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

ConditionBTC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older, regardless of gender.

Disqualifiers

Histopathologically or cytologically confirmed hepatocellular carcinoma, mixed hepatocellular-cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, or fibrolamellar hepatocellular carcinoma.

Trial design

Design model

Parallel

Treatments tested in this trial

  • surgery

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Resection of the extrahepatic bile duct with thorough lymph node dissectionPlacebo comparator 1 intervention
Group B: Extrahepatic bile duct preservation with hepatoduodenal ligamentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

OS

overall

Time frame
2year

Secondary outcomes

Other outcomes

Sponsors and contacts

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