800 patients to help build a crystal ball for gallstone surgery success
NCT ID NCT07245108
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows 800 people with gallstones and belly pain who are scheduled for gallbladder removal surgery. Researchers will track their symptoms and quality of life before and three months after surgery. The goal is to create a simple tool that predicts who will actually get pain relief from the operation, helping patients and doctors make better decisions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Laparoscopic cholecystectomy (surgical removal of the gallbladder)
- What this could lead to
- If successful, this could help doctors and patients decide whether gallbladder surgery is likely to relieve pain, avoiding unnecessary procedures.
- What could go wrong
- This is an observational study, not a treatment trial. It only builds a prediction model, so it won't directly improve outcomes. Results may not apply to all patients.
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.
- Participants
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About 800 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- 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.
Who is studied
The population will include patients referred to outpatient clinics either from primary care general practitioners or from a hospital department. Currently six hospitals are included from four out of five Danish health care regions.
- Ages
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18 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: * Ultrasound examination with presence of gallstones and description of size, number and presence of stones in infundibulum or cystic duct * Abdominal symptoms believed to be caused by symptomatic uncomplicated gallstones * Indication and candidate for elective laparoscopic cholecystectomy * Above 18 years of age * Ability to give oral and written consent * Ability to understand, speak and read Danish * Ability to receive digital post Exclusion Criteria: * History of complicated gallstone disease including acute cholecystitis, pancreatitis, common bile duct stones, or cholangitis * Previous sphincterotomy * Abnormal liver function test (ALAT/ASAT, alkaline phosphatase, bilirubin) without magnetic resonance cholangio-pancreatography or endoscopic ultrasound to rule out common bile duct pathology * Indication for urgent cholecystectomy * Current pregnancy
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Aalborg Universitetshospital
RECRUITINGAalborg, 9000, Denmark
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Bispebjerg Hospital
RECRUITINGCopenhagen, Bispebjerg, 2400, Denmark
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Herlev Hospital
RECRUITINGHerlev, 2730, Denmark
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Hvidovre Hospital
RECRUITINGHvidovre, 2650, Denmark
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Nordsjællands Hospital Hillerød
RECRUITINGHillerød, 3400, Denmark
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Regionshospital Nordjylland Hjørring
RECRUITINGHjørring, 9800, Denmark
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Regionshospital Viborg
RECRUITINGViborg, 8800, Denmark
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