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Gastroparesis PostoperativeG-POEMNCT03126513

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

A study testing G-POEM in people with Gastroparesis Postoperative and Gastroparesis Due to Diabetes Mellitus, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
G-POEM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteMexico
Study dates
1 Apr 2017to 27 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Pregnancy
  • Portal hypertension
  • Gastric malignant condition
  • Active prepyloric ulcer
  • Mechanical pyloric stenosis

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Centro Medico Nacional Siglo XXI Hospital de Especialidades

    Mexico City, Mexico City, 06700

Other trials in Mexico

About this study

Official title: 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.

Read the 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.

Being tested
G-POEM
Keywords
G-POEM, Safety, Efficacy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • G-POEMProcedure or surgery

    Also called Gastric per-oral endoscopic myotomy

    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.

Study groups in NCT03126513
Study groupRoleWhat they receive
G-POEM in refractory gastroparesisExperimentalParticipants with refractory gastroparesis will be confirmed by endoscopy, clinical and scintigraphy studies.
Receives: Procedure: G-POEM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1, 6 and 12 months

Secondary outcomes (1)

  1. security of G-POEM in gastroparesis

    measured as the presence of complications during or after procedure

    Measured: up to 30 days after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2017
  2. Study start1 Apr 2017
  3. Primary completion1 Apr 2020
  4. Study completion27 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03126513
Sponsor's protocol ID
R-2017-3601-45
Acronym
G-POEM
Status last verified
Jan 2022
First submitted
18 Apr 2017
Last updated
10 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28124202

  • 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.

    PubMed 27354102

  • 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.

    PubMed 27197717

  • 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.

    PubMed 28409375

  • 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.

    PubMed 27556100

  • 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.

    PubMed 27478028

Questions about this trial

What is this clinical trial studying?

A study testing G-POEM in people with Gastroparesis Postoperative and Gastroparesis Due to Diabetes Mellitus, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of G-POEM in gastroparesis in percentage of scintigraphic improvement at 4hrs (time frame: 1, 6 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03126513, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.

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