G-POEM vs PEG-J in Gastroparesis Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: G-POEM.
- Who it may be relevant to
- Registry conditions: Gastroparesis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
'Treatment Outcome of Gastric Peroral Endoscopic Pyloromyotomy in Comparison With Percutaneous Endoscopic Gastrostomy With Jejunal Extension in Medically Refractory Gastroparesis: a Prospective Randomized Controlled Trial'
Overview
Study design: A randomized non-blinded controlled clinical trial with two study arms (G-POEM and PEG-J). Treatment success is measured using the GCSI at baseline before intervention and six months after intervention with a possible cross-over after six months of follow-up. Study population: 50 patients with therapy refractory GP on dietary advices, prokinetics and possibly tube feeding (gastric rest) who have already been referred for additional treatment options in the form of PEG-J/ G-POEM. Intervention: Group 1 will receive G-POEM treatment and group 2 will receive PEG-J treatment. Main study parameters/endpoints: A clinically meaningful treatment success six months after G-POEM treatment, measured using the GCSI-score defined as a decrease of 1 or more point.
Interventions
- Procedure G-POEM
Gastric Per-Oral Endoscopic Pyloromyotomy
Primary outcome measures
- Number of patients with treatment success using the GCSI-score in patients with refractory GP undergoing G-POEM compared to patients receiving a PEG-J at t = 6 months. [Time frame: 6 months]
Secondary outcome measures (5)
- Number of patients with treatment success using the GCSI-score in patients with refractory GP undergoing G-POEM compared to patients receiving a PEG-J at t = 12 months. [Time frame: 12 months]
- Degree of quality of life using the PAGI-QOL in the G-POEM group in comparison with the PEG-J intervention six months after intervention. [Time frame: 6 months]
- Number and severity of (s)AEs in the treatment groups. [Time frame: 12 months]
- Predictive value of the etiology of gastroparesis on treatment outcomes following G-POEM by measuring the rate of treatment success quantified by improvements in the GCSI-score. [Time frame: 6-12 months]
- Predictive value of the etiology of gastroparesis on treatment outcomes following PEG-J by measuring the rate of treatment success quantified by improvements in the GCSI-score. [Time frame: 6-12 months]
Eligibility criteria
Inclusion criteria
- Patients with GP
- 13C octanoic acid test or gastric scintigraphy (minimal 4-hour measurement) within the past twelve months
- 18 years old
Exclusion criteria
- < 18 years old
- Medical history of stomach surgery in which resection of antrum and/ or pylorus took place
- Medical history of surgical or laparoscopic pyloromyotomy
- Gastric bypass
- Current opioid use
- Pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Maastricht University Medical Center — Maastricht
Identifiers
NCT: NCT06372132 · NL85305.068.23