A multicenter prospective adapttive trial (Non-comparative phase2 and non-inferiority phase3 study) of underwater endoscopic miucosal resection (UEMR) compared to endoscopic submucosal dissection (ESD) for early colorectal cancer.

A multicenter prospective adapttive trial (Non-comparative phase2 and non-inferiority phase3 study) of underwater endoscopic miucosal resection (UEMR) compared to endoscopic submucosal dissection (ESD) for early colorectal cancer. - ESUMA study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1030210015

Enrollment

Registered

2021-04-06

Start date

2021-04-22

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

early colorectal cancer

Interventions

ESD or UEMR

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients 20 years and over diagnosed with early colorectal cancer (diameter from 21mm to 30mm), adaptable for ESD or UEMR. One lesion per 1 patient.

Exclusion criteria

Exclusion criteria: 1. Gastrointestinal polyposis (familial adenomatous polyposis [FAP], etc., but Lynch syndrome [HNPCC] is not excluded) 2. Inflammatory bowel disease (ulcerative colitis, Crohn's disease, etc.) 3. Lesions with obvious fibrosis (including post-treatment recurrence) 4. Preoperative tumor suspected of SM infiltration 5. Lesions with stoke and lesions with obvious depressions 6. Pregnant 7. During dialysis 8. American Society of Anesthesia Class Classification III or above (patients with severe systemic disease) 9. After colectomy (including after partial resection) 10. Platelet and coagulation factor dysfunction (such as hemophilia) 11. Patients taking 2 or more antithrombotic drugs, taking warfarin, or requiring heparinization of anticoagulants. (For patients taking 2 or more antithrombotic drugs, even if 1 drug can be discontinued for a certain period of time Excluded from this study. Patients taking one antithrombotic drug can be treated according to the guidelines of gastrointestinal endoscopy. Oral thienopyridine alone is replaced with aspirin or cilostazol from 7 days before the procedure. Above, it can be enforced.) 12. Other patients who are judged to be ineligible by the doctor in charge

Design outcomes

Primary

Measure	Time frame
Pathological complete resection rate [The tumor component in the resected specimen shall be negative for horizontal margin and negative for vertical margin (R0 resection).]	—

Secondary

Measure	Time frame
1. Endoscopic en-block resection rate (number of divided resection samples in split resection) 2. Presence or absence of residual endoscopic lesions after excision 3. Pathological curative resection rate (R0 resection and negative vascular invasion, budding grade 1) 4. Treatment time (minutes) (ESD from submucosal injection to specimen resection. UEMR from water injection to specimen resection. UEMR also records the amount of water used.) 5. Incidence of complications as a safety endpoint (intraoperative perforation, intraoperative bleeding, post-bleeding, delayed perforation, post polypectomy syndrome)	—

Measure

Time frame

1. Endoscopic en-block resection rate (number of divided resection samples in split resection) 2. Presence or absence of residual endoscopic lesions after excision 3. Pathological curative resection rate (R0 resection and negative vascular invasion, budding grade 1) 4. Treatment time (minutes) (ESD from submucosal injection to specimen resection. UEMR from water injection to specimen resection. UEMR also records the amount of water used.) 5. Incidence of complications as a safety endpoint (intraoperative perforation, intraoperative bleeding, post-bleeding, delayed perforation, post polypectomy syndrome)

—

Contacts

Public ContactKenichiro Okimoto

Chiba University

okimoto-k@chiba-u.jp+81-43-222-7171

Outcome results

None listed

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