Endoscopic Pyloromyotomy for Refractory Gastroparesis

NCT03356067 | Completed DMC

• 1 other identifier: IClinicalEM2
• Study Type: interventional
• Target: 42
• Locations: 10 countries
• Sites: 14

Brief 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

Outcome Measures

Primary Outcomes (1)

• Main outcome is the proportion of patients with treatment success after the procedure.

  Treatment success is defined as a decrease of a total Gastroparesis Cardinal Symptom Index (GCSI) symptom score at least 50% from the baseline

  6 months

Secondary Outcomes (15)

• Proportion of patients with treatment success in the active arm after 3 months

  3 months

• Proportion of patients with treatment success in the active arm after 12 months

  12 months

• Proportion of patients with treatment success in the active arm after 24 months

  24 months

• Proportion of patients with treatment success in the active arm after 36 months

  36 months

• Proportion of patients with treatment success in the sham group at 3M

  3 months

Study Arms (2)

Esophago-gastro-duodenoscopy

SHAM COMPARATOR

Standard endoscopic examination of the upper GI tract with flexible endoscope.

Procedure: Esophago-gastro-duodenoscopy

Gastric endoscopic peroral pyloromyotomy

EXPERIMENTAL

Experimental per-oral endoscopic myotomy of the pyloric sphincter

Procedure: Gastric endoscopic peroral pyloromyotomy

Interventions

Gastric endoscopic peroral pyloromyotomy PROCEDURE

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)

Also known as: G-POEM

Gastric endoscopic peroral pyloromyotomy

Esophago-gastro-duodenoscopy PROCEDURE

Standard endoscopic examination of the upper GI tract with flexible endoscope

Esophago-gastro-duodenoscopy

Eligibility Criteria

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

You may qualify if:

• Refractory (\> 6 months) and severe (based on a validated total GSCI = Gastroparesis Cardinal Symptom Index) gastroparesis, with confirmed gastric emptying based on a gastric emptying study: standardized protocol of scintigraphy in all patients (performed less than 4 months prior to enrolment), or confirmed by a validated gastric emptying breath test \[27\]. The total GSCI score must be \>2.3 \[28\].
• Abnormal gastric emptying is defined as retention of Tc-99 m \>60% at 2 h and/or ≥10% of residual activity at 4 h on a standardized sulphur colloid solid-phase gastric emptying study.
• Radiolabelled liquids emptying study will be reserved as alternative technique for patients with poor tolerance of solids during scintigraphy. Abnormal gastric emptying will represent \>50% retention of radiolabelled content (e.g. In-111) at 1 hour.
• Abnormal gastric empyting breath test based on a solid normal range determination for the test used (e.g. T1/2 \> 109 min)

You may not qualify if:

• Age less than 18 years
• No previous attempt with at least one prokinetic drug
• No previous attempt to withdraw anticholinergic agents and glucagon like peptide -1 (GLP-1) and amylin analogues\* in patients treated with these substances
• Active treatment with opioids or a history of treatment with opioids within 12 months before enrolment.
• Previous gastric surgery BI or II, esophagectomy, gastric pull-through
• Previous pyloromyotomy or pyloroplasty
• Known eosinophilic gastroenteritis
• Organic pyloric (or intestinal) obstruction (fibrotic stricture, etc.)
• Severe coagulopathy
• Esophageal or gastric varices and /or portal hypertensive gastropathy
• Advanced liver cirrhosis (Child B or Child C)
• Active peptic ulcer disease
• Pregnancy or puerperium
• Malignant or pre-malignant gastric diseases (dysplasia, gastric cancer, GIST)
• Any other condition, which in the opinion of the investigator would interfere with study requirements

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• KU Leuven: collaborator
• King's College Hospital NHS Trust: collaborator
• University Hospital Augsburg: collaborator
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: collaborator
• Karolinska Institutet: collaborator
• University of Amsterdam: collaborator
• University Hospital Trnava: collaborator
• Rigshospitalet, Denmark: collaborator
• Comenius University: collaborator
• Pavol Jozef Safarik University: collaborator
• University of Chicago: collaborator
• University of Cluj Napoca: collaborator
• Charles University, Czech Republic: collaborator

Study Sites (14)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Department of Hepatogastroenterology at Cliniques universitaires St-Luc, Brussels, Belgium

Brussels, Belgium

Location

Translational Research in GastroIntestinal Disorders, Leuven, Belgium

Leuven, Belgium

Location

Institute for Clinical and Experimental Medicine

Prague, Prague, 14021, Czechia

Location

University Hospital in Hradec Kralove

Hradec Králové, 50005, Czechia

Location

The Department of Surgical Gastroenterology L, Denmark

Aarhus, Denmark

Location

III. Medizinische Klinik, Medical Center/Klinikum Augsburg, Germany

Augsburg, 86156, Germany

Location

University Medical Center Hamburg- Eppendorf | UKE Department for Interdisciplinary Endoscopy, Germany

Hamburg- Eppendorf, 20246, Germany

Location

Department of Gastroenterology and Hepatology, Amsterdam, The Netherlands

Amsterdam, Netherlands

Location

Regional Institute of Gastroenterology

Cluj-Napoca, Romania

Location

Jesenius Faculty of Medicine in Martin, Clinic of Gastroenterological Internal Medicine, Slovak Republic

Martin, Slovakia

Location

Department of Internal Medicine, University Hospital Trnava, Slovak Republic

Trnava, Slovakia

Location

Department of Surgical Gastroenterology, Karolinska University Hospital, Stockholm, Sweden

Stockholm, 17176, Sweden

Location

King's Institute of Therapeutic Endoscopy, London, UK

London, SE5 9RS, United Kingdom

Location

Related Publications (1)

• Martinek J, Hustak R, Mares J, Vackova Z, Spicak J, Kieslichova E, Buncova M, Pohl D, Amin S, Tack J. Endoscopic pyloromyotomy for the treatment of severe and refractory gastroparesis: a pilot, randomised, sham-controlled trial. Gut. 2022 Nov;71(11):2170-2178. doi: 10.1136/gutjnl-2022-326904. Epub 2022 Apr 25.

  PMID: 35470243 DERIVED

MeSH Terms

Conditions

Gastroparesis

Interventions

Pyloromyotomy

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Thomas Rösch, MD, PhD

  University Medical Center Hamburg- Eppendorf | UKE Department for Interdisciplinary Endoscopy, Germany

  PRINCIPAL INVESTIGATOR

• Jan Martinek, MD, PhD

  Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. prof.

Model Details: Randomized sham-procedure controlled trial with crossover after 6 months after procedure

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 29, 2017
• Study Start: December 1, 2017
• Primary Completion: December 24, 2020
• Study Completion: January 26, 2021
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

DK (1); NL (1); BE (2); RO (1); SL (2); US (1); SE (1); CZ (2); GB (1); DE (2)