Robot-assisted surgery for perihilar cholangiocarcinoma
Robotically Assisted Surgery For Perihilar Cholangiocarcinoma: A Prospective Study
This study is testing if robot-assisted surgery can help patients with perihilar cholangiocarcinoma remove their tumors safely and recover better than with traditional surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera di Padova Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Padova) |
| Trial ID | NCT06720883 on ClinicalTrials.gov |
What this trial studies
This study focuses on the use of robotically assisted surgery for patients diagnosed with perihilar cholangiocarcinoma, a challenging type of bile duct cancer. It aims to evaluate the effectiveness and safety of minimally invasive surgical techniques in achieving complete tumor resection, which is crucial for improving long-term survival rates. The study will include patients who meet specific eligibility criteria, including age and histological confirmation of the disease, and will assess outcomes related to surgical success and recovery. The approach is designed to minimize complications and enhance recovery compared to traditional open surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed perihilar cholangiocarcinoma who are eligible for curative surgery.
Not a fit: Patients with distant metastases, previous radiotherapy, or those at high operative risk may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and survival rates for patients with perihilar cholangiocarcinoma.
How similar studies have performed: Other studies have shown promising results with minimally invasive techniques in liver surgery, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Padova
- Azienda Ospedaliera di Padova — Padova, Italy (Recruiting)
Study contacts
- Study coordinator: Umberto Prof. Cillo, MD
- Email: cillo@unipd.it
- Phone: +390498211846
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.