Robotically Assisted Surgery For Perihilar Cholangiocarcinoma: A Prospective Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliera di Padova
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs.
Previous radiotherapy
Vascular encasement
Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score>4.
Trial population
All patients affected by pCCA that will undergo curative intent robotic major liver resection that requires 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Major hepatectomy
Procedure/SurgeryAll patients will undergo robotic major hepatectomy with S1 resection, hilar lymphadenectomy and biliary reconstruction
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: Patients affected by pCCA requiring curative intent robotic surgery with biliary reconstruction1 intervention
Trial outcomes
Primary outcomes
1
Morbidity
Defined as major and minor complication rate according to Dindo-Clavien classification and Comprehensive Complication Index (CCI), including ninety-days mortality
Time frame
From surgery to 90-days after surgerySecondary outcomes
1
Conversion rate
Conversion is defined as the transition from robot-assisted surgery to open surgery and is measured by calculating the percentage ratio between the number of conversions and the total number of procedures performed.
Time frame
Day of surgery2
Margins status
All surgical specimens will be submitted for histopathological evaluation by adopting a standardised protocol where only dedicated pathologists with expertise in gastro-intestinal pathology will assess the specimens. To adequately determine residual disease status, five resection planes (common bile duct, proximal bile duct, hepatic artery, portal vein, and liver parenchyma) and one periductal dissection plane will be obtained from each surgical specimen. The annular resection margins (common bile duct, proximal bile duct, hepatic artery, and portal vein) will be recorded as positive or negative, since their slices are generally 1 to 3 mm thick and a "negative" annular plane ensures a margin of \> 1 mm. For non-annular planes (periductal and liver parenchyma), margins will be assessed as positive if cancer is up to 1 mm along the dissection plane in the hepatoduodenal ligament or on the liver transection plane.
Time frame
Day of surgery3
Biliary fistula
As defined by International Study Group of Liver Surgery, drain/serum bilirubin ratio \> 3 at day 3
Time frame
From surgery to 90 days after surgery4
Liver failure
As defined by International Study Group of Liver Surgery, the deterioration (increase in INR and bilirubin levels) in the synthesis, excretion, and detoxification functions of the liver after liver surgery (day 5 or later)
Time frame
From surgery to 90 days after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov