G-POEM vs PEG-J in Gastroparesis Patients

'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'

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.

Study Overview

• Status: Recruiting
• Conditions: Gastroparesis
• Intervention / Treatment: Procedure: G-POEM

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kim Sweerts; Phone Number: +31 88 388 7298; Email: kim.sweerts@maastrichtuniversity.nl

Study Locations

• Netherlands
  • Zuid-Limburg
    • Maastricht, Zuid-Limburg, Netherlands, 6229 HX
      • Recruiting
      • Maastricht University Medical Center
      • Contact: Kim Sweerts, MD; Phone Number: 0883887298; Email: kim.sweerts@maastrichtuniversity.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: G-POEM	Procedure: G-POEM; Gastric Per-Oral Endoscopic Pyloromyotomy; Other Names: PEG J
Active Comparator: PEG-J	Procedure: G-POEM; Gastric Per-Oral Endoscopic Pyloromyotomy; Other Names: PEG J

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	A treatment success will be defined as a decrease of at least one point on the GCSI (range 0-5), representing a clinically relevant difference, six months after intervention in comparison with baseline before intervention.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 = 12 months.	We hypothesize that the treatment success rate is higher in the G-POEM group in comparison with the PEG-J intervention group twelve months after intervention compared to baseline.	12 months
Degree of quality of life using the PAGI-QOL in the G-POEM group in comparison with the PEG-J intervention six months after intervention.	We hypothesize that quality of life is higher in the G-POEM intervention group compared to the PEG-J intervention group six months after treatment.	6 months
Number and severity of (s)AEs in the treatment groups.	We hypothesize that no severe adverse events take place and the only mild to moderate adverse events that will take place are expected to be abdominal pain, pneumoperitoneum, mucosal injury, or wound infection.	12 months
Predictive value of the etiology of gastroparesis on treatment outcomes following G-POEM by measuring the rate of treatment success quantified by improvements in the GCSI-score.	We hypothesize that differences in etiology can predict treatment success after G-POEM.	6-12 months
Predictive value of the etiology of gastroparesis on treatment outcomes following PEG-J by measuring the rate of treatment success quantified by improvements in the GCSI-score.	We hypothesize that differences in etiology can predict treatment success after PEG-J.	6-12 months

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: NL85305.068.23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No