Safety and Efficacy of Endoscopic Full Thickness Biopsy in Patients With Chronic Intestinal Pseudo-obstruction

Not Applicable

Not yet recruiting

• Conditions: Chronic Intestinal Pseudo-obstruction

• Registration Number: NCT06943417
• Lead Sponsor: International University of Health and Welfare

Brief Summary

To evaluate the safety and efficacy of endoscopic full thickness biopsy for the diagnostic purpose of chronic intestinal pseudo-obstruction.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-13
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-16
• Last Update Submitted: 2025-04-16
• Study First Posted: 2025-04-24
• Last Update Posted: 2025-04-24
• Study Start: 2025-06-01
• Primary Completion: 2030-02
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients with chronic pseudo intestinal obstruction or suspected chronic pseudo intestinal obstruction
• Patients who are 18 years of age or older at the time of obtaining consent
• Gender: Any

Exclusion Criteria

• Patients for whom it is difficult to perform endoscopy
• Patients who cannot obtain consent
• Patients with serious renal, hepatic, or cardiac disease
• Patients who are participating in other clinical research, except for observational research.
• Other patients whom the principal investigator or subinvestigator determines to be inappropriate to conduct this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of total perforations (intraoperative and delayed perforations)	Immediately after the intervention	Percentage of total perforations (intraoperative and delayed perforations)

Secondary Outcome Measures

Name	Time	Method
Whether tissue evaluation is acceptable for biopsy purposes	Immediately after procedure	Whether tissue evaluation is acceptable for biopsy purposes
Ratio of postoperative complications	Immediately after procedure	Ratio of postoperative complications
Time or days of fluid intake postoperatively	From date of procedure until the date of first fluid intake assessed up to 12 months	Time or days of fluid intake postoperatively
Time or number of days of food intake after procedure	From date of procedure until the date of first food intake assessed up to 12 months	Time or number of days of food intake after procedure
Length of hospital stay	From date of procedure until the date of discharge assessed up to 12 months	Length of hospital stay
Intraoperative perforation rate	Under procedure	Intraoperative perforation rate
Rate of delayed perforation	Periprocedural	Rate of delayed perforation
Intraoperative complications	Under procedure	Intraoperative complications
Intraoperative death rate	Under procedure	Intraoperative death rate
Examination time	Under procedure	Examination time
Macroscopic specimen size	Immediately after procedure	Macroscopic specimen size
Findings of tissue specimens	Immediately after procedure	Findings of tissue specimens

Trial Locations

Locations (1)

International university health and welfare Narita hospital; 🇯🇵 Narita, Japan