GastroparesisGASTROPOPNCT02779920
Feasibility of Endoscopic Pylorotomy in the Treatment of Refractory Gastroparesis, Pilot Study.
A study testing per oral pylorotomy in people with Gastroparesis, run by University Hospital, Limoges at 1 site in France.
Trial summary
Gastroparesis is a common chronic condition, disabling the limited therapeutic resources justifying the exploration of new therapeutic possibilities. By analogy to the technique of Per Oral Endoscopic Myotomy (POEM), we believe that myotomy pyloric muscle (POP = Per Oral Pyloromyotomy) endoscopically could become a… 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 pylorotomy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to Jul 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with refractory gastroparesis to drug treatment (post-diabetic, post-Sjogren, postsurgical or idiopathic)
- Signed Consent
- Affiliate or beneficiary of a French social security scheme
Who cannot join
- Contraindications to gastroesophageal gastroduodenal endoscopy,
- Early Unable to follow protocol,
- Contraindications to general anesthesia,
- Can not Stop anticoagulants for the gesture,
- Can not stop antiplatelet agents for the gesture,
- Pregnant or lactating women,
Show all 9Show fewer
- Gastric resection surgery History of pyloric
- Patients under guardianship, curatorship or safeguard justice,
- Disorders of hemostasis against-indicating the endoscopic procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Gastroparesis is a common chronic condition, disabling the limited therapeutic resources justifying the exploration of new therapeutic possibilities.
By analogy to the technique of Per Oral Endoscopic Myotomy (POEM), we believe that myotomy pyloric muscle (POP = Per Oral Pyloromyotomy) endoscopically could become a treatment of choice in the refractory gastroparesis with drug treatments by attacking the pyloric obstacle often spastic that counteracts an effective gastric emptying.
Read the detailed description
Experimental study, prospective, single-center, POP feasibility pilot in the treatment of refractory gastroparesis.
Patients with gastroparesis (significant prolongation of gastric emptying) unimproved by prokinetic treatment and meet all the eligibility criteria will be included after a period of reflection of two weeks minimum.
20 patients will be prospectively included 10 patients with diabetic gastroparesis, 10 patients with non-diabetic gastroparesis (post-surgical, post-Sjogren, idiopathic).
POP will be performed under general anesthesia in intubated-ventilated patients using a carbon dioxide (CO2) inflator. The published standard technique and learned by our team on the pig model will be conducted: submucosal tunnel at the anterior surface of the gastric antrum starting 3-5 cm proximal to the pylorus front section to the fiber by fiber to the muscular pyloric, then closing the inlet tunnel by hemostatic clips.
An evaluation of symptoms by the Gastroparesis Cardinal Symptom Index (ISCC) of the quality of life of the patient Assessment of upper gastrointestinal disorders-Quality Of Life (PAGI-QoL), SF-36 and gastrointestinal Quality of Life Index (GIQLI ) and gastric emptying by a scintigraphic gastric emptying will be carried out at 3 months.
- Conditions
- Gastroparesis
- Being tested
- per oral pylorotomy
- Keywords
- refractory gastroparesis, per oral pyloromyotomy
- 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 pylorotomyProcedure or surgery
The procedure is endoscopic pylorotomy. The standard procedure consists in the realization of a longitudinal incision of 2 cm at the anterior surface of the gastric antrum at 5 cm from the pylorus after a submucosal injection of a solution containing 85% saline 10% glycerol and 5% fructose. This longitudinal incision serve as an input for producing a submucosal tunnel dissected fibers gastric submucosa step. The internal circular of the pyloric muscle is then severed fiber after fiber over its entire length and its entire thickness. Once the pyloric section completed, the tunnel inlet will be closed by means of hemostatic clips.
| Study group | Role | What they receive |
|---|---|---|
| Per oral pylorotomy | Experimental | Patients with gastroparesis (significant prolongation of gastric emptying) not improved prokinetic and antiemetic treatments undergoing per oral pylorotomy Receives: Procedure: per oral pylorotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of technical success for endoscopic pylorotomy on the total number of gestures.
Technical feasibility will be the feasibility of endoscopic pylorotomy gesture by the technique of the tunnel.
Measured: 3 months
Secondary outcomes (8)
Incidence of adverse events of pylorotomy
analysis of adverse events during the 3 months following the pylorotomy (including perforation per-gesture, bleeding post-gesture)
Measured: 3 months
Ratio between the diameter of the pyloric canal and the pyloric pressure
Evaluation of the pyloric compliance by the Endolumenal Functional Lumen Imaging Probe (EndoFLIP) system before the procedure and at 3 months, depending on etiology.
Measured: Baseline and 3 months
Assessment of gastric emptying scintigraphy
Assessment of gastric emptying scintigraphy before the procedure and at 3 months by measuring the half gastric emptying time and percentage retention to 4 hours
Measured: baseline and 3 months
Assessment of gastroparesis severity symptom using the Gastroparesis Cardinal Symptom Index (GCSI)
Evaluation of the severity of gastroparesis symptom using the GCSI questionnaire
Measured: Baseline, 1 month and 3 month
Assessment of Quality of Life in Upper Gastrointestinal Disorders (PAGI-QOL)
Evaluation of the quality of life of patient with Upper Gastrointestinal Disorders using PAGI-QOL questionnaire
Measured: Baseline, 1 month and 3 month
Assessment of Quality of Life in Gastrointestinal disease (GIQLI)
Evaluation of quality of life of patients with gastrointestinal Disease using GIQLI questionnaire
Measured: Baseline, 1 month and 3 month
Assessment of functional health and well-being from the patient's point of view (SF-36)
Evaluation of of functional health and well-being from the patient's point of view using SF-36 questionnaire
Measured: Baseline, 1 month and 3 month
Consumption of gastric prokinetic drugs
Data collecting about domperidone, metoclopramide and erythromycin consumption.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérémie Jacques, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779920
- Sponsor's protocol ID
- I15002 (GASTROPOP)
- Acronym
- GASTROPOP
- Status last verified
- Mar 2020
- First submitted
- 23 Feb 2016
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jacques J, Pagnon L, Hure F, Legros R, Crepin S, Fauchais AL, Palat S, Ducrotte P, Marin B, Fontaine S, Boubaddi NE, Clement MP, Sautereau D, Loustaud-Ratti V, Gourcerol G, Monteil J. Peroral endoscopic pyloromyotomy is efficacious and safe for refractory gastroparesis: prospective trial with assessment of pyloric function. Endoscopy. 2019 Jan;51(1):40-49. doi: 10.1055/a-0628-6639. Epub 2018 Jun 12.
PubMed 29895073
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Endoscopic Pylorotomy in the Treatment of Refractory Gastroparesis, Pilot Study.
- ClinicalTrials.gov ID
- NCT02779920
- Acronym / sponsor ID
- GASTROPOP / I15002 (GASTROPOP)
- Conditions
- Gastroparesis
- Keywords
- refractory gastroparesis, per oral pyloromyotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 23 May 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.
Gastroparesis is a common chronic condition, disabling the limited therapeutic resources justifying the exploration of new therapeutic possibilities.
By analogy to the technique of Per Oral Endoscopic Myotomy (POEM), we believe that myotomy pyloric muscle (POP = Per Oral Pyloromyotomy) endoscopically could become a treatment of choice in the refractory gastroparesis with drug treatments by attacking the pyloric obstacle often spastic that counteracts an effective gastric emptying.
Detailed description
Experimental study, prospective, single-center, POP feasibility pilot in the treatment of refractory gastroparesis.
Patients with gastroparesis (significant prolongation of gastric emptying) unimproved by prokinetic treatment and meet all the eligibility criteria will be included after a period of reflection of two weeks minimum.
20 patients will be prospectively included 10 patients with diabetic gastroparesis, 10 patients with non-diabetic gastroparesis (post-surgical, post-Sjogren, idiopathic).
POP will be performed under general anesthesia in intubated-ventilated patients using a carbon dioxide (CO2) inflator. The published standard technique and learned by our team on the pig model will be conducted: submucosal tunnel at the anterior surface of the gastric antrum starting 3-5 cm proximal to the pylorus front section to the fiber by fiber to the muscular pyloric, then closing the inlet tunnel by hemostatic clips.
An evaluation of symptoms by the Gastroparesis Cardinal Symptom Index (ISCC) of the quality of life of the patient Assessment of upper gastrointestinal disorders-Quality Of Life (PAGI-QoL), SF-36 and gastrointestinal Quality of Life Index (GIQLI ) and gastric emptying by a scintigraphic gastric emptying will be carried out at 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Per oral pylorotomy | Experimental | Procedure: per oral pylorotomyPatients with gastroparesis (significant prolongation of gastric emptying) not improved prokinetic and antiemetic treatments undergoing per oral pylorotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with refractory gastroparesis to drug treatment (post-diabetic, post-Sjogren, postsurgical or idiopathic)
- Signed Consent
- Affiliate or beneficiary of a French social security scheme
Key exclusion criteria (9 listed)
- Contraindications to gastroesophageal gastroduodenal endoscopy,
- Early Unable to follow protocol,
- Contraindications to general anesthesia,
- Can not Stop anticoagulants for the gesture,
- Can not stop antiplatelet agents for the gesture,
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 pylorotomyThe procedure is endoscopic pylorotomy. The standard procedure consists in the realization of a longitudinal incision of 2 cm at the anterior surface of the gastric antrum at 5 cm from the pylorus after a submucosal injection of a solution containing 85% saline 10% glycerol and 5% fructose. This longitudinal incision serve as an input for producing a submucosal tunnel dissected fibers gastric submucosa step. The internal circular of the pyloric muscle is then severed fiber after fiber over its entire length and its entire thickness. Once the pyloric section completed, the tunnel inlet will be closed by means of hemostatic clips. | Procedure or surgery | Per oral pylorotomy |
Primary outcome
Number of technical success for endoscopic pylorotomy on the total number of gestures.
Time frame: 3 months
Technical feasibility will be the feasibility of endoscopic pylorotomy gesture by the technique of the tunnel.
8 secondary outcomes
Incidence of adverse events of pylorotomy
Time frame: 3 months
Ratio between the diameter of the pyloric canal and the pyloric pressure
Time frame: Baseline and 3 months
Assessment of gastric emptying scintigraphy
Time frame: baseline and 3 months
Assessment of gastroparesis severity symptom using the Gastroparesis Cardinal Symptom Index (GCSI)
Time frame: Baseline, 1 month and 3 month
Assessment of Quality of Life in Upper Gastrointestinal Disorders (PAGI-QOL)
Time frame: Baseline, 1 month and 3 month
Assessment of Quality of Life in Gastrointestinal disease (GIQLI)
Time frame: Baseline, 1 month and 3 month
Assessment of functional health and well-being from the patient's point of view (SF-36)
Time frame: Baseline, 1 month and 3 month
Consumption of gastric prokinetic drugs
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Results publication: PubMed 29895073Jacques J, Pagnon L, Hure F, Legros R, Crepin S, Fauchais AL, Palat S, Ducrotte P, Marin B, Fontaine S, Boubaddi NE, Clement MP, Sautereau D, Loustaud-Ratti V, Gourcerol G, Monteil J. Peroral endoscopic pyloromyotomy is efficacious and safe for refractory gastroparesis: prospective trial with assessment of pyloric function. Endoscopy. 2019 Jan;51(1):40-49. doi: 10.1055/a-0628-6639. Epub 2018 Jun 12.
- Individual participant dataSharing planned: No
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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.
Jérémie Jacques, MD principal investigator
University Hospital, Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing per oral pylorotomy in people with Gastroparesis, run by University Hospital, Limoges 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 18 Mar 2020. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of technical success for endoscopic pylorotomy on the total number of gestures. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02779920, which also lists 1 linked publication.
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 Mar 2020.