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Completed

NCT Number: NCT03085407

Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy

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.

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Key information

Conditions

Acute Biliary Pancreatitis

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Inclusion criteria

  • 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 Exclusion criteria
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

early cholecystectomy

Procedure

cholecystectomy was done within 48 after admission

delayed cholecystectomy

Procedure

cholecystectomy was done after 30 days after randomization

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Collaborators

  • Sohag University

Registry information

Official study title

Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy: A Prospective Randomized Study

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 21, 2017
Registry last updated
Sep 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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