SOUTEN trial

JRCT ID: jRCTs042200033

Registered date:20/07/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: colorectal adenoma, adenocarcinoma, serrated polyps
• Date of first enrollment: 08/11/2022
• Target sample size: 352
• Study type: Interventional

Intervention(s)

ESD arm: endoscopic removal by standard ESD using a dedicated knife
Hybrid ESD arm: endoscopic removal by Hybrid ESD using the multi-functional snare (SOUTEN)

Outcome(s)

• Primary Outcome: en bloc R0 resection rate

Secondary Outcome

i) Mean procedure time
ii) En bloc R0 resection rate adjusted by location and macroscopic type
iii) En bloc R0 resection rate in protruded and flat-elevated /sessile lesions
iv) En bloc resection rate
v) Medical cost for assigned treatment
vi) Adverse events including intraprocedural perforation, delayed perforation, delayed bleeding, and post-endoscopic resection coagulation syndrome

Key inclusion & exclusion criteria

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

Include criteria

i) Patients are at least twenty years old at the time of obtaining consent
ii) Patients have non-pedunculated colorectal neoplasms, 20 to 30 mm in size
iii) Patients are performance status of zero or one
iv) Patients can be followed up for post operative twenty eight days
v) Patients provided a written consent based on the patients free will after he or she has a thorough understanding of the instructions given regarding study participation

• Exclude criteria: Patients i) with a history of enrolment in this study, ii) with inflammatory bowel disease or polyposis syndrome, iii) with continuous steroid administration, iv) taking antithronbotic therapy with infeasibility of suspending antithronboticdrugs, v) with blood coagulation disorder, renal failure requring dialysis, or respiratory disease requring oxygen therapy, vi) with pregnancy, vii) with significant mental disorder, viii) with infectious disease requring sistemic therapy, ix) with other invasive colorectal cancer, x) with possible previous treatment, xi) who are determined to be unfit for study by an investigator

Related Information

• Primary Sponsor: Imai Kenichiro
• Secondary Sponsor: Tanaka Shinji,Yamano Hiro-o
• Source(s) of Monetary Support: Kaneka Corporation