Study Results
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Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2017-12-01
2021-01-26
Brief Summary
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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).
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Detailed Description
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Recently, a new endoscopic technique, gastric endoscopic per oral pyloromyotomy (G-POEM) has been introduced with promising preliminary results. Uncontrolled studies with so far limited number of patients have demonstrated a significant symptomatic improvement in approximately 70% of patients and improved or normalized of gastric emptying in more than a half of patients after G-POEM. A prospective uncontrolled study suggested that patients with idiopathic or post-surgical gastroparesis experiences higher success rate after G-POEM (70-80%) compared to patients with diabetic gastroparesis (50%).
G-POEM is, in principle, adaptation of POEM (per-oral endoscopic myotomy) in the stomach. POEM is now considered a standard treatment for esophageal achalasia and it has been shown to be safe and effective. In contrast to achalasia, pathophysiology of pyloric function in patients with gastroparesis is less understood and the explanation of how and why G-POEM should work is some-how hypothetical. For example, presumed pylorospasm has not been demonstrated as the predictive factor for treatment success of G-POEM yet. Refractory gastroparesis is often accompanied by psychological or even psychiatric disturbances and hence a placebo" effect of G-POEM cannot be ruled out. Therefore, the real clinical efficacy of G-POEM can only be demonstrated in a clinical randomized sham-controlled trial.
To assess the severity of gastroparesis-related symptoms, the Gastroparesis Cardinal Symptom Index (GCSI) has been developed for this item. The GCSI is part of a larger questionnaire PAGI-SYM (Patient Assessment of Upper Gastrointestinal Symptom severity index) established for assessment of patient-reported symptoms in gastroparesis (dyspepsia and gastroesophageal reflux). PAGI-SYM as well as GCSI subscale scores varied significantly by global disease severity, with higher (worse) scores observed in those subjects who rated their gastroparesis as moderate to severe.
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).
Investigators plan to randomize 86 patients (43 in the active arm, ratio 1:1 active vs. sham). Sample size is calculated based on expected therapeutic success of G-POEM in 50% of patients vs. 20% in the sham group; significance level 0,05; study power 0,8; beta error 0,2; adjustment for 15% expected drop out.
Patients will be randomised in blocks of 6, stratified according to the etiologies: (idiopathic, diabetic, and post-surgical; patients after esophagectomy with gastric pull-through will not be included). Control visits will be scheduled at 3, 6, 12, 24, and 36 months. The primary outcome will be the proportion of patients with treatment success in the active group vs. sham group at 6 months after the procedure. Several secondary outcomes will also be assessed, including procedure-related parameters and safety parameters and change in Gastric Emptying Study (GET) after G-POEM vs. sham. After 6 months, patients randomized to the sham group will be offered G-POEM procedure and further followed up (cross-over part of the study) providing that they did not have a therapeutic effect of the sham procedure.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Esophago-gastro-duodenoscopy
Standard endoscopic examination of the upper GI tract with flexible endoscope.
Esophago-gastro-duodenoscopy
Standard endoscopic examination of the upper GI tract with flexible endoscope
Gastric endoscopic peroral pyloromyotomy
Experimental per-oral endoscopic myotomy of the pyloric sphincter
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)
Interventions
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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)
Esophago-gastro-duodenoscopy
Standard endoscopic examination of the upper GI tract with flexible endoscope
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Universitätsklinikum Hamburg-Eppendorf
OTHER
KU Leuven
OTHER
King's College Hospital NHS Trust
OTHER
University Hospital Augsburg
OTHER
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
OTHER
Karolinska Institutet
OTHER
University of Amsterdam
OTHER
University Hospital Trnava
NETWORK
Rigshospitalet, Denmark
OTHER
Comenius University
OTHER
Pavol Jozef Safarik University
OTHER
University of Chicago
OTHER
University of Cluj Napoca
UNKNOWN
Charles University, Czech Republic
OTHER
Institute for Clinical and Experimental Medicine
OTHER_GOV
Responsible Party
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Doc. (Ass. prof.) Jan Martinek, MD, PhD, AGAF
Ass. prof.
Principal Investigators
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Thomas Rösch, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Hamburg- Eppendorf | UKE Department for Interdisciplinary Endoscopy, Germany
Jan Martinek, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
Locations
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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
Countries
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References
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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.
Other Identifiers
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IClinicalEM2
Identifier Type: -
Identifier Source: org_study_id
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