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

April 16, 2025 updated by: International University of Health and Welfare

Safety and Efficacy of Endoscopic Full Thickness Biopsy With Over the Scope Clip in Patients With Chronic Intestinal Pseudo-obstruction: A Single-Center, Single-Arm, Open-label, Interventional Trial

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yo Ishihara, M.D.
  • Phone Number: +81-476-35-5600

Study Locations

  • Japan
      • Narita, Japan
        • International university health and welfare Narita hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Over the scope clip
Device: Over the scope clip
over the scope clip group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of total perforations (intraoperative and delayed perforations)
Time Frame: Immediately after the intervention
Percentage of total perforations (intraoperative and delayed perforations)
Immediately after the intervention

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International University of Health and Welfare

Investigators

  • Principal Investigator: Takaomi Kessoku, M.D., Ph.D., International University of Health and Welfare Narita Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-CN-021
  • UMIN000057266 (Registry Identifier: UMIN-CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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