Robotically Assisted Surgery For Perihilar Cholangiocarcinoma: A Prospective Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Major hepatectomy: All patients will undergo robotic major hepatectomy with S1 resection, hilar lymphadenectomy and biliary reconstruction

Study summary

Cholangiocarcinoma (CCA) represents the most common biliary tract malignancy, and the second most common primary hepatic malignancy, accounting for 15% to 20% of primary liver tumours.

Perihilar cholangiocarcinoma (pCCA) involves the biliary confluence with or without involvement of the right and left hepatic ducts. Complete resection with negative histologic margins is the only chance of cure and the most robust predictor of long-term survival for patients affected by any type of locally advanced CCA. However, the proximity of perihilar tumors to vital structures makes curative excision technically difficult.

Minimally invasive approaches are progressively spreading in liver surgery units worldwide. Significant advantages of minimally invasive liver resections, if compared to open one, have been diffusely shown, such as shorter hospital stay and possibility of complex reconstructive procedures similar to those performed in open surgery. Robot-assisted liver surgery represents a natural consequence of such a minimally invasive evolution.

This is a monocentric, single arm, observational, prospective study that aims at analyzing the outcomes of robotic major liver resection and biliary recontruction for perihilar cholangiocarcinoma.

Among study outcomes, the primary outcome is evaluation of morbidity; secondary outcomes includes conversion rate, margin status, biliary fistula, liver failure, disease specific survival, overall Survival

Data related to patient condition (laboratory tests, etc.), surgery performed, and post-surgical course will be collected.

The protocol for this study has been developed in accordance with the European Union Good Clinical Practice guidelines and the Declaration of Helsinki, and it has been approved by the Territorial Ethics Committee of the East-Central Veneto Area (CETAEV).

Eligibility

Primary outcome measure(s)

• Morbidity — From surgery to 90-days after surgery
  Defined as major and minor complication rate according to Dindo-Clavien classification and Comprehensive Complication Index (CCI), including ninety-days mortality

Trial sites (1)

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