Endoscopic Pyloromyotomy for Refractory Gastroparesis

Summary

Gastroparesis is a disorder triggered by numerous causes and it is defined by symptoms and with an objective evidence of delayed gastric emptying in the absence of obstruction.

Effective treatment for gastroparesis is challenging especially in patients with severe symptoms. In refractory gastroparesis, endoscopic or surgical treatments may therefore be considered. Endoscopic treatments include intrapyloric injection of botulinum toxin and transpyloric insertion of a metallic stent. Surgical options involve implantation of a gastric "pacemaker" (gastric stimulation), pyloroplasty and subtotal gastrectomy.

Recently, a new endoscopic technique, gastric endoscopic per oral pyloromyotomy (G-POEM) has been introduced with promising preliminary results.

The aim of this prospective, sham-controlled, cross-over study (cross-over for patients randomized to the sham arm) is to compare short and long-term efficacy and safety of G-POEM in patients with refractory gastroparesis. Symptoms and objective parameters of gastric emptying will be the main outcome criteria. The reason of using a sham protocol is to control for the potential confounders (therapeutic effects of touch and belief, which are components of the placebo effect).

Conditions

• Gastroparesis

Interventions

PROCEDURE

Gastric endoscopic peroral pyloromyotomy

G-POEM is, in principle, adaptation of POEM (per-oral endoscopic myotomy) in the stomach. The procedure consists of: 1. Mucosal incision at the greater curvature 3-5 cm from the pylorus 2. Submucosal tunnelling 3. Finding pyloric sphincter 4. Myotomy (2-3 cm) of the pyloric muscle 5. Incision closure (endoclips or suture device)

PROCEDURE

Esophago-gastro-duodenoscopy

Standard endoscopic examination of the upper GI tract with flexible endoscope

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• KU Leuven

  collaborator OTHER

• King's College Hospital NHS Trust

  collaborator OTHER

• University Hospital Augsburg

  collaborator OTHER

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• University of Amsterdam

  collaborator OTHER

• University Hospital Trnava

  collaborator NETWORK

• Rigshospitalet, Denmark

  collaborator OTHER

• Comenius University

  collaborator OTHER

• Pavol Jozef Safarik University

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• University of Cluj Napoca

  collaborator UNKNOWN

• Charles University, Czech Republic

  collaborator OTHER

• Institute for Clinical and Experimental Medicine

  lead OTHER_GOV

Principal Investigators

• Thomas Rösch, MD, PhD · University Medical Center Hamburg- Eppendorf | UKE Department for Interdisciplinary Endoscopy, Germany

• Jan Martinek, MD, PhD · Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-01

Primary Completion

2020-12-24

Completion

2021-01-26

Countries

• United States
• Belgium
• Czechia
• Denmark
• Germany
• Netherlands
• Romania
• Slovakia
• Sweden
• United Kingdom

Study Locations