Tokyo, July 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062186) titled 'The efficacy and safety of Underwater ESMRL for rectal NET' on July 28.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Active
Primary Sponsor:
Institute - Okayama university
Condition:
Condition - Rectal neuroendocrine tumor
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - The efficacy and safety of underwater ESMRL for rectal NET
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Underwater ESMRL
Interventions/Control_2 - Conventional ESMRL with injection
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - (1) Patients who are 18 years of age or older at the time of obtaining consent
(2) A person for whom the patient's written consent has been obtained
(3) histologic or endoscopic diagnosis of rectal NET
(4) Lesions located at the rectal Ra or Rb
(5) Tumor size less than or equal to 10mm
Key exclusion criteria - (1) Tumor invasion into the muscularis propria
(2) Lymph nodes or distant metastasis
(3) Patients who are deemed unsuitable as research subjects by the principal investigator or sub-researcher
Target Size - 116
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 28 Day
Anticipated trial start date - 2026 Year 07 Month 28 Day
Last follow-up date - 2030 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071006
Disclaimer: Curated by HT Syndication.
