A randomized control trial of efficacy of endoscopic submucosal dissection using an ITknife nano for colorectal neoplasms larger than 30 mm in size

Phase 3

• Conditions: colorectal neoplasms

• Registration Number: JPRN-jRCT1042180137
• Lead Sponsor: Hotta Kinichi

Brief Summary

In colorectal ESD for 30-50 mm colorectal neoplasms, DualKnife plus ITKnife nano did not reduce ESD procedure time.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-27
• Study Completion: 2022-12-16
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

1) Colorectal epitherial neoplasms, including serrated polyps which are larger than 30 mm and smaller than 50 mm. 2) Lesions classified as Laterally spreading tumor (LST). 3) Age at registration is over 20 years old. 4) Written informed consent is obtained.

Exclusion Criteria

1) Submucosal invasive cancer (cT1b). 2) Lesions can not classified as Laterally spreading tumor (LST). 3) Local recurrences/ Scar lesions. 4) Hemorrhagic disease (severe anemia or inflammatory bowel disease etc.) 5) Easy bleeding disorder. 6) Impossible to suspend anticoagulant or antiplatelet medications. 7) Female during pregnancy. 8) Inappropriate cases by investigators.

Study & Design

• Study Type: Interventional
• Study Design: Not specified