Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Completed NCT03941288 - Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia Phase 2
Terminated NCT03285308 - A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01 Phase 3
Completed NCT00733551 - Evaluation of the Safety, Tolerability and Pharmacokinetics of Repeat Oral Doses of GSK962040 Administered to Healthy Adult Subjects. Phase 1
Completed NCT01650714 - Endoscopic Full Thickness Biopsy, Gastric Wall. N/A
Completed NCT01452815 - Affects of Once-daily Oral Administration of TZP-102 on the Treatment of Symptoms Associated With Diabetic Gastroparesis Phase 2
Completed NCT01039974 - GSK962040 Drug-drug Interaction Study With Ketoconazole Phase 1
Terminated NCT04844190 - Use of EndoFLIP and Manometry Prior to G-POEM N/A
Enrolling by invitation NCT06215547 - Medtronic Enterra II Neurostimulator N/A
Completed NCT04026997 - A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis Phase 2
Completed NCT00562848 - A Study to Evaluate Safety, Side Effects, Muscle Activity and Speed of Gastric Emptying of GSK962040 Phase 1
Enrolling by invitation NCT04207996 - Vagus Nerve Response in Gastroparesis Patients
Completed NCT04607304 - ABCA2 GIRMS Analytical Validation Clinical Performance Study N/A
Recruiting NCT06068114 - Gastric Pathophysiology in Diabetes
Completed NCT03259841 - Ultrasound Assessment of Gastric Contents in Fasted Patient Undergoing Cholecystectomy
Active, not recruiting NCT04300127 - Pioglitazone for Idiopathic Gastroparesis Early Phase 1
Recruiting NCT01696734 - Domperidone in Treating Patients With Gastrointestinal Disorders Phase 3
Terminated NCT04635306 - 13C-Spirulina Nitrogen Content GEBT Study N/A
Withdrawn NCT02420925 - Effect of Celiac Plexus Block on Gastric Emptying and Symptoms Caused by Gastroparesis N/A
Recruiting NCT00777439 - Domperidone for Refractory Gastrointestinal Disorders N/A
Terminated NCT00760461 - Domperidone in Refractory Gastroparesis Phase 2