c.s.t.o. who would have thought it? banded gastric bypass works! mal fobi md facs, fics, facn...
TRANSCRIPT
C.S.T.O.C.S.T.O.
Who Would Have Thought It? Banded Gastric Bypass Works!Who Would Have Thought It? Banded Gastric Bypass Works!
MAL Fobi MD FACS, FICS, FACN MAL Fobi MD FACS, FICS, FACN
Medical DirectorCenter for Surgical Treatment of
ObesityLong Beach CA, USA
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Banded Gastric Bypass
Disclosures
President of Bariatec Corporation. A device Compny
I had a Banded Gastric Bypass
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Obesity, particularly Morbid Obesity, is a life long disease that is recalcitrant to any treatment, even surgical treatment.
Obesity, particularly Morbid Obesity, is a life long disease that is recalcitrant to any treatment, even surgical treatment.
Why the Banded Gastric Bypass?Why the Banded Gastric Bypass?
Obesity: A World EpidemicObesity: A World Epidemic
The exact method of genetic translation is not known at this time. The
Expression of obesity varies with social, cultural, environmental, economic
and psychological influences.
The exact method of genetic translation is not known at this time. The
Expression of obesity varies with social, cultural, environmental, economic
and psychological influences.
EATING DIS.
EATING DIS. HORMONAL
HORMONALIMBALANCE
IMBALANCE
PSYCHO-PSYCHO-LOGICALLOGICAL
DIS.DIS.
SOCI
O-
SOCI
O-
ECOM
OM
ICS
ECOM
OM
ICS
WIL
L
WIL
L
POWER
POWER
GENETIGENETIC C
Obesity is a disease with a Genetic Predisposition
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ECONOMICECONOMIC
MEDICALMEDICAL
SOCIALSOCIAL
PSYCHOLOGICALPSYCHOLOGICAL
Significant ramifications of obesity
Significant ramifications of obesity
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• Prolonged and sustained weight loss has not bee proven with drug therapy.
*• Published studies of medical approaches to treatment of obesity
include few reports or indications of efficacy in person with clinically severe obesity.
*• Evidence of long-term efficacy of behavior modification in
persons with clinically severe obesity is lacking.*
• VLDC's used under close medical supervision generally have not been successful for achieving permanent weight loss.
• Prolonged and sustained weight loss has not bee proven with drug therapy.
*• Published studies of medical approaches to treatment of obesity
include few reports or indications of efficacy in person with clinically severe obesity.
*• Evidence of long-term efficacy of behavior modification in
persons with clinically severe obesity is lacking.*
• VLDC's used under close medical supervision generally have not been successful for achieving permanent weight loss.
NIH Consensus Statements 1991
NIH Consensus Statements 1991
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Gastric Bypass/Banded Gastric bypassGastroplasty/Sleeve GastrectomyGastric BandingBilio-pancreatic Diversion with or without a Switch
Intestinal Bypass
Gastric Bypass/Banded Gastric bypassGastroplasty/Sleeve GastrectomyGastric BandingBilio-pancreatic Diversion with or without a Switch
Intestinal Bypass
Surgical Treatment is the only treatment that provides effective long-term controlSurgical Treatment is the only treatment that provides effective long-term control
Surgical Treatment and Management of ObesitySurgical Treatment and Management of Obesity
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INTESTINAL BYPASS
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GASTRIC BYPASS
Simple operation???
•As effective
•Less morbidity
•Less mortality
Mason Gastroplasty 1971Mason Gastroplasty 1971
T
T
T
Evolution of the Gastric BypassEvolution of the Gastric Bypass
Linner’s Banded Gastric Bypass
1984
Evolution of the Gastric BypassEvolution of the Gastric Bypass
Salmon’s Banded Vertical Gastroplasty Distal
RYGBP1986
Evolution of the Gastric BypassEvolution of the Gastric Bypass
Banded Gastric Bypass Fobi Modification
1986
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Banded Gastric BypassBanded Gastric Bypass
VS
3-4cm
Howard, Obesity Surgery, 1995Howard, Obesity Surgery, 1995
VBG VS. GBPVBG VS. GBP
Howard, Obesity Surgery, 1995Howard, Obesity Surgery, 1995
VBG VS. GBPVBG VS. GBP
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0.0
38.0
57.0
73.578.2 77.7 76.8 75.0
73.2 72.3 71.0
69.8
0.0
10.0
20.0
30.0
40.0
50.0
60.0
70.0
80.0
90.0
0M 3M 6M 1Y 2Y 3Y 4Y 5Y 6Y 7Y 8Y 9Y
TIME POST-OP
PE
WL
(%)
ALL PTS
Average PEWL (All Pts.) Banded Gastric Bypass
Average PEWL (All Pts.) Banded Gastric Bypass
FobiObes. Surg.2005
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Why the Banded Gastric Bypass
Why the Banded Gastric Bypass
Historical and Experimental Data:
•There are eight series with long term (6-14years) follow-up documenting 70+ PEWL and weight loss maintenance in more patients, even the old and super obese
• Capella, USA, AJS; Fobi, USA, SOARD; White, New Zealand, Obes Surg; Salinas, Venuzuela SOARD; D.Margo, Obes Surg; Mali, Obes Surg; Cruz, Obes Surg; and Awad, Obesity Surgery 2012
•There are only six long term series reported with the non-banded gastric bypass with an average of 55 PEWL, except Sutter with 70+ PEWL
• Pories, Sutter, Dinitz, Christou, Higa, and the Swedish study
Historical and Experimental Data:
•There are eight series with long term (6-14years) follow-up documenting 70+ PEWL and weight loss maintenance in more patients, even the old and super obese
• Capella, USA, AJS; Fobi, USA, SOARD; White, New Zealand, Obes Surg; Salinas, Venuzuela SOARD; D.Margo, Obes Surg; Mali, Obes Surg; Cruz, Obes Surg; and Awad, Obesity Surgery 2012
•There are only six long term series reported with the non-banded gastric bypass with an average of 55 PEWL, except Sutter with 70+ PEWL
• Pories, Sutter, Dinitz, Christou, Higa, and the Swedish study
83,5(45-115)
61,5(27-109)
Awad et al Obes. Surg.2012
Presented at IFSO_LAC Congress Cartagenia, Columbia, March 2011
There is a significative difference in %EWL at 36-96 month. We followed the banded patients for 10 and 12 years and they maintained the same %EWL.
% EWL% EWLBanded vs Non Banded Gastric Bypass
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Banded Gastric Bypass vs. Non-Banded Gastric Bypass Banded Gastric Bypass vs.
Non-Banded Gastric Bypass
Dr. LemmensIFSO Dehli2012
Retrospective Review
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Prospective comparative evaluation of the Laparoscopically banded gastricbypass vs. the Laparoscopically non-banded gastric bypass.
Banded GBP Non-Banded GBP (n= 20) (n=20)
BMI 58.7 51.18
Age (years) 46 47
6 months %EWL 43.1 38.6
12 months %EWL 64.0 57.800
36 months %EWL 67.6 55.7Complications %(n) 20%(5) 35%.(7)
% of patients achieving 50%EWL 85% 65%
BGBP vs. GBP BGBP vs. GBP
Fobi et al IFSO 2011 Hamburg Germany
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Prospective comparative evaluation of the Laparoscopically banded gastric bypass vs. the Laparoscopically non-banded gastric bypass in the super obese.
Banded GBP Non-Banded GBP (n=46) (n=44)
BMI 59.4 59.7
Age (years) 40.6 42.6
6 months %EWL 43.1 24.7
12 months %EWL 64.0 57.8
24 months %EWL 64.2 57.1
38 months %EWL 73.4 57.7Complications %(n) 23.9 (11) 29.5 (13)
% of patients achieving 50%EWL 63% 45%His conclusion: It appears the banded gastric bypass produces more weight loss in more patients
Marc Bressler, SOARD, July/August 2007
Banded Gastric Bypass VS. Non Banded Gastric Bypass. Banded Gastric Bypass VS. Non Banded Gastric Bypass.
Schauer and Associates at the Cleveland Clinic
•Presented Prospective Evaluation with two year follow-up at IFSO Congress in Hamburg (2011)
•Showed more weight loss and maintenance with the BGBP
BGBP vs. GBP BGBP vs. GBP
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Karcz et al. GaBP Ring European multicenter clinical trials.
IFSO, Dehli 2012
Banded Gastric Bypass vs. Non-Banded Gastric Bypass Banded Gastric Bypass vs.
Non-Banded Gastric Bypass
Herrera, Mexico, SOARD 2009
•Prospective Evaluation with two years follow-up•Showed no difference
BGBP vs. GBP BGBP vs. GBP
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Published reports of band placement in failed gastric bypass document increased weight loss and waight loss maintenance
• Bressler M. Obes Surg 2005;15:1443-48 • Kyzer S. Obes Surg 2001;11:66-9• Gobble RM. Surg Edosc. 2008;22:1019-22• Heath D. Obes Surg 2009;19:1439-41• Himpens Obes Surg 2001, 11(4):528-31• Avinoah E. obes surg 2006; 6:213-15
Banded Gastric BypassBanded Gastric Bypass
Adjustable Band Placement for Revision of failed Gastric Bypass
Adjustable Band Placement for Revision of failed Gastric Bypass
BresslerObes. Surg.2005
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“Since Roux-en-Y Gastric Bypass is primarily a restriction operation, just as with VBG, it is
important that the outlet of the pouch does not stretch.”
( E.Mason, Obesity Surgery 1994; 4:66-72)
“Since Roux-en-Y Gastric Bypass is primarily a restriction operation, just as with VBG, it is
important that the outlet of the pouch does not stretch.”
( E.Mason, Obesity Surgery 1994; 4:66-72)
Banding the Pouch in GBPBanding the Pouch in GBP
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At this time, the most promising technique based on a large series is that described by Capella and Capella, the “Banded Gastric Bypass”
At this time, the most promising technique based on a large series is that described by Capella and Capella, the “Banded Gastric Bypass”
MacLean, J Am Coll Surg 97; 185:1-7
Banded Gastric BypassBanded Gastric Bypass
• Fisher after an in depth review concluded that “Long-term results suggest that a silastic ring encircling the stomach pouch proximal to the gastroenterostomy may improve the outcome following gastric bypass surgery, resulting in more weight loss by a greater number of patients sustained for a longer time”- Fisher BL, Barber AE, Eur J Gatroenterol Hepatol 1999; 11:93-97
Why the Band in the Gastric Bypass Operation
Why the Band in the Gastric Bypass Operation
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(* P < 0.05).
[O’Brien P.E.:Systemic review of mdium term-weight loss after bariatric surgery.; Obesity Surgery:2006; 16; 1032-40]
%EWL for standard RYGBP and its two hybrid forms of LL-RYGBP
and Banded RYGBP
%EWL for standard RYGBP and its two hybrid forms of LL-RYGBP
and Banded RYGBP
Banded Gastric Bypass Banded Gastric Bypass
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Reservoir sizeReservoir size
change with change with timetime
Non-banded Roux-en-Y GBPNon-banded Roux-en-Y GBP
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Non-banded Roux-en-Y GBPNon-banded Roux-en-Y GBP
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Non-banded Roux-en-Y GBPNon-banded Roux-en-Y GBP
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Reservoir sizeReservoir size
change with change with timetime
Banded Roux-en-Y GBPBanded Roux-en-Y GBP
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Banded Gastric BypassBanded Gastric Bypass
Ring Banded Gastric Bypass
Stubbs, Obes Surg; 2005
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Optimal Ring Size6.5 cm 2.07cm Diameter1.47cm functional diameter.
3-D Recon Image of Ring Banded Gastric Bypass
Mohit BhandariIndore, India 2012
French Catheter Size1 Fr. = 1/3 mm diameter34 Fr. = 1.13cm diameter40 Fr. = 1.33cm diameter60 Fr. = 2.0cm diameter
Ring or bandshould be loosearound the pouchat time of banding
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Band erosion: - 0-7%. Incident directly related totype of the device used, the diameter and size of the device and thepresence of contamination or infection.
Ring sizes < 6.5cm cause more erosion and dysphagiawithout increase in effectiveness.
Kinking or Slippage: - - 0-1%. Functional ObstructionTreated by endoscopic dilatation or laparoscopic re exploration
Solid Food intolerance: - 5-7 %. Not disabling.Treated by dietary counseling.Occasional need for Ring removal
Complications from Banding the Gastric Bypass
Banded Gastric Bypass
Banded Gastric Bypass
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Surgeons have used various devices to band the pouch
Surgeon fashioned devices
Marlex Mesh
Silastic Tubing
Ethibond Suture
Linea Alba Fascia
Porchine Graft
Bovine Graft
Commercially prefabricated devices
GaBP Ring. (Designed for use with the gastric bypass and sleeve gastrectomy)
IOC Band
AMI Band
Minimizer Band
Bioring
GaBP Ring Autolock™ and Gastrostomy Site Marker Clinical Research Study ProtocolIDE G050231
IPERSONNEL ---------------------------------------------------------------------------------------------------------2IISTUDY SYNOPSIS --------------------------------------------------------------------------------------------------3IIICLINICAL TRIAL --------------------------------------------------------------------------------------------------51.Introduction and Rationale -----------------------------------------------------------------------------------52.Study Objective ------------------------------------------------------------------------------------------------62.1Effectiveness Endpoints -----------------------------------------------------------------------------62.2Safety Endpoints --------------------------------------------------------------------------------------63.Study Design --------------------------------------------------------------------------------------------------74.Patient Population ---------------------------------------------------------------------------------------------84.1Exclusion Criteria -------------------------------------------------------------------------------------84.2Inclusion Criteria --------------------------------------------------------------------------------------95.Device Characterization -------------------------------------------------------------------------------------95.1Intended Use and Description ------------------------------------------------------------------------96.Study Methods -------------------------------------------------------------------------------------------------106.1Patient Entry and Pre-operative Evaluation -------------------------------------------------------106.2Device Installation and Intra-operative Evaluation -----------------------------------------------116.3Post-operative Care -----------------------------------------------------------------------------------116.4Post-operative Evaluation ----------------------------------------------------------------------------117.Study Procedures ----------------------------------------------------------------------------------------------138.Data Monitoring -----------------------------------------------------------------------------------------------138.1Data Reporting and Monitoring Procedures -------------------------------------------------------138.2Adverse Reaction and Adverse Event Reporting -------------------------------------------------159.Study Analysis -------------------------------------------------------------------------------------------------159.1Sample Sizes -------------------------------------------------------------------------------------------159.2Statistical Methods ------------------------------------------------------------------------------------1510.Bibliography --------------------------------------------------------------------------------------------------16IVAPPENDICES -------------------------------------------------------------------------------------------------------17Appendix 1:Consent to Act as a Human Research Subject -------------------------------------------------17Appendix 2:Device Design and Labeling --------------------------------------------------------------------27Appendix 3:Prior Clinical Investigations --------------------------------------------------------------------44Appendix 4:Surgical Procedure ------------------------------------------------------------------------------50Appendix 5:Device Removal Indications and Procedures --------------------------------------------------57Appendix 6:Examination Procedures, Study Equipment and Techniques -------------------------------58Appendix 7:Sponsor’s Commitments -------------------------------------------------------------------------60Appendix 8:Investigator’s Qualifications and Responsibilities -------------------------------------------61Appendix 9:Investigator’s Agreement ------------------------------------------------------------------------62Appendix 10:Investigator’s Financial Disclosure Declaration ---------------------------------------------65Appendix 11:Declaration of Helsinki/Protection of Human Subjects/Belmont Report/Institutional Review Board --------------------------------------------------------------------------------------66Appendix 12: Physician Information Letter --------------------------------------------------------------------96Appendix 13:Case Report Forms -------------------------------------------------------------------------------105
GaBP RingTM DeviceGaBP RingTM Device
GaBP Ring™ is a prefabricated, sterilized ring designed to band the proximal pouch of the sleeve gastrectomy and gastric bypass operations.
GaBP RingTM DeviceGaBP RingTM Device
Banded Gastric Bypass3,632 (100 %)
Primary3007
( 82.79 %)
Secondary405
( 11.15 %)
Revision220
( 6.06 %)
Band Erosion57 ( 1.89 %)
Band Erosion24 ( 5.92 %)
Band Erosion10 ( 4.54%)
Total Incidence of Band Erosion:91/ 3,632 (2.5 %)
Total Incidence of Band Erosion:91/ 3,632 (2.5 %)
Incidence of Band Erosion(May 1992 – May 2002)
Incidence of Band Erosion(May 1992 – May 2002)
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Banded Gastric Bypass vs. Non-Banded Gastric Bypass Banded Gastric Bypass vs.
Non-Banded Gastric Bypass
Dr. LemmensIFSO Dehli2012
Retrospective Review
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Karcz et al. GaBP Ring European multicenter clinical trials.
IFSO, Dehli 2012
Banded Gastric Bypass vs. Non-Banded Gastric Bypass Banded Gastric Bypass vs.
Non-Banded Gastric Bypass
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1. Outlet Stenosis/vomiting/dysphagia
2. Stomal Ulcer/ pain/bleeding/melana
3. Pain, epigastric and or left shoulder
4. UGI Bleeding
5. Acute weight loss followed by
weight regain.
1. Outlet Stenosis/vomiting/dysphagia
2. Stomal Ulcer/ pain/bleeding/melana
3. Pain, epigastric and or left shoulder
4. UGI Bleeding
5. Acute weight loss followed by
weight regain.
Symptoms of Band ErosionSymptoms of Band Erosion
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1 - Expectant treatment- spontaneous extrusion
2 - Endoscopic removal
3 - Surgical Removal with revision. Band replacement vs. addition of mal absorption component
1 - Expectant treatment- spontaneous extrusion
2 - Endoscopic removal
3 - Surgical Removal with revision. Band replacement vs. addition of mal absorption component
Treatment of Band ErosionTreatment of Band Erosion
Endoscopic RemovalEndoscopic Removal
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Outlet Stenosis Requiring Dilatation
GBP 1-16%
BGBP 1-3%
Outlet Stenosis Requiring Dilatation
GBP 1-16%
BGBP 1-3%
Banded Gastric BypassBanded Gastric Bypass
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Reactive Hypoglycemia:
-Observed in patients with Band removal or band erosion.
Fobi et al. Presentation at OSSICON, 2004
-Treated with ring placement Kasper Z’Graggen. Obes Surg, 2008
Reactive Hypoglycemia:
-Observed in patients with Band removal or band erosion.
Fobi et al. Presentation at OSSICON, 2004
-Treated with ring placement Kasper Z’Graggen. Obes Surg, 2008
Banded Gastric BypassBanded Gastric Bypass
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CONCLUSION:
There is enough evidence that:“The banding the Gastric Bypass to standardize the restrictive effect:
• results in more weight loss• results in weight loss in more patients
even the super obese and • results in better weight loss maintenance”
CONCLUSION:
There is enough evidence that:“The banding the Gastric Bypass to standardize the restrictive effect:
• results in more weight loss• results in weight loss in more patients
even the super obese and • results in better weight loss maintenance”
Banded Gastric BypassBanded Gastric Bypass
C.S.T.O.C.S.T.O.
CONCLUSION:
There is evidence that banding the
gastric bypass also results in less
incidence of:
• outlet stenosis requiring dilatation,
• dumping syndrome
• reactive hypoglycemia
CONCLUSION:
There is evidence that banding the
gastric bypass also results in less
incidence of:
• outlet stenosis requiring dilatation,
• dumping syndrome
• reactive hypoglycemia
Banded Gastric BypassBanded Gastric Bypass
C.S.T.O.C.S.T.O.
BANDED GASTRIC BYPASS • Is an operation with weight loss outcome similar if not
better than the BPD and the Duodenal Switch operations without the associated metabolic consequences and complications?
• 1-7% Incidence of Band related complication is
observed.(erosion, slippage, obstruction, infection, and device coming apart)
BANDED GASTRIC BYPASS • Is an operation with weight loss outcome similar if not
better than the BPD and the Duodenal Switch operations without the associated metabolic consequences and complications?
• 1-7% Incidence of Band related complication is
observed.(erosion, slippage, obstruction, infection, and device coming apart)
Banded Gastric Bypass Banded Gastric Bypass
Felipe De La Cruz, Handbook of Obesity Surgery, FD- Communications Inc 2010
C.S.T.O.C.S.T.O.
Who would Have Thought It?
Banded Gastric Bypass Works!
Banded Gastric Bypass Banded Gastric Bypass
Center for Surgical Treatment of Obesity MAL Fobi MD FASMBS, FACS FICS, FACN.
www.bariatec.comwww.fobipouch.com
Center for Surgical Treatment of Obesity MAL Fobi MD FASMBS, FACS FICS, FACN.
www.bariatec.comwww.fobipouch.com
Thank You
Obrigado
MerciGracias
Merushi
Grazie
Dankeschön
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Hand Sewn Gastro-jejunostomy distal to GaBP Ring
Banded Gastric BypassBanded Gastric Bypass
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Ring placement forces use of a small tubular pouch with a standard stoma