Feasibility of Endoscopic Pylorotomy in the Treatment of Refractory Gastroparesis, Pilot Study.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility of Endoscopic Pylorotomy in the Treatment of Refractory Gastroparesis, Pilot Study.

Conditions
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Gastroparesis

Intervention / Treatment
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* Procedure: per oral pylorotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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, Gastric resection surgery History of pyloric Patients under guardianship, curatorship or safeguard justice, Disorders of hemostasis against-indicating the endoscopic procedure.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Per oral pylorotomy<br>Patients with gastroparesis (significant prolongation of gastric emptying) not improved prokinetic and antiemetic treatments undergoing per oral pylorotomy | Procedure: per oral pylorotomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events of pylorotomy | analysis of adverse events during the 3 months following the pylorotomy (including perforation per-gesture, bleeding post-gesture) | 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. | 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 | 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 | 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 | 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 | 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 | Baseline, 1 month and 3 month | 
| Consumption of gastric prokinetic drugs | Data collecting about domperidone, metoclopramide and erythromycin consumption. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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refractory gastroparesis, per oral pyloromyotomy