Using da Vinci SP System for Patients With Cholelithiasis and Choledocholithiasis

Recruiting now · Not applicable

Conditions studied: Cholelithiasis, Choledocholithiasis

In brief

A prospective, interventional, single arm study to investigate clinical feasibility of single-stage cholecystectomy and common bile duct exploration using da Vinci SP Surgical System (robotic surgery)

Key facts

Study ID

NCT06852937

Run by

National Taiwan University Hospital

People needed

25

Starts

2024-12-21

Expected to finish

2026-12-01

Last updated by the study team

2025-02-28

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 20 years or more
• Symptomatic cholelithiasis with or without choledocholithiasis, symptomatic chronic cholecystitis with or without biliary tract injury or stricture
• Indication of cholecystectomy with or without common bile duct exploration and deemed feasible for robotic surgery
• Patient not feasible or have failed stone extraction or intervention for choledocholithiasis by endoscopic retrograde cholangiopancreatography for patients with choledocholithiasis could be included
• ASA physical status classification 1-2 and adequate organ function
• Patients willing and able to comply with study protocol requirements and follow-up
• 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.
• With informed consent

You may not qualify if…

• Severe acute cholecystitis
• Suspected biliary tract cancer or untreated biliary tract cancer
• BMI ≥35 or BMI <18.5
• Unable to tolerate robotic surgery position
• Severe adhesion due to prior abdominopelvic surgery
• Prior major upper abdominal surgery judged by the investigator as not feasible for robotic surgery
• 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
• Patients with coagulopathy
• Emergency surgery

Where it is running

• National Taiwan University Hospital — Taipei, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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