Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy
1 other identifier
interventional
2
0 countries
N/A
Brief Summary
In patients with mild gallstone pancreatitis, early cholecystectomy within 48 hours might reduce the risk of recurrent gallstone-related complications, compared with the more commonly used strategy in our locality of conservative management and delayed cholecystectomy. However, evidence to support early cholecystectomy is poor, and concerns exist about an increased risk of cholecystectomy-related complications with this approach. In this study, we aimed to compare the benefits and harms of early versus delayed cholecystectomy in patients with mild biliary pancreatitis.
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 Jun 2014
Longer than P75 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
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 19, 2017
CompletedFirst Posted
Study publicly available on registry
March 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedSeptember 6, 2018
September 1, 2018
3.3 years
March 19, 2017
September 4, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Gallstone related complications
recurrent pancreatitis, cholecystitis, cholangitis, obstructive choledocholithiasis needing endoscopic retrograde cholangiopancreatography, or gallstone colic
6 month of onset of pancreatitis
Secondary Outcomes (12)
Difficulty of cholecystectomy
up to 3 hours
Conversion to open cholecystectomy
up to 2 hours
Operative time
up to 10 hours
Cholecystectomy related complications
up to 1 month
additional surgical, endoscopic, or radiological intervention
up to 6 month
- +7 more secondary outcomes
Study Arms (2)
early cholecystectomy
ACTIVE COMPARATOREarly cholecystectomy was done within 48 after admission
delayed cholecystectomy
SHAM COMPARATORDelayed cholecystectomy was done after 30 days after randomization.
Interventions
cholecystectomy was done within 48 after admission
cholecystectomy was done after 30 days after randomization
Eligibility Criteria
You may qualify if:
- Patient diagnosed with a first attack of mild biliary pancreatitis
- Age ≥ 18 years
- American Society of Anesthesiologists (ASA) grade I, II or III
- a serum C-reactive protein (CRP) concentration less than 100 mg/L,
- no need for opioid analgesics,
- normal oral diet tolerance
You may not qualify if:
- \. chronic pancreatitis 2. alcohol abuse 3. pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- South Valley Universitylead
- Sohag Universitycollaborator
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of GIT surgery and laparoendoscopy
Study Record Dates
First Submitted
March 19, 2017
First Posted
March 21, 2017
Study Start
June 1, 2014
Primary Completion
September 1, 2017
Study Completion
December 1, 2017
Last Updated
September 6, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share