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NCT05704907 Clinical Trial

Diagnostic Performance of Dual Energy CT for the Detection of Gallbladder Gallstones

Gallstone Clinical Trial

— DUAL-GB  

Official title:
Diagnostic Performance of Dual Energy CT for the Detection of Gallbladder Gallstones

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05704907
Other study ID # 2022/743
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2023
Est. completion date June 2023

Study information
Verified date December 2022
Source Centre Hospitalier Universitaire de Besancon
Contact Astrid Pozet
Phone +33381218988
Email promotion-interne@chu-besancon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess diagnostic performance of Dual Energy CT fo gallblader gallstone detection.

Description:

Detection of gallbladder gallstone using Dual Energy CT compare to gallblader ultrasound (gold standard). All patients who undergo dual-energy CT scans will undergo abdominal ultrasound for gallstones. Performance of CT to conventionnal KeV will be compare to low Kev monoenergetic reconstruction, and Effective Z. Expected duration of inclusion 3-6 months. No follow-up.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 115
Est. completion date June 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patient referred to the radiology department for an abdominal CT for abdominal pain, suspicion of cholangitis, cholecystitis, migration of stones, acute pancreatitis, suspicion of perforated ulcer in the emergency setting. - Non-objection of the subject to participate in the study - Affiliation to a French social security scheme or beneficiary of such a scheme. Exclusion Criteria: - Cholecystectomy - Legal incapacity or limited legal capacity, legal safeguard - Pregnant women - Subject unlikely to cooperate in the study and/or low cooperation anticipated by the investigator - Subject being in the exclusion period of another study

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• gallbladder ultrasound
gallbladder ultrasound

Locations
Country Name City State
France CHU de Besançon Besançon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gallstone detection using Dual Energy CT Number - size of gallstones Day 0
Secondary Gallstone detection using reconstruction to conventionnal KeV. Number - size of gallstones Day 0
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