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

Coordinación de Investigación en Salud, Mexico

Status: Completed

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

Treatments: Procedure: G-POEM

Study type: Interventional

Funder types: Other

Identifiers

NCT03126513

R-2017-3601-45

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 1 patient group

G-POEM in refractory gastroparesis

Experimental group

Description:

Participants with refractory gastroparesis will be confirmed by endoscopy, clinical and scintigraphy studies.

Treatment:

Procedure: G-POEM