- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03126513
Gastric Per Oral Endoscopic Myotomy (G-POEM) in Refractory Gastroparesis (G-POEM)
January 5, 2022 updated by: Coordinación de Investigación en Salud, Mexico
Safety and Efficacy of Gastric Per Oral Endoscopic Myotomy (G-POEM) in Patients With 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
82
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Mexico City
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Mexico, Mexico City, Mexico, 06700
- Centro Medico Nacional Siglo XXI Hospital de Especialidades
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: G-POEM in refractory gastroparesis
Participants with refractory gastroparesis will be confirmed by endoscopy, clinical and scintigraphy studies.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of G-POEM in gastroparesis in percentage of scintigraphic improvement at 4hrs
Time Frame: 1, 6 and 12 months
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The investigators will compare the percentage of improvement in scintigraphy before and after procedure
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1, 6 and 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
security of G-POEM in gastroparesis
Time Frame: up to 30 days after procedure
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measured as the presence of complications during or after procedure
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up to 30 days after procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Oscar V Hernandez, MD, IMSS
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Khashab MA, Ngamruengphong S, Carr-Locke D, Bapaye A, Benias PC, Serouya S, Dorwat S, Chaves DM, Artifon E, de Moura EG, Kumbhari V, Chavez YH, Bukhari M, Hajiyeva G, Ismail A, Chen YI, Chung H. Gastric per-oral endoscopic myotomy for refractory gastroparesis: results from the first multicenter study on endoscopic pyloromyotomy (with video). Gastrointest Endosc. 2017 Jan;85(1):123-128. doi: 10.1016/j.gie.2016.06.048. Epub 2016 Jun 25.
- Ahuja NK, Clarke JO. Pyloric Therapies for Gastroparesis. Curr Treat Options Gastroenterol. 2017 Mar;15(1):230-240. doi: 10.1007/s11938-017-0124-4.
- Mekaroonkamol P, Li LY, Dacha S, Xu Y, Keilin SD, Willingham FF, Cai Q. Gastric peroral endoscopic pyloromyotomy (G-POEM) as a salvage therapy for refractory gastroparesis: a case series of different subtypes. Neurogastroenterol Motil. 2016 Aug;28(8):1272-7. doi: 10.1111/nmo.12854. Epub 2016 May 15.
- Xue HB, Fan HZ, Meng XM, Cristofaro S, Mekaroonkamol P, Dacha S, Li LY, Fu XL, Zhan SH, Cai Q. Fluoroscopy-guided gastric peroral endoscopic pyloromyotomy (G-POEM): a more reliable and efficient method for treatment of refractory gastroparesis. Surg Endosc. 2017 Nov;31(11):4617-4624. doi: 10.1007/s00464-017-5524-y. Epub 2017 Apr 13.
- Geyl S, Legros R, Charissou A, Mesturoux L, Couquet CY, Carrier P, Brayette A, El-Ouafi Z, Loustaud-Ratti V, Sautereau D, Monteil J, Jacques J. Peroral endoscopic pyloromyotomy accelerates gastric emptying in healthy pigs: proof of concept. Endosc Int Open. 2016 Jul;4(7):E796-9. doi: 10.1055/s-0042-108192. Epub 2016 Jun 29.
- Gonzalez JM, Lestelle V, Benezech A, Cohen J, Vitton V, Grimaud JC, Barthet M. Gastric per-oral endoscopic myotomy with antropyloromyotomy in the treatment of refractory gastroparesis: clinical experience with follow-up and scintigraphic evaluation (with video). Gastrointest Endosc. 2017 Jan;85(1):132-139. doi: 10.1016/j.gie.2016.07.050. Epub 2016 Jul 28.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2017
Primary Completion (Actual)
April 1, 2020
Study Completion (Actual)
December 27, 2021
Study Registration Dates
First Submitted
April 18, 2017
First Submitted That Met QC Criteria
April 20, 2017
First Posted (Actual)
April 24, 2017
Study Record Updates
Last Update Posted (Actual)
January 10, 2022
Last Update Submitted That Met QC Criteria
January 5, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-2017-3601-45
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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