Per-oral Endoscopy Pyloromyotomy (G-POEM) in the Treatment of Refractory Diabetic Gastroparesis : Prospective Evaluation of Efficacy

Phase 3

• Conditions: Gastroparesis
• Interventions: Procedure: Per-oral endoscopy pyloromyotomy; Procedure: Intrapyloric injection of Botulinum toxin

• Registration Number: NCT02927886
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

The objective of the study is to document the clinical efficacy and complications of endoscopic pyloromyotomy in patients with refractory gastroparesis (diabetic, post-operative and idiopathic), compared to Botulinic toxin injection intra-pyloric the results of which are close to the placebo.

Detailed Description

Gastroparesis is a functional disease affecting 4% of the population, which is consecutive to diabetes in 30% of cases and considerably alters the patients' quality of life. The diagnosis is based on gastric fullness symptoms, endoscopy and gastric emptying scintigraphy. The therapeutic alternatives including drug therapies (Metoclopramide, Erythrocin), surgery (Electric gastric stimulation) or endoscopy (Botulinic toxin), are insufficiently effective. Two surgical series suggested an interesting efficacy of laparoscopic pyloroplasty, which remains invasive for a motility disorder. More recently, an US team performed the first case of G-POEM with an excellent outcome and no adverse event. This promising result was confirmed by a Brazilian case, a short retrospective series (7 patients) and the first European case performed and published by our team that has performed 5 cases since. Based on experience, it is proposed a prospective monocentric study to evaluate the efficacy of the G-POEM technique on refractory gastroparesis. This study will include 40 patients on a period of three years, whom suffer from refractory gastroparesis, confirmed by clinical evaluation (GCSI and analogic visual scale), upper GI endoscopy and gastric emptying scintigraphy at the inclusion.

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-06
• Study First Submitted QC: 2016-10-06
• Study First Posted: 2016-10-07
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18
• Study Start: 2016-11
• Primary Completion: 2019-09
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Older than 18 years.
• Presenting a clinical refractory gastroparesis for> 1 year, that is to say whose functional nonspecific symptoms persisting despite medical therapy (prokinetic) optimal.
• Having a calculation before inclusion GCSI score (Gastroparesis Cardinal Symptom Index) and a scan of the pathological gastric emptying finding gastroparesis older than 3 months.
• No history of gastric surgery (partial gastrectomy Sleeve gastrectomy, ...) or esophageal surgery
• Not having endoscopic gastric lesions (ulcers antro-pyloric cancer).
• Having no indication against anesthetic.
• Having consented to participate in the study.
• Affiliated with a social security scheme (beneficiary or assignee).

Exclusion criteria:

• Minors.
• Pregnant or breastfeeding
• Having an anesthetic against indication.
• Scan the normal gastric emptying
• Under curative dose anticoagulants whose suspension is inappropriate.
• Under dual anti-platelet aggregation whose suspension is inappropriate.
• Being unable to give informed consent

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Per-oral Endoscopy Pyloromyotomy (G-POEM)	Per-oral endoscopy pyloromyotomy	-
Intrapyloric injection of botulinum toxin	Intrapyloric injection of Botulinum toxin	-

Primary Outcome Measures

Name	Time	Method
Gastroparesis Cardinal Symptom Index score calculation	Up to 3 months

Trial Locations

Locations (1)

Gastro-entérologie, Hôpital Nord ,Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France