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Official title Surgical Total Clearance Versus Extrahepatic Bile Duct Preservation for Biliary Tract Malignancies: A Single-Center, Randomized, Two-Arm, Prospective Phase II Clinical Trial
ClinicalTrials.gov ID: NCT07609641
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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...
You likely can't join if
- Histopathologically or cytologically confirmed hepatocellular carcinoma, mixed hepatocellular-cholangiocarcinoma, sarcomatoid hepatocellular...
- Other malignancy within 5 years, except for cured localized tumors, including non-melanoma skin basal cell carcinoma, cervical carcinoma in situ, and...
- 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...
- Left ventricular ejection fraction (LVEF) \< 50% on echocardiography;
See the full eligibility criteria
Who can join
- 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...
- 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;
- Serum total bilirubin ≤ 2 × upper limit of normal (ULN); any biliary obstruction must be resolved before randomization;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN;
- Creatinine clearance (CrCl) ≥ 50 mL/min (calculated using the Cockcroft-Gault formula);
- International normalized ratio (INR) ≤ 2 and prothrombin time (PT) prolonged ≤ 3 seconds above the ULN.
- For active hepatitis B, effective antiviral therapy (per local standard of care, e.g., entecavir or tenofovir) is required, with HBV DNA \< 2000 IU/mL or a ≥ 10-fold decrease in HBV DNA after antiviral treatment...
- Within 7 days prior to randomization, women of childbearing potential must have a negative serum pregnancy test and agree to use effective contraception during the study treatment period and for 6 months after the last...
What rules you out
- 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;
- Use of aspirin (\> 325 mg/day), clopidogrel (\> 75 mg/day), dipyridamole, ticlopidine, or cilostazol within 10 days prior to randomization.
- Known central nervous system metastasis and/or meningeal metastasis (including dural and leptomeningeal metastasis).
- Any other condition that, in the investigator's opinion, renders the patient unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.