Predicting pain relief after gallbladder removal
The ProChol Study - Prospective Assessment of Symptoms Following Cholecystectomy in Patients With Symptomatic Uncomplicated Gallstones
This will test a prediction score to see if people with uncomplicated gallstones scheduled for laparoscopic gallbladder removal will be pain-free three months after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nordsjaellands Hospital Academic / other |
| Locations | 7 sites (Copenhagen, Bispebjerg and 6 other locations) |
| Trial ID | NCT07245108 on ClinicalTrials.gov |
What this trial studies
This is a prospective multicenter cohort of adults with ultrasound-confirmed uncomplicated gallstones scheduled for elective laparoscopic cholecystectomy across Danish surgical hospitals. Before surgery the study collects patient-reported measures (quality of life and detailed abdominal pain characteristics) along with routine clinical and imaging data. Outcomes, including pain resolution, are measured three months after surgery and analyzed to find determinants of persistent symptoms. The collected data will be used to develop and internally validate a clinical prediction score that combines patient-reported and readily available objective variables.
Who should consider this trial
Good fit: Adults (≥18) with ultrasound-confirmed gallstones and abdominal symptoms attributed to uncomplicated gallstone disease who are candidates for elective laparoscopic cholecystectomy, can give informed consent, speak and read Danish, and can receive digital post.
Not a fit: Patients with prior complicated gallstone disease (acute cholecystitis, pancreatitis, common bile duct stones, or cholangitis), prior sphincterotomy, unexplained abnormal liver tests without further imaging, indication for urgent cholecystectomy, or current pregnancy are unlikely to benefit from this prediction score.
Why it matters
Potential benefit: If successful, the prediction score could help clinicians and patients choose who is most likely to become pain-free after gallbladder removal and avoid unnecessary surgery.
How similar studies have performed: Prior observational cohorts have reported that about 35% of patients have persistent symptoms after cholecystectomy, but validated prediction tools for individual pain resolution are limited, so this approach builds on existing findings but is not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen, Bispebjerg and 6 other locations
- Bispebjerg Hospital — Copenhagen, Bispebjerg, Denmark (Recruiting)
- Aalborg Universitetshospital — Aalborg, Denmark (Recruiting)
- Herlev Hospital — Herlev, Denmark (Recruiting)
- Nordsjællands Hospital Hillerød — Hillerød, Denmark (Recruiting)
- Regionshospital Nordjylland Hjørring — Hjørring, Denmark (Recruiting)
- Hvidovre Hospital — Hvidovre, Denmark (Recruiting)
- Regionshospital Viborg — Viborg, Denmark (Recruiting)
Study contacts
- Principal investigator: Daniel Mønsted Shabanzadeh, DMSc, PhD, MD — Dansk: Offentligt hospital (inkl. universitetshospital)
- Study coordinator: Daniel Mønsted Shabanzadeh, DMSc, PhD, MD
- Email: daniel.moensted.shabanzadeh.01@regionh.dk
- Phone: +45 48295796
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.