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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

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
NameTimeMethod
Percentage of total perforations (intraoperative and delayed perforations)Immediately after the intervention

Percentage of total perforations (intraoperative and delayed perforations)

Secondary Outcome Measures
NameTimeMethod
Whether tissue evaluation is acceptable for biopsy purposesImmediately after procedure

Whether tissue evaluation is acceptable for biopsy purposes

Ratio of postoperative complicationsImmediately after procedure

Ratio of postoperative complications

Time or days of fluid intake postoperativelyFrom 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 procedureFrom 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 stayFrom date of procedure until the date of discharge assessed up to 12 months

Length of hospital stay

Intraoperative perforation rateUnder procedure

Intraoperative perforation rate

Rate of delayed perforationPeriprocedural

Rate of delayed perforation

Intraoperative complicationsUnder procedure

Intraoperative complications

Intraoperative death rateUnder procedure

Intraoperative death rate

Examination timeUnder procedure

Examination time

Macroscopic specimen sizeImmediately after procedure

Macroscopic specimen size

Findings of tissue specimensImmediately after procedure

Findings of tissue specimens

Trial Locations

Locations (1)

International university health and welfare Narita hospital

🇯🇵

Narita, Japan

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