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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A01365-46 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Per-oral Endoscopy Pyloromyotomy (G-POEM) | Experimental |
| |
| Intrapyloric injection of botulinum toxin | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Per-oral endoscopy pyloromyotomy | Procedure |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Gastroparesis Cardinal Symptom Index score calculation | Up to 3 months |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Michel Gonzalez | Contact | jean-michel.gonzalez@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| Catherine Geindre | Assistance Publique Hôpitaux de Marseille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastro-entérologie, Hôpital Nord ,Assistance Publique Hôpitaux de Marseille | Marseille | 13015 | France |
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| Intrapyloric injection of Botulinum toxin |
| Procedure |
|
| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000074882 | Pyloromyotomy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D005743 | Gastrectomy |
| D000074433 | Myotomy |
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