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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

Tracking Information
First Submitted Date  ICMJE March 19, 2017
First Posted Date  ICMJE March 21, 2017
Last Update Posted Date September 6, 2018
Actual Study Start Date  ICMJE June 1, 2014
Actual Primary Completion Date September 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2017)
Gallstone related complications [ Time Frame: 6 month of onset of pancreatitis ]
recurrent pancreatitis, cholecystitis, cholangitis, obstructive choledocholithiasis needing endoscopic retrograde cholangiopancreatography, or gallstone colic
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03085407 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2017)
  • 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
  • Conversion to open cholecystectomy [ Time Frame: up to 2 hours ]
  • Operative time [ Time Frame: up to 10 hours ]
    from the begging of the operation to recovery of patient
  • Cholecystectomy related complications [ Time Frame: up to 1 month ]
  • additional surgical, endoscopic, or radiological intervention [ Time Frame: up to 6 month ]
  • Gall stones non related complications [ Time Frame: up to 6 month ]
  • Length of hospital stay of index admission [ Time Frame: from admission to discharge of patient, up to 10 days ]
  • Number of readmission [ Time Frame: up to 6 month ]
  • Total length of hospital stay (including readmission) [ Time Frame: up to 6 month ]
  • The number of patient-reported colics irrespective of readmission [ Time Frame: up to 6 month ]
  • Need for intensive care unit admission [ Time Frame: up to 6 month ]
  • Mortality [ Time Frame: up to 6 month ]
    death from gall stone related complication
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy
Official Title  ICMJE Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy: A Prospective Randomized Study
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Biliary Pancreatitis
Intervention  ICMJE
  • Procedure: early cholecystectomy
    cholecystectomy was done within 48 after admission
  • Procedure: delayed cholecystectomy
    cholecystectomy was done after 30 days after randomization
Study Arms  ICMJE
  • Active Comparator: early cholecystectomy
    Early cholecystectomy was done within 48 after admission
    Intervention: Procedure: early cholecystectomy
  • Sham Comparator: delayed cholecystectomy
    Delayed cholecystectomy was done after 30 days after randomization.
    Intervention: Procedure: delayed cholecystectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2017)
2
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1, 2017
Actual Primary Completion Date September 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03085407
Other Study ID Numbers  ICMJE SVU 148
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mohammed Ahmed Omar, South Valley University
Study Sponsor  ICMJE South Valley University
Collaborators  ICMJE Sohag University
Investigators  ICMJE Not Provided
PRS Account South Valley University
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP