Gastric Peroral Endoscopic Pyloromyotomy (G-POEM)NCT03040817
Cooperative Group for Clinical Research in G-POEM (POP), Jiangsu, China
A study testing Gastric peroral endoscopic pyloromyotomy (G-POEM) and Esomeprazole + Mosapride in people with Gastric Peroral Endoscopic Pyloromyotomy (G-POEM), run by Zhongda Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Gastric Peroral Endoscopic Pyloromyotomy (G-POEM)
- What is being tested?
- Gastric peroral endoscopic pyloromyotomy (G-POEM) and Esomeprazole + Mosapride
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 16 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age between 16 to 80 years old
- Full sufficiency in literacy
- Be off proton pump inhibitor, antacids and prokinetics ≥ 2 weeks
- Refractory gastroesophageal reflux disease induced by postsurgical gastroparesis
Who cannot join
- Severe heart, lung, and cerebrovascular disease
- Severe hematopoietic system disease
- Abnormal blood coagulation function
- Oropharyngeal abnormalities
- Severe spine malformation
- In pregnancy and lactation at present, or plan to become pregnant within 2 years
- Severe inflammation or huge ulcers in stomach
- Mental and psychological disorder
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu
Ruihua Shi, ruihuashi@126.com
About this study
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.
Read the 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).
- Being tested
- Gastric peroral endoscopic pyloromyotomy (G-POEM), Esomeprazole + Mosapride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric peroral endoscopic pyloromyotomy (G-POEM)Procedure or surgery
Also called Peroral endoscopic pyloromyotomy (POP)
G-POEM procedure:
- Premixed methylene blue/normal saline were injected into gastric antrum submucosa at greater curvature, 5 cm proximal to the pylorus.
- 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.
- Pyloromyotomy starts with dissection of the pyloric ring exposing muscular layer underneath.
- 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 + MosaprideDrug
Also called Nexium + Mosapride Citrate Tablets
Each participant receive Esomeprazole （Nexium） 40mg bid + Mosapride （Mosapride Citrate Tablets） 5mg tid.
| Study group | Role | What they receive |
|---|---|---|
| G-POEM | Experimental | Each participant receive gastric peroral endoscopic pyloromyotomy (G-POEM). Receives: Procedure: Gastric peroral endoscopic pyloromyotomy (G-POEM) |
| Esomeprazole + Mosapride | Active comparator | Each participant receive Esomeprazole+ Mosapride. The dosages are：Nexium 40mg bid， Mosapride Citrate Tablets 5mg tid. Receives: Drug: Esomeprazole + Mosapride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Gastric Emptying Imaging at 6 months.
Each participant will receive gastric emptying imaging measurement both at baseline and 6 months.
Measured: From baseline to 6 months.
Change from Baseline in Gastric Emptying Imaging at 12 months.
Each participant will receive gastric emptying imaging measurement both at baseline and 12 months.
Measured: From baseline to 12 months.
Change from Baseline in Gastric Emptying Imaging at 24 months.
Each participant will receive gastric emptying imaging measurement both at baseline and 24 months.
Measured: From baseline to 24 months.
Change from Baseline in Gastric Antrum Volume at 6 months.
Each participant will receive gastric antrum volume measurement both at baseline and 6 months.
Measured: From baseline to 6 months.
Change from Baseline in Gastric Antrum Volume at 12 months.
Each participant will receive gastric antrum volume measurement both at baseline and 12 months.
Measured: From baseline to 12 months.
Change from Baseline in Gastric Antrum Volume at 24 months.
Each participant will receive gastric antrum volume measurement both at baseline and 24 months.
Measured: From baseline to 24 months.
Change from Baseline in Gastric Emptying Time at 6 months.
Each participant will receive gastric emptying time measurement both at baseline and 6 months.
Measured: From baseline to 6 months.
Change from Baseline in Gastric Emptying Time at 12 months.
Each participant will receive gastric emptying time measurement both at baseline and 12 months.
Measured: From baseline to 12 months.
Change from Baseline in Gastric Emptying Time at 24 months.
Each participant will receive gastric emptying time measurement both at baseline and 24 months.
Measured: From baseline to 24 months.
Change from Baseline in Gastroparesis Cardinal Symptoms Index at 6 months.
Each participant will receive gastroparesis cardinal symptoms index evaluation both at baseline and 6 months.
Measured: From baseline to 6 months.
Change from Baseline in Gastroparesis Cardinal Symptoms Index at 12 months.
Each participant will receive gastroparesis cardinal symptoms index evaluation both at baseline and 12 months.
Measured: From baseline to 12 months.
Change from Baseline in Gastroparesis Cardinal Symptoms Index at 24 months.
Each participant will receive gastroparesis cardinal symptoms index evaluation both at baseline and 24 months.
Measured: From baseline to 24 months.
Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 6 months.
Each participant will receive gastroesophageal reflux disease questionnaire evaluation both at baseline and 6 months.
Measured: From baseline to 6 months.
Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 12 months.
Each participant will receive gastroesophageal reflux disease questionnaire evaluation both at baseline and 12 months.
Measured: From baseline to 12 months.
Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 24 months.
Each participant will receive gastroesophageal reflux disease questionnaire evaluation both at baseline and 24 months.
Measured: From baseline to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start1 Sep 2017 (estimated)
- Primary completion16 Aug 2019 (estimated)
- Study completion16 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Peroral Endoscopic Pyloromyotomy (G-POEM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruihua Shi, Zhongda Hospital
- Investigators
- Huiping Wang, Study chair, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040817
- Sponsor's protocol ID
- GI of ZhongdaH
- Status last verified
- Aug 2017
- First submitted
- 31 Jan 2017
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooperative Group for Clinical Research in G-POEM (POP), Jiangsu, China
- ClinicalTrials.gov ID
- NCT03040817
- Acronym / sponsor ID
- GI of ZhongdaH
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 16 Aug 2019 (estimated)
- Study completion
- 16 Dec 2019 (estimated)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-POEM | Experimental | Procedure: Gastric peroral endoscopic pyloromyotomy (G-POEM)Each participant receive gastric peroral endoscopic pyloromyotomy (G-POEM). |
| Esomeprazole + Mosapride | Active comparator | Drug: Esomeprazole + MosaprideEach participant receive Esomeprazole+ Mosapride. The dosages are：Nexium 40mg bid， Mosapride Citrate Tablets 5mg tid. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 16 to 80 years old
- Full sufficiency in literacy
- Be off proton pump inhibitor, antacids and prokinetics ≥ 2 weeks
- Refractory gastroesophageal reflux disease induced by postsurgical gastroparesis
Key exclusion criteria (8 listed)
- Severe heart, lung, and cerebrovascular disease
- Severe hematopoietic system disease
- Abnormal blood coagulation function
- Oropharyngeal abnormalities
- Severe spine malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric peroral endoscopic pyloromyotomy (G-POEM)Also: Peroral endoscopic pyloromyotomy (POP)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. | Procedure or surgery | G-POEM |
| Esomeprazole + MosaprideAlso: Nexium + Mosapride Citrate TabletsEach participant receive Esomeprazole （Nexium） 40mg bid + Mosapride （Mosapride Citrate Tablets） 5mg tid. | Drug | Esomeprazole + Mosapride |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huiping Wang study chair
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric peroral endoscopic pyloromyotomy (G-POEM) and Esomeprazole + Mosapride in people with Gastric Peroral Endoscopic Pyloromyotomy (G-POEM), run by Zhongda Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruihua Shi, MD,PhD (+8613951799326, ruihuashi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Gastric Emptying Imaging at 6 months. (time frame: From baseline to 6 months.). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.