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Endoscopic Pyloromyotomy for Refractory Gastroparesis (GREG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03356067
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : January 27, 2021
Sponsor:
Collaborators:
Universitätsklinikum Hamburg-Eppendorf
KU Leuven
King's College Hospital NHS Trust
University Hospital Augsburg
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Karolinska Institutet
University of Amsterdam
University Hospital Trnava
Rigshospitalet, Denmark
Comenius University
Pavol Jozef Safarik University
University of Chicago
University of Cluj Napoca
Charles University, Czech Republic
Information provided by (Responsible Party):
Doc. (Ass. prof.) Jan Martinek, MD, PhD, AGAF, Institute for Clinical and Experimental Medicine

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).


Condition or disease Intervention/treatment Phase
Gastroparesis Procedure: Gastric endoscopic peroral pyloromyotomy Procedure: Esophago-gastro-duodenoscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized sham-procedure controlled trial with crossover after 6 months after procedure
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Sham and Cross-Over-Controlled Trial of Per-oral Endoscopic Pyloromyotomy (G-POEM) in Patients With Refractory Gastroparesis
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : December 24, 2020
Actual Study Completion Date : January 26, 2021


Arm Intervention/treatment
Sham Comparator: Esophago-gastro-duodenoscopy
Standard endoscopic examination of the upper GI tract with flexible endoscope.
Procedure: Esophago-gastro-duodenoscopy
Standard endoscopic examination of the upper GI tract with flexible endoscope

Experimental: Gastric endoscopic peroral pyloromyotomy
Experimental per-oral endoscopic myotomy of the pyloric sphincter
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)
Other Name: G-POEM




Primary Outcome Measures :
  1. Main outcome is the proportion of patients with treatment success after the procedure. [ Time Frame: 6 months ]
    Treatment success is defined as a decrease of a total Gastroparesis Cardinal Symptom Index (GCSI) symptom score at least 50% from the baseline


Secondary Outcome Measures :
  1. Proportion of patients with treatment success in the active arm after 3 months [ Time Frame: 3 months ]
    Treatment success is defined as a decrease of a total Gastroparesis Cardinal Symptom Index (GCSI) symptom score at least 50% from the baseline

  2. Proportion of patients with treatment success in the active arm after 12 months [ Time Frame: 12 months ]
    Treatment success is defined as a decrease of a total Gastroparesis Cardinal Symptom Index (GCSI) symptom score at least 50% from the baseline

  3. Proportion of patients with treatment success in the active arm after 24 months [ Time Frame: 24 months ]
    Treatment success is defined as a decrease of a total Gastroparesis Cardinal Symptom Index (GCSI) symptom score at least 50% from the baseline

  4. Proportion of patients with treatment success in the active arm after 36 months [ Time Frame: 36 months ]
    Treatment success is defined as a decrease of a total Gastroparesis Cardinal Symptom Index (GCSI) symptom score at least 50% from the baseline

  5. Proportion of patients with treatment success in the sham group at 3M [ Time Frame: 3 months ]
    Treatment success is defined as a decrease of a total Gastroparesis Cardinal Symptom Index (GCSI) symptom score at least 50% from the baseline

  6. Change in Gastroparesis Cardinal Symptom Index (GCSI) before and after G-POEM at 3, 6, 12, 24 and 36M and before vs. after sham procedure at 3M and 6M; [ Time Frame: 3, 6, 12, 24 and 36 months ]
    Comparison of the change of the scores between the active and sham groups.

  7. Change in The Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) before and after G-POEM at 3, 6, 12, 24 and 36M and before vs. after sham procedure at 3M and 6M; [ Time Frame: 3, 6, 12, 24 and 36 months ]
    Comparison of the change of the scores between the active and sham groups.

  8. Proportion of crossed-over patients with treatment success after 6 moths [ Time Frame: 12 months ]
    Treatment success is defined as a decrease of a total GSCI symptom score at least 50% from the baseline

  9. Change in Gastroparesis Cardinal Symptom Index (GCSI) crossed-over patients after the G-POEM procedure [ Time Frame: 12 months ]
    Comparison of the change of the scores pre and post-procedure

  10. Change in The Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) in crossed-over patients after the G-POEM procedure [ Time Frame: 12 months ]
    Comparison of the change of the scores pre and post-procedure

  11. Subgroup post-hoc analyses of the treatment success and change in symptomatic scores according to etiology of gastroparesis. [ Time Frame: 3, 6, 12, 24 and 36 months ]
    Treatment success is defined as a decrease of a total GSCI symptom score at least 50%, change in GCSI and PAGY-SYM scores

  12. Change in gastric emptying (scintigraphy) study and/or gastric emptying breath test before and after both G-POEM and sham procedure [ Time Frame: 3, 6, 12, 24 and 36 months ]
    Comparison of the mean change of these parameters between active and sham groups.

  13. Procedure details [ Time Frame: 1 month ]
    length of the procedure

  14. Procedural adverse events [ Time Frame: 1 month ]
    perioperative adverse events (complications)

  15. Long term adverse events [ Time Frame: 3, 6, 12, 24 and 36 months ]
    Incidence rate of adverse events in treatment and sham groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356067


Locations
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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Belgium
Department of Hepatogastroenterology at Cliniques universitaires St-Luc, Brussels, Belgium
Brussels, Belgium
Translational Research in GastroIntestinal Disorders, Leuven, Belgium
Leuven, Belgium
Czechia
Institute for Clinical and Experimental Medicine
Prague 4, Prague, Czechia, 14021
University Hospital in Hradec Kralove
Hradec Králové, Czechia, 50005
Denmark
The Department of Surgical Gastroenterology L, Denmark
Aarhus, Denmark
Germany
III. Medizinische Klinik, Medical Center/Klinikum Augsburg, Germany
Augsburg, Germany, 86156
University Medical Center Hamburg- Eppendorf | UKE Department for Interdisciplinary Endoscopy, Germany
Hamburg- Eppendorf, Germany, 20246
Netherlands
Department of Gastroenterology and Hepatology, Amsterdam, The Netherlands
Amsterdam, Netherlands
Romania
Regional Institute of Gastroenterology
Cluj-Napoca, Romania
Slovakia
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
Sweden
Department of Surgical Gastroenterology, Karolinska University Hospital, Stockholm, Sweden
Stockholm, Sweden, 17176
United Kingdom
King's Institute of Therapeutic Endoscopy, London, UK
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Institute for Clinical and Experimental Medicine
Universitätsklinikum Hamburg-Eppendorf
KU Leuven
King's College Hospital NHS Trust
University Hospital Augsburg
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Karolinska Institutet
University of Amsterdam
University Hospital Trnava
Rigshospitalet, Denmark
Comenius University
Pavol Jozef Safarik University
University of Chicago
University of Cluj Napoca
Charles University, Czech Republic
Investigators
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Principal Investigator: 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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Doc. (Ass. prof.) Jan Martinek, MD, PhD, AGAF, Ass. prof., Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier: NCT03356067    
Other Study ID Numbers: IClinicalEM2
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations