Tokyo, Aug. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058757) titled 'Efficacy and safety of underwater precutting endoscopic mucosal resection for colorectal polyps 20-30mm in size: a prospective single center study' on Aug. 12.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Kanagawa Cancer Center
Condition:
Condition - a single clinically diagnosed colorectal polyps measuring 20 to 30 mm in size
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the efficacy and safety of underwater precutting EMR for colonic polyps 20-30 mm in size
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - All patients provided written informed consent to participate in this study. The colorectal polyps measuring 20 to 30 mm in size is resected by Underwater precutting EMR. All patients were followed up at outpatient visit to check any postoperative adverse events with 28 days after Underwater precutting EMR. The patient was invited for 6 months surveillance colonoscopy. During surveillance colonoscopy, the scar induced by Underwater precutting EMR was identified, the scar was examined for residual using Narrow Band Imaging with magnification. A biopsy of the scar was performed to confirm the histological evaluation.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - The inclusion criteria were as follows:
1. a single clinically diagnosed colorectal polyps measuring 20 to 30 mm in size,
2 age > 20 years;
3 Eastern Cooperative Oncology Group performance status of 0-1.
Key exclusion criteria - The exclusion criteria were as follows: (1) inflammatory bowel disease, (2) familial polyposis syndrome (3) clinically diagnosed invasive cancer (4) recurrent lesion (5) scheduled for surgery for active cancer (6) blood coagulation disorder (7) hemodialysis (8) severe heart disease (9) psychiatric disorder (10) pregnancy.
Target Size - 25
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 02 Month 17 Day
Date of IRB - 2025 Year 02 Month 17 Day
Anticipated trial start date - 2025 Year 03 Month 01 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067186
Disclaimer: Curated by HT Syndication.
