Acute Biliary PancreatitisNCT03085407
Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy
A study testing early cholecystectomy and delayed cholecystectomy in people with Acute Biliary Pancreatitis, run by South Valley University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Biliary Pancreatitis
- What is being tested?
- early cholecystectomy and delayed cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2014to 1 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 1. chronic pancreatitis 2. alcohol abuse 3. pregnancy
About this study
Official title: Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy: A Prospective Randomized Study
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.
Read the 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
- 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.
- Conditions
- Acute Biliary Pancreatitis
- Being tested
- early cholecystectomy, delayed cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early cholecystectomyProcedure or surgery
cholecystectomy was done within 48 after admission
delayed cholecystectomyProcedure or surgery
cholecystectomy was done after 30 days after randomization
| Study group | Role | What they receive |
|---|---|---|
| early cholecystectomy | Active comparator | Early cholecystectomy was done within 48 after admission Receives: Procedure: early cholecystectomy |
| delayed cholecystectomy | Sham comparator | Delayed cholecystectomy was done after 30 days after randomization. Receives: Procedure: delayed cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gallstone related complications
recurrent pancreatitis, cholecystitis, cholangitis, obstructive choledocholithiasis needing endoscopic retrograde cholangiopancreatography, or gallstone colic
Measured: 6 month of onset of pancreatitis
Secondary outcomes (12)
Difficulty of cholecystectomy
the degree of difficulty of the procedureas assessed by the most experienced surgeon on a 0-10 visual analogue scale
Measured: up to 3 hours
Conversion to open cholecystectomy
Measured: up to 2 hours
Operative time
from the begging of the operation to recovery of patient
Measured: up to 10 hours
Cholecystectomy related complications
Measured: up to 1 month
additional surgical, endoscopic, or radiological intervention
Measured: up to 6 month
Gall stones non related complications
Measured: up to 6 month
Length of hospital stay of index admission
Measured: from admission to discharge of patient, up to 10 days
Number of readmission
Measured: up to 6 month
Total length of hospital stay (including readmission)
Measured: up to 6 month
The number of patient-reported colics irrespective of readmission
Measured: up to 6 month
Need for intensive care unit admission
Measured: up to 6 month
Mortality
death from gall stone related complication
Measured: up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start1 Jun 2014
- Primary completion1 Sep 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Biliary PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Collaborators
- Sohag University
- Responsible party
- Principal investigator, Mohammed Ahmed Omar, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085407
- Sponsor's protocol ID
- SVU 148
- Status last verified
- Sep 2018
- First submitted
- 19 Mar 2017
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03085407
- Acronym / sponsor ID
- SVU 148
- Conditions
- Acute Biliary Pancreatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Collaborators
- Sohag University
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early cholecystectomy | Active comparator | Procedure: early cholecystectomyEarly cholecystectomy was done within 48 after admission |
| delayed cholecystectomy | Sham comparator | Procedure: delayed cholecystectomyDelayed cholecystectomy was done after 30 days after randomization. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (1 listed)
- 1. chronic pancreatitis 2. alcohol abuse 3. pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early cholecystectomycholecystectomy was done within 48 after admission | Procedure or surgery | early cholecystectomy |
| delayed cholecystectomycholecystectomy was done after 30 days after randomization | Procedure or surgery | delayed cholecystectomy |
Primary outcome
Gallstone related complications
Time frame: 6 month of onset of pancreatitis
recurrent pancreatitis, cholecystitis, cholangitis, obstructive choledocholithiasis needing endoscopic retrograde cholangiopancreatography, or gallstone colic
12 secondary outcomes
Difficulty of cholecystectomy
Time frame: up to 3 hours
Conversion to open cholecystectomy
Time frame: up to 2 hours
Operative time
Time frame: up to 10 hours
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing early cholecystectomy and delayed cholecystectomy in people with Acute Biliary Pancreatitis, run by South Valley University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gallstone related complications (time frame: 6 month of onset of pancreatitis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.