Tokyo, Jan. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060161) titled 'An Exploratory Study on the Association Between Bile, Duodenal Fluid, and Tissue Specimens and the Formation of Biliary Sludge and Stent Occlusion in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP)' on Jan. 5.
Study Type:
Observational
Primary Sponsor:
Institute - Tsukuba Universiy
Condition:
Condition - Common bile duct stones, Benign biliary strictures, Malignant biliary strictures caused by pancreatic cancer or distal bile duct cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To elucidate the factors and underlying mechanisms involved in biliary sludge formation and biliary stent occlusion by analyzing bile, duodenal fluid, and bile duct tissue.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1 Patients aged 20 years or older.
2 Patients who undergo ERCP at our institution and meet at least one of the following criteria.
3 Patients who have been fully informed of the purpose and methods of this study and who have provided written informed consent.
Key exclusion criteria - 1 Patients presenting with severe (Grade III) acute cholangitis, as defined by the Tokyo Guidelines 2018.
2 Patients unable to provide written informed consent for participation in this study.
3 Patients who are deemed inappropriate for participation in this study at the discretion of the attending physician.
Target Size - 150
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 12 Month 03 Day
Date of IRB - 2025 Year 12 Month 17 Day
Anticipated trial start date - 2025 Year 12 Month 17 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=R000068808
Disclaimer: Curated by HT Syndication.
