Choledocholithiasis, Cholelithiasis
Conditions
Brief 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)
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.
Interventions
DEVICEda Vinci SP Surgery System
da Vinci SP Surgery System
Sponsors
National Taiwan University Hospital
Intuitive Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of conversion rate | During Surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events | up to 6 months | 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. |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORYao-Ming Wu
Vice Superintendent of NTUCC
Outcome results
None listed