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

NCT ID: NCT03040817

Last Updated: 2017-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-12-16

Brief 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.

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).

Conditions

Gastric Peroral Endoscopic Pyloromyotomy (G-POEM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

G-POEM

Each participant receive gastric peroral endoscopic pyloromyotomy (G-POEM).

Group Type: EXPERIMENTAL

Gastric peroral endoscopic pyloromyotomy (G-POEM)

Intervention Type: PROCEDURE

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.

Esomeprazole + Mosapride

Each participant receive Esomeprazole+ Mosapride. The dosages are：Nexium 40mg bid， Mosapride Citrate Tablets 5mg tid.

Group Type: ACTIVE_COMPARATOR

Esomeprazole + Mosapride

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: PROCEDURE

Esomeprazole + Mosapride

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

Intervention Type: DRUG

Other Intervention Names

Peroral endoscopic pyloromyotomy (POP); Nexium + Mosapride Citrate Tablets

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongda Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ruihua Shi

MD, PhD, Postdoctoral Mentor, Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huiping Wang

Role: STUDY_CHAIR

Zhongda Hospital

Locations

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ruihua Shi, MD,PhD

Role: CONTACT

ruihuashi@126.com

+8613951799326

Jiacheng Tan, MD,PhD

Role: CONTACT

cencen_njjs@126.com

+8615105165989

Facility Contacts

Ruihua Shi

Role: primary

ruihuashi@126.com

Other Identifiers

GI of ZhongdaH

Identifier Type: -

Identifier Source: org_study_id