5. Introduction
• The first surgical exploration of the CBD was done in 1890 by Ludwig Courvoisier,
a Swiss surgeon who made an incision in the CBD and removed a gallstone
• Prior to the development of laparoscopic cholecystectomy, patients found to
have bile duct stones at surgery underwent open CBD exploration with greater
than 90% successful duct clearance
• With Laparoscopic cholecystectomy as the current standard of care for
gallbladder stone disease, endoscopic stone extraction following laparoscopic
cholecystectomy currently prefered
6. • Single stage management of concomitant CBD and gallbladder stones is gaining
popularity with increasing experience of surgeons with advanced laparoscopic
procedure
• It avoids the morbidity and mortality associated with ERCP as well as the need for
multiple procedures
7. Objective of the study
• To compare single and two stage management for uncomplicated concomitant
gallbladder and CBD stone in terms of success, complications and cost
effectiveness.
8. Methodology
• Data collection:
Randomized clinical trial (RCT)
February 2009 to October 2012
Randomly divided into two equal groups(using computer generated
randomization)
Consort guidelines followed
All India Institute of Medical Sciences, New Delhi, India
Sample size: 168
9. Study protocol:
Not blinded: Patients and health care provider
Informed written consent taken
All patients underwent general anesthesia
Performed by the same group of surgeons
10. Selection criteria
Inclusion criteria:
Patients with gallbladder stones and concomitant stone in CBD
Patients undergoing elective surgery
Those with American Society of Anesthesiologists (ASA) grade I/II/III
11. Exclusion criteria:
Acute Cholecystitis
Acute Cholangitis
Obstructive jaundice with a serum bilirubin level >10 mg/dl
CBD diameter smaller than 10mm
History of hepatobiliary surgery or a previous ERCP
Morbid obesity
Uncorrectable coagulopathy
ASA class 4 or 5 disease
Patient who refused to give consent
12. Workup of patients
• Patients with a provisional daignosis of GB stones and CBD stones
were evaluated clinically and underwent standard hematological and
biochemical investigations including LFT
• Imaging-if USG showed GB stones and suspicion of CBD stones with a
CBD diameter greater than 10mm, a MRCP or EUS was performed to
confirm the presence of stones in CBD before the patient’s inclusion
in study
13.
14. Intervention
• Single stage Laparoscopic CBD exploartion
Prophylactic broad spectrum iv antibiotics with third generation
cephalosporin together with an aminoglycoside at time of induction
5 ports were made
Dissection around calots triangle and cystic duct/cystic artery ligated
then GB partially dissected from its bed
15. Longitudinal supraduodenal choledochotomy was made using the
Endoknife
The stones and debris from the CBD were removed either by thorough
flushing with a copious amount of NS or by using forcep
Choledochoscopy was performed using either a flexible choledochoscope
or a rigid nephroscope inserted through epigastric port
Closure done with 4-0 vicryl
16. • Two stage endoscopic stone extraction
ERCP procedure was performed with a side-viewing duodenoscope,
selective cannulation of bile duct was achieved using a wire guided
sphincterotome and a hydrophilic guidewire
Contrast dye was injected to confirm presence of CBD stone
For extraction of stone biliary sphincterotomy was performed then
stone extracted with the help of a dormia basket
17. • Mechanical lithotripsy was used for large stone(>15mm)
• After the endoscopic extraction of CBD stone, the patients underwent
Laparoscopic cholecystectomy after 2-3 weeks
18. Follow-up assessment
• 1 week
• 6 week
• 3 months
• 6 months
• 1 year or at any time if symptoms developes
19. • The presence of pain and its severity, condition of the wound, history
of jaundice, and any other problems were noted
• At a 6 week follow up evaluation, overall satisfaction was assessed on
a verbal rating scale
0- not satisfied
1- partially satisfied
2- satisfied
3- very satisfied
• Transabdominal USG and LFT were performed at 3 month follow up
evaluation to assess the status of CBD
21. Data management and analysis
• Data were collected and managed using Microsoft Excel(Microsoft, Seattle, WA,
USA, annexure 8)
• SPSS version 14(SPSS, Chicago, IL, USA)
22. Primary Outcome Measure
• Success, defined as removal of CBD stones and gallbladder by the
intended approach, was the primary outcome measure
• In group 1, if the CBD exploration could not be completed
laparoscopically, it was considered as a failure
• In group 2, if the CBD stones were not retrieved by the endoscopic
approach, they were subjected to surgical removal, and this was
defined as a failure of endoscopic treatment
• In addition, if choleystectomy could not be completed
laparoscopically, it was considered as a failure
23. Secondary Outcome Measure
1. Complication: according to Clavien-Dindo classification
2. Operative time in minutes
3. Difficulty of the surgery
4. Hospital stay
5. Pain score: using visual analog scale ranging from 1 to 10 at 24h, 1
week and 6 week postoperatively
6. Cost of procedure
7. Patient satisfaction score
24.
25. • overall complication rates between two groups were comparable 23.8% vs 22.6%
-superficial SSI was present in 7.1% of patient in both group
-bile leak was 16.7% in group1 vs 2.4% in group2
-bleeding 3 patient in group2 (2 pt after sphincterotomy and managed conservatively, 1 pt after LC ) and none in group1
-acute pancreatitis observed in 3 group2 patient (2 pt recovered and 1 pt died of organ failure)
-Duodenal injury with perforation peritonitis occured in 2 patient both underwent exploratory laparotmy
-overall 3 mortality in group2 (2 after ERCP related complication and one after LC related complication)
26. -The average cost for the treatment in group1 is 21,258.20INR($394.10) compared to 27,328.2INR($506.50) in group2
-Two groups also were compared for cost effectiveness by calculation of incremental cost-effectiveness ratio, which
turned out to be -63,812.5($1182.7) making single stage laparoscopic CBD exploartaion more effective and less costly
27. Discussion
• The management of CBD stones has evolved considerably since the advent of
laparoscopic surgery
• With advancement in laparoscopic surgery, primary laparoscopic CBD exploration
currently is challenging the present standard of ERCP followed by LC for patients
with gallbladder and CBD stones
• Earlier, surgical management of CBD stones was limited to patients in whom the
endoscopic approach had previously failed.
28. • Overall comlication rates were similar but more morbidity and mortality in group
2 patient
• Complications were SSI, bile leak, bleeding, acute pancreatitis, peritonitis
• Single stage laparoscopic CBD exploration more effective and less costly than the
two stage procedure
• The average postoperative hospital stay of the patients undergoing single-stage
procedure was significantly shorter(4.6 ± 2.4 days; range 2–15 days) than the
hospital stay of the patients in group 2 (5.3 ± 6.2 days; range 2–37 days)
• The patient in group1 had higher satisfaction scores than the patients in group 2
29. Limitation of the study
• Study may not be generalized to other hospital
• Sampling study is not precise
30. Conclusion of the study
Single stage management vs two stage management of concomitant GB and CBD
stone has following advantages
Fewer procedure
Fewer postoperative complications
Better overall satisfaction
Cost effectiveness
Shorter hospital stay
31. Critical Appraisal
• Did trial clearly address a focused issue?
-Participants, intervention, comparison group and outcomes are clearly
identified
• Was assignment of the patient randomized?
-Computer based simple randomization done
32. • Were the group similar at the start of the trial?
-the baseline characteristics in both group were quite comparable
-Demographic characteristics like age, sex, address, phone number and
baseline characteristics of all patients were recorded using a standard
questionnaire
• Can result be applied to our context?
-standard guideline recommend two stage management i.e ERCP
followed by LC
-But Laparoscopic advancement being upmost Lap CBD exploration is
associated with less morbidity and mortality