NCT02779920

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospital, Limoges · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroparesis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-06-01
• Completion: 2017-07-01
• First posted: 2016-05-23
• Last updated: 2020-03-18

Locations

1 site across 1 country: France