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Completed

NCT Number: NCT03126513

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Medico Nacional Siglo XXI Hospital de Especialidades

Mexico City, 06700, Mexico

About this study

Gastroparesis is a chronic, condition characterized by a delayed gastric emptying without a mechanical obstruction. This disease is associated with high morbidity and mortality with a prevalence up to 4% of population. Patients with this disease have a reduced quality of life. The principal etiologies include: post-surgical, diabetes, medications and idiopathic. Symptoms include nausea, vomiting, early satiety, bloating and abdominal pain. Diagnosis is based on the combination of symptoms and studies as gastroscopy that shows retained food in the stomach without a gastric outlet obstruction and confirmed with a gastric emptying scintigraphy. Treatments have limited effect in these patients, including medications, botulinum toxin injection, surgical gastric electrical stimulation, laparoscopic pyloroplasty and stent placement. G-POEM is a new technique based on per-oral endoscopic myotomy treatment in achalasia patients, which has been recently proposed for treatment of patients with refractory gastroparesis with good initial results. The investigators aim is to evaluate the safety and efficacy of this new technique in a group of mexican participants with this disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with refractory gastroparesis based on delayed gastric emptying symptoms: Nausea, retching, vomiting, abdominal pain, early satiety, post-prandial fullness, bloating.
  • Refractoriness defines as the presence of symptoms with failure or recurrence after other type of treatment.
  • Any etiology: diabetes, post-surgical, idiopathic

Exclusion criteria

  • Pregnancy
  • Portal hypertension
  • Gastric malignant condition
  • Active prepyloric ulcer
  • Mechanical pyloric stenosis

Treatment and study plan

G-POEM

Procedure

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.

Other names: Gastric per-oral endoscopic myotomy

Primary outcomes

  1. Efficacy of G-POEM in gastroparesis in percentage of scintigraphic improvement at 4hrs

    Time frame: 1, 6 and 12 months

    The investigators will compare the percentage of improvement in scintigraphy before and after procedure

Secondary outcomes

  1. security of G-POEM in gastroparesis

    Time frame: up to 30 days after procedure

    measured as the presence of complications during or after procedure

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Registry information

Official study title

Safety and Efficacy of Gastric Per Oral Endoscopic Myotomy (G-POEM) in Patients With Refractory Gastroparesis

Acronym: G-POEM

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Apr 24, 2017
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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