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Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy

Primary Purpose

Acute Biliary Pancreatitis

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

early cholecystectomy

delayed cholecystectomy

About this trial

This is an interventional treatment trial for Acute Biliary Pancreatitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

early cholecystectomy

delayed cholecystectomy

Arm Description

Early cholecystectomy was done within 48 after admission

Delayed cholecystectomy was done after 30 days after randomization.

Outcomes

Primary Outcome Measures

Gallstone related complications

recurrent pancreatitis, cholecystitis, cholangitis, obstructive choledocholithiasis needing endoscopic retrograde cholangiopancreatography, or gallstone colic

Secondary Outcome Measures

Difficulty of cholecystectomy

the degree of difficulty of the procedureas assessed by the most experienced surgeon on a 0-10 visual analogue scale

Conversion to open cholecystectomy

Operative time

from the begging of the operation to recovery of patient

Cholecystectomy related complications

additional surgical, endoscopic, or radiological intervention

Gall stones non related complications

Length of hospital stay of index admission

Number of readmission

Total length of hospital stay (including readmission)

The number of patient-reported colics irrespective of readmission

Need for intensive care unit admission

Mortality

death from gall stone related complication

Full Information

NCT ID

NCT03085407

First Posted

March 19, 2017

Last Updated

September 4, 2018

Sponsor

South Valley University

Collaborators

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT03085407

Brief Title

Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

June 1, 2014 (Actual)

Primary Completion Date

September 1, 2017 (Actual)

Study Completion Date

December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

South Valley University

Collaborators

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Biliary Pancreatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

early cholecystectomy

Arm Type

Active Comparator

Arm Description

Early cholecystectomy was done within 48 after admission

Arm Title

delayed cholecystectomy

Arm Type

Sham Comparator

Arm Description

Delayed cholecystectomy was done after 30 days after randomization.

Intervention Type

Procedure

Intervention Name(s)

early cholecystectomy

Intervention Description

cholecystectomy was done within 48 after admission

Intervention Type

Procedure

Intervention Name(s)

delayed cholecystectomy

Intervention Description

cholecystectomy was done after 30 days after randomization

Primary Outcome Measure Information:

Title

Gallstone related complications

Description

recurrent pancreatitis, cholecystitis, cholangitis, obstructive choledocholithiasis needing endoscopic retrograde cholangiopancreatography, or gallstone colic

Time Frame

6 month of onset of pancreatitis

Secondary Outcome Measure Information:

Title

Difficulty of cholecystectomy

Description

the degree of difficulty of the procedureas assessed by the most experienced surgeon on a 0-10 visual analogue scale

Time Frame

up to 3 hours

Title

Conversion to open cholecystectomy

Time Frame

up to 2 hours

Title

Operative time

Description

from the begging of the operation to recovery of patient

Time Frame

up to 10 hours

Title

Cholecystectomy related complications

Time Frame

up to 1 month

Title

additional surgical, endoscopic, or radiological intervention

Time Frame

up to 6 month

Title

Gall stones non related complications

Time Frame

up to 6 month

Title

Length of hospital stay of index admission

Time Frame

from admission to discharge of patient, up to 10 days

Title

Number of readmission

Time Frame

up to 6 month

Title

Total length of hospital stay (including readmission)

Time Frame

up to 6 month

Title

The number of patient-reported colics irrespective of readmission

Time Frame

up to 6 month

Title

Need for intensive care unit admission

Time Frame

up to 6 month

Title

Mortality

Description

death from gall stone related complication

Time Frame

up to 6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

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Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy

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