Trial Investigating Efficacy of G-POEM

NCT05830994 | Unknown

• 1 other identifier: SJ-981
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroparesis With Diabetes Mellitus

Keywords

gastroparesis; G-POEM; gastric peroral endoscopic myotomy; technetium-scintigraphy

Outcome Measures

Primary Outcomes (1)

• Changes in gastric emptying

  assessed by technetium scintigraphy

  90 days after intervention

Secondary Outcomes (6)

• Changes in gastroparesis cardinal symptom index (GCSI)

  7, 30 and 90 days after intervention.

• Changes in Plasma glucose

  90 days after intervention.

• Changes in postprandial incretinhormones

  90 days after intervention.

• Concentration of C-peptide in pmol/L

  90 days after intervention.

• Changes in continuous glucose

  90 days after intervention.

Study Arms (2)

G-POEM procedure

ACTIVE COMPARATOR

Gastric peroral endoscopic myotomy

Procedure: G-POEM

Sham procedure

PLACEBO COMPARATOR

sham endsocopy with biopsy

Procedure: Sham

Interventions

G-POEM PROCEDURE

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.

G-POEM procedure

Sham PROCEDURE

Endoscopy is performed and tissue samples are collected from fundus and antrum as part of the Sham procedure

Also known as: Endoscopy with tissue sample

Sham procedure

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The ability to give signed written informed consent,
• Patients with diabetes and gastroparesis,
• Age \>18 years,
• Gastroparesis is diagnosed with technetium-scintigraphy,
• Normal gastroscopy,

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Zealand University Hospital: collaborator
• Steno Diabetes Center Copenhagen: collaborator

Study Sites (1)

Melina Svraka Hansen

Hvidovre, Capital Region, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Gastroparesis

Interventions

Pyloromyotomy; salicylhydroxamic acid; Endoscopy; Histocompatibility Testing

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; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Immunologic Tests; Clinical Laboratory Techniques; Investigative Techniques; Immunologic Techniques

Study Officials

• John G Karstensen, MD

  Copenhagen University Hospital, Hvidovre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melina S Hansen, MD

CONTACT

+4528304757; melina.svraka.hansen.01@regionh.dk

John G Karstensen

CONTACT

+4540944465; john.gasdal.karstensen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients and researchers will be blinded to allocation in the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 26, 2023
• Study Start: April 12, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)