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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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 treatment of choice in the refractory gastroparesis with drug treatments by attacking the pyloric obstacle often spastic that counteracts an effective gastric emptying.

Detailed Summary:

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.

Sponsor: University Hospital, Limoges

Current Primary Outcome: Number of technical success for endoscopic pylorotomy on the total number of gestures. [ Time Frame: 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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)
• 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.
• 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
• 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
• 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
• 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
• 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
• Consumption of gastric prokinetic drugs [ Time Frame: 3 months ]
  Data collecting about domperidone, metoclopramide and erythromycin consumption.

Original Secondary Outcome:

• Incidence of adverce 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)
• 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 EndoFLIP system before the procedure and at 3 months, depending on etiology.
• 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
• Assessment of gastroparesis severity symptom using the GCSI [ Time Frame: Baseline, 1 month and 3 month ]
  Evaluation of the severity of gastroparesis symptom using the GCSI questionnaire
• 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-COL questionnaire
• 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
• 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
• Consumption of gastric prokinetic drugs [ Time Frame: 3 months ]
  Data collecting about domperidone, metoclopramide and erythromycin consumption.

Information By: University Hospital, Limoges

Dates:
Date Received: February 23, 2016
Date Started: April 2016
Date Completion: July 2017
Last Updated: March 30, 2017
Last Verified: March 2017