journal club

1. JOURNAL CLUB
EARLY VERSUS DELAYED
CHOLECYSTECTOMY IN PATIENTS
WITH
MILD TO MODERATE
ACUTE BILIARY PANCREATITIS
Dr. ARAVIND.T.K

2. PLACE OF STUDY:
SELAYANG HOSPITAL, MALAYSIA
AUTHORS
Shir Li Jee, Razman Jarmin, Kin Foong Lim, Krishnan Raman.
YEAR OF PUBLICATION:
2016
Accepted – 30th MAY, 2016
Available online – 13th AUGUST, 2016.

3. ETHICS :
APPROVED BY CLINICAL RESEARCH ETHICS COMMITTEE OF NATIONAL
UNIVERSITY OF MALAYSIA MEDICAL CENTRE AND MEDICAL RESEARCH
ETHICS COMMITTEE OF MINISTRY OF HEALTH, MALAYSIA.
CONFLICT OF INTEREST :
NONE

4. JOURNAL :
ASIAN JOURNAL OF SURGERY, VOLUME 41, NUMBER 47-54, 2016.
TIME FRAME :
1 YEAR(NOVEMBER 2013 TO NOVEMBER 2014)
HYPOTHESIS PROPOSED :
EARLY CHOLECYSTECTOMY AS COMPARED TO DELAYED
CHOLECYSTECTOMY REDUCES RECURRENT BILIARY EVENTS WITHOUT A
HIGHER PERI-OPERATIVE COMPLICATION RATE.

5. JOURNAL-ASIAN JOURNAL OF SURGERY
• ISSN: 1015-9584
• Ranking: Surgery 98/200
• Impact Factor: 1.895
• 5 year impact factor: 1.602

6. BACKGROUND
VARIOUS RECOMMENDATIONS WITH NO FIXED
DEFINITION
• The International Association of Pancreatology (IAP) recommends
that all patients with gallstone pancreatitis should undergo
cholecystectomy as soon as the patient has recovered from the
attacks
• British Society of Gastroenterology recommends cholecystectomy
within the same hospital admission or up to 2 weeks after discharge
• The American Gastroenterological Association guidelines suggest
that cholecystectomy should be performed as soon as possibleand in
no case beyond 2 - 4 weeks after discharge
• The American College of Gastroenterology recommends
cholecystectomy within index admission.

7. RESEARCH QUESTION
TO OPTIMISE THE TIMING OF
SURGERY IN ACUTE BILIARY
PANCREATITIS WHICH REMAINS
A TOPIC OF CONTROVERSY AND
ONGOING DEBATE

8. OBJECTIVES :
To find out the Optimal timing of surgery for acute biliary
pancreatitis and to assess the outcomes of early versus delayed
cholecystectomy
METHODS :
STUDY DESIGN : PROSPECTIVE RANDOMISED CONTROLLED STUDY

9. SAMPLE SIZE CALCULATIONS
• To demonstrate a reduction of recurrent biliary events with a power
80% alpha value of 5%
• 55 patients will have to be included in each group
• With an estimated drop out rate of 10%, a sample size of 60 in each
group was decided.

10. INCLUSION CRITERIA :
1. Age – 18 years or older
2. Admitted with mild to moderate ABP
3. Consenting for the study
DEFINITION OF ACUTE PANCREATITIS (2/3):
1. Clinical signs (upper abdominal pain, nausea , vomiting and epigastric
tenderness)
2. Elevated serum amylase of atleast thrice the upper limit of normal
3. Characteristic findings of acute pancreatitis on imaging
BILIARY PANCREATITIS WAS DEFINED BY :
1. Radiology – gallstones/ sludge
2. Absence of ethanol abuse (males >3units/d or females >2units/d)

11. • MILD TO MODERATE PANCREATITIS WAS DEFINED BY
1. No pancreatic necrosis and/or peripancreatic collections
2. No persistent (>48 hours) organ failure
3. Clinical stability with no necessity of ICU or HDU care
4. Absence of concomitant acute cholangitis

12. EXCLUSION CRITERIA:
1. Severe pancreatitis (presence of 3 or more of ranson or imrie
criteria on admission)
2. Admission to ICU or HDU
3. Suspected concomitant acute cholangitis
4. Severe pre-existing medical comorbidity contraindicating
cholecystectomy
5. Pregnancy
6. Prior gastric bypass surgery

13. RANDOMISATION :
Random assignment was performed by drawing a sealed, unlabelled,
unordered envelope from a container by an independent party
immediately after informed consent was obtained.

14. randomisation
Early group
Cholecystectomy
done within index
admission when
1.Pt no longer requires opoid analgesics
2. Can tolerate a normal oral diet
3.Serum C- reactive protein concentration <100 mg/L
Delayed group
Cholecystectomy performed on an elective basis after
hospital discharge from index admission at approx. 6
weeks from pancreatitis episode
1. Cholecystectomy was performed as a laproscopic procedure
which if contraindicated an open procedure was done
2. All cholecystectomies was performed by a single surgeon
3. All patients received perioperative antibiotic prophylaxis

15. STATISTICAL METHODS :
1. Data entry utilising codes were performed using SPSS
software version 16.0
2. Mann whitney U test was performed to assess significant
differences between the 2 groups.

16. OUTCOMES
• The parameters evaluated between the two groups were,
1. Recurrent biliary events
2. Peri-operative complications
3. Conversion rate
4. Length of surgery
5. Total length of hospital stay (includes the index admission plus
admission for pre-cholecystectomy recurrences plus admission for
cholecystectomy).

17. FLOW OF STUDY
Randomisation
(Initially planned sample size – 60 in each
group)
Interim analysis made, reveals a significant difference in rate of readmissions in delayed group
Discussion done with ethics committee and decision was made to terminate the study
At time of termination of study a total of 82 patients where in the study as recruited
subjects
10 patients withdrew from the study due
reasons like
1. Alternative medicine therapy
2.Change of mind in undergoing surgery
3. Deciding to undergo surgery in another
institution
Remaining 72 patients
were enrolled in the
final analysis
38 patients randomised
into
the early group
19 patients – ERCP
DONE PREOP in view of
suspected CBD calculi
ES WITH STONE REMOVAL
DONE IN 33 PATIENTS
(ONE PT HAD NO STONE )
34 patients randomised
into
the delayed group
15 patients – ERCP
DONE PREOP in view of
suspected CBD calculi
2 patients – ERCP DONE
POSTOP in view
accidental CBD calculi
in IOC

18. MEASURES TO ENSURE COMPARABILITY
Patient parameters Early group Delayed group P value
Median Age 42.5 42.5 0.977
Sex
Male
Female
18
22
13
21
0.435
Race
Malay
Chinese
Indian
foreigner
24
6
1
7
16
7
4
7
0.353
ERCP 19 17 >0.99
Operative intervention Done By a Single surgeon
P value of <0.005 Considered
significant

19. RESULTS AND CONCLUSIONS:
outcomes Early group Delayed group P value
1. Conversion to open surgery 4 4 >0.99
2.Median duration of surgery 80 minutes 85 minutes 0.752
3. Operative complications
a. Intraoperative
b. Post operative
c. Mortality
0
3
0
1
3
0
0.700
0.472
>0.99
4. Median Total length of hospital
stay(LOS)
8 9 0.002
5.Recurrent biliary events
a. Biliary colic
b. Acute cholecystitis
c. Recurrent biliary pancreatitis
0 15
10
3
2
<0.0001
* It is also noted that in the study majority of the recurrent biliary events occurred within 4 weeks after
discharge(73.33%).

20. CONCLUSIONS DRAWN
• In mild to moderate ABP , early laprascopic cholecystectomy within
the same index admission reduces the risk of recurrent biliary events
without an increase in operative difficulty or perioperative morbidity.

21. + -
Comparability between both groups Specialist hepato-biliary surgeon
Single operative surgeon Small sample size
Proper definitions of disease entity under evaluation Discontinuity of study
Prospective study Study conducted a single centre
Attempt at identifying using of ERCP and ES Crude randomisation technique
No mention about the perioperative antibiotics