| NCT ID | NCT07245108 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nordsjaellands Hospital |
| Condition | Gallstones |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2024-01-22 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2024-01-22 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Daniel Mønsted Shabanzadeh, DMSc, PhD, MD
✉ daniel.moensted.shabanzadeh.01@regionh.dk📞 +45 48295796
Daniel Mønsted Shabanzadeh, DMSc, PhD, MD
PRINCIPAL INVESTIGATOR
Dansk: Offentligt hospital (inkl. universitetshospital)
Frequently Asked Questions
Who can join the NCT07245108 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gallstones. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07245108 currently recruiting?
Yes, NCT07245108 is actively recruiting participants. Contact the research team at daniel.moensted.shabanzadeh.01@regionh.dk for enrollment information.
Where is the NCT07245108 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Aalborg, Denmark, Herlev, Denmark, Hillerød, Denmark and 3 additional locations.
Who is sponsoring the NCT07245108 clinical trial?
NCT07245108 is sponsored by Nordsjaellands Hospital. The principal investigator is Daniel Mønsted Shabanzadeh, DMSc, PhD, MD at Dansk: Offentligt hospital (inkl. universitetshospital). The trial plans to enroll 800 participants.