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Cooperative Group for Clinical Research in G-POEM (POP), Jiangsu, China

NCT03040817 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-08-29

No results posted yet for this study

Summary

Diabetic gastroparesis, postsurgical gastroparesis, idiopathic gastroparesis and primary pyloric stenosis are debilitating gastrointestinal motility disorder. However, there is limited medical therapeutic options for these diseases. Gastric peroral endoscopic pyloromyotomy (G-POEM) is an emerging novel endoscopic technique which is reported as a minimally invasive therapy. But so far, the efficacy and safety of G-POEM on these diseases are rarely explored. So, there is a cooperative group composed of five clinical centers for clinical research in G-POEM.

Conditions

  • Gastric Peroral Endoscopic Pyloromyotomy (G-POEM)

Interventions

PROCEDURE

Gastric peroral endoscopic pyloromyotomy (G-POEM)

G-POEM procedure: A. Premixed methylene blue/normal saline were injected into gastric antrum submucosa at greater curvature, 5 cm proximal to the pylorus. B. Submucosal tunnel was created via endoscopic submucosal dissection. C. A white thick pyloric band, was in contrast to a thin-walled submucosal space of the duodenum observed distally. D. Pyloromyotomy starts with dissection of the pyloric ring exposing muscular layer underneath. E. Circular and longitudinal myotomy for 2-3 cm. F. Serosa indicates appropriate depth of myotomy. G. Reevaluation of the mucosotomy site. H. Mucosal entry was closed with clips from distal mucosal incision point.

DRUG

Esomeprazole + Mosapride

Each participant receive Esomeprazole （Nexium） 40mg bid + Mosapride （Mosapride Citrate Tablets） 5mg tid.

Sponsors & Collaborators

  • Zhongda Hospital

    lead OTHER

Principal Investigators

  • Huiping Wang · Zhongda Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2019-08-16
Completion
2019-12-16

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03040817 on ClinicalTrials.gov