Status:
COMPLETED
Endoscopic Pyloromyotomy for Refractory Gastroparesis
Lead Sponsor:
Institute for Clinical and Experimental Medicine
Collaborating Sponsors:
Universitätsklinikum Hamburg-Eppendorf
KU Leuven
Conditions:
Gastroparesis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Gastroparesis is a disorder triggered by numerous causes and it is defined by symptoms and with an objective evidence of delayed gastric emptying in the absence of obstruction. Effective treatment fo...
Detailed Description
Gastroparesis is a disorder triggered by numerous causes and it is defined by symptoms and with an objective evidence of delayed gastric emptying in the absence of obstruction (albeit pyloric spasms m...
Eligibility Criteria
Inclusion
- Refractory (\> 6 months) and severe (based on a validated total GSCI = Gastroparesis Cardinal Symptom Index) gastroparesis, with confirmed gastric emptying based on a gastric emptying study: standardized protocol of scintigraphy in all patients (performed less than 4 months prior to enrolment), or confirmed by a validated gastric emptying breath test \[27\]. The total GSCI score must be \>2.3 \[28\].
- Abnormal gastric emptying is defined as retention of Tc-99 m \>60% at 2 h and/or ≥10% of residual activity at 4 h on a standardized sulphur colloid solid-phase gastric emptying study.
- Radiolabelled liquids emptying study will be reserved as alternative technique for patients with poor tolerance of solids during scintigraphy. Abnormal gastric emptying will represent \>50% retention of radiolabelled content (e.g. In-111) at 1 hour.
- Abnormal gastric empyting breath test based on a solid normal range determination for the test used (e.g. T1/2 \> 109 min)
Exclusion
- Age less than 18 years
- No previous attempt with at least one prokinetic drug
- No previous attempt to withdraw anticholinergic agents and glucagon like peptide -1 (GLP-1) and amylin analogues\* in patients treated with these substances
- Active treatment with opioids or a history of treatment with opioids within 12 months before enrolment.
- Previous gastric surgery BI or II, esophagectomy, gastric pull-through
- Previous pyloromyotomy or pyloroplasty
- Known eosinophilic gastroenteritis
- Organic pyloric (or intestinal) obstruction (fibrotic stricture, etc.)
- Severe coagulopathy
- Esophageal or gastric varices and /or portal hypertensive gastropathy
- Advanced liver cirrhosis (Child B or Child C)
- Active peptic ulcer disease
- Pregnancy or puerperium
- Malignant or pre-malignant gastric diseases (dysplasia, gastric cancer, GIST)
- Any other condition, which in the opinion of the investigator would interfere with study requirements
- Uncontrolled diabetes mellitus
- Diagnosis of rumination syndrome or "eating" disorder (mental anorexia, bulimia nervosa) \*\*
- Severe constipation without using laxatives
- Inability to obtain informed consent
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03356067
Start Date
December 1 2017
End Date
January 26 2021
Last Update
January 27 2021
Active Locations (14)
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1
University of Chicago
Chicago, Illinois, United States, 60637
2
Department of Hepatogastroenterology at Cliniques universitaires St-Luc, Brussels, Belgium
Brussels, Belgium
3
Translational Research in GastroIntestinal Disorders, Leuven, Belgium
Leuven, Belgium
4
Institute for Clinical and Experimental Medicine
Prague, Prague, Czechia, 14021