Multicenter randomized control study of SO clip in colorectal ESD.

JRCT ID: jRCTs052190089

Registered date:25/12/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: colorectal tumor
• Date of first enrollment: 04/03/2020
• Target sample size: 200
• Study type: Interventional
• Intervention(s): SO clip use

Outcome(s)

• Primary Outcome: procedure time

Secondary Outcome

1 en bloc resection rate
2 curative resection rate
3 complications associated with the procedure (intraoperative perforation , delayed perforation , afterbleeding , Post ESD Electrocoagulation Syndrome(PECS).
4 time from starting traction by SO clip to completion of submucosal dissection in test group
5 rate of conversion (cases requiring SO clip in standard group and unnecessary SO clip in test group)
6 rate of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1 over 20 years old
2 colorectal tumor that is ESD-adaptive by lower gastrointestinal endoscopy in accordance with the 2014's colorectal ESD / EMR guidelines (regardless of size,form,circumference,fibrosis)
3 performance status 0-3
4 obtained written informed consent after appropriate explanation prior to study

Exclude criteria

1 tumor suspected of deep submucosal invasion
2 tumor diagnosed as neuroendocrine tumor
3 whole invisible tumor
4 tumor involving in anal, ileum end, appendix vermiformis, diveculum
5 over two colorectal lesions which are adaptive to ESD
6 easy bleeding( Plt<50000uL)
7 Patients taking two or more antiplatelet agents or anticoagulants (excluding warfarin) that cannot be withdrawn, or patients taking warfarin with a PT-INR of 2.6 (PT-INR 3.0 if taken after mitral valve replacement surgery) or higher.
8 severe disease in other organs by ASA classification over class 4
9 pregnancy
10 any other reasons for ineligibility according to investigator judgment

Related Information

• Primary Sponsor: Taki Shinya
• Source(s) of Monetary Support: ZEON MEDICAL INC.