Endoscopic Myotomy of the Pylorus to Improve Emptying and Symptoms Trial

Not Applicable

Recruiting

• Conditions: Gastroparesis

• Registration Number: NCT05039424
• Lead Sponsor: Matthew Allemang

Brief Summary

A randomized clinical trial comparing endoscopic per-oral pyloromyotomy (POP) versus a control sham intervention (diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption) in patients with medically refractory gastroparesis.

Detailed Description

A comparative effectiveness, single center (with two surgical units), randomized (1:1) study of endoscopic per-oral pyloromyotomy (POP) versus a control sham intervention (diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption) in adult patients with medically refractory gastroparesis who have failed management with dietary, lifestyle, and pharmacological therapy for at least six months.

Study Timeline

• Study First Submitted: 2021-08-19
• Study First Submitted QC: 2021-09-02
• Study First Posted: 2021-09-09
• Study Start: 2022-02-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Male or female, aged 18-75
2. Diagnosis of medically refractory gastroparesis by 4 hour non-extrapolated solid phase gastric emptying study completed within 12 months of enrollment. Medical refractoriness is defined by at least 6 months of medical treatment with no significant improvement in baseline symptoms
3. Completion of all routine assessments in our multidisciplinary gastroparesis clinic, which includes evaluation by gastroenterology, behavioral health, and nutrition specialists
4. Ability to take oral medication and be willing to adhere to the post-procedure dietary and medication regimen
5. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
6. Stated willingness to comply with all study procedures and availability for the duration of the study
7. Willingness and reasonable expectation that the individual will be able to travel to the study site for the intervention and each scheduled in-person assessment, as well as virtual assessments if necessary
8. Be able to speak and read the English language.

Exclusion Criteria

1. Active use of narcotic pain medication
2. Presence of concomitant gastrointestinal transit disorder such as small bowel dysmotility or uncontrolled colonic dysmotility (As defined by clinical judgement or < 3 bowel movements per week)
3. Etiology of gastroparesis is post-surgical
4. Pregnancy or lactation
5. History of egg allergy
6. Prior surgical intervention of the stomach or gastric pylorus
7. Current parenteral nutrition
8. Uncontrolled coagulopathy (platelet count <50,000 and INR>1.5) or use of anticoagulant medications (with the exception of antiplatelet therapy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Gastroparesis Cardinal Symptom Index (GCSI)	Baseline, 12 weeks post-procedure	Change in Gastroparesis Cardinal Symptom Index (GCSI) at Baseline to 12 weeks post-procedure. Possible scores range from 0 (None) to 5 (Very Severe).

Secondary Outcome Measures

Name	Time	Method
Gastric Emptying	Baseline, 12 weeks post-procedure	Change in gastric emptying as measured by a standardized 4-hour solid scintigraphic gastric emptying study at Baseline to 12 weeks post-procedure
36-Item Short Form; Quality of Life Survey	Baseline,12 weeks post-procedure	Change in 36-Item Short Form Survey (SF-36) score from Baseline to 12 weeks post-procedure. The weighted sums of responses to questions in the survey produce eight separate scales which are scored from 0-100, with zero indication maximum disability and one hundred indicating no disability in that domain.

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States