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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
Consorci Sanitari Integral
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 6, 2020
    Last Updated
    November 11, 2020
    Sponsor
    Consorci Sanitari Integral
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    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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