Clinical trial · Observational
Robotically Assisted Surgery For Perihilar Cholangiocarcinoma: A Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma Cancer | — | UNRESOLVED | — |
| Perihilar Cholangiocarcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Major hepatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients affected by pCCA requiring curative intent robotic surgery with biliary reconstruction
- description
- 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
- interventionNames
- Procedure: Major hepatectomy
Primary outcomes (1)
- measure
- Morbidity
- timeFrame
- From surgery to 90-days after surgery
- description
- Defined as major and minor complication rate according to Dindo-Clavien classification and Comprehensive Complication Index (CCI), including ninety-days mortality
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available