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Satish S. C. Rao, MD, PhD, FACG
GastroparesisGastroparesis: : New Tools & New ParadigmsNew Tools & New Paradigms
GastroparesisGastroparesis: : New Tools & New ParadigmsNew Tools & New Paradigms
Satish SC Rao, MD, PhD, FRCP, FACG, AGAFSatish SC Rao, MD, PhD, FRCP, FACG, AGAF
Professor of Medicine & Section ChiefProfessor of Medicine & Section Chief
Director, Digestive Health CenterDirector, Digestive Health Center
Medical College of GeorgiaMedical College of Georgia
Georgia Regents University, Augusta, GAGeorgia Regents University, Augusta, GA
OBJECTIVESOBJECTIVESOBJECTIVESOBJECTIVES
Physiology/PathophysiologyPhysiology/Pathophysiology
Clinical EvaluationClinical Evaluation
Diagnostic EvaluationDiagnostic Evaluation
TreatmentTreatment TreatmentTreatment
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Satish S. C. Rao, MD, PhD, FACG
Normal Normal Function Function -- StomachStomachNormal Normal Function Function -- StomachStomach
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Satish S. C. Rao, MD, PhD, FACG
Case StudyCase Study
24 y/o female with 10 year history of IDDM. retinopathy, postural hypotension, dysautonomiawith labile blood pressure and orthostasiswith labile blood pressure and orthostasis. Gastroparesis since 2002
Poor glycemic control on insulin 8 hospitalizations in past 4 months with DKA,
weight loss and failure to thrive HgbA1c were >15%. Now, HgbA1c are still > 8%.
S t f t i f l t i l d Symptoms of gastroparesis for last year include severe nausea and vomiting, abdominal pain, abdominal bloating and dizziness
Failed multiple prokinetics and antiemeticsincluding metoclopramide, ondansetron, prochlorperazine
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DefinitionsDefinitions
GastroparesisSymptomatic chronic disorder of the stomach Symptomatic chronic disorder of the stomach
characterized by delayed gastric emptying in thecharacterized by delayed gastric emptying in thecharacterized by delayed gastric emptying in the characterized by delayed gastric emptying in the absence of mechanical obstructionabsence of mechanical obstruction11. .
Symptoms are variable and include early satiety, Symptoms are variable and include early satiety, nausea, vomiting, bloating, and upper abdominal nausea, vomiting, bloating, and upper abdominal discomfort.discomfort.
Scintigraphy considered the Scintigraphy considered the ““gold standardgold standard””
Functional DyspepsiaFunctional DyspepsiaPain or discomfort centered in the upper abdomenPain or discomfort centered in the upper abdomenno structural or biochemical abnormality is identifiedno structural or biochemical abnormality is identifieddelayed gastric emptying in 25delayed gastric emptying in 25--50%50%
Parkman HP. Gastroenterol. 2005; 127:1592Hasler WL. J Clin Gastroenterol. 2005; 39(Suppl 3):S223
EpidemiologyEpidemiologyEpidemiologyEpidemiology
Diabetes Type 1Diabetes Type 1-- 40% (tertiary), 5% 40% (tertiary), 5% (Community)(Community)
Diabetes Type 2Diabetes Type 2-- 1010--20%(tertiary), 1% 20%(tertiary), 1% (community)(community)
Choung RS et al;Am J Gastroenterol 2011
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Satish S. C. Rao, MD, PhD, FACG
GastroparesisGastroparesis -- Rising Incidence?Rising Incidence?18 fold increase over 10 yrs18 fold increase over 10 yrsProbably more awarenessProbably more awareness
GastroparesisGastroparesis -- Rising Incidence?Rising Incidence?18 fold increase over 10 yrs18 fold increase over 10 yrsProbably more awarenessProbably more awareness
Nusrat S ; Bielefeldt K; NGM 2013
PathophysiologyPathophysiology--GastroparesisGastroparesis
PathophysiologyPathophysiology--GastroparesisGastroparesis
AlteredAlteredAccommodationAccommodation
AntroAntro
PyloricPyloricDysmotilityDysmotility
DelayedDelayedIntragastricIntragastricTransportTransport
Abnormal TriturationAbnormal Trituration
Small Bowel /Small Bowel /Colonic DysmotilityColonic Dysmotility
DuodenalDuodenalCoordinationCoordination
Abnormal TriturationAbnormal TriturationAntral HypomotilityAntral Hypomotility
Tachy / Brady GastriaTachy / Brady Gastria
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60% diabetics are hypersensitive to
Diabetic Gastroparesis-More than an emptying problem!
yp
gastric balloon distension.
90% diabetics have an impaired
accommodation response to a liquid
mealmeal.
The hypersensitivity was often
associated with impaired
accommodation. Kumar, Rao et al;Neurogastro Mot 2007
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Satish S. C. Rao, MD, PhD, FACG
NoneNone VeryVeryMildMild
MildMild ModeratModeratee
SeverSeveree
VeryVery
SevereSevere
Gastroparesis Cardinal Symptom Index (GCSI)
Gastroparesis Cardinal Symptom Index (GCSI)
Circle the number that best describes how severe the symptom has been during the prior 2 weeks
SevereSevere
Nausea 00 11 22 33 44 55
Retching 0 1 2 3 4 5
VomitingVomiting 00 11 22 33 44 55
Stomach FullnessStomach Fullness 00 11 22 33 44 55
Unable to finish normalUnable to finish normal--sized sized 00 11 22 33 44 55mealmeal
Feeling excessively full after Feeling excessively full after mealsmeals
00 11 22 33 44 55
Loss of appetiteLoss of appetite 00 11 22 33 44 55
BloatingBloating 00 11 22 33 44 55
Stomach or belly visibly largerStomach or belly visibly larger 00 11 22 33 44 55
Case StudyCase Study--Symptom Symptom profilesprofiles
Case StudyCase Study--Symptom Symptom profilesprofiles
NauseaNausea-- 55
VomitingVomiting--44
Postprandial fullness Postprandial fullness --44
Early Satiety Early Satiety --44
Wt lossWt loss--44
ConstipationConstipation
Abdominal PainAbdominal Pain--44
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Satish S. C. Rao, MD, PhD, FACG
146 patients in a tertiary care146 patients in a tertiary care center
Soykan, McCallum. DDS 1998;43:2398Soykan, McCallum. DDS 1998;43:2398BILE GASTRITIS
PostPost--Viral Gastroparesis Viral Gastroparesis Criteria for clinical diagnosisCriteria for clinical diagnosis 1. 1. Previously healthy subjects with acute onset of viralPreviously healthy subjects with acute onset of viral--
illness illness with nausea, vomiting, diarrhea, fever, crampswith nausea, vomiting, diarrhea, fever, cramps
2. Persistence of symptoms (N, V, early satiety) for > 3 2. Persistence of symptoms (N, V, early satiety) for > 3 monthsmonths
3. Delayed gastric emptying3. Delayed gastric emptying 4. No evidence of obstruction, metabolic disease, systemic 4. No evidence of obstruction, metabolic disease, systemic
illnessillness
Potential viruses: CMV EBVPotential viruses: CMV EBV HerpesHerpes ZosterZoster Potential viruses: CMV, EBV, Potential viruses: CMV, EBV, HerpesHerpes--ZosterZoster Less severe symptoms than other idiopathic Less severe symptoms than other idiopathic
gastroparesisgastroparesis Good prognosis: Usually slow resolution of symptomsGood prognosis: Usually slow resolution of symptoms
BityutskiyBityutskiy, , SoykanSoykan, McCallum. AJG , McCallum. AJG 1997; 92: 1501.1997; 92: 1501.
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Satish S. C. Rao, MD, PhD, FACG
Nuclear Scintigraphy
Tests of Gastric Sensori-Motor Function
Tests of Gastric Sensori-Motor Function
Nuclear Scintigraphy
Wireless Capsule Motility
Octanoic acid breath test
Electrogastrography
Antroduodenal manometry
Gastric barostat with sensation/Tone/compliance
Water load test
Gastric ultrasound
Standard MealStandard Meal
120 g 99Tc labeled egg substitute 120 g 99Tc-labeled egg substitute (Eggbeater)
2 slices of bread
30 g strawberry jam
120 ml water
255 kcal, 2% fat
Tougas G, Am J Gastroenterol 2000; 95: 1456.
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Satish S. C. Rao, MD, PhD, FACG
Scintigraphic Images showing Delayed Scintigraphic Images showing Delayed Gastric EmptyingGastric Emptying
Scintigraphic Images showing Delayed Scintigraphic Images showing Delayed Gastric EmptyingGastric Emptying
NORMAL DUMPING
Gastric EmptyingGastric Emptying
Lag PhaseLag Phase
Liquidsfollow a simplefollow a simpleLag PhaseLag Phase
Mea
l R
emai
nin
gM
eal
Rem
ain
ing
30
40
50
60
70
80
90
100
Solids
follow a simple follow a simple exponential patternexponential pattern
mediated by fundic mediated by fundic tonetone
Solidslag phase lag phase
MinutesMinutes
% M
% M
0
10
20
30
0 20 40 60 80 100 120
Liquids
g pg pcorresponds to antral corresponds to antral triturationtrituration
followed by followed by exponential pattern of exponential pattern of emptyingemptying
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Definitions:Rapid: <30% retention at 2 hrs.Slow: >10% at 4 hrs.
Tougas G, Am J Gastroenterol 2000; 95: 1456.
MANOMETRY PROBE PLACEMENT UNDER
FLUOROSCOPY
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Satish S. C. Rao, MD, PhD, FACG
Normal Fasting Gastric & Small Bowel Normal Fasting Gastric & Small Bowel MotilityMotility
Normal Fasting Gastric & Small Bowel Normal Fasting Gastric & Small Bowel MotilityMotility
Body
A tAntrum
Duodenum 2
Duodenum 1III IIIPhase
Jejumum 1
Jejumum 2
Antrum 1
Meal
TYPICAL UPPER GUT RESPONSE TO A MEAL
Figure 4
Antrum 2
Duodenum 1
Duodenum 2
Jejunum 1
Jejunum 2
1 hr 2hr 3hrMeal
Time
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Satish S. C. Rao, MD, PhD, FACG
Gastric Barostat TestGastric Barostat TestGastric Barostat TestGastric Barostat Test
CASE
AccommodationAccommodation
ToneTone
SensationSensation
FundoFundo--antral antral R flR fl
Impaired
Decreased
Hypersensitive
Absent
CASE
ReflexReflex
The Wireless Motility Capsule (SmartPill) is anThe Wireless Motility Capsule (SmartPill) is an ingestible capsule that measures pH, pressure and
temperature using miniaturized wireless sensor technology.
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GRT GRT --HealthyHealthyGRT GRT --
HealthyHealthyGRTGRT--
GastropareticGastropareticGRTGRT--
GastropareticGastroparetic
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Satish S. C. Rao, MD, PhD, FACG
Relationship Between Scintigraphy and Relationship Between Scintigraphy and Capsule EmptyingCapsule Emptying
Relationship Between Scintigraphy and Relationship Between Scintigraphy and Capsule EmptyingCapsule Emptying
100 7 Non-digestible solid, emptied after the fed state by high amplitude
20
30
40
50
60
70
80
90
Mea
l lef
t in
th
e st
omac
h (
%)
1
2
3
4
5
6
pH
T 50%
T 90%
the fed state, by high amplitude contractions like the return of the fasting phase III MMCs
0
10
0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 5.5 6
Time (hours)
0
1
Scintigraphic gastric emptying
Capsule pH recording
Correlation of T90% to GET: r=82%
WMC GET Comparison to WMC GET Comparison to Scintigraphy Scintigraphy
WMC GET Comparison to WMC GET Comparison to Scintigraphy Scintigraphy
Total Subjects Studied: 148 81 Healthy/67
Median Median T50 T50
Median Median T90 T90
Median Median GET GET
HealthyHealthy 88 min88 min 160 min160 min 215 min215 min
Total Subjects Studied: 148 81 Healthy/67 Gastroparetic
astric emptying scintigraphy
GastrosGastros 123 min123 min 237 min237 min 360 min360 min
SmartPill Correlation to Scintigraphy:SmartPill Correlation to Scintigraphy:T50T50 0.500.50T90T90 0.820.82
Kuo B et al APT 2006.
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Satish S. C. Rao, MD, PhD, FACG
WMC compared to WMC compared to ScintigraphyScintigraphy
WMC compared to WMC compared to ScintigraphyScintigraphy
ParameterParameter GRT GRT Corr.Corr.
SensitivitySensitivity SpecificitSpecificityy
AUCAUC Cutoff Cutoff (Hrs)(Hrs)
T50T50 0.500.50 0.690.69 0.750.75 0.770.77 1.751.75
T90T90 0 820 82 0 900 90 0 720 72 0 850 85 2 922 92T90T90 0.820.82 0.900.90 0.720.72 0.850.85 2.922.92
GRTGRT 0.850.85 0.720.72 0.830.83 4.004.00
Kuo B et al APT 2006.
Strengths & Drawbacks of Current Strengths & Drawbacks of Current MethodsMethods
Strengths & Drawbacks of Current Strengths & Drawbacks of Current MethodsMethods
Scintigraphy WMC
Radiation ++ No
Invasive + No
GET & SBTT + +++
CTT No +++
WGTT No +++WGTT No +++
Myopathy/
Neuropathy
No ?
Availability +++ ++
Rao SSC. Neurogastro Mot 2011
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Satish S. C. Rao, MD, PhD, FACG
Gastroparesis-Principles of Management
Gastroparesis-Principles of Managementgg
Restoration of Metabolic Restoration of Metabolic EquilibriumEquilibrium
NutritionNutrition
Pain ManagementPain Management
ProkineticsProkinetics
AntiemeticsAntiemetics
Endoscopic / Surgical Therapy Endoscopic / Surgical Therapy
Electrical PacingElectrical Pacing
ProkineticProkinetic -- MetoclopramideMetoclopramideProkineticProkinetic -- MetoclopramideMetoclopramide
Camilleri et al;Am J Gastroenterol 2013
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Dose 125 mg tid- IV or Syrup formulation
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Satish S. C. Rao, MD, PhD, FACG
Camilleri et al;Am J Gastroenterol2013
Tegaserod on Gastric Emptying in Gastroparetic Patients (163 Gastroparetic Patients Randomized to 4 Treatments for 8 Weeks)
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Satish S. C. Rao, MD, PhD, FACG
Ghrelin AgonistGhrelin AgonistGhrelin AgonistGhrelin Agonist
GhrelinGhrelin
Gut peptide hormoneGut peptide hormone
A i l d li i l d tA i l d li i l d t
TZPTZP--102 (Ghrelin 102 (Ghrelin agonist)agonist)
SS Animal and clinical data Animal and clinical data show that IV ghrelin show that IV ghrelin enhances gastric enhances gastric emptying* emptying*
Short plasma halfShort plasma half--life of 6 life of 6 to 12 minutesto 12 minutes
Selective, potent agonistSelective, potent agonist
Small moleculeSmall molecule
Prokinetic activity in an Prokinetic activity in an animal model of gastric animal model of gastric emptyingemptying
PK profile in human supportsPK profile in human supports
39
PK profile in human supports PK profile in human supports onceonce--daily oral dosing daily oral dosing
* Murray et al. Gut 2005;54(12):1693-8. Poitras et al. Peptides 2005;26(9): 1598-601. Tack et al. Gut 2006;55(3):327-33. Binn et al. Peptides 2006;27(7): 1603-6.
Improvement in Vomiting Severity over BL on Follow-up Day 30
Dosing Day 4 Improvement in N/V Subscale over Baseline
0
IV, TZPIV, TZP--101 (Ghrelin Agonist) Therapy 101 (Ghrelin Agonist) Therapy for Gastroparesisfor Gastroparesis
-3
-2
-1
0
Dose GroupGC
SI V
om
itin
g S
core
Imp
(PD
-BL
)
-4
-3
-2
-1
0
GC
SI N
/V S
ub
scal
e S
core
Imp
p=0.023 p=0.040
Dose Group
Placebo (n=8) All TZP-101 (n=12) 80 ug/kg (n=6)
Dose Group
Placebo (n=8) All TZP-101 (n=12) 80 ug/kg (n=6)
Wo et al Neurogastro Mot 2010
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Satish S. C. Rao, MD, PhD, FACG
TZP-102 in gastroparesis: GCSI Scores, n=87
TZP-102 in gastroparesis: GCSI Scores, n=87
Nausea/Vomiting Subscale Score
0 2
0.0
0.2
ine
Treatment Post-Treatment
-1.2
-1.0
-0.8
-0.6
-0.4
-0.2n
Cha
nge
from
Bas
el
p = 0.22
p = 0.02 p = 0.11
41
-1.8
-1.6
-1.4
Mea
n
PBO 20mg
Day: 0 8 2815 42 58
Wo et al Am J Gastro, ACG 2010
RMRM--131131-- Ghrelin Agonist Ghrelin Agonist (pentapeptide)(pentapeptide)
RMRM--131131-- Ghrelin Agonist Ghrelin Agonist (pentapeptide)(pentapeptide)
Shin A et al, Diabetes Care 2013; 36: 41-8.
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Satish S. C. Rao, MD, PhD, FACG
Prokinetic Therapy for GastroparesisProkinetic Therapy for Gastroparesis
MetoclopramideMetoclopramide Dopamine (DDopamine (D22) receptor 10) receptor 10--20 20 mg,po,tidmg,po,tid
antagonist (central/peripheral)antagonist (central/peripheral)
ErythromycinErythromycin MotilinMotilin receptor receptor agonist 125 agonist 125 mg/mg/popo/Iv//Iv/tidtid
DomperidoneDomperidone Dopamine (DDopamine (D22) receptor ) receptor 1010--20 20 mg po.tidmg po.tid
antagonist antagonist (peripheral)(peripheral)
CisaprideCisapride 5HT5HT4 4 receptor agonist receptor agonist 1010--20 20 mg mg popo bidbid
TZP 102TZP 102 GhrelinGhrelin agonistagonist 20 20 mg mg popo
Gastroparesis Refractory to Medical Gastroparesis Refractory to Medical TherapyTherapy
Anti-emetics S.C or SL Metoclopramide Phenothiazines Avoid OndansetronMegase
Avoid Opiods for pain Visceral analgesicsMirtazapineMirtazapine Sertraline Buspirone Citalopram
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Gastroparesis Refractory to Medical Gastroparesis Refractory to Medical TherapyTherapy
Improve Accommodationmirtazapinep
Hospitalization and IV Erythromycin/Azithromycin 125 mg tid-5 days Botox Injection NutritionEnteralParenteral
Dietary Considerations in Dietary Considerations in GastroparesisGastroparesis
Dietary modifications are aimed at promoting Dietary modifications are aimed at promoting GEGE
Liquids empty better than solidsLiquids empty better than solids
Small, frequent, lowSmall, frequent, low--fat meals of complex fat meals of complex carbohydratescarbohydrates
Mechanically soft and low indigestible fiberMechanically soft and low indigestible fiber--limit chance of limit chance of bezoarbezoar formationformation
No carbonated beveragesNo carbonated beverages
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Gastroparesis Refractory to Medical Therapy-2
Gastroparesis Refractory to Medical Therapy-2
Venting Venting gastrostomygastrostomy + Feeding + Feeding JejunostomyJejunostomy
Botox InjectionBotox Injection
Total parenteral nutritionTotal parenteral nutrition
Gastric electrical stimulation Gastric electrical stimulation
Partial RouxPartial Roux--enen--Y Y gastrectomygastrectomy
Programmer Pulse Generator
Gastric Electrical Stimulation for Gastroparesis:
ENTERRA Therapy
Lead
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Wavess Study: SummaryWavess Study: SummaryWavess Study: SummaryWavess Study: Summary
Reduces frequency of vomiting & Reduces frequency of vomiting & improves nauseaimproves nausea
Improves QOLImproves QOL
Reduces hospitalizationsReduces hospitalizations
Improves Diabetic controlImproves Diabetic control
No change in GETNo change in GET
Efficacy of Long Term ENS In Efficacy of Long Term ENS In Idiopathic GastroparesisIdiopathic Gastroparesis
Efficacy of Long Term ENS In Efficacy of Long Term ENS In Idiopathic GastroparesisIdiopathic Gastroparesis
Mccallum et al NGM 2013
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Long Term Clinical Utility of Long Term Clinical Utility of EnterraEnterraTotal Total Symptom ScoreSymptom Score--, n=188, 1, n=188, 1-- 10 yrs10 yrsnausea, vomiting, pain, bloating, satiety, PPF, nausea, vomiting, pain, bloating, satiety, PPF,
burning, 0burning, 0--44
Long Term Clinical Utility of Long Term Clinical Utility of EnterraEnterraTotal Total Symptom ScoreSymptom Score--, n=188, 1, n=188, 1-- 10 yrs10 yrsnausea, vomiting, pain, bloating, satiety, PPF, nausea, vomiting, pain, bloating, satiety, PPF,
burning, 0burning, 0--44
Di b ti Idi thi P tDiabetic, n=114
Idiopathic, n=43
Post-surgical,
n=31
Baseline 20 + 5 19 + 6 19 + 3
Follow up 9 + 6 10 + 8 11+ 7
% improvement
55% 47% 48%
Mccallum et al CGH 2011
CYCLIC VOMITING SYNDROME
Recurrent bouts of unexplained vomiting lasting 2-5 days with complete recovery in between episodesAssociated with intense abdominal pain, nausea Women>men Rising incidence inWomen>men, Rising incidence in adultsDysregulation of CRFCannabinoid syndrome !!!
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CYCLIC VOMITING SYNDROME
Management: Hospitalization/prophylaxisManagement: Hospitalization/prophylaxis Antiemetics:Antiemetics:Antiemetics:Antiemetics: 55--HT3 antagonistsHT3 antagonists
AntiAnti--migraine treatments:migraine treatments: TriptansTriptans
BenzodiazepinesBenzodiazepines Tricyclic antidepressantsTricyclic antidepressants
A tiA ti il tiil ti AntiAnti--epileptics:epileptics:ZonisamideZonisamide
LevetiracetamLevetiracetam
AntiAnti--migraine treatments:migraine treatments:Beta blockersBeta blockers
CyproheptadineCyproheptadine
SUSPECTED GASTROPARESIS
History, Exam, Drugs, Metabolic Disorders, Surgery
Hb, U + Electrolytes, TFT, Abdo Xray, Glucose,HbA1C
Gastric Emptying TestGastric Emptying Test--Scintigraphy or WMCScintigraphy or WMC
EGD or Barium/CAT(Exclude Obstruction/Mucosal Disease)
Delayed Normal
-Ve
Gastric Barostat
Not Known
Gastroduodenal Manometry
Neuropathy Myopathy
Delayed
Etiology Known
Rx
Normal
VisceralHyperalgesia
Gastric Barostat
Impaired Accommodation
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Satish S. C. Rao, MD, PhD, FACG
Eating should be a joyful Eating should be a joyful experienceexperience--Lets strive to restore itLets strive to restore it
Eating should be a joyful Eating should be a joyful experienceexperience--Lets strive to restore itLets strive to restore it
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