Robotic surgery for gallstones and bile duct stones
Pilot Study of Single-Port Robot-Assisted Surgery Using Da Vinci SP Surgical System for Patients With Complex Cholelithiasis and Choledocholithiasis
This study is testing if using a robotic system for gallbladder and bile duct surgery can help patients with complex gallstone issues have better results with less invasiveness.
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 |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06852937 on ClinicalTrials.gov |
What this trial studies
This study investigates the clinical feasibility of performing a single-stage cholecystectomy and common bile duct exploration using the da Vinci SP Surgical System, a robotic surgical platform. It aims to evaluate the technical feasibility and clinical outcomes of robotic biliary surgery for patients with complex cholelithiasis. The study focuses on the advantages of robotic surgery, such as enhanced vision and instrument dexterity, while minimizing invasiveness through a single access port. The research is particularly relevant given the high prevalence of gallstones in the adult population in Taiwan.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20 and older with symptomatic cholelithiasis and/or choledocholithiasis who are suitable for robotic surgery.
Not a fit: Patients with severe comorbidities or those who are not candidates for surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes, reduced post-operative pain, and enhanced patient satisfaction.
How similar studies have performed: While robotic surgery has been successful in various applications, this specific approach using the da Vinci SP system for cholecystectomy and common bile duct exploration is novel and has not been previously published.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 20 years or more 2. Symptomatic cholelithiasis with or without choledocholithiasis, symptomatic chronic cholecystitis with or without biliary tract injury or stricture 3. Indication of cholecystectomy with or without common bile duct exploration and deemed feasible for robotic surgery 4. Patient not feasible or have failed stone extraction or intervention for choledocholithiasis by endoscopic retrograde cholangiopancreatography for patients with choledocholithiasis could be included 5. ASA physical status classification 1-2 and adequate organ function 6. Patients willing and able to comply with study protocol requirements and follow-up 7. Patients who are taking anti-platelet or anti-coagulation medications are eligible for this trial, but the associated agents should be discontinued 5 days prior to the operation day. Patients who are taking Wafarin should be admitted two days earlier for bridging to Heparin. Other medications for underlying diseases can be taken as usual. 8. With informed consent Exclusion Criteria: 1. Severe acute cholecystitis 2. Suspected biliary tract cancer or untreated biliary tract cancer 3. BMI ≥35 or BMI \<18.5 4. Unable to tolerate robotic surgery position 5. Severe adhesion due to prior abdominopelvic surgery 6. Prior major upper abdominal surgery judged by the investigator as not feasible for robotic surgery 7. Active infectious disease 8. 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) 9. Cannot follow trial-required procedures 10. Concomitant systemic or pelvic disease that increases the risk of surgery 11. Patients with coagulopathy 12. Emergency surgery
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Yao-Ming Wu — Vice Superintendent of NTUCC
- Study coordinator: Weichieh Tsai
- Email: jill.hataka@gmail.com
- Phone: 886-978226836
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.