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

NCT ID: NCT02779920

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-07-31

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.

Conditions

Gastroparesis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Per oral pylorotomy

Patients with gastroparesis (significant prolongation of gastric emptying) not improved prokinetic and antiemetic treatments undergoing per oral pylorotomy

Group Type: EXPERIMENTAL

per oral pylorotomy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jérémie Jacques, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Locations

CHU de LIMOGES

Limoges, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 29895073 (View on PubMed)

Other Identifiers

I15002 (GASTROPOP)

Identifier Type: -

Identifier Source: org_study_id