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

NCT ID: NCT05704907

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-04

Study Completion Date

2024-09-19

Brief Summary

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

Detailed Description

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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.

Conditions

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Gallstone

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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gallblader ultrasound

Group Type OTHER

gallbladder ultrasound

Intervention Type OTHER

gallbladder ultrasound

Interventions

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gallbladder ultrasound

gallbladder ultrasound

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul CALAME, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Besançon

Locations

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CHU de Besançon

Besançon, , France

Site Status

Countries

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France

Other Identifiers

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2022/743

Identifier Type: -

Identifier Source: org_study_id

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