Robot could remove gallbladder and clear bile duct stones in one operation

NCT ID NCT06852937

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

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Status unknown
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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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

24 people

The number who actually took part.

Started

Dec 2024

Finished

Feb 2026

Lead sponsor

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

20 years and older

Sex

Anyone

Healthy volunteers

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

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

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

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