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

NCT03126513 | Completed DMC

• 1 other identifier: R-2017-3601-45
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

G-POEM; Safety; Efficacy

Outcome Measures

Primary Outcomes (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

  1, 6 and 12 months

Secondary Outcomes (1)

• security of G-POEM in gastroparesis

  up to 30 days after procedure

Study Arms (1)

G-POEM in refractory gastroparesis

EXPERIMENTAL

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

Procedure: G-POEM

Interventions

G-POEM PROCEDURE

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.

Also known as: Gastric per-oral endoscopic myotomy

G-POEM in refractory gastroparesis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Centro Medico Nacional Siglo XXI Hospital de Especialidades

Mexico City, Mexico City, 06700, Mexico

Location

Related Publications (6)

• 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.

  PMID: 28124202 RESULT

• 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.

  PMID: 27354102 RESULT

• 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.

  PMID: 27197717 RESULT

• 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.

  PMID: 28409375 RESULT

• 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.

  PMID: 27556100 RESULT

• 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.

  PMID: 27478028 RESULT

MeSH Terms

Interventions

Pyloromyotomy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Digestive System Surgical Procedures; Surgical Procedures, Operative; Gastrectomy; Myotomy

Study Officials

• Oscar V Hernandez, MD

  IMSS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This a prospective study that evaluates G-POEM in a group of participants with diagnosis of refractory gastroparesis. Participants are sequentially recruited as diagnosed.

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 24, 2017
• Study Start: April 1, 2017
• Primary Completion: April 1, 2020
• Study Completion: December 27, 2021
• Last Updated: January 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)