC (LoE 4). DAS and EASL advise LC within 72 hours after sphincterotomy [22,29]. They base this on the randomized trial by Reinders et al that showed that LC within 72 hours leads to significantly less recurrent biliary events (2.1% vs 36.2%) when compared to LC following 6-8 weeks [36]. There was no difference in the number of conversions or operating time. NICE found little evidence and did not feel ‘confident’ to make a specific recommendation [19].

Quality assessment of the included guidelinesThe appraisal of individual guidelines is shown in appendix 4. Five of the guidelines reached an overall quality assessment of 70 or more (out of 100) and, being high quality, are recom-mended for use in clinical practice [15,19,21,22,29]. Five guidelines received a total overall score between 50 and 70 and were in need of considerable modifications before recommending their clinical use. Four other guidelines were not considered suitable for use in clinical situa-tions due to an overall assessment of only 50 or less.

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Chapter 1

Mean scores for each domain and the overall score were calculated (appendix 4). The domain ‘applicability’ reached the lowest score of 37 (out of a 100, with an SD of 17). This domain handles the implementation strategy of the guideline. The total overall mean score of the guidelines was 57 (out of a 100, SD 19).

DISCUSSION

This systematic review is the first to assess the evidence and quality of guidelines on gallstone disease. Thirteen guidelines were included after a systematic search of the litera-ture and relevant websites. Ten topics with a low level of evidence or where there was lack of consensus were also identified for further discussion. The development of guidelines has increased gradually over recent decades as a result of the rising demand for evidence-based practice. Ideally, guidelines should incorporate the best available and most recent evidence, which should be assessed and rated with reliable and validated instruments. Perceived benefits of a well-developed guideline include improved efficiency, a reduction of inappropriate care and lower overall healthcare costs [37]. Unques-tionably, guidelines are effective in improving patient care when they are appropriately conceived, developed, distributed and implemented [38,39].This review showed that only 33 guidelines exist worldwide, which is surprising considering that gallstones are such a common clinical problem. Furthermore, 19 of these guidelines had to be excluded, mostly due to lack of a critical appraisal of the relevant literature. Also, only eight out of the 14 guidelines selected for review were developed or updated in the last five years. The 14 guidelines analyzed were of low to moderate quality only, with a mean overall score of 57 (out of a 100, SD 19). Ultimately, only five were deemed to be of high enough quality to be used in clinical practice. Interestingly, they originated from Germany, The Netherlands and the United Kingdom, arguably representing the views of only one part of the world. Six out of 14 included guidelines were in need of considerable modifications to be imple-mented in clinical practice. As ‘applicability’ was the domain that had the lowest mean score in the AGREE II assessment, this is one of the areas that needs more attention in the devel-opment of guidelines. ‘Applicability’ pertains mostly to the implementation and dissemina-tion of the guideline. Failure to translate research into daily clinical practice is a well-known problem with clinical guidelines. In general, up to 40% of patients never receive evidence based treatment despite the availability of a clinical evidence based guideline [40]. This suggests that correct implementation and dissemination of information is just as important as accurate content and development of the guideline. Also, measuring the long-term impact of a guideline on mainstream clinical practice remains problematic, but is important when considering updates or modifications of the guideline. Not only are guidelines important in clinical practice, in medico-legal cases they are often used to assess if the doctor under scrutiny has followed the right policy. In these situations, it could have serious consequences

31


when guidelines are not reliable.Ten recommendations were identified where there was no consensus or where there was only limited evidence to support the recommendations. Interestingly, one of these relates to the definition of ‘uncomplicated symptomatic gallstone disease’. Lack of a worldwide consensus of this definition may be the biggest impediment to establishing guidelines for managing this condition. The first issue a new and improved guideline must assess is what constitutes ‘typical biliary symptoms’ and ‘atypical biliary symptoms’, as the rest of the guideline is based solely on this definition. The current definition of the ‘Rome criteria’ is clearly not effective, as 30-40% of patients still suffer from symptoms after cholecystectomy.Other important recommendations with no consensus or only limited evidence include the value of the CVS during surgery, the role of preoperative laboratory tests, absolute and relative contraindications for cholecystectomy, the role of partial cholecystectomy, and per-formance of an IOC during LC. The lack of consensus on these subjects between guidelines is most likely due to lack of high-quality evidence. In these situations, it is impossible for a guideline committee to form an evidence-based recommendation on that topic and the recommendation will be based on expert opinion. It is notable, that daily practice in such a common disease as gallstones is mostly based on habits and historical principles. More research is certainly needed in certain topics and large numbers of patients may be needed to settle some of the recommendations with low quality of evidence.Guidelines in other areas of medicine suffer from the same problem. Several reviews of guide-lines have been published in the last 5 years. Most of the authors conclude that guideline committees need to improve their methodology to create evidence-based guidelines that concur on major topics [41–44]. Apparently, the varying quality of guidelines is a worldwide problem and not specific to one medical specialty. This systematic review has several limitations. Firstly, there is a selection bias in the included reviews, since not all guidelines are published or placed online. Secondly, the evidence as used in the included guidelines was only categorized, but a systematic review of the selected recommendations was not performed. Consequently, this review is not representative of all current available evidence. Also, for this review all available guidelines were included, regardless of their publication date. There is a certain bias in comparing older and newer guidelines, as newer guidelines could incorporate more recent evidence and as such may differ in recommendation when compared to the older guideline. In conclusion, this study has highlighted significant deficiencies in the evidencebase of gallstone disease and as a result most guidelines are associated with a low level of evidence and lack consensus. Focused high quality research is needed to definitively address the knowledge gaps in the diagnosis and management of gallstone disease.. Ultimately, when focused research is completed updated guidelines should be developed by an international, multidisciplinary team, and then well implemented with endorsement by a wide range of international medical and surgical societies. This will contribute to a decrease in practice variation and improve patient care.

32

Chapter 1

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28. The Rome Group for Epidemiology and Prevention of Cholelithiasis (GREPCO). The epidemiol-ogy of gallstone disease in Rome, Italy. Part II. Factors associated with the disease. Hepatol-ogy. 1988;8(4):907–13.

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31. Agresta F, Ricciardelli L, Davoli M, Barlera S. Consensus Development Conferences on lapa-roscopic cholecystectomy of the Associazione Chirurghi Ospedalieri Italiani (ACOI); Società Italiana di Chirurgia Endoscopica e nuove tecnologie (SICE); Società Italiana di Chirurgia nell’Ospedalità Privata (SICOP). 2013;

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33. Ford JA, Soop M, Du J, Loveday BPT, Rodgers M. Systematic review of intraoperative cholangi-ography in cholecystectomy. Br J Surg. 2012 Feb;99(2):160–7.

34. Shaffer EA. Gallstone disease: Epidemiology of gallbladder stone disease. Best Pract Res Clin Gastroenterol. 2006 Jan;20(6):981–96.

35. Stewart L, Smith AL, Pellegrini CA, Motson RW, Way LW. Pigment gallstones form as a compos-ite of bacterial microcolonies and pigment solids. Ann Surg. 1987 Sep;206(3):242–50.

36. Reinders JSK, Goud A, Timmer R, Kruyt PM, Kruijt PM, Witteman BJM, et al. Early laparoscopic cholecystectomy improves outcomes after endoscopic sphincterotomy for choledochocysto-lithiasis. Gastroenterology. 2010 Jun;138(7):2315–20.

37. Grimshaw J, Russell I. Achieving health gain through clinical guidelines. I: Developing scientifi-cally valid guidelines. Qual Health Care. 1993 Dec;2(4):243–8.

38. Grimshaw JM, Russell IT. Effect of clinical guidelines on medical practice: a systematic review of rigorous evaluations. Lancet. 1993 Nov;342(8883):1317–22.

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40. Grimshaw J, Eccles M, Tetroe J. Implementing clinical guidelines: current evidence and future implications. J Contin Educ Health Prof. 2004 Jan;24 Suppl 1:S31–7.

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42. Sabharwal S, Patel V, Nijjer SS, Kirresh A, Darzi A, Chambers JC, et al. Guidelines in cardiac clinical practice: evaluation of their methodological quality using the AGREE II instrument. J R Soc Med. 2013 Aug;106(8):315–22.

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19.

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49. The Association of Laparoscopic Surgeons of Great Britain and Ireland. The Gallbladder and Bile Ducts. 1996;1–12.

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36

Chapter 1

APPENDIX

Appendix 1. Search strategyFor every keyword (MeSH for Medline and EMTREE for EMBASE) the matching textwords were searched as well, but are not named below for clarity. Medline, 14-10-2015, 1516 hits 1. "cholecystectomy, laparoscopic"[MeSH Terms] OR "Cholecystectomy"[Mesh] OR

cholecyst*2. "gallstones"[MeSH Terms] OR "cholecystolithiasis"[MeSH Terms] 3. "biliary tract"[MeSH Terms] OR "Biliary Tract Surgical Procedures"[Mesh] OR "Biliary

Tract Diseases"[Mesh] OR "Gallbladder"[Mesh] OR "Gallbladder Diseases"[Mesh]4. "Guideline" [Publication Type] OR "Guidelines as Topic"[Mesh] OR "Practice Guideline"

[Publication Type] OR "Guideline Adherence"[Mesh] OR guideline* OR "guideline"[All Fields]

5. "Consensus"[Mesh] OR "Consensus Development Conference, NIH" [Publication Type] OR "Consensus Development Conference" [Publication Type] OR "Consensus Develop-ment Conferences, NIH as Topic"[Mesh] OR "Consensus Development Conferences as Topic"[Mesh] OR consensus* OR"consensus"[All Fields]

6. 1 OR 2 OR 37. 4 OR 58. 6 AND 7

EMBASE, 14-10-2015, 2725 hits1. laparoscopic cholecystectomy.mp. OR exp cholecystectomy/2. cholecystolithiasis.mp. OR cholelithiasis.mp. OR gallstones.mp. OR gallstone.mp. 3. exp gallbladder/ OR exp cholecystitis/ OR galbladder diseases.mp. 4. biliary tract.mp. OR biliary tract surgery.mp. 5. guideline.mp. OR exp practice guideline/6. exp consensus development/ OR exp consensus/ OR consensus.mp.7. practice parameter.mp. OR (consensus or guideline*).mp.8. 1 OR 2 OR 3 OR 49. 5 OR 6 OR 710. 8 AND 9

Cochrane library, 14-10-2015, 29 hits1. Cholecystectomy2. Gallstone3. Guideline 4. 1 OR 25. 4 AND 3

37


Appendix 2. Levels of evidence (adapted from the OCEBM Levels of Evidence[11] and GRADE[12])Level of Evidence (LoE)

Subject of article: Diagnosis

Subject of article: Treatment GRADE

LoE 1 Systematic review of good quality cross-sectional studies

Systematic review of randomized trials

High-Moderate

LoE 2 Individual good quality cross sectional studies

Randomized trial or observational study

Moderate

LoE 3 Non-consecutive studies Non-randomized controlled cohort / follow-up study

Moderate-Low

LoE 4 Case-control studies Case series, case-control studies or poor quality prognostic cohort

Low-Very low

LoE 5 Mechanism-based reasoning

Mechanism-based reasoning Very low

38

Chapter 1

Appendix 3. Details of excluded guidelines

No. Organisation Guideline Reason for exclusion

1 National Institute of Health

Consensus Development Conference Statement: Gallstones and Laparoscopic Cholecystectomy[45]

No critical appraisal of literature

2 National Institute of Health

Gallstones and laparoscopic cholecystec-tomy[46]


3 Society of American Gas-trointestinal Endoscopic Surgeons

The role of laparoscopic cholecystec-tomy[47]


4 American College of Phy-sicians

Guidelines for the treatment of Gall-stones[48]


5 Association of Laparo-scopic Surgeons

The gallbladder and bile ducts[49] No critical appraisal of literature

6 Malaysian Society of Gastroenterology & Hepatology

Consensus on Management of Gallstone Disease[50]


7 European Association of Endoscopic Surgery

Diagnosis and treatment of common bile duct stones (CBDS)[51]


8 Japan Biliary Associa-tion

Evidence-based guideline for the treatment of gallstones[52]

No full text available

9 World Gastroenterology Organisation

Asymptomatic gallstone disease[53] No critical appraisal of literature

10 Society for Surgery of the Alimentary tract

Treatment of Gallstone and Gallbladder Disease[54]


11 National Institute for Health and Clinical Excellence

Single-incision laparoscopic cholecystec-tomy[55]


12 Russian Scientific Society of Gastroenter-ologists

Guidelines in the diagnosis and treatment of cholelithiasis[56]

Full text not available

39


13 Department of Health, Government of Western Australia

Diagnostic Imaging Pathways: Laparo-scopic Cholecystectomy[57]

Unknown grading of litera-ture

14 Society for Surgery of the Alimentary Tract

Evidence-based Current Surgical Practice: Calculous Gallbladder Disease[58]


15 Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland

Commissioning Guide for Gallstone Disease[59]


16 and 17

Society of American Gas-trointestinal Endoscopic Surgeons

The role of laparoscopic cholecystectomy. Guidelines for clinical application. Society of American Gastrointestinal Endoscopic Surgeons (SAGES)[47]

Earlier version of included guideline

18 Society of American Gas-trointestinal Endoscopic Surgeons

Guidelines for the clinical application of laparoscopic biliary tract surgery (1994[60] and 2000[61])


19 European Association of Endoscopic Surgery

The E.A.E.S. Consensus Development Conferences on laparoscopic cholecystec-tomy,appendectomy, and hernia repair. Consensus statements[62]


20 Dutch Association of Surgery

Gallstone[32] Earlier version of included guideline

40

Chapter 1

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