Ejection Fraction of Normal Gall Bladder on Ultrasonography in Patients With Biliary Colic: Is it a Predictor of Cholecystectomy?
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
In this study investigators aim to evaluate gallbladder ejection fraction as a predictor for cholecystectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2022
CompletedFirst Posted
Study publicly available on registry
October 20, 2022
CompletedStudy Start
First participant enrolled
October 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedOctober 20, 2022
October 1, 2022
6 months
September 24, 2022
October 18, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of quality of life improvment after cholecystectomy according to ROME IV criteria
abdominal pain, nausea and vomiting
6 months
Study Arms (1)
operative
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients older than 14 years of age
- food-related abdominal pain
- normal gallbladder ultrasound (US)
- GB EF 80% and greater or 35% and less on HIDA scan with CCK injection
You may not qualify if:
- Patients younger than 14 years old
- Patients with the positive US defined as the presence of gallstones, gallbladder wall thickening (\> 4 mm), pericholecystic fluid, sludge, or polyps
- Normal GB EF
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- General surgery resident
Study Record Dates
First Submitted
September 24, 2022
First Posted
October 20, 2022
Study Start
October 25, 2022
Primary Completion
May 1, 2023
Study Completion
July 1, 2023
Last Updated
October 20, 2022
Record last verified: 2022-10