Clinical trial NCT03040817: Cooperative Group for Clinical Research in G-POEM (POP), Jiangsu, China
Official title: Cooperative Group for Clinical Research in G-POEM (POP), Jiangsu, China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Peroral Endoscopic Pyloromyotomy (G-POEM)
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change from Baseline in Gastric Emptying Imaging at 6 months.
timeFrame: From baseline to 6 months.
measure: Change from Baseline in Gastric Emptying Imaging at 12 months.
timeFrame: From baseline to 12 months.
measure: Change from Baseline in Gastric Emptying Imaging at 24 months.
timeFrame: From baseline to 24 months.
measure: Change from Baseline in Gastric Antrum Volume at 6 months.
timeFrame: From baseline to 6 months.
measure: Change from Baseline in Gastric Antrum Volume at 12 months.
timeFrame: From baseline to 12 months.
measure: Change from Baseline in Gastric Antrum Volume at 24 months.
timeFrame: From baseline to 24 months.
measure: Change from Baseline in Gastric Emptying Time at 6 months.
timeFrame: From baseline to 6 months.
measure: Change from Baseline in Gastric Emptying Time at 12 months.
timeFrame: From baseline to 12 months.
measure: Change from Baseline in Gastric Emptying Time at 24 months.
timeFrame: From baseline to 24 months.
measure: Change from Baseline in Gastroparesis Cardinal Symptoms Index at 6 months.
timeFrame: From baseline to 6 months.
measure: Change from Baseline in Gastroparesis Cardinal Symptoms Index at 12 months.
timeFrame: From baseline to 12 months.
measure: Change from Baseline in Gastroparesis Cardinal Symptoms Index at 24 months.
timeFrame: From baseline to 24 months.
measure: Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 6 months.
timeFrame: From baseline to 6 months.
measure: Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 12 months.
timeFrame: From baseline to 12 months.
measure: Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 24 months.
timeFrame: From baseline to 24 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Huiping Wang
role: STUDY_CHAIR
References: