Safety and Efficacy of Endoscopic Full Thickness Biopsy in Patients With Chronic Intestinal Pseudo-obstruction
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Related Research Topics
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Trial Locations
- Locations (1)
International university health and welfare Narita hospital
🇯🇵Narita, Japan
International university health and welfare Narita hospital🇯🇵Narita, Japan