Robotically Assisted Surgery For Perihilar Cholangiocarcinoma: A Prospective Study

NCT06720883 | Recruiting DMC FDA Device

• 1 other identifier: AOP3105
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cholangiocarcinoma Cancer; Perihilar Cholangiocarcinoma

Keywords

cholangiocarcinoma; robot; robotic; perihilar; cca; phc

Outcome Measures

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

  From surgery to 90-days after surgery

Secondary Outcomes (6)

• Conversion rate

  Day of surgery

• Margins status

  Day of surgery

• Biliary fistula

  From surgery to 90 days after surgery

• Liver failure

  From surgery to 90 days after surgery

• Diseases specific survival

  From surgery to 5 years after surgery

Study Arms (1)

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

Procedure: Major hepatectomy

Interventions

Major hepatectomy PROCEDURE

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

Patients affected by pCCA requiring curative intent robotic surgery with biliary reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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.
• Synchronous malignancy in other organs.
• Palliative surgery

Sponsors & Collaborators

• Azienda Ospedaliera di Padova: lead

Study Sites (1)

Azienda Ospedaliera di Padova

Padua, 35121, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

liver samples, lymphnodes

MeSH Terms

Conditions

Klatskin Tumor; Cholangiocarcinoma; Congenital contractural arachnodactyly

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Umberto Prof. Cillo, MD

CONTACT

+390498211846; cillo@unipd.it

Francesco Enrico D'Amico, MD

CONTACT

+390498211846; francescoenrico.damico@unipd.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Umberto Cillo

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: June 7, 2024
• Primary Completion (Estimated): July 7, 2027
• Study Completion (Estimated): July 7, 2031
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD and supporting information will be available from 07/07/2027 till 07/07/2031

Locations

IT (1)