Election of the Optimal Moment of Colecistectomy After Mild Biliary Pancreatitis
Primary Purpose
Pancreatitis, Acute
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatitis, Acute
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years.
- Diagnosis of acute mild biliary pancreatitis according to Altanta 2012 criteria.
- Signed informed consent. Exclusion Criteria
- ASA IV.
- Alcohol abuse or chronic pancreatitis.
- Not having assessed the presence of residual choledocolithiasis (cholangioNMR / intraoperative cholangiography)
- Pregnancy.
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A (experimental arm, surgery intervention)
Group B (active comparator, surgery intervention)
Arm Description
Cholecystectomy within the first week after a mild acute biliary pancreatitis.
Cholecystectomy four weeks later a mild acute biliary pancreatitis.
Outcomes
Primary Outcome Measures
Number of patients presenting morbidity associated with cholescystectomy
Number of patients with surgical complications
Secondary Outcome Measures
Full Information
NCT ID
NCT04625712
First Posted
November 6, 2020
Last Updated
November 11, 2020
Sponsor
Consorci Sanitari Integral
1. Study Identification
Unique Protocol Identification Number
NCT04625712
Brief Title
Election of the Optimal Moment of Colecistectomy After Mild Biliary Pancreatitis
Official Title
Multicenter Prospective Randomized Study to Choose the Optimal Moment of Colecistectomy After Mild Biliary Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Consorci Sanitari Integral
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Introduction Acute pancreatitis is the third gastrointestinal cause of hospital admission. It is estimated that 35-60% have a biliary origin, and most of them are mild.
After a mild acute biliary pancreatitis (ABP), there is a high risk of recurrence of others biliary events. 15-20% of patients will suffer another pancreatitis, cholangitis, choledocolithiasis, or cholecystitis. Therefore, is necessary a definitive treatment.
Although it is suggested to perform cholecystectomy early, there is still insufficient scientific evidence on this subject. All publications have biases and do not allow establish recommendations. In addition, the usual clinical practice tends to postpone the cholecystectomy, because of doubts about the safety of early intervention and for hospital logistical reasons. On the other hand, is discussing if early cholecystectomy carried out more persistence of residual cholelithiasis, explains for the pathophysiology of the ABP.
Finally, it is important to mention, that in our environment 25% of the patients with an ABP are more than 75 years old. There are not any trial that includes this age group.
Objectives Demonstrate that early cholecystectomy is feasible in all patients, including elderly patients, and decreases the number of readmissions for other biliary events.
Material and Methods It is being done a multicenter prospective randomized trial. After an ABP, patients are randomized in two treatment branches. Group A is cholecystectomy within the first week after the ABP. Group B four weeks later.
There are collect data from demographic information, comorbidities, biliary events before the surgery, residual choledocolithiasis, difficulty of the surgical technique, postoperative complications and patients are follow-up for 6 months.
To obtain a representative sample of the population, we consider it appropriate to include all age groups, including patients older than 75 years.
Expected results With this study we pretend to demonstrate that early cholecystectomy is feasible and safe. It does not increase the number of residual choledocolithiasis, and prevents readmissions for new biliary events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A (experimental arm, surgery intervention)
Arm Type
Experimental
Arm Description
Cholecystectomy within the first week after a mild acute biliary pancreatitis.
Arm Title
Group B (active comparator, surgery intervention)
Arm Type
Active Comparator
Arm Description
Cholecystectomy four weeks later a mild acute biliary pancreatitis.
Intervention Type
Procedure
Intervention Name(s)
Cholecystectomy
Intervention Description
Cholecystectomy within the first week after a mild acute biliary pancreatitis
Primary Outcome Measure Information:
Title
Number of patients presenting morbidity associated with cholescystectomy
Description
Number of patients with surgical complications
Time Frame
30 days after surgical intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years.
Diagnosis of acute mild biliary pancreatitis according to Altanta 2012 criteria.
Signed informed consent. Exclusion Criteria
ASA IV.
Alcohol abuse or chronic pancreatitis.
Not having assessed the presence of residual choledocolithiasis (cholangioNMR / intraoperative cholangiography)
Pregnancy.
Exclusion Criteria:
-
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Election of the Optimal Moment of Colecistectomy After Mild Biliary Pancreatitis
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