Clinical trial NCT02779920: Feasibility of Endoscopic Pylorotomy in the Treatment of Refractory Gastroparesis, Pilot Study.
Official title: Feasibility of Endoscopic Pylorotomy in the Treatment of Refractory Gastroparesis, Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroparesis
Keywords: refractory gastroparesis
per oral pyloromyotomy
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2016-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of technical success for endoscopic pylorotomy on the total number of gestures.
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of adverse events of pylorotomy
timeFrame: 3 months
measure: Ratio between the diameter of the pyloric canal and the pyloric pressure
timeFrame: Baseline and 3 months
measure: Assessment of gastric emptying scintigraphy
timeFrame: baseline and 3 months
measure: Assessment of gastroparesis severity symptom using the Gastroparesis Cardinal Symptom Index (GCSI)
timeFrame: Baseline, 1 month and 3 month
measure: Assessment of Quality of Life in Upper Gastrointestinal Disorders (PAGI-QOL)
timeFrame: Baseline, 1 month and 3 month
measure: Assessment of Quality of Life in Gastrointestinal disease (GIQLI)
timeFrame: Baseline, 1 month and 3 month
measure: Assessment of functional health and well-being from the patient's point of view (SF-36)
timeFrame: Baseline, 1 month and 3 month
measure: Consumption of gastric prokinetic drugs
timeFrame: 3 months
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU de LIMOGES
Study officials:
affiliation: University Hospital, Limoges
name: Jérémie Jacques, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jacques J, Pagnon L, Hure F, Legros R, Crepin S, Fauchais AL, Palat S, Ducrotte P, Marin B, Fontaine S, Boubaddi NE, Clement MP, Sautereau D, Loustaud-Ratti V, Gourcerol G, Monteil J. Peroral endoscopic pyloromyotomy is efficacious and safe for refractory gastroparesis: prospective trial with assessment of pyloric function. Endoscopy. 2019 Jan;51(1):40-49. doi: 10.1055/a-0628-6639. Epub 2018 Jun 12.