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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
CHU de LIMOGES
Limoges, France
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.
Time frame: 3 months
Incidence of adverse events of pylorotomy
analysis of adverse events during the 3 months following the pylorotomy (including perforation per-gesture, bleeding post-gesture)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 1 month and 3 month
Assessment of Quality of Life in Gastrointestinal disease (GIQLI)
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Evaluation of quality of life of patients with gastrointestinal Disease using GIQLI questionnaire
Time frame: 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
Time frame: Baseline, 1 month and 3 month
Consumption of gastric prokinetic drugs
Data collecting about domperidone, metoclopramide and erythromycin consumption.
Time frame: 3 months