G-POEM vs PEG-J in Gastroparesis Patients

NCT ID: NCT06372132

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-14

Study Completion Date

2028-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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G-POEM

Group Type OTHER

G-POEM

Intervention Type PROCEDURE

Gastric Per-Oral Endoscopic Pyloromyotomy

PEG-J

Group Type ACTIVE_COMPARATOR

G-POEM

Intervention Type PROCEDURE

Gastric Per-Oral Endoscopic Pyloromyotomy

Interventions

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G-POEM

Gastric Per-Oral Endoscopic Pyloromyotomy

Intervention Type PROCEDURE

Other Intervention Names

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PEG J

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maastricht University Medical Center

Maastricht, Zuid-Limburg, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Kim Sweerts

Role: CONTACT

+31 88 388 7298

Facility Contacts

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Kim Sweerts, MD

Role: primary

0883887298

Other Identifiers

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NL85305.068.23

Identifier Type: -

Identifier Source: org_study_id

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