Trial Investigating Efficacy of G-POEM

Sponsor
Hvidovre University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05830994
Collaborator
Zealand University Hospital (Other), Steno Diabetes Center Copenhagen (Other)
20
1
2
25.7
0.8

Study Details

Study Description

Brief Summary

The goal of this randomized sham-controlled trial is to ivestigate efficacy and safety of G-POEM in treatment of diabetic gastroparesis and explore impact of G-POEM on glucose metabolism and incretine hormones.

Condition or Disease Intervention/Treatment Phase
  • Procedure: G-POEM
  • Procedure: Sham
N/A

Detailed Description

Study Design The study is a single-centre double-blinded sham-controlled randomized trial. All patients have the same baseline characterization. Patients and researchers will be blinded to allocation in trial. Before randomization patients will have an additional meal test performed addressing metabolic characterization of the incretine hormones at baseline. Patients will afterwards be allocated to either the group receiving G-POEM or to the control group where a sham procedure consisting of a gastroscopy with biopsy during general anaesthesia will be done. The randomization will be carried out per-operatively. A computer-generated bloc randomization with sizes of four will be applied. The study will consist of 5 study visits, with a follow-up of 90 days after procedure. Symptoms and adverse event will be monitored 7, 30, and 90 days after intervention. During the 90-day follow-up all primary and secondary outcome will be reassessed.

G-POEM procedure is carried out in general anaesthesia in the operating theatre at the Department of Surgery, Hvidovre Hospital. Procedures will be performed by experienced surgeons from the Gastro Unit at Hvidovre Hospital,who postoperatively will have no contact with the research team or study participants. Patients will receive the same care during hospitalization.

Patients allocated to sham procedure will have 4 mucosa biopsies from antrum. All biopsies will be handled with formalin and transported to Zealand University Hospital. Here they will be formalin fixed paraffin-embedded and kept in a biobank.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients will be allocated to either the group receiving G-POEM or to the control group where a sham procedure consisting of a gastroscopy with biopsy during general anaesthesia will be done. The randomization will be carried out per-operatively. A computer-generated bloc randomization with sizes of four will be applied.Patients will be allocated to either the group receiving G-POEM or to the control group where a sham procedure consisting of a gastroscopy with biopsy during general anaesthesia will be done. The randomization will be carried out per-operatively. A computer-generated bloc randomization with sizes of four will be applied.
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Patients and researchers will be blinded to allocation in the trial.
Primary Purpose:
Treatment
Official Title:
Randomized Sham-controlled Trial Investigating Efficacy of Gastric Peroral Endoscopic Myotomy in Treatment of Diabetic Gastroparesis
Actual Study Start Date :
Apr 12, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: G-POEM procedure

Gastric peroral endoscopic myotomy

Procedure: G-POEM
An Endoscopic submucosal tunnel is formed and extended to the first part of the duodenum, followed by a pyloromyotomy, beginning approximately two centimetres proximal to the pylorus and ending in the first part of duodenum.

Placebo Comparator: Sham procedure

sham endsocopy with biopsy

Procedure: Sham
Endoscopy is performed and tissue samples are collected from fundus and antrum as part of the Sham procedure
Other Names:
  • Endoscopy with tissue sample
  • Outcome Measures

    Primary Outcome Measures

    1. Changes in gastric emptying [90 days after intervention]

      assessed by technetium scintigraphy

    Secondary Outcome Measures

    1. Changes in gastroparesis cardinal symptom index (GCSI) [7, 30 and 90 days after intervention.]

      patient-rated gastroparesis cardinal symptom index score for gastroparesis-related symptoms (naseau, vomiting, early satiety, postprandial fulness, upper abdominal pain). Range from 0-none to 5-very servere.

    2. Changes in Plasma glucose [90 days after intervention.]

      concentration of plasma glucose in mmol/L

    3. Changes in postprandial incretinhormones [90 days after intervention.]

      gastrin, CCK, GIP, GLP-1, GLP-2, glucagon, ghrelin, pancreatic polypeptide (PP)

    4. Concentration of C-peptide in pmol/L [90 days after intervention.]

      Concentration of C-peptide in pmol/L

    5. Changes in continuous glucose [90 days after intervention.]

      Measure of 10-days interstitial glucose levels with a Dexcom monitor device attached to the abdominal skin

    6. Incidence of Treatment-Emergent Adverse Events rated by the ASGE lexicon for adverse events [7,30 and 90 days]

      rate and severity of adverse events rated by the ASGE lexicon for adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • The ability to give signed written informed consent,

    • Patients with diabetes and gastroparesis,

    • Age >18 years,

    • Gastroparesis is diagnosed with technetium-scintigraphy,

    • Normal gastroscopy,

    Exclusion Criteria:
    • Ongoing cancer treatment or other concurrent illness that will make the patient unable to attend the study on the discretion of the investigator,

    • Recent gastrointestinal surgery,

    • Active duodenal/gastric ulcer disease,

    • Diseases in the ventricle or previously complicated upper abdominal surgery,

    • Previous bariatric surgery,

    • Pregnancy or breastfeeding,

    • Parkinson disease,

    • Persons who, in the judgement of the investigator, may be unable to follow the protocol, Use of metoclopramide, domperidone, prucalopride, ghrelin, macrolide antibiotics (eg, azithromycin, clarithromycin, erythromycin) during study period.

    • drugs with an anti-cholinergic mechanism,

    • Use of motility slowing agents: anticholinergic agents, calcium channel blockers, TCA, GLP-1 analogs, Lithium, diphenhydramin, glucagon, dopamine agonists, progesterone, L-dopa, calcitonine, octreotide, interferon alfa, sucralsulfate,

    • botulinum toxin injections (eg, Botox┬«) by pyloric injection less than 4 months prior to procedure

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Melina Svraka Hansen Hvidovre Region Hovedstaden Denmark 2650

    Sponsors and Collaborators

    • Hvidovre University Hospital
    • Zealand University Hospital
    • Steno Diabetes Center Copenhagen

    Investigators

    • Principal Investigator: John G Karstensen, MD, Copenhagen University Hospital, Hvidovre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Melina Svraka Hansen, Principal Investigator, Hvidovre University Hospital
    ClinicalTrials.gov Identifier:
    NCT05830994
    Other Study ID Numbers:
    • SJ-981
    First Posted:
    Apr 26, 2023
    Last Update Posted:
    Apr 26, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Melina Svraka Hansen, Principal Investigator, Hvidovre University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 26, 2023