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

NCT02927886 | Unknown Phase 3

• 2 other identifiers: 2016-172016-A01365-46
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Gastroparesis Cardinal Symptom Index score calculation

  Up to 3 months

Study Arms (2)

Per-oral Endoscopy Pyloromyotomy (G-POEM)

EXPERIMENTAL

Procedure: Per-oral endoscopy pyloromyotomy

Intrapyloric injection of botulinum toxin

PLACEBO COMPARATOR

Procedure: Intrapyloric injection of Botulinum toxin

Interventions

Per-oral endoscopy pyloromyotomy PROCEDURE

Also known as: G-POEM

Per-oral Endoscopy Pyloromyotomy (G-POEM)

Intrapyloric injection of Botulinum toxin PROCEDURE

Intrapyloric injection of botulinum toxin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Gastro-entérologie, Hôpital Nord ,Assistance Publique Hôpitaux de Marseille

Marseille, 13015, France

Location

MeSH Terms

Conditions

Gastroparesis

Interventions

Pyloromyotomy

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Digestive System Surgical Procedures; Surgical Procedures, Operative; Gastrectomy; Myotomy

Study Officials

• Catherine Geindre

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Central Study Contacts

Jean-Michel Gonzalez

CONTACT

jean-michel.gonzalez@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 7, 2016
• Study Start: November 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: March 1, 2020
• Last Updated: October 18, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)