'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'

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with GP

• 13C octanoic acid test or gastric scintigraphy (minimal 4-hour measurement) within the past twelve months

• 18 years old

Locations
Other Locations
Netherlands
Maastricht University Medical Center
RECRUITING
Maastricht
Contact Information
Primary
Kim Sweerts
kim.sweerts@maastrichtuniversity.nl
+31 88 388 7298
Time Frame
Start Date: 2024-03-14
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 50
Treatments
Other: G-POEM
Active_comparator: PEG-J
Related Therapeutic Areas
Sponsors
Leads: Maastricht University Medical Center

This content was sourced from clinicaltrials.gov