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.

JRCT ID: jRCT1030210015

Registered date:06/04/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: early colorectal cancer
• Date of first enrollment: 22/04/2021
• Target sample size: 88
• Study type: Interventional
• Intervention(s): ESD or UEMR

Outcome(s)

• Primary Outcome: 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 Outcome

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)

Key inclusion & exclusion criteria

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

Exclude 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

Related Information

• Primary Sponsor: Katou Naoya