NIPH Clinical Trials Search

JRCT ID: jRCT1030210015

Registered date:06/04/2021

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.

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedearly colorectal cancer
Date of first enrollment22/04/2021
Target sample size88
Countries of recruitment
Study typeInterventional
Intervention(s)ESD or UEMR


Primary OutcomePathological complete resection rate [The tumor component in the resected specimen shall be negative for horizontal margin and negative for vertical margin (R0 resection).]
Secondary Outcome1. 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)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteriapatients 20 years and over diagnosed with early colorectal cancer (diameter from 21mm to 30mm), adaptable for ESD or UEMR. One lesion per 1 patient.
Exclude criteria1. 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

Related Information


Public contact
Name Kenichiro Okimoto
Address 1-8-1 Inohana Cyuo-ku Chiba city Chiba prefecture Chiba Japan 260-8677
Telephone +81-43-222-7171
Affiliation Chiba University
Scientific contact
Name Naoya Katou
Address 1-8-1 Inohana Cyuo-ku Chiba city Chiba prefecture Chiba Japan 260-8677
Telephone +81-43-222-7171
Affiliation Chiba University