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NCT Number: NCT06943417

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

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

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Key information

Conditions

Chronic Intestinal Pseudo-obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International university health and welfare Narita hospital

Narita, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Over the scope clip

Device

over the scope clip group

Primary outcomes

  1. Percentage of total perforations (intraoperative and delayed perforations)

    Time frame: Immediately after the intervention

    Percentage of total perforations (intraoperative and delayed perforations)

Secondary outcomes

  1. Intraoperative perforation rate

    Time frame: Under procedure

    Intraoperative perforation rate

  2. Rate of delayed perforation

    Time frame: Periprocedural

    Rate of delayed perforation

  3. Intraoperative complications

    Time frame: Under procedure

    Intraoperative complications

  4. Intraoperative death rate

    Time frame: Under procedure

    Intraoperative death rate

  5. Examination time

    Time frame: Under procedure

    Examination time

  6. Macroscopic specimen size

    Time frame: Immediately after procedure

    Macroscopic specimen size

  7. Findings of tissue specimens

    Time frame: Immediately after procedure

    Findings of tissue specimens

  8. Whether tissue evaluation is acceptable for biopsy purposes

    Time frame: Immediately after procedure

    Whether tissue evaluation is acceptable for biopsy purposes

  9. Ratio of postoperative complications

    Time frame: Immediately after procedure

    Ratio of postoperative complications

  10. 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

  11. 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

  12. Length of hospital stay

    Time frame: From date of procedure until the date of discharge assessed up to 12 months

    Length of hospital stay

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+81-476-35-5600 ext. 900538

Yo Ishihara, M.D.

CONTACT

+81-476-35-5600

Sponsors and collaborators

Lead sponsor

International University of Health and Welfare

Other

Registry information

Official study title

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

Acronym: EFTB-CIPO

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Apr 24, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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