GastroparesisPhase 3G-POEMNCT02927886
Per-oral Endoscopy Pyloromyotomy (G-POEM) in the Treatment of Refractory Diabetic Gastroparesis : Prospective Evaluation of Efficacy
A Phase 3 study testing Per-oral endoscopy pyloromyotomy and Intrapyloric injection of Botulinum toxin in people with Gastroparesis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The objective of the study is to document the clinical efficacy and complications of endoscopic pyloromyotomy in patients with refractory gastroparesis (diabetic, post-operative and idiopathic), compared to Botulinic toxin injection intra-pyloric the results of which are close to the placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Per-oral endoscopy pyloromyotomy and Intrapyloric injection of Botulinum toxin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2016to Mar 2020
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years.
- Presenting a clinical refractory gastroparesis for> 1 year, that is to say whose functional nonspecific symptoms persisting despite medical therapy (prokinetic) optimal.
- Having a calculation before inclusion GCSI score (Gastroparesis Cardinal Symptom Index) and a scan of the pathological gastric emptying finding gastroparesis older than 3 months.
- No history of gastric surgery (partial gastrectomy Sleeve gastrectomy, ...) or esophageal surgery
- Not having endoscopic gastric lesions (ulcers antro-pyloric cancer).
- Having no indication against anesthetic.
- Having consented to participate in the study.
- Affiliated with a social security scheme (beneficiary or assignee).
Who cannot join
- Minors.
- Pregnant or breastfeeding
- Having an anesthetic against indication.
- Scan the normal gastric emptying
- Under curative dose anticoagulants whose suspension is inappropriate.
- Under dual anti-platelet aggregation whose suspension is inappropriate.
- Being unable to give informed consent
Trial locations and contacts
1 site in 1 country.
Jean-Michel Gonzalez contact
France1 site
Gastro-entérologie, Hôpital Nord ,Assistance Publique Hôpitaux de Marseille
Marseille, 13015
Jean-Michel GONZALEZ, jean-michel.gonzalez@ap-hm.fr
About this study
The objective of the study is to document the clinical efficacy and complications of endoscopic pyloromyotomy in patients with refractory gastroparesis (diabetic, post-operative and idiopathic), compared to Botulinic toxin injection intra-pyloric the results of which are close to the placebo.
Read the detailed description
Gastroparesis is a functional disease affecting 4% of the population, which is consecutive to diabetes in 30% of cases and considerably alters the patients' quality of life. The diagnosis is based on gastric fullness symptoms, endoscopy and gastric emptying scintigraphy. The therapeutic alternatives including drug therapies (Metoclopramide, Erythrocin), surgery (Electric gastric stimulation) or endoscopy (Botulinic toxin), are insufficiently effective. Two surgical series suggested an interesting efficacy of laparoscopic pyloroplasty, which remains invasive for a motility disorder. More recently, an US team performed the first case of G-POEM with an excellent outcome and no adverse event. This promising result was confirmed by a Brazilian case, a short retrospective series (7 patients) and the first European case performed and published by our team that has performed 5 cases since. Based on experience, it is proposed a prospective monocentric study to evaluate the efficacy of the G-POEM technique on refractory gastroparesis. This study will include 40 patients on a period of three years, whom suffer from refractory gastroparesis, confirmed by clinical evaluation (GCSI and analogic visual scale), upper GI endoscopy and gastric emptying scintigraphy at the inclusion.
- Conditions
- Gastroparesis
- Being tested
- Per-oral endoscopy pyloromyotomy, Intrapyloric injection of Botulinum toxin
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Per-oral endoscopy pyloromyotomyProcedure or surgery
Also called G-POEM
Intrapyloric injection of Botulinum toxinProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Per-oral Endoscopy Pyloromyotomy (G-POEM) | Experimental | Not described Receives: Procedure: Per-oral endoscopy pyloromyotomy |
| Intrapyloric injection of botulinum toxin | Placebo comparator | Not described Receives: Procedure: Intrapyloric injection of Botulinum toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastroparesis Cardinal Symptom Index score calculation
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Geindre, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927886
- Sponsor's protocol ID
- 2016-17
- Other IDs
- 2016-A01365-46
- Acronym
- G-POEM
- Status last verified
- Oct 2016
- First submitted
- 6 Oct 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Per-oral Endoscopy Pyloromyotomy (G-POEM) in the Treatment of Refractory Diabetic Gastroparesis : Prospective Evaluation of Efficacy
- ClinicalTrials.gov ID
- NCT02927886
- Acronym / sponsor ID
- G-POEM / 2016-17
- Conditions
- Gastroparesis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 7 Oct 2016 (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.
The objective of the study is to document the clinical efficacy and complications of endoscopic pyloromyotomy in patients with refractory gastroparesis (diabetic, post-operative and idiopathic), compared to Botulinic toxin injection intra-pyloric the results of which are close to the placebo.
Detailed description
Gastroparesis is a functional disease affecting 4% of the population, which is consecutive to diabetes in 30% of cases and considerably alters the patients' quality of life. The diagnosis is based on gastric fullness symptoms, endoscopy and gastric emptying scintigraphy. The therapeutic alternatives including drug therapies (Metoclopramide, Erythrocin), surgery (Electric gastric stimulation) or endoscopy (Botulinic toxin), are insufficiently effective. Two surgical series suggested an interesting efficacy of laparoscopic pyloroplasty, which remains invasive for a motility disorder. More recently, an US team performed the first case of G-POEM with an excellent outcome and no adverse event. This promising result was confirmed by a Brazilian case, a short retrospective series (7 patients) and the first European case performed and published by our team that has performed 5 cases since. Based on experience, it is proposed a prospective monocentric study to evaluate the efficacy of the G-POEM technique on refractory gastroparesis. This study will include 40 patients on a period of three years, whom suffer from refractory gastroparesis, confirmed by clinical evaluation (GCSI and analogic visual scale), upper GI endoscopy and gastric emptying scintigraphy at the inclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Per-oral Endoscopy Pyloromyotomy (G-POEM) | Experimental | Procedure: Per-oral endoscopy pyloromyotomy |
| Intrapyloric injection of botulinum toxin | Placebo comparator | Procedure: Intrapyloric injection of Botulinum toxin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Older than 18 years.
- Presenting a clinical refractory gastroparesis for> 1 year, that is to say whose functional nonspecific symptoms persisting despite medical therapy (prokinetic) optimal.
- Having a calculation before inclusion GCSI score (Gastroparesis Cardinal Symptom Index) and a scan of the pathological gastric emptying finding gastroparesis older than 3 months.
- No history of gastric surgery (partial gastrectomy Sleeve gastrectomy, ...) or esophageal surgery
- Not having endoscopic gastric lesions (ulcers antro-pyloric cancer).
Key exclusion criteria (7 listed)
- Minors.
- Pregnant or breastfeeding
- Having an anesthetic against indication.
- Scan the normal gastric emptying
- Under curative dose anticoagulants whose suspension is inappropriate.
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 |
|---|---|---|
| Per-oral endoscopy pyloromyotomyAlso: G-POEM | Procedure or surgery | Per-oral Endoscopy Pyloromyotomy (G-POEM) |
| Intrapyloric injection of Botulinum toxin | Procedure or surgery | Intrapyloric injection of botulinum toxin |
Primary outcome
Gastroparesis Cardinal Symptom Index score calculation
Time frame: Up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Gastroparesis
Recruiting
Gastric Focused Ultrasound Stimulation
Gastroparesis, Delayed Gastric Emptying
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Not yet recruiting
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
Gastric Cancer, Gastric Outlet Obstruction
Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
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.
Jean-Michel Gonzalez contact
Catherine Geindre study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Per-oral endoscopy pyloromyotomy and Intrapyloric injection of Botulinum toxin in people with Gastroparesis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 8 inclusion and 7 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 18 Oct 2016. 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 France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jean-Michel Gonzalez (jean-michel.gonzalez@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastroparesis Cardinal Symptom Index score calculation (time frame: Up to 3 months). 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 18 Oct 2016.