Clinical Trial

Surgical Total Clearance Versus Extrahepatic Bile Duct Preservation for Biliary Tract Malignancies: A Single-Center, Randomized, Two-Arm, Prospective Phase II Clinical Trial

Recruiting
View on ClinicalTrials.gov →
Summary
When lymph node dissection of stations 12 and 13 is performed, resecting the bile duct from the superior portion of the pancreas to the confluence of the right and left hepatic ducts allows complete removal of the station 12 and 13 lymph nodes. Preserving the bile duct from the superior pancreas to the hepatic confluence, however, makes a skeletonizing dissection of the duct impossible in order to safeguard the biliary blood supply, inevitably leaving behind a small amount of periductal lymphoid tissue. This results in incomplete lymph node clearance, which may increase the risk of postoperative recurrence and reduce the R0 resection rate. This study aims to investigate the lymph node dissection approach for surgically resected cholangiocarcinoma following induction therapy, to establish criteria for evaluating surgical indications, and to provide a basis for surgical treatment strategies in patients with cholangiocarcinoma.
Trial Details
NCT Number NCT07609641
Lead Sponsor Tianjin Medical University Cancer Institute and Hospital
Conditions BTC
Enrollment 60 participants
Start Date 2025-10-20
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-27