Robotically Assisted Surgery For Perihilar Cholangiocarcinoma: A Prospective Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age≥18 years

• Histologically proven pCCA or highly presumed bile duct malignancy with difficulties to obtain histological evidence with negative Immunoglobulin G4 (IgG4 sample)

• Preoperative staging work up performed by abdomen enhanced CT scan.

• The subject understands the nature of this trial and is willing to comply.

• Ability to provide written informed consent.

• Patients treated with curative intent in accordance to international guidelines

Locations
Other Locations
Italy
Azienda Ospedaliera di Padova
RECRUITING
Padua
Contact Information
Primary
Umberto Prof. Cillo, MD
cillo@unipd.it
+390498211846
Backup
Francesco Enrico D'Amico, MD
francescoenrico.damico@unipd.it
+390498211846
Time Frame
Start Date: 2024-06-07
Estimated Completion Date: 2031-07-07
Participants
Target number of participants: 32
Treatments
Patients affected by pCCA requiring curative intent robotic surgery with biliary reconstruction
All patients affected by pCCA candidate for curative intent robotic liver resection with biliary reconstruction will be enrolled in the study after the work up for surgery. Preoperative, intraoperative and postoperative data will be collected. The DaVinci® robotic platform available at the Padova University hospital will be utilised primarily. We will include patients with age≥18 years, with histologically proven pCCA or highly presumed bile duct malignancy with difficulties to obtain histological evidence with negative Immunoglobulin G4 (IgG4 sample). We will not include patients with distant metastases, previous radiotherapy, vascular encasement, ASA score\>4, synchronous malignancy in other organs or indication for palliative surgery
Sponsors
Leads: Azienda Ospedaliera di Padova

This content was sourced from clinicaltrials.gov