Using da Vinci SP System for Patients With Cholelithiasis and Choledocholithiasis

Last updated: February 25, 2025
Sponsor: National Taiwan University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disorders

Gall Bladder Disorders

Treatment

da Vinci SP Surgery System

Clinical Study ID

NCT06852937
202409006DIPD
  • Ages > 20
  • All Genders

Study Summary

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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 20 years or more

  2. Symptomatic cholelithiasis with or without choledocholithiasis, symptomatic chroniccholecystitis with or without biliary tract injury or stricture

  3. Indication of cholecystectomy with or without common bile duct exploration anddeemed feasible for robotic surgery

  4. Patient not feasible or have failed stone extraction or intervention forcholedocholithiasis by endoscopic retrograde cholangiopancreatography for patientswith 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 eligiblefor this trial, but the associated agents should be discontinued 5 days prior to theoperation day. Patients who are taking Wafarin should be admitted two days earlierfor bridging to Heparin. Other medications for underlying diseases can be taken asusual.

  8. With informed consent

Exclusion

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 forrobotic surgery

  7. Active infectious disease

  8. Severe concomitant illness that drastically shortens life expectancy or increasesrisk of therapeutic interventions, such as: severe heart disease (NYHA functionalclass 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

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: da Vinci SP Surgery System
Phase:
Study Start date:
December 21, 2024
Estimated Completion Date:
December 31, 2026

Study Description

Cholelithiasis (gallstones) is a common disease of digestive tract in adults. It has been reported that 5-10% or 2 million of Taiwanese adults have gallstones according to National Health Insurance Administration.

Laparoscopic cholecystectomy is deemed a surgical standard of care for its safety, effectiveness, and benefits: less post-operative pain, faster recovery, shorter hospital stay, and better cosmesis. However, the advantages of da Vinci surgical system include enhanced vision, wristed instruments, and dexterity of control.

Robotic cholecystectomy by single-port SP system is associated with shorter operation time, shorter dissection time, and less post-operative pain.

Further improvement in robotic cholecystectomy with CBDE regarding cosmesis and patient satisfaction could be made by adopting da Vinci SP system which preserves enhanced vision and instrument dexterity with only one access port. So far there is no published data on robotic cholecystectomy with CBDE using da Vinci SP. Current study is set forth to evaluate technical feasibility and clinical outcome of robotic biliary surgery using da Vinci SP Surgical System for patients with complex cholelithiasis.

Connect with a study center

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Active - Recruiting

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