This document details a clinical study comparing single-stage laparoscopic CBD exploration and two-stage endoscopic stone extraction for managing concomitant gallbladder and CBD stones. The study found that the single-stage approach is more effective, less costly, and associated with fewer complications and a shorter hospital stay. Overall satisfaction scores were higher in the single-stage group, emphasizing its advantages over the traditional two-stage procedure.

1. Journal Club
Dr. Saujanya Jung Pandey
1st
year resident
General surgery

2. Contents
• Introduction
• Objective of the study
• Methodology
• Results
• Discussion
• Limitation
• Conclusion

3. Original Article
From <https://pubmed.ncbi.nlm.nih.gov/24162138/>

4. Pyramid of evidence

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

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

20. Clavin-Dindo Classification of surgical
complication

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 cholecystectomy 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

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 occurred in 2 patient both underwent exploratory laparotomy
-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

33. Thank You!