Using da Vinci SP System for Patients With Cholelithiasis and Choledocholithiasis

Pilot Study of Single-Port Robot-Assisted Surgery Using Da Vinci SP Surgical System for Patients With Complex Cholelithiasis and Choledocholithiasis

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)

Study Overview

• Status: Recruiting
• Conditions: Cholelithiasis; Choledocholithiasis
• Intervention / Treatment: Device: da Vinci SP Surgery System

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weichieh Tsai; Phone Number: 886-978226836; Email: jill.hataka@gmail.com
• Study Contact Backup: Name: Jacqueline Liang; Phone Number: 886-914255380; Email: jacqueline.liang@intusurg.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Yao-Ming Wu Professor, Department of Surgery, NTUH; Phone Number: 886-978226836; Email: jill.hataka@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Operation of focus procedure with da Vinci SP Surgery System; Operation of cholecystectomy and common bile duct exploration with da Vinci SP Surgery System	Device: da Vinci SP Surgery System; da Vinci SP Surgery System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of conversion rate	The primary performance endpoint will be assessed as the ability to successfully completed the planned procedure with da Vinci SP System, with no conversion to alternative surgery including open surgery or laparoscopy.	During Surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment Emergent Adverse Events	The safety endpoint will be assessed as the incidence of all intra-operatvie and post-operative adverse events that occur through the follow up period.	up to 6 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Intuitive Surgical
• Investigators: Principal Investigator: Yao-Ming Wu, Vice Superintendent of NTUCC

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Calculi; Pathological Conditions, Anatomical; Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Gallbladder Diseases; Common Bile Duct Diseases; Gallstones; Cholelithiasis; Cholecystolithiasis; Choledocholithiasis
• Other Study ID Numbers: 202409006DIPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes