NCT02779920

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 23, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

February 23, 2016

Last Update Submit

March 16, 2020

Conditions

Gastroparesis

Keywords

refractory gastroparesisper oral pyloromyotomy

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (8)

  • Incidence of adverse events of pylorotomy

    3 months

  • Ratio between the diameter of the pyloric canal and the pyloric pressure

    Baseline and 3 months

  • Assessment of gastric emptying scintigraphy

    baseline and 3 months

  • Assessment of gastroparesis severity symptom using the Gastroparesis Cardinal Symptom Index (GCSI)

    Baseline, 1 month and 3 month

  • Assessment of Quality of Life in Upper Gastrointestinal Disorders (PAGI-QOL)

    Baseline, 1 month and 3 month

  • +3 more secondary outcomes

Study Arms (1)

Per oral pylorotomy

EXPERIMENTAL

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

Procedure: per oral pylorotomy

Interventions

per oral pylorotomyPROCEDURE

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.

Per oral pylorotomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de LIMOGES

Limoges, 87042, France

Location

Related Publications (1)

  • 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.

    PMID: 29895073RESULT

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jérémie Jacques, MD

    University Hospital, Limoges

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2016

First Posted

May 23, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)