G-POEM vs PEG-J in Gastroparesis Patients

Sponsor
Maastricht University Medical Center
Study ID
NCT06372132
Status
Recruiting
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Conditions

  • Gastroparesis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • G-POEM — PROCEDURE
    Gastric Per-Oral Endoscopic Pyloromyotomy

Study Details

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.

Key Dates

First listed
Apr 17, 2024
Start date
Mar 14, 2024
Status verified
Apr 2024
Primary completion
Jan 31, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Other: G-POEM
  • Active Comparator: PEG-J

Primary Outcome Measure

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 ]

Central Contacts

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