Safety and efficacy of biopsy technique using over the scope clip in high-risk patients for gastrointestinal endoscopic biopsy: a single-center, single-arm, open-label, interventional study

Safety and efficacy of biopsy technique using over the scope clip in high-risk patients for gastrointestinal endoscopic biopsy: a single-center, single-arm, open-label, interventional study - Safety and efficacy of biopsy technique using over the scope clip in high-risk patients for gastrointestinal endoscopic biopsy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000057267

Enrollment

Registered

2025-03-15

Start date

2025-03-15

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal biopsy high-risk cases

Interventions

Perform a endoscopic biopsy with prophylactic use of an over the scope clip (OTSC).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients at risk for gastrointestinal biopsy (chronic pseudo intestinal obstruction, giant colon disease, inflammatory bowel disease, patients with colonic diverticulum disease, etc.) (2) Patients who are at least 18 years old at the time of consent (3) Gender: Any

Exclusion criteria

Exclusion criteria: (1) Patients for whom it is difficult to perform endoscopy (2) Patients who cannot obtain consent (3) Patients with serious renal, hepatic, or cardiac disease (4) Patients who are participating in other clinical studies. (4) Patients who are participating in other clinical research, except for observational research. (5) Other patients whom the principal investigator or subinvestigator determines to be inappropriate to conduct this study.

Design outcomes

Primary

Measure	Time frame
Percentage of total perforations (intraoperative and delayed perforations)	—

Secondary

Measure	Time frame
Intraoperative perforation rate Rate of delayed perforation Intraoperative complications Intraoperative death rate Examination time Macroscopic specimen size Macroscopic specimen findings Findings of tissue specimens Whether tissue evaluation is acceptable for biopsy purposes Ratio of postoperative complications Ratio of postoperative complications Time or days of fluid intake postoperatively Time or number of days of food intake after surgery Length of hospital stay Abdominal symptons	—

Measure

Time frame

Intraoperative perforation rate Rate of delayed perforation Intraoperative complications Intraoperative death rate Examination time Macroscopic specimen size Macroscopic specimen findings Findings of tissue specimens Whether tissue evaluation is acceptable for biopsy purposes Ratio of postoperative complications Ratio of postoperative complications Time or days of fluid intake postoperatively Time or number of days of food intake after surgery Length of hospital stay Abdominal symptons

—

Countries

Japan

Contacts

Public ContactTakaomi Kessoku

International university health and welfare Narita hospitall Palliative medicine and Gastroenterology

takaomi0027@gmail.com0476355600

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026