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

NCT07609641 | Recruiting

• 1 other identifier: BTC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

BTC

Keywords

BTC

Outcome Measures

Primary Outcomes (1)

• OS

  overall

  2year

Study Arms (2)

Resection of the extrahepatic bile duct with thorough lymph node dissection

PLACEBO COMPARATOR

In cholangiocarcinoma surgery after induction therapy, the extrahepatic bile duct is resected and a thorough lymph node dissection of the hepatoduodenal ligament and the posterior pancreatic head is performed.

Other: surgery

Extrahepatic bile duct preservation with hepatoduodenal ligament

EXPERIMENTAL

Extrahepatic bile duct preservation with hepatoduodenal ligament and retropancreatic lymph node dissection.

Other: surgery

Interventions

surgery OTHER

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.

Extrahepatic bile duct preservation with hepatoduodenal ligament; Resection of the extrahepatic bile duct with thorough lymph node dissection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Life expectancy ≥ 12 weeks.
• Adequate organ function meeting the following requirements (no blood transfusion, blood products, hematopoietic growth factors, or other medications to correct blood counts within 14 days prior to randomization):
• White blood cell count ≥ 4.0 × 10⁹/L;
• Absolute neutrophil count ≥ 1.5 × 10⁹/L;
• Platelet count ≥ 90 × 10⁹/L;
• Hemoglobin ≥ 90 g/L;
• Serum albumin ≥ 30 g/L;

You may not qualify if:

• Histopathologically or cytologically confirmed hepatocellular carcinoma, mixed hepatocellular-cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, or fibrolamellar hepatocellular carcinoma.
• Other malignancy within 5 years, except for cured localized tumors, including non-melanoma skin basal cell carcinoma, cervical carcinoma in situ, and papillary thyroid carcinoma.
• Radiotherapy for CCA within 4 weeks prior to randomization; major surgery (excluding diagnostic biopsy) within 4 weeks prior to randomization.
• History of severe cardiovascular or cerebrovascular disease:
• New York Heart Association (NYHA) class II or greater congestive heart failure, unstable angina, myocardial infarction, poorly controlled arrhythmia, or cerebrovascular accident within 12 months prior to randomization;
• Left ventricular ejection fraction (LVEF) \< 50% on echocardiography;
• Corrected QT interval (QTc) \> 480 ms (calculated using the Fridericia method; if QTc is abnormal, it may be measured three times consecutively at 2-minute intervals, and the average taken);
• Poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg, based on the average of ≥ 2 readings);
• Prior hypertensive crisis or hypertensive encephalopathy.
• Evidence of significant bleeding/coagulation disorder or bleeding tendency:
• Clinically significant hemoptysis or tumor bleeding of any cause within 4 weeks prior to randomization;
• Prior tumor rupture (unless surgically treated);
• Thrombotic or embolic event within 6 months prior to randomization;
• Therapeutic anticoagulation within 2 weeks prior to randomization (except for low-molecular-weight heparin);
• Need for antiplatelet therapy;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, 300308, China

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Central Study Contacts

Li Huikai, MD

CONTACT

18622228639; tjchlhk@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: October 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 27, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)