Tokyo, Jan. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060434) titled 'Efficacy and Safety of Endoscopic Mucosal Resection with a Cap (EMRC) for Duodenal Epithelial Tumors < 12 mm' on Jan. 21.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - NTT Medical Center Tokyo
Condition:
Condition - duodenal tumor
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - We evaluate the efficacy and safety of endoscopic mucosal resection with a cap (EMRC) for duodenal tumors <12 mm.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - EMRC will be performed for superficial duodenal tumors 12 mm or smaller.
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - SNADETs 12 mm or smaller in size
Key exclusion criteria - Lesions involving the major or minor duodenal papilla.
Patients with a general condition not suitable for endoscopic treatment.
Cases in which multiple lesions were resected in a single treatment session.
Patients who did not provide informed consent to participate in this study.
Target Size - 80
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 10 Month 30 Day
Date of IRB - 2025 Year 10 Month 30 Day
Anticipated trial start date - 2026 Year 11 Month 01 Day
Last follow-up date - 2030 Year 03 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069107
Disclaimer: Curated by HT Syndication.
