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Trial record 22 of 43 for:    Recruiting, Not yet recruiting, Available Studies | "Gastroparesis"

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

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ClinicalTrials.gov Identifier: NCT03126513
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gastroparesis Postoperative Gastroparesis Due to Diabetes Mellitus Idiopathic Gastric Stasis Procedure: G-POEM Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Gastric Per Oral Endoscopic Myotomy (G-POEM) in Patients With Refractory Gastroparesis
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: G-POEM in refractory gastroparesis
Participants with refractory gastroparesis will be confirmed by endoscopy, clinical and scintigraphy studies.
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.
Other Name: Gastric per-oral endoscopic myotomy




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126513


Contacts
Contact: Oscar V Hernandez Mondragón, MD +525556276900 ext 21317-8 mondragonmd@yahoo.co.uk
Contact: Raquel Palos Cuellar, Fellow +525556276900 ext 21317-8 palosc5092@gmail.com

Locations
Mexico
Centro Medico Nacional Siglo XXI Hospital de Especialidades Recruiting
Mexico, Mexico City, Mexico, 06700
Contact: Oscar V Hernandez Mondragon, MD    +525556276900 ext 21317-8    mondragonmd@yahoo.co.uk   
Contact: Raquel Palos Cuellar, MD    +525556276900 ext 21317-8    palosc5092@gmail.com   
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
Principal Investigator: Oscar V Hernandez, MD IMSS

Publications of Results:

Responsible Party: Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT03126513     History of Changes
Other Study ID Numbers: R-2017-3601-45
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Coordinación de Investigación en Salud, Mexico:
G-POEM
Safety
Efficacy

Additional relevant MeSH terms:
Gastroparesis
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms