Feasibility of Endoscopic Pylorotomy in the Treatment of Refractory Gastroparesis, Pilot Study.
- Conditions
- Gastroparesis
- Interventions
- Procedure: per oral pylorotomy
- Registration Number
- NCT02779920
- Lead Sponsor
- University Hospital, Limoges
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Per oral pylorotomy per oral pylorotomy Patients with gastroparesis (significant prolongation of gastric emptying) not improved prokinetic and antiemetic treatments undergoing per oral pylorotomy
- Primary Outcome Measures
Name Time Method Number of technical success for endoscopic pylorotomy on the total number of gestures. 3 months Technical feasibility will be the feasibility of endoscopic pylorotomy gesture by the technique of the tunnel.
- Secondary Outcome Measures
Name Time Method Incidence of adverse events of pylorotomy 3 months analysis of adverse events during the 3 months following the pylorotomy (including perforation per-gesture, bleeding post-gesture)
Assessment of gastroparesis severity symptom using the Gastroparesis Cardinal Symptom Index (GCSI) Baseline, 1 month and 3 month Evaluation of the severity of gastroparesis symptom using the GCSI questionnaire
Assessment of functional health and well-being from the patient's point of view (SF-36) 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
Assessment of Quality of Life in Upper Gastrointestinal Disorders (PAGI-QOL) Baseline, 1 month and 3 month Evaluation of the quality of life of patient with Upper Gastrointestinal Disorders using PAGI-QOL questionnaire
Ratio between the diameter of the pyloric canal and the pyloric pressure 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 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 Quality of Life in Gastrointestinal disease (GIQLI) Baseline, 1 month and 3 month Evaluation of quality of life of patients with gastrointestinal Disease using GIQLI questionnaire
Consumption of gastric prokinetic drugs 3 months Data collecting about domperidone, metoclopramide and erythromycin consumption.
Trial Locations
- Locations (1)
CHU de LIMOGES
🇫🇷Limoges, France