Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
NCT06852937

Using da Vinci SP System for Patients With Cholelithiasis and Choledocholithiasis

Led by National Taiwan University Hospital · Updated on 2025-02-28

25

Participants Needed

1

Research Sites

101 weeks

Total Duration

On this page

Sponsors

N

National Taiwan University Hospital

Lead Sponsor

I

Intuitive Surgical

Collaborating Sponsor

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

Using da Vinci SP System for Patients With Cholelithiasis and Choledocholithiasis

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 20 years or more
  • Symptomatic cholelithiasis with or without choledocholithiasis or symptomatic chronic cholecystitis with or without biliary tract injury or stricture
  • Indicated for cholecystectomy with or without common bile duct exploration and suitable for robotic surgery
  • Patients who failed or are not suitable for stone extraction by endoscopic retrograde cholangiopancreatography for choledocholithiasis
  • ASA physical status classification 1-2 with adequate organ function
  • Willing and able to comply with study protocol and follow-up
  • Patients on anti-platelet or anti-coagulation medications can participate if medications are stopped 5 days before surgery; those on Warfarin require hospital admission for bridging therapy
  • Provided informed consent
Not Eligible

You will not qualify if you...

  • Severe acute cholecystitis
  • Suspected or untreated biliary tract cancer
  • Body mass index (BMI) 35 or higher, or less than 18.5
  • Unable to tolerate the robotic surgery position
  • Severe abdominal adhesions from previous surgery
  • Prior major upper abdominal surgery deemed unsuitable for robotic surgery
  • Active infection
  • Severe illnesses that greatly reduce life expectancy or increase surgery risk, such as severe heart disease (NYHA III-IV) or severe lung disease (GOLD C-D)
  • Unable to follow study procedures
  • Systemic or pelvic disease increasing surgical risk
  • Coagulopathy
  • Emergency surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan, 100

Actively Recruiting

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Research Team

W

Weichieh Tsai

CONTACT

J

Jacqueline Liang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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