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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
NCT03012243 |
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Date of registration:
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04/01/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Bile Aspiration vs Drain in Acute Cholecystitis
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Scientific title:
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Randomized Controlled Trial of Bile Aspiration vs Drain in Acute Cholecystitis |
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Date of first enrolment:
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August 1, 2024 |
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Target sample size:
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40 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03012243 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Gabriel Sandblom, Assoc Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Karolinska Institutet |
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Name:
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Agnieszka Popowicz, MD |
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Address:
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Telephone:
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+46 73 582 62 13 |
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Email:
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a.e.popowicz@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Acute cholecystitis, not warranting acute cholecystectomy
Exclusion Criteria:
- Indication for acute cholecystectomy, i.e. history < 5 days and no contraindication to
surgery
- Liver cirrhosis
- Ascites
- Emphysematous cholecystitis
- Gallbladder perforation
- Suspected malignant condition
- Portal Hypertension
- Biliary pancreatitis
- Common bile duct stones
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cholecystitis, Acute
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Intervention(s)
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Procedure: Cholecystostomy
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Procedure: Gallbladder aspiration
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Primary Outcome(s)
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Amount of morphine administrated
[Time Frame: 24 hours]
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Secondary Outcome(s)
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Complications
[Time Frame: 30 days]
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Re-intervention
[Time Frame: 5 days]
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Nausea
[Time Frame: 5 days]
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Body temperature
[Time Frame: 5 days]
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LPK
[Time Frame: 5 days]
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Pain
[Time Frame: 5 days]
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Time to discharge
[Time Frame: 30 days]
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CRP
[Time Frame: 5 days]
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Secondary ID(s)
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Bile aspiration vs drain trial
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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