G-POEM vs PEG-J in Gastroparesis Patients

Maastricht University Medical Centre (MUMC)

Status: Enrolling

Conditions: Gastroparesis

Treatments: Procedure: G-POEM

Study type: Interventional

Funder types: Other

Identifiers

NCT06372132

NL85305.068.23

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

G-POEM

Other group

Treatment:

Procedure: G-POEM

PEG-J

Active Comparator group

Treatment:

Procedure: G-POEM