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G-POEM vs PEG-J in Gastroparesis Patients

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ClinicalTrials.gov Identifier: NCT06372132
Recruitment Status : Recruiting
First Posted : April 17, 2024
Last Update Posted : April 17, 2024
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Tracking Information
First Submitted Date  ICMJE February 29, 2024
First Posted Date  ICMJE April 17, 2024
Last Update Posted Date April 17, 2024
Actual Study Start Date  ICMJE March 14, 2024
Estimated Primary Completion Date January 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2024)		 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. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2024)
  • 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. [ Time Frame: 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.
  • 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. [ Time Frame: 6 months ]
    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.
  • Number and severity of (s)AEs in the treatment groups. [ Time Frame: 12 months ]
    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.
  • 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. [ Time Frame: 6-12 months ]
    We hypothesize that differences in etiology can predict treatment success after G-POEM.
  • 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. [ Time Frame: 6-12 months ]
    We hypothesize that differences in etiology can predict treatment success after PEG-J.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE G-POEM vs PEG-J in Gastroparesis Patients
Official Title  ICMJE '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'
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastroparesis
Intervention  ICMJE Procedure: G-POEM
Gastric Per-Oral Endoscopic Pyloromyotomy
Other Name: PEG J
Study Arms  ICMJE
  • G-POEM
    Intervention: Procedure: G-POEM
  • Active Comparator: PEG-J
    Intervention: Procedure: G-POEM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2024)		 50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2028
Estimated Primary Completion Date January 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kim Sweerts +31 88 388 7298 kim.sweerts@maastrichtuniversity.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06372132
Other Study ID Numbers  ICMJE NL85305.068.23
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Maastricht University Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Maastricht University Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Maastricht University Medical Center
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP