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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastroparesis Postoperative, Gastroparesis Due to Diabetes Mellitus, Idiopathic Gastric Stasis

Intervention / Treatment
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* Procedure: G-POEM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This a prospective study that evaluates G-POEM in a group of participants with diagnosis of refractory gastroparesis. Participants are sequentially recruited as diagnosed.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G-POEM in refractory gastroparesis<br>Participants with refractory gastroparesis will be confirmed by endoscopy, clinical and scintigraphy studies. | Procedure: G-POEM<br>* 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.<br>* Other names: Gastric per-oral endoscopic myotomy;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| security of G-POEM in gastroparesis | measured as the presence of complications during or after procedure | up to 30 days after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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G-POEM, Safety, Efficacy