Robot could remove gallbladder and clear bile duct stones in one operation
NCT ID NCT06852937
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers at National Taiwan University Hospital are testing whether a single-port robotic surgery system can safely remove the gallbladder and clear stones from the bile duct in one operation. The study enrolls 24 adults with symptomatic gallstones, with or without bile duct stones, who are not eligible for or have failed standard endoscopic stone removal. Surgeons use the da Vinci SP Surgical System to perform both steps through a single small incision. The main goal is to see how often the planned robotic operation is completed without switching to open or standard keyhole surgery, while tracking any complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- single-port robotic surgery using the da Vinci SP Surgical System
- What this could lead to
- If it works, this could offer patients with complex gallstones a single operation that removes the gallbladder and clears bile duct stones, instead of multiple procedures.
- What could go wrong
- This is a small pilot study with 24 participants, so it can only show whether the approach is feasible, not whether it is better than standard surgery. Some operations may need to switch to open or standard keyhole surgery, and risks include bleeding, infection, or injury to the bile duct.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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24 people
The number who actually took part.
- Started
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Dec 2024
- Finished
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Feb 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Taiwan University Hospital
Taipei, 100, Taiwan
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Other studies related to the condition(s) this trial covers.
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