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Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy

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ClinicalTrials.gov Identifier: NCT03085407
Recruitment Status : Completed
First Posted : March 21, 2017
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
Sohag University
Information provided by (Responsible Party):
Mohammed Ahmed Omar, South Valley University

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.

Condition or disease Intervention/treatment Phase
Acute Biliary Pancreatitis Procedure: early cholecystectomy Procedure: delayed cholecystectomy Not Applicable

Detailed Description:

Inclusion criteria

  1. Patient diagnosed with a first attack of mild biliary pancreatitis
  2. Age ≥ 18 years
  3. American Society of Anesthesiologists (ASA) grade I, II or III
  4. a serum C-reactive protein (CRP) concentration less than 100 mg/L,
  5. no need for opioid analgesics,
  6. normal oral diet tolerance Exclusion criteria

1. chronic pancreatitis 2. alcohol abuse 3. pregnancy The number of patients needed was calculated. Considering a power of 80% and reliability of 0.05, we found that 53 patients should be present in each group. Eligible patients will be randomly divided into two equal groups (Group 1: early cholecystectomy, Group 2: delayed cholecystectomy) according to a computer-generated random numbers.

Procedure Early cholecystectomy was done within 48 after admission. Delayed cholecystectomy was done after 30 days after randomization. All cholecystectomies were done by, or under the direct supervision of, a surgeon who had undertaken at least 100 cholecystectomies in the past 5 years.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy: A Prospective Randomized Study
Actual Study Start Date : June 1, 2014
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: early cholecystectomy
Early cholecystectomy was done within 48 after admission
Procedure: early cholecystectomy
cholecystectomy was done within 48 after admission

Sham Comparator: delayed cholecystectomy
Delayed cholecystectomy was done after 30 days after randomization.
Procedure: delayed cholecystectomy
cholecystectomy was done after 30 days after randomization




Primary Outcome Measures :
  1. Gallstone related complications [ Time Frame: 6 month of onset of pancreatitis ]
    recurrent pancreatitis, cholecystitis, cholangitis, obstructive choledocholithiasis needing endoscopic retrograde cholangiopancreatography, or gallstone colic


Secondary Outcome Measures :
  1. Difficulty of cholecystectomy [ Time Frame: up to 3 hours ]
    the degree of difficulty of the procedureas assessed by the most experienced surgeon on a 0-10 visual analogue scale

  2. Conversion to open cholecystectomy [ Time Frame: up to 2 hours ]
  3. Operative time [ Time Frame: up to 10 hours ]
    from the begging of the operation to recovery of patient

  4. Cholecystectomy related complications [ Time Frame: up to 1 month ]
  5. additional surgical, endoscopic, or radiological intervention [ Time Frame: up to 6 month ]
  6. Gall stones non related complications [ Time Frame: up to 6 month ]
  7. Length of hospital stay of index admission [ Time Frame: from admission to discharge of patient, up to 10 days ]
  8. Number of readmission [ Time Frame: up to 6 month ]
  9. Total length of hospital stay (including readmission) [ Time Frame: up to 6 month ]
  10. The number of patient-reported colics irrespective of readmission [ Time Frame: up to 6 month ]
  11. Need for intensive care unit admission [ Time Frame: up to 6 month ]
  12. Mortality [ Time Frame: up to 6 month ]
    death from gall stone related complication



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patient diagnosed with a first attack of mild biliary pancreatitis
  2. Age ≥ 18 years
  3. American Society of Anesthesiologists (ASA) grade I, II or III
  4. a serum C-reactive protein (CRP) concentration less than 100 mg/L,
  5. no need for opioid analgesics,
  6. normal oral diet tolerance

Exclusion Criteria:

  • 1. chronic pancreatitis 2. alcohol abuse 3. pregnancy

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Responsible Party: Mohammed Ahmed Omar, Lecturer of GIT surgery and laparoendoscopy, South Valley University
ClinicalTrials.gov Identifier: NCT03085407     History of Changes
Other Study ID Numbers: SVU 148
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases