G-POEM vs PEG-J in Gastroparesis Patients

Gastroparesis Clinical Trial

Official 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'

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06372132
• Other study ID #: NL85305.068.23
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2024
• Est. completion date: January 1, 2028

Study information

• Verified date: April 2024
• Source: Maastricht University Medical Center
• Contact: Kim Sweerts
• Phone: +31 88 388 7298
• Email: kim.sweerts[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 1, 2028
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Procedure:
• G-POEM
Gastric Per-Oral Endoscopic Pyloromyotomy

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Zuid-Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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