The Pro-Chol Study

NCT07245108 · tracked via the Priya Life Science Denmark tracker

Sponsor

Nordsjaellands Hospital

Phase

Observational

Started

2024-01-22

Last updated

2025-11-24

Condition(s) studied

GallstonesGallstone AttackUncomplicated CholelithiasisCholecystolithiasis

Investigational drug(s) / intervention(s)

Laparoscopic cholecystectomyLaparoscopic cholecystectomy

Laparoscopic cholecystectomy: A surgical removal of the gallbladder through laparoscopy

Laparoscopic cholecystectomy: The intervention is intended laparoscopic cholecystectomy. Patients that undergo conversion to open (traditional) cholecystectomy will still be included. Patients scheduled for open cholecystectomy will not be included.

Study summary

This prospective clinical cohort study will include patients with gallstones and abdominal pain scheduled for surgery (laparoscopic cholecystectomy). Data on quality of life, abdominal pain, gallstone disease, and patient characteristics will be collected before surgery. The outcomes will be assessed three months following surgery and will primarily be determinants for resolution of pain. The aim is to make a prediction score that may aid clinicians and patients in decision making about surgery.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Prediction model for resolution of pain — From baseline before surgery to follow-up at three months after surgery
To build and validate a prediction model for resolution of pain (VAS≤4) following laparoscopic cholecystectomy

Trial sites (7)

Facility	City	Region	Status
Bispebjerg Hospital	Copenhagen	Bispebjerg	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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07245108 on ClinicalTrials.gov ↗ ← All trials in Denmark