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.

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. - G-POEM vs PEG-J for refractory gastroparesis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56563

Enrollment

Registered

2023-09-13

Start date

2024-03-14

Completion date

Unknown

Last updated

2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroparesis GP

Interventions

&nbsp

Group 1 will receive G-POEM treatment and group 2 will receive PEG-J treatment.&nbsp

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria:  - Patients with therapy refractory gastroparesis - 13C octanoic acid test or gastric scintigraphy (minimal 4-hour measurement)  within the past twelve months  - >= 18 years old 

Exclusion criteria

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 

Design outcomes

Primary

Measure	Time frame
A clinically meaningful treatment success six months after G-POEM treatment, measured using the GCSI-score defined as a decrease of 1 point or more.	—

Secondary

Measure	Time frame
- A clinically meaningful treatment success twelve months after G-POEM treatment, measured using the GCSI defined as a decrease of >= 1 point, measured as a difference between GCSI at t=0 vs t=12 months after intervention. - Quality of life six months after treatment using the PAGI-QOL compared to baseline and 3 month after treatment, determined as the difference between t = 0 months vs t = 3 months and t = 6 months after intervention. - Number and severity of (s)AEs - Etiology characteristics predictive for treatment success after G-POEM. - Etiology characteristics predictive for treatment success after PEG-J. - A clinically meaningful treatment success six months after G-POEM intervention, measured using the modified GCSI (exclusion of question 5 and 6) defined as a decrease of 1 point or more, measured as a difference between GCSI at t = 0 months vs t = 3 month and t = 6 months after intervention. - To investigate predictors for treatment success 6 months after G-POEM by means of Body Surface Gastric Mapping (BSGM) with the Gastric Alimetry system.	—

Measure

Time frame

- A clinically meaningful treatment success twelve months after G-POEM treatment, measured using the GCSI defined as a decrease of >= 1 point, measured as a difference between GCSI at t=0 vs t=12 months after intervention. - Quality of life six months after treatment using the PAGI-QOL compared to baseline and 3 month after treatment, determined as the difference between t = 0 months vs t = 3 months and t = 6 months after intervention. - Number and severity of (s)AEs - Etiology characteristics predictive for treatment success after G-POEM. - Etiology characteristics predictive for treatment success after PEG-J. - A clinically meaningful treatment success six months after G-POEM intervention, measured using the modified GCSI (exclusion of question 5 and 6) defined as a decrease of 1 point or more, measured as a difference between GCSI at t = 0 months vs t = 3 month and t = 6 months after intervention. - To investigate predictors for treatment success 6 months after G-POEM by means of Body Surface Gastric Mapping (BSGM) with the Gastric Alimetry system.

—

Countries

Netherlands

Contacts

Public ContactJ.M. Conchillo

Maastricht Universitair Medisch Centrum +

j.conchillo@mumc.nl+31 43 3875021

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)