Surgical Total Clearance Versus Extrahepatic Bile Duct Preservation for Biliary Tract Mali
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 confluen
| Condition(s) | BTC |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 c |
| Who can participate | Inclusion Criteria: * Age 18 years or older, regardless of gender. Voluntary participation with full informed consent; signed written informed consent form; good compliance. Histologically or cytologically confirmed cholangiocarcinoma (CCA). Gallbladder cancer or intrahepatic cholangiocarcinoma with preoperative lymph node metastasis. No prior systemic chemotherapy, immunotherapy, targeted therapy, or local treatment for CCA (including but not limited to transarterial chemoembolization, arterial embolization, arterial infusion chemotherapy, and radioactive particle embolization). At least one measurable lesion according to RECIST v1.1. Child-Pugh class A liver function, and no history of hepatic encephalopathy. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1. |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Locations | Tianjin, Tianjin Municipality, China |
| Start date | 2025-10-20 |
| NCT ID | NCT07609641 |
| Official listing | https://clinicaltrials.gov/study/NCT07609641 |