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NCT Number: NCT06372132

G-POEM vs PEG-J in Gastroparesis Patients

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.

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Key information

Conditions

Gastroparesis Digestive System Diseases Gastrointestinal Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Zuid-Limburg, 6229 HX, Netherlands

Location status: Recruiting

Location contact

Kim Sweerts, MD

CONTACT

[email protected]

0883887298

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

G-POEM

Procedure

Gastric Per-Oral Endoscopic Pyloromyotomy

Other names: PEG J

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kim Sweerts

CONTACT

[email protected]

+31 88 388 7298

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

'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'

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Apr 17, 2024
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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