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

Not Applicable

Completed

• Conditions: Idiopathic Gastric Stasis; Gastroparesis Postoperative; Gastroparesis Due to Diabetes Mellitus

• Registration Number: NCT03126513
• Lead Sponsor: Coordinación de Investigación en Salud, Mexico

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-04-18
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-24
• Primary Completion: 2020-04-01
• Study Completion: 2021-12-27
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-05
• Last Update Posted: 2022-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy of G-POEM in gastroparesis in percentage of scintigraphic improvement at 4hrs	1, 6 and 12 months	The investigators will compare the percentage of improvement in scintigraphy before and after procedure

Secondary Outcome Measures

Name	Time	Method
security of G-POEM in gastroparesis	up to 30 days after procedure	measured as the presence of complications during or after procedure

Trial Locations

Locations (1)

Centro Medico Nacional Siglo XXI Hospital de Especialidades; 🇲🇽 Mexico, Mexico City, Mexico