Actively Recruiting
Robotically Assisted Surgery for Perihilar Cholangiocarcinoma: A Prospective Observational Study
Led by Azienda Ospedaliera di Padova · Updated on 2024-12-06
32
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cholangiocarcinoma (CCA) is the most common cancer of the bile ducts and the second most common primary liver cancer, making up 15% to 20% of primary liver tumors. This research focuses on perihilar cholangiocarcinoma (pCCA), which affects the bile duct confluence near important blood vessels. Surgery offering complete tumor removal with clear margins is the only potential cure, but it is technically challenging due to the tumor's location near vital structures. This prospective observational study aims to analyze outcomes of robotic major liver resection and biliary reconstruction for pCCA. Participants will undergo robotic major hepatectomy using the DaVinci robotic platform, including removal of liver segments, dissection of lymph nodes, and reconstruction of the bile duct, typically with a jejunal loop. The study collects data from preoperative assessment, through surgery, to postoperative recovery. If newer robotic systems become available, they may also be used. The primary outcome measured is morbidity within 90 days post-surgery, while secondary outcomes include rates of conversion to open surgery, margin status, biliary fistula, liver failure, disease-specific survival, and overall survival up to 5 years. During the study, researchers will gather detailed clinical data including lab tests, surgical details, and postoperative progress. Pathological analysis of removed tissues will assess tumor characteristics and margin status. Participants will be monitored for complications and survival over several years. Statistical analyses will compare outcomes with historical data from over 150 previous cases. Total participation includes surgery and follow-up extending up to 5 years to assess long-term survival and disease control.
CONDITIONS
Brief Title
Robotically Assisted Surgery For Perihilar Cholangiocarcinoma: A Prospective Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed perihilar cholangiocarcinoma or strongly suspected bile duct cancer with negative Immunoglobulin G4 (IgG4) test
- Preoperative staging completed with enhanced abdominal CT scan
- Willingness and ability to comply with the study procedures
- Ability to provide written informed consent
- Patients planned for curative surgery according to international guidelines
You will not qualify if you...
- Presence of distant metastases such as peritoneal carcinomatosis, liver metastases, or distant lymph node metastases
- Previous radiotherapy treatment
- Vascular encasement by tumor
- High operative risk defined by American Society of Anesthesiologists (ASA) score greater than 4
- Presence of other simultaneous cancers in different organs
- Planned palliative surgery instead of curative intent surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for preoperative staging and eligibility assessment
Duration - Day of surgery and up to hospital discharge
Participants undergo robotic major hepatectomy with biliary reconstruction and receive immediate post-operative care.
1 surgical visit and daily hospital visits until discharge
Duration - Up to 90 days after surgery
Participants are monitored for complications, biliary fistula, liver failure, and recovery up to 90 days after surgery.
Approximately 6 post-operative visits
Duration - Up to 5 years after surgery
Participants are followed for disease-specific and overall survival for up to 5 years after surgery.
Annual visits for survival assessment
Trial Site Locations
Total: 1 location
1
Azienda Ospedaliera di Padova
Padova, Italy, 35121
Actively Recruiting
Research Team
U
Umberto Prof. Cillo, MD
F
Francesco Enrico D'Amico, MD
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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