RecruitingNCT06720883

Robotically Assisted Surgery For Perihilar Cholangiocarcinoma: A Prospective Study


Sponsor

Azienda Ospedaliera di Padova

Enrollment

32 participants

Start Date

Jun 7, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety and outcomes of using robotic-assisted surgery to remove a type of bile duct cancer called perihilar cholangiocarcinoma (cancer near where the bile ducts exit the liver). Robotic surgery may offer greater precision in a very technically difficult operation, and this study will track patient outcomes. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with perihilar bile duct cancer (either confirmed by biopsy or highly suspected with supportive tests) - Imaging (CT scan) has been performed to assess the extent of the disease - Your surgery is intended to be curative (aimed at removing all the cancer) - You are willing and able to give informed consent **You may NOT be eligible if...** - Your cancer has spread to distant sites (such as the liver, other organs, or distant lymph nodes) - You have previously had radiation therapy to the area - Your major blood vessels are involved in the tumor - Your overall surgical risk is very high (ASA score above 4) - You have another active cancer - You are only having palliative surgery (to relieve symptoms, not cure) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREMajor hepatectomy

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


Locations(1)

Azienda Ospedaliera di Padova

Padova, Italy

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NCT06720883


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