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Gastric Per Oral Endoscopic Myotomy (G-POEM) in Refractory Gastroparesis

NCT03126513 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2022-01-10

No results posted yet for this study

Summary

Refractory gastroparesis is a disease characterized by a delayed gastric emptying without a mechanical obstruction. Actual treatments have a limited efficacy and gastric per-oral endoscopic myotomy (G-POEM) is a new treatment that has demonstrated initial promising results in these patients. The investigators aims are to evaluate security and efficacy of this endoscopic treatment in participants with refractory gastroparesis.

Conditions

  • Gastroparesis Postoperative
  • Gastroparesis Due to Diabetes Mellitus
  • Idiopathic Gastric Stasis

Interventions

PROCEDURE

G-POEM

After confirmation of refractory gastroparesis, participants will undergo to gastric POEM. Participants will be admitted to hospital 24hrs before procedure and IV antibiotics will be given and then the procedure will be done. Technique consist of 4 steps: First: a submucosa injection of saline solution with methylene blue at 3-4cms from pylorus. Second: a submucosa incision and tunnel creation up to pyloric area. Third: Myotomy of the circular and longitudinal muscular layers of the pylorus and the antrum. Fourth: closure of the mucosal incision with hemoclips. After procedure they will be kept on surveillance and will be followed-up with clinical, endoscopic and scintigraphic studies up to 1 year after procedure.

Sponsors & Collaborators

  • Coordinación de Investigación en Salud, Mexico

    lead OTHER_GOV

Principal Investigators

  • Oscar V Hernandez, MD · IMSS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2020-04-01
Completion
2021-12-27

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03126513 on ClinicalTrials.gov