Usefulness of cold snare polypectomy for colorectal sessIle serrated lesions with intermediate size: an open-label, multicenter, randomized controlled trial

JRCT ID: jRCT1062230020

Registered date:02/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Colorectal serrated lesion
• Date of first enrollment: 02/06/2023
• Target sample size: 980
• Study type: Interventional
• Intervention(s): Colorectal serrated lesion with 10-20 mm in size is enrolled, and assigned conventional treatment (EMR/HSP/UEMR/tip-in EMR) or novel treatment (CSP).

Outcome(s)

• Primary Outcome: Remnant and recurrence rate within 12 month in all enrolled lesions.

Secondary Outcome

1 Remnant and recurrence rate within 12 month in all eligible lesions
2 Remnant and recurrence rate within 12 month in lesions assigned treatment applied successfully
3 En bloc resection rate
4 R0 resection rate
5 Adverse events rate
6 Success rate of assigned treatment
7 Treatment time

Key inclusion & exclusion criteria

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

Include criteria

1Colorectal serrated lesion, size 10-20 mm in endoscopic image
2More than 20 years of age
3Patients with provided written informed consent

Exclude criteria

1 Suspicious lesion for dysplasia or cancer in endoscopic appearance
2 Recurrent lesion
3 Follow-up is impossible
4 Inflammatory bowel disease or familial adenomatous polyposis
5 Severe blood coagulation dysfunction
6 Severe infectious disease
7 Haemodialysis
8 Continuation of more than two antithrombotic agents during endoscopic resection or requirement of heparin bridging for past comorbid illness
9 Pregnancy
10 Patients judged by the study director or researcher to be ineligible for the study

Related Information

• Primary Sponsor: Yamasaki Yasushi