Skip to content

SOUTEN trial

A randomized controlled trial comparing hybrid endoscopic submucosal dissection using multi-functional snare with endoscopic submucosal dissection for large non-pedunculated colorectal neoplasms (SOUTEN trial) - SOUTEN trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042200033
Enrollment
352
Registered
2020-07-20
Start date
2022-11-08
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

colorectal adenoma, adenocarcinoma, serrated polyps Colorectal neoplasms, Colorectal polyps

Interventions

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)
Endoscopic mucosal resection, Colonic Neoplasms, Colonoscopy, Adenoma
Endoscopic mucosal resection

Sponsors

Imai Kenichiro
Lead Sponsor
Tanaka Shinji
Collaborator
Yamano Hiro-o
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
en bloc R0 resection rate

Secondary

MeasureTime frame
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

Contacts

Public ContactKenichiro Imai

Shizuoka Cancer Center

ke.imai@scchr.jp+81-55-989-5222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026