Trial Investigating Efficacy of G-POEM
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 |
|---|---|---|
|
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
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:
|
Outcome Measures
Primary Outcome Measures
- Changes in gastric emptying [90 days after intervention]
assessed by technetium scintigraphy
Secondary Outcome Measures
- 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.
- Changes in Plasma glucose [90 days after intervention.]
concentration of plasma glucose in mmol/L
- Changes in postprandial incretinhormones [90 days after intervention.]
gastrin, CCK, GIP, GLP-1, GLP-2, glucagon, ghrelin, pancreatic polypeptide (PP)
- Concentration of C-peptide in pmol/L [90 days after intervention.]
Concentration of C-peptide in pmol/L
- 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
- 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
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.- SJ-981