Endoscopic Pyloromyotomy for Refractory Gastroparesis

Completed · Not applicable · Has a placebo group

Conditions studied: Gastroparesis

In brief

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).

Key facts

Study ID

NCT03356067

Run by

Institute for Clinical and Experimental Medicine

People needed

42

Starts

2017-12-01

Expected to finish

2021-01-26

Last updated by the study team

2021-01-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Uncontrolled diabetes mellitus
• Diagnosis of rumination syndrome or "eating" disorder (mental anorexia, bulimia nervosa) **
• Severe constipation without using laxatives
• Inability to obtain informed consent

Where it is running

• University of Chicago — Chicago, Illinois, United States
• Department of Hepatogastroenterology at Cliniques universitaires St-Luc, Brussels, Belgium — Brussels, Belgium
• Translational Research in GastroIntestinal Disorders, Leuven, Belgium — Leuven, Belgium
• Institute for Clinical and Experimental Medicine — Prague, Prague, Czechia
• University Hospital in Hradec Kralove — Hradec Králové, Czechia
• The Department of Surgical Gastroenterology L, Denmark — Aarhus, Denmark
• III. Medizinische Klinik, Medical Center/Klinikum Augsburg, Germany — Augsburg, Germany
• University Medical Center Hamburg- Eppendorf | UKE Department for Interdisciplinary Endoscopy, Germany — Hamburg- Eppendorf, Germany
• Department of Gastroenterology and Hepatology, Amsterdam, The Netherlands — Amsterdam, Netherlands
• Regional Institute of Gastroenterology — Cluj-Napoca, Romania
• Jesenius Faculty of Medicine in Martin, Clinic of Gastroenterological Internal Medicine, Slovak Republic — Martin, Slovakia
• Department of Internal Medicine, University Hospital Trnava, Slovak Republic — Trnava, Slovakia
• Department of Surgical Gastroenterology, Karolinska University Hospital, Stockholm, Sweden — Stockholm, Sweden
• King's Institute of Therapeutic Endoscopy, London, UK — London, United Kingdom

Full record on ClinicalTrials.gov

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