Actively Recruiting

Age: 18Years +
All Genders
NCT06720883

Robotically Assisted Surgery For Perihilar Cholangiocarcinoma: A Prospective Study

Led by Azienda Ospedaliera di Padova · Updated on 2024-12-06

32

Participants Needed

1

Research Sites

369 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Robotically Assisted Surgery For Perihilar Cholangiocarcinoma: A Prospective Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histologically confirmed perihilar cholangiocarcinoma or highly suspected bile duct cancer with negative Immunoglobulin G4
  • Preoperative staging completed by abdomen enhanced CT scan
  • Understands the trial and agrees to comply
  • Able to provide written informed consent
  • Patients treated with curative intent following international guidelines
Not Eligible

You will not qualify if you...

  • Presence of distant metastases including peritoneal carcinomatosis, liver metastases, or distant lymph node metastases
  • Previous radiotherapy treatment
  • Vascular encasement preventing surgery
  • High operative risk with ASA score greater than 4
  • Having other simultaneous cancers
  • Undergoing palliative surgery rather than curative surgery

AI-Screening

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Trial Site Locations

Total: 1 location

1

Azienda Ospedaliera di Padova

Padova, Italy, 35121

Actively Recruiting

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Research Team

U

Umberto Prof. Cillo, MD

CONTACT

F

Francesco Enrico D'Amico, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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