6
EVIDENCE BASED
REVIEW
P R E S E N T E D B Y
TIMING OF CHOLECYSTECTOMY IN MILD ACUTE BILIARY PANCREATITIS
INCIDENCE: 40 per 100,000 people.
ADMISSIONS: >300,000
COSTS: exceeding $2.2 billion per year
DEATHS: 20,000 annually
INTRODUCTION
IN THE UNITED STATE
35-55%
In patients with mild gallstone pancreatitis—characterized by the absence of organ failure, peripancreatic fluid collections or necrosis, and typical resolution within 1 week—evidence-based guidelines recommend cholecystectomy during index admission but do not specify further management recommendations. The practice of waiting for clinical and laboratory resolution of acute gallstone pancreatitis stemmed from a 1980s randomized trial that showed higher morbidity and mortality with surgery performed prior to 48 hours after admission. However, this practice is questioned based on recent data.
of pancreatitis cases are related to gallstones.
S T U D Y 1
U S E D I T I O N
INCEPTION
March 2019
STUDY DESIGN
A meta-analysis
The inclusion criteria were as follows:
1. Patients with mild gallstone pancreatitis according to a clear MAGP severity scoring system. ( Ranson score < 3 or according to Atlanta classification.)
2. Trials comparing the clinical indicators between ELC ( within 2 weeks/admission) and DLC.
3. Studies that provided adequate and extracted clinical outcome data.
4. Original high-quality English articles.
The exclusion criteria were:
1. Conference abstracts, expert opinion, review articles, case reports, editorials, and letters to the editor.
2. Articles that included patients with severe and/or other origins of pancreatitis.
3. Articles that lack clinical outcome data and unable to get full text.
Data sources and search strategy
A comprehensive search of MEDLINE, EMBASE, PubMed, Cochrane, and
the ISI Web of Science databases. “cholecystectomy” and “pancreatitis”
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M E T H O D S
Data extraction
To reduce inaccuracy in the extracted outcome indicator, this work was performed by 2 independent investigators.
Quality assessment
A total of
19 studies were included. The quality evaluation of the
literature was assessed using the Newcastle–Ottawa Scale.
The highest score is 9 points. The higher scores reflect a better methodological quality. This work was performed independently by 2 investigators. Disagreements were resolved through discussion or third party ruling.
Statistical analyses
Meta-analysis was performed using Review Manager5.3 software (Cochrane Collaboration, Copenhagen, Denmark).
Statistical heterogeneity between trials was evaluated by the ChiSquared test.
R E S U L T S ?
U S E D I T I O N
Meta-analysis
- Complications.
- Conversion to open cholecystectomy
- Hospital length of stay.
- Operative time.
- Gallstone-related events.
Study characteristics:
A total of 3297 articles were identified after a
comprehensive search of the database. Ultimately, 19 eligible studies were chosen.
- Re-admission
- ERCP usage rate.
R E S U L T S
U S E D I T I O N
Author's Conclusions
Results of this meta-analysis show that for patients with mild acute gallstone pancreatitis, early laparoscopic cholecystectomy is safe and effective and can shorten hospital stays, decrease the incidence of gallstone-related events, and reduce the overall usage of ERCP during the course of the disease without increasing postoperative complications, conversion to open cholecystectomy, re-admission, and operation time.
For clinically experienced surgeons, the difficulty of surgery is
similar, irrespective of the timing.
LIMITATIONS
First, Ranson scores were mostly used -APACHE-II score was more predictive
Second, most of the literature contains non-randomized controlled trials. Results from more randomized controlled trials are required to support this study.
Third,only published English articles were included. Therefore, the summary statistics obtained may not approximate the true average.
RELEVANCE OF THE STUDY
Does the study address a common problem in my practice?
Does the study address on outcome that is important to me & my patient?
Would it lead to change of my practice?
V A L I D I T Y
Were the inclusion & exclusion criteria/ Risk of bias done independently by two authors?
Was the search comprehensive?
Were the studies similar that combining them in a meta-analysis was appropriate?
Do the results from individual trials vary by more than would be expected by a chance?
S T U D Y 2
June 2016- June 2018
STUDY DESIGN:
RCT
97 patients.
Conducted at Lyndon Baines Johnson
General Hospital in Houston, Texas.
INCLUSION CRITERIA
EXCLUSION CRITERIA
1) 2 strong or 1 very strong indicator for choledocholithiasis based on the (ASGE) guidelines .
because of a high likelihood of requiring preoperative ERCP as laparoscopic common bile duct explorations were not routinely performed at this institution.
2)pregnancy, developmental delay, severe preexisting medical comorbidities precluding surgery, chronic pancreatitis, native language other than English and Spanish, and patient refusal.
1) upper abdominal pain, nausea, vomiting.
2) absence of alcohol use disorder.
3) elevated plasma lipase level above the upper limit of normal (≥370 U/L).
4) imaging confirmation of gallstones or sludge.
Predicted mild pancreatitis was defined as a Bedside Index of Severity in Acute Pancreatitis (BISAP) score of 0 to 2 and no evidence of organ failure or local or systemic complications.
in August 2017
a 12-hour observational period between patient enrollment and randomization to ensure that there was no evidence of clinical deterioration from mild to more severe pancreatitis.
RANDOMIZATION AND MASKING
Patients were randomized utilizing variable permuted blocks of 4, 6, and 8.
Using a computer-generated random sequence.
Patients and the healthcare providers were not able to be blinded.
Postop PRO assessors and data analysts were blinded. In addition, a blinded adjudication committee reviewed the outcomes.
P R O C E D U R E
The intervention was laparoscopic cholecystectomy with IOC within 24 hours of presentation regardless of laboratory or clinical symptom resolution. The primary surgeon was allowed to refuse to perform cholecystectomy if the patient demonstrated worsening pancreatitis.
The control was laparoscopic cholecystectomy with IOC once the patient had resolution of abdominal pain and down-trending laboratory values and was deemed appropriate for surgery by the clinical team.
Outcomes Measures
The primary endpoint was total 30-day hospital LOS in hours.
Secondary endpoints included ERCP rates, complications (unplanned transfusions, surgical site infections, pneumonia, bile duct injury, retained stone at 30 d, and bowel injury), Clavien-Dindo grading of complications, readmissions within 30 days, exacerbation of pancreatitis, and conversion to open cholecystectomy.
PROs were assessed by a short-term change in functional health status between admission and postoperative assessment at 1 month using the Gastrointestinal Quality-of-Life Index (GIQLI).
R E S U L T S ?
During the study period, 147 patients with gallstone pancreatitis were screened for eligibility. Of 100 consented patients
A negative binomial regression was used to compare 30-day LOS between the 2 groups.
Binary secondary outcomes were analyzed using chi-square tests.
Bayesian analysis was also performed for the primary outcome and complication rates.
OUTCOMES
Change in Functional
Health Status
C O N C L U S I O N
Author's
C O N C L U S I O N
Early laparoscopic cholecystectomy between 12 and 24 hours of admission is feasible at a busy safety-net hospital and decreased 30-day hospital LOS.
Early cholecystectomy also decreased index hospital LOS, need for ERCP, and had similar improvements in patient reported quality of life after surgery as compared with control cholecystectomy.
The complication rates were 2% and 6% in the control and early groups, respectively.
Furthermore there were no major complications (ie, Clavien–Dindo IV or V) in either group. From a Bayesian perspective, early cholecystectomy has a 99% probability of reducing 30-day LOS, 93% probability of decreasing ERCP use, and 72% probability of increasing complications.
Thus, larger trials are necessary to evaluate the risks of postoperative cholecystectomy and to validate the benefits across a broad range of hospitals.
L I M I T A T I O N S
First, results may not be generalizable to other hospitals.
Second, the trial did not incorporate laparoscopic common bile duct exploration which is commonly performed at other institutions and which may have an effect on the results.
Third, the inability to accurately predict the severity of acute pancreatitis soon after admission may limit implementation, particularly given the possibility of increased complications noted on Bayesian analysis.
In patients with predicted mild gallstone pancreatitis, cholecystectomy within 24 hours of admission significantly reduced rate of ERCPs, time to surgery, and 30-day length-of-stay.
However, early cholecystectomy may increase the risk of Clavien–Dindo Grade I–III complications suggesting caution should be employed in applying the results of this trial.
Identification of patients with mild gallstone pancreatitis in whom early cholecystectomy is safe given limitations in current prediction models of disease severity warrants further investigation.
S T U D Y 2
RELEVANCE AND
V A L I D I T Y
RELEVANCE OF THE STUDY:
DOSE THE STUDY ADDRESS A COMMON PROBLEM IN OUR PRACTICE ?
DOSE THE STUDY ADDRESS ON OUTCOME THAT IS IMPORTANT TO US AND OUR PATIENTS?
WOULD IT LEAD TO CHANGE IN OUR PRACTICE?
VALIDITY
WAS RANDOMIZAITON DONE PROPERLY AND WAS THE RANDOMIZATION SEQUANCE CONCEALED?
WERE ALL PATIENTS IN THE STUDY ACCOUNTED FOR IT'S CONCLUSION?
WERE BOTH GROUPS SIMILAR AT BASILELINE?