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

August 26, 2017 updated by: Ruihua Shi, Zhongda Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Participants are randomly devided into 'G-POEM group' and 'Esomeprazole+Mosapride group'. In G-POEM group, each participant receives G-POEM treatment. In Esomeprazole+Mosapride group, each participant receives Nexium 40mg bid + Mosapride Citrate Tablets 5mg tid. The whole outcome measure time fram is up to two years. Outcome evaluations include: gastric emptying imaging, gastric antrum volume, gastric emptying time, gastroparesis cardinal symptoms index and gastroesophageal reflux disease questionnaire. All the outcomes are assessed at different time points (from baseline to 6 months, 12months and 24months).

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Zhongda Hospital Southeast University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 16 to 80 years old
  2. Full sufficiency in literacy
  3. Be off proton pump inhibitor, antacids and prokinetics ≥ 2 weeks
  4. Refractory gastroesophageal reflux disease induced by postsurgical gastroparesis

Exclusion Criteria:

  1. Severe heart, lung, and cerebrovascular disease
  2. Severe hematopoietic system disease
  3. Abnormal blood coagulation function
  4. Oropharyngeal abnormalities
  5. Severe spine malformation
  6. In pregnancy and lactation at present, or plan to become pregnant within 2 years
  7. Severe inflammation or huge ulcers in stomach
  8. Mental and psychological disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: G-POEM
Each participant receive gastric peroral endoscopic pyloromyotomy (G-POEM).
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.

Other Names:
  • Peroral endoscopic pyloromyotomy (POP)
Active Comparator: Esomeprazole + Mosapride
Each participant receive Esomeprazole+ Mosapride. The dosages are：Nexium 40mg bid， Mosapride Citrate Tablets 5mg tid.
Drug: Esomeprazole + Mosapride
Each participant receive Esomeprazole （Nexium） 40mg bid + Mosapride （Mosapride Citrate Tablets） 5mg tid.
Other Names:
  • Nexium + Mosapride Citrate Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Gastric Emptying Imaging at 6 months.
Time Frame: From baseline to 6 months.
Each participant will receive gastric emptying imaging measurement both at baseline and 6 months.
From baseline to 6 months.
Change from Baseline in Gastric Emptying Imaging at 12 months.
Time Frame: From baseline to 12 months.
Each participant will receive gastric emptying imaging measurement both at baseline and 12 months.
From baseline to 12 months.
Change from Baseline in Gastric Emptying Imaging at 24 months.
Time Frame: From baseline to 24 months.
Each participant will receive gastric emptying imaging measurement both at baseline and 24 months.
From baseline to 24 months.
Change from Baseline in Gastric Antrum Volume at 6 months.
Time Frame: From baseline to 6 months.
Each participant will receive gastric antrum volume measurement both at baseline and 6 months.
From baseline to 6 months.
Change from Baseline in Gastric Antrum Volume at 12 months.
Time Frame: From baseline to 12 months.
Each participant will receive gastric antrum volume measurement both at baseline and 12 months.
From baseline to 12 months.
Change from Baseline in Gastric Antrum Volume at 24 months.
Time Frame: From baseline to 24 months.
Each participant will receive gastric antrum volume measurement both at baseline and 24 months.
From baseline to 24 months.
Change from Baseline in Gastric Emptying Time at 6 months.
Time Frame: From baseline to 6 months.
Each participant will receive gastric emptying time measurement both at baseline and 6 months.
From baseline to 6 months.
Change from Baseline in Gastric Emptying Time at 12 months.
Time Frame: From baseline to 12 months.
Each participant will receive gastric emptying time measurement both at baseline and 12 months.
From baseline to 12 months.
Change from Baseline in Gastric Emptying Time at 24 months.
Time Frame: From baseline to 24 months.
Each participant will receive gastric emptying time measurement both at baseline and 24 months.
From baseline to 24 months.
Change from Baseline in Gastroparesis Cardinal Symptoms Index at 6 months.
Time Frame: From baseline to 6 months.
Each participant will receive gastroparesis cardinal symptoms index evaluation both at baseline and 6 months.
From baseline to 6 months.
Change from Baseline in Gastroparesis Cardinal Symptoms Index at 12 months.
Time Frame: From baseline to 12 months.
Each participant will receive gastroparesis cardinal symptoms index evaluation both at baseline and 12 months.
From baseline to 12 months.
Change from Baseline in Gastroparesis Cardinal Symptoms Index at 24 months.
Time Frame: From baseline to 24 months.
Each participant will receive gastroparesis cardinal symptoms index evaluation both at baseline and 24 months.
From baseline to 24 months.
Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 6 months.
Time Frame: From baseline to 6 months.
Each participant will receive gastroesophageal reflux disease questionnaire evaluation both at baseline and 6 months.
From baseline to 6 months.
Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 12 months.
Time Frame: From baseline to 12 months.
Each participant will receive gastroesophageal reflux disease questionnaire evaluation both at baseline and 12 months.
From baseline to 12 months.
Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 24 months.
Time Frame: From baseline to 24 months.
Each participant will receive gastroesophageal reflux disease questionnaire evaluation both at baseline and 24 months.
From baseline to 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongda Hospital

Investigators

  • Study Chair: Huiping Wang, Zhongda Hospital Southeast University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2017

Primary Completion (Anticipated)

August 16, 2019

Study Completion (Anticipated)

December 16, 2019

Study Registration Dates

First Submitted

January 31, 2017

First Submitted That Met QC Criteria

January 31, 2017

First Posted (Estimate)

February 2, 2017

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 26, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GI of ZhongdaH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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