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

Gastroparesis Clinical Trial

— G-POEM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02927886
• Other study ID #: 2016-17
• Secondary ID: 2016-A01365-46
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 6, 2016
• Last updated: October 17, 2016
• Start date: November 2016
• Est. completion date: March 2020

Study information

• Verified date: October 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Jean-Michel Gonzalez
• Email: jean-michel.gonzalez[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Procedure:
• Per-oral endoscopy pyloromyotomy

• Intrapyloric injection of Botulinum toxin

Locations

Country	Name	City	State
France	Gastro-entérologie, Hôpital Nord ,Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastroparesis Cardinal Symptom Index score calculation		Up to 3 months	Yes