A randomized controlled trial comparing conventional and underwater endoscopic submucosal dissection for colorectal tumors

A randomized controlled trial comparing conventional ESD versus underwater ESD for superficial colorectal epithelial tumors - RCT comparing conventional and underwater ESD for colorectal tumors

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000054735

Enrollment

686

Registered

2024-06-24

Start date

2024-09-09

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

Superficial colorectal epithelial tumors

Interventions

Underwater ESD Conventional ESD

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients aged 20 years or older scheduled for ESD for colorectal epithelial tumors 2) The lesion endoscopically diagnosed to have a long diameter of 50 mm or less before treatment 3) Scheduled for endoscopic treatment of one lesion. 4) Patient age is between 20 and 85 years at enrollment of this study. 5) PS (ECOG) is 0, 1 or 2. 6) The patient has been fully informed about participation in the study and written consent has been obtained from the patient.

Exclusion criteria

Exclusion criteria: 1) Remnant or recurrence after endoscopic resection 2) Critical organ failure (heart, lung, liver, kidney, bone marrow) 3) Patients with a history of colorectal surgery (excluding appendicectomy) 4) cT1b (clinical deep submucosal invasive cancer) 5) lesion with muscular layer retraction 6) the lesion extending into the appendix orifice, ileum, diverticulum or anal canal 7) Patients with ulcerative colitis 8) Patients with familial adenomatous polyposis 9) Pregnant and lactating women 10) Patients taking antithrombotic agents which are not able to be interrupted or replaced in accordance with the guidelines for Japanese Gastroenterological Endoscopy Society. 11) Other cases which an attending doctor judge inappropriate

Design outcomes

Primary

Measure	Time frame
Procedure time	—

Secondary

Measure	Time frame
Time of making mucosal flap, number of patient'sposition changes during ESD, number of intraoperative bleeds requiring hemostatic forceps, incidence of intraoperative perforation, incidence of muscle layer injury, amount of sedation, dissection speed, procedure completion rate, en bloc resection rate, complete resection rate (R0 resection rate), presence of bowel fluid/air in case with intraoperative perforation, incidence of postoperative bleeding, incidence of delayed perforation, incidence of post-ESD coagulation syndrome (PECS; post-ESD coagulation syndrome), hospitalization period	—

Measure

Time frame

Time of making mucosal flap, number of patient'sposition changes during ESD, number of intraoperative bleeds requiring hemostatic forceps, incidence of intraoperative perforation, incidence of muscle layer injury, amount of sedation, dissection speed, procedure completion rate, en bloc resection rate, complete resection rate (R0 resection rate), presence of bowel fluid/air in case with intraoperative perforation, incidence of postoperative bleeding, incidence of delayed perforation, incidence of post-ESD coagulation syndrome (PECS; post-ESD coagulation syndrome), hospitalization period

—

Countries

Japan

Contacts

Public ContactTeppei Akimoto

Keio University School of Medicine Division of Research and Development for Minimally Invasive Treatment, Cancer Center

t-akimoto@nms.ac.jp03-5363-3437

Outcome results

None listed

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