Using da Vinci SP System for Patients With Cholelithiasis and Choledocholithiasis

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Feb 25, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the use of a robotic surgical system called the da Vinci SP for patients who have gallstones (cholelithiasis) or stones in the bile duct (choledocholithiasis). The goal is to see how well this advanced surgical technique can help remove the gallbladder and explore the bile duct in one procedure, instead of doing it in separate surgeries. The trial is currently recruiting participants aged 20 and older who are experiencing symptoms from these conditions and are suitable for robotic surgery.

To be eligible for the trial, participants should be in good health overall, with some exceptions, such as not having severe heart or lung issues. They should also be willing to follow the study's requirements and attend follow-up appointments. If you decide to join, you’ll undergo a single robotic surgery that aims to alleviate your symptoms, and you’ll receive careful monitoring throughout the process. It’s important to note that certain medications may need to be adjusted before the surgery, so discussing your current medications with the study team is essential.

Gender

ALL

Eligibility 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