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

N/ANot Yet RecruitingNCT06943417

International University of Health and Welfare20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Chronic Intestinal Pseudo-obstruction

Interventions

Over the scope clipDEVICE

over the scope clip group

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

International university health and welfare Narita hospital

Narita, Japan

Outcomes

Primary Outcomes

Percentage of total perforations (intraoperative and delayed perforations)

Time frame: Immediately after the intervention

Secondary Outcomes

Intraoperative perforation rate

Time frame: Under procedure

Rate of delayed perforation

Time frame: Periprocedural

Intraoperative complications

Time frame: Under procedure

Intraoperative death rate

Time frame: Under procedure

Examination time

Time frame: Under procedure

Macroscopic specimen size

Time frame: Immediately after procedure

Findings of tissue specimens

Time frame: Immediately after procedure

Whether tissue evaluation is acceptable for biopsy purposes

Central Contacts

Takaomi Kessoku, M.D., Ph.D.

CONTACT

+81-476-35-5600 takaomi0027@gmail.com

Yo Ishihara, M.D.

CONTACT

+81-476-35-5600

Data from ClinicalTrials.gov

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