Robotic surgery for upper tract urothelial cancer patients
A Pilot Study of Single-Port Robot-Assisted Surgery Using Da Vinci SP Surgical System for Patients With Upper Tract Urothelial Cancer
This study tests whether using a special robotic system for kidney and ureter surgery can safely help patients with upper tract urothelial cancer recover better and have good outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06987552 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of radical nephroureterectomy performed using the single-port Da Vinci SP Surgical System for patients with upper tract urothelial cancer. It focuses on assessing surgical outcomes, patient characteristics, and patient-reported outcomes following the procedure. The study aims to provide insights into the feasibility and benefits of this minimally invasive surgical approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 years or older with a confirmed diagnosis of upper tract urothelial cancer who are suitable for robotic surgery.
Not a fit: Patients with synchronous bladder cancer, distant metastasis, or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and quality of life for patients undergoing treatment for upper tract urothelial cancer.
How similar studies have performed: Other studies using robotic surgical techniques for similar conditions have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 20 years or more * Histologically or cytologically diagnosed upper tract urothelial cancer * Fitting indications of radical nephroureterectomy and ipsilateral bladder cuff resection, and deemed feasible for robotic surgery * ASA physical status classification 1-2 and adequate organ function * Patients willing and able to comply with study protocol requirements and follow-up * With informed consent Exclusion Criteria: * Synchronous bladder cancer * Distant metastasis of cancer * BMI ≥30 or BMI \<18.5 * Unable to tolerate lateral decubitus or Trendelenburg position (relative contra-indication) * Severe adhesion due to prior abdominopelvic surgery (relative contra-indication) * Previous radiation treatment to the pelvic area * Active infectious disease * Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions, such as: severe heart disease (NYHA functional class III-IV) or severe lung disease (GOLD Group C-D) * Cannot follow trial-required procedures * Concomitant systemic or pelvic disease that increases the risk of surgery * Long-term use of anti-coagulant(s) * Patients with coagulopathy * Emergency surgery
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Shih-Chieh Chueh, Director
- Email: jeffchueh@gmail.com
- Phone: 02 23123456
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.