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

Southeast University

Status: Unknown

Conditions: Gastric Peroral Endoscopic Pyloromyotomy (G-POEM)

Treatments: Drug: Esomeprazole + Mosapride; Procedure: Gastric peroral endoscopic pyloromyotomy (G-POEM)

Study type: Interventional

Funder types: Other

Identifiers

NCT03040817

GI of ZhongdaH

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

G-POEM

Experimental group

Description:

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

Treatment:

Procedure: Gastric peroral endoscopic pyloromyotomy (G-POEM)

Esomeprazole + Mosapride

Active Comparator group

Description:

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

Treatment:

Drug: Esomeprazole + Mosapride