Bile Aspiration vs Drain in Acute Cholecystitis
Randomized Controlled Trial of Bile Aspiration vs Drain in Acute Cholecystitis
1 other identifier
interventional
40
1 country
1
Brief Summary
In order to compare percutaneous cholecystostomy and leaving a drain in situ with percutaneous gallbladder aspiration we plan to undertake a double-blind randomized controlled trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2026
Typical duration for not_applicable
1 active site
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
January 4, 2017
CompletedFirst Posted
Study publicly available on registry
January 6, 2017
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
August 13, 2025
August 1, 2025
1.8 years
January 4, 2017
August 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Amount of morphine administrated
The total amount of morphine required to relieve the pain the first 24 hours
24 hours
Secondary Outcomes (8)
Pain
5 days
Nausea
5 days
Re-intervention
5 days
Body temperature
5 days
CRP
5 days
- +3 more secondary outcomes
Study Arms (2)
Cholecystostomy
ACTIVE COMPARATORPercutaneous cholecystostomy, leaving drain in situ
Gallbladder aspiration
EXPERIMENTALGallblader aspiration without drain
Interventions
Percutaneous ultrasound-guided aspiration of bile from the gallbladder. This is performed without leaving a drain in the gallbladder. The aspiration is performed with the intention to relief the pressure in the gallbladder, without drain.
Ultrasound-guided insertion of drain in the gallbladder. The drain is left in the gallbladder until clinical assessment and laboratory analyses show that the acute cholecystitis has been successfully treated.
Eligibility Criteria
You may qualify if:
- Acute cholecystitis, not warranting acute cholecystectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska University Hospital, Center for Digestive Diseases
Stockholm, 14186, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriel Sandblom, Assoc Prof
Karolinska Institutet
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 4, 2017
First Posted
January 6, 2017
Study Start
March 1, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
March 31, 2028
Last Updated
August 13, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share