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

March 16, 2020 updated by: University Hospital, Limoges

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87042
        • CHU de Limoges

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events of pylorotomy
Time Frame: 3 months
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
Time Frame: Baseline and 3 months
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
Time Frame: baseline and 3 months
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)
Time Frame: Baseline, 1 month and 3 month
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)
Time Frame: Baseline, 1 month and 3 month
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)
Time Frame: Baseline, 1 month and 3 month
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)
Time Frame: Baseline, 1 month and 3 month
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
Time Frame: 3 months
Data collecting about domperidone, metoclopramide and erythromycin consumption.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Investigators

  • Principal Investigator: Jérémie Jacques, MD, University Hospital, Limoges

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimate)

May 23, 2016

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I15002 (GASTROPOP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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