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multiple medical co-morbidities would be best managed with minimally invasive endoscopic techniques. But what about the asymptomatic patient with mild eleva­tions in serum alkaline phosphatase and bilirubin with common bile duct dilation? What is the natural history of that disorder? Identifi cation of the non-dilatable stric­ture is diffi cult and is the crux of the patient selection process. When patients have symptomatic terminal biliary stenosis with fi brosing pancreatitis repeated endo­scopic stent ing may be needed indefi nitely. Choledochoduodenostomy is an attrac­tive long-term solution and may be performed with minimally invasive laparoscopic techniques. However, chronic peripancreatic and peri-duodenal infl ammation may make the operation diffi cult and hazardous. Normal anatomic landmarks may be hidden and simple identifi cation of the infl amed and dilated common bile duct can be a challenge. When duodenal fi brosis is severe, mobilization and anastomosis between a fi brotic duodenum and the bile duct may not be possible. In this situation pre-operatively placed transpapillary biliary stent s are useful to protect the anasto­mosis post-operatively. Alternatively, Roux-en-Y hepaticojejunostomy may be more prudent when the duodenum is unfavorable for anastomosis. Patients who have cavernous transformation of the portal vein associated with CP superior mes­enteric and portal vein stenosis can safely undergo CDD though increased operative blood loss is expected, and these patients are frequently directed towards endo­scopic therapy. An evidence-based approach to biliary stricture s in chronic pancre­atitis is problematic and patient selection remains grounded in local experience. As new minimally invasive laparoscopic and endoscopic tools and techniques are developed they can be better tested against traditional open surgical techniques in appropriately classifi ed patient cohorts and evidence will replace experience in clin­ical practice.

References

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and endoscopy for the treatment of bile duct strictures in patients with chronic pancreatitis. Surg Endosc. 2012;26:2902–8.
2. Sanders RL. Indications for and value of choledochoduodenostomy. Ann Surg.
1946;123:847–55.
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bad? J Gastrointest Surg. 2011;15:754–7.
4. Bosanquet DC, Cole M, Conway KC, Lewis M. Choledochoduodenostomy reevaluated in the
endoscopic and laparoscopic era. HepatoGastroenterology. 2012;59:2410–5.
5. Mendes De Almeida A, Dos Santos N, et al. Choledochoduodenostomy in the management of
common duct stones or associated pathology- an obsolete method? HPB Surg. 1996;10:27–33.
6. Escudero-Fabre A, Escallon A, et al. Choledochoduodenostomy: analysis of 71 cases followed
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9. Khajanchee YS, Cassera MA, Hammill CW, Swanstrom LL, Hanson PD. Outcomes following
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into the resection cavity during duodenum-preserving resection of the head of the pancreas for chronic pancreatitis. Br J Surg. 1997;84:791–2.
15. Cataldegirmen G, Bogoevski D, Mann O, Kaifi JT, Izbicki JR, Yekebas EF. Late morbidity
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treatment of chronic pancreatitis associated with common bile duct stricture. Hepatobiliary Pancreat Dis Int. 2013;12:637–44.
17. Davids PH, Rauws EA, Coene PP, Tytgat GN, Huibregtse K. Endoscopic stenting for post-
operative biliary strictures. Gastrointest Endosc. 1992;38:12–8.
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19. Costamagna G, Tringali A, Mutignani M, Perri V, Spada C, Pandolfi M, Galasso D. Endotherapy
of postoperative biliary strictures with multiple stents: results after more than 10 years of fol­low- up. Gastrointest Endosc. 2010;72:551–7.
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Gastrointest Endosc. 1990;36:96–100.
21. Barthet M, Bernard JP, Duval JL, Affriat C, et al. Biliary stenting in benign biliary stenosis
complicating chronic calcifying pancreatitis. Endoscopy. 1994;26:569–72.
22. Smits ME, Rauws EA, van Gulik TM, Gouma DJ, Tytgat GN. Long-term results of endoscopic
stenting and surgical drainage for biliary stricture due to chronic pancreatitis. Br J Surg. 1996;83:764–8.
23. Vitale GC, Reed Jr DN, Nguyen CT, et al. Endoscopic treatment of distal bile duct stricture
from chronic pancreatitis. Surg Endosc. 2000;14:227–31.
24. Farnbacher MJ, Rabenstein T, Ell C, et al. Is endoscopic drainage of common bile duct stenosis
in chronic pancreatitis up to date? Am J Gastroenterol. 2000;95:1466–71.
25. Eickhoff A, Jakobs R, Leonhardt A, et al. Endoscopic stenting for common bile duct stenosis
in chronic pancreatitis: results and impact on long-term outcome. Eur J Gastroenterol Hepatol. 2001;13:1161–7.
26. Kahl S, Zimmerman S, Genz I, Glasbrenner B, Pross M, et al. Risk factors for failure of endo-
scopic stenting in chronic pancreatitis: a prospective follow-up study. Am J Gastroenterol. 2003;98:2448–53.
27. Catalano MF, Linder JD, George S, Alcocer E, Geenen JE. Treatment of symptomatic distal
common bile duct stenosis secondary to chronic pancreatitis: comparison of single vs multiple simultaneous stents. Gastrointest Endosc. 2004;60:945–52.
28. Cahen DL, van Berkel A-MM, Oskam D, et al. Long-term results of endoscopic drainage of
common bile duct strictures in chronic pancreatitis. Eur J Gastroenterol Hepatol. 2005;17:103–8.
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29. Dragonov P, Hoffman B, Marsh W, et al. Long-term outcome in patients with benign biliary
strictures treated endoscopically with multiple stents. Gastrointest Endosc. 2002;55:680–6.
30. Pozsar J, Sahin P, Laszlo F, Forro G, Topa L. Medium-term results of endoscopic treatment of
common bile duct strictures in chronic calcifying pancreatitis with increasing numbers of stents. J Clin Gastroenterol. 2004;38:118–23.
31. Weber A, Zellner S, Wagenpfeil S, Schneider J, Gerngross C, et al. Long-term follow-up after
endoscopic stent therapy for benign biliary strictures. J Clin Gastroenterol. 2014;48:88–93.
32. Cahen D, Rauws EA, Gouma DJ, et al. Removable fully covered self-expandable metal stents
to prevent migration in patients with benign biliary strictures: a multicenter, prospective, com­parative pilot study. Endoscopy. 2008;40:697–700.
33. Behm B, Brock A, Clarke BW, et al. Partially covered self-expandable metallic stents for
benign biliary strictures due to chronic pancreatitis. Endoscopy. 2009;41:547–51.
34. Mahajan A, Ho H, Sauer B, et al. Temporary placement of fully covered self-expandable metal
stents in benign biliary strictures: midterm evaluation. Gastrointest Endosc. 2009;70:303–9.
35. Poley JW, Cahen DL, Metselaar HJ, et al. A prospective group sequential study evaluating a
new type of fully covered self-expandable metal stent for the treatment of benign biliary stric­tures. Gastrointest Endosc. 2012;75:783–9.
36. Perri V, Boskoski I, Tringali A, et al. Fully covered self-expandable metal stents in biliary
strictures caused by chronic pancreatitis not responding to plastic stenting: a prospective study with 2 years of follow-up. Gastrointest Endosc. 2012;75:1271–8.
37. Kahaleh M, Brijbassie A, Sethi A, et al. Multicenter trial evaluating the use of covered self-
expanding metal stents in benign biliary strictures: time to revisit our therapeutic options? J Clin Gastroenterol. 2013;47:695–9.
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benign biliary strictures with fully covered self-expanding metal stents. Gastroenterol. 2014;147:385–95.
39. Keck T, Marjanovic G, Fernandez-del Castillo C, Makowiec F, Schäfer AO, Rodriguez JR,
Razo O, Hopt UT, Warshaw AL. The infl ammatory pancreatic head mass: signifi cant differ­ences in the anatomic pathology of German and American patients with chronic pancreatitis determine very different surgical strategies. Ann Surg. 2009;249:105–10.
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26 Surgery or Endoscopy for Bile Duct Strictures Secondary to Chronic Pancreatitis?
311© Springer International Publishing Switzerland 2016 J.M. Millis, J.B. Matthews (eds.), Diffi cult Decisions in Hepatobiliary and Pancreatic Surgery, Diffi cult Decisions in Surgery: An Evidence-Based Approach, DOI 10.1007/978-3-319-27365-5_27
Chapter 27
Routine or Selective Cholangiography for Elective Laparoscopic Cholecystectomy?
Shane Svoboda and Brian L. Bello
Abstract Laparoscopic cholecystectomy (LC) is one of the most commonly per-
formed surgical procedures today and is considered the standard of care for gall­bladder removal. The role of routine versus selective intraoperative cholangiography (IOC) in elective LC to prevent bile duct injury and detect choledocholithiasis remains in dispute. Routine cholangiography may decrease the overall incidence or severity of bile duct injuries. IOC may also play a role in the optimal management of patients with risk of a common duct stone. Controversy arises with routine IOC which may to added operative time, cost, and secondary procedures, suggesting a more selective approach may be more benefi cial. Newer techniques such as near­infrared fl uorescence cholangiography may be an alternative to traditional IOC.
Keywords Cholangiography • Cholecystectomy • Laparoscopy • Bile duct injury • Fluorescent cholangiography

Introduction

Laparoscopic cholecystectomy (LC) is one of the most commonly performed abdominal procedures in the world. Morbidity associated with LC may be as high as 2–4 % with bile duct injury (BDI) a rare but devastating complication leading to a potential threefold increase in mortality [ 1 ]. In the era of laparoscopy , recent stud- ies have demonstrated consistently an increased incidence of bile duct injury of about 0.2–0.6 % [ 1 , 2 ] compared to that of 0.1–0.3 % for open cholecystectomy [ 3 , 4 ]. Improving these rates in the technique currently considered standard of care must be addressed.
The use of intraoperative cholangiogram (IOC) during elective LC remains con-
troversial in its role as routine practice for all patients versus selective practice,
S. Svoboda • B. L. Bello (*) Department of Surgery , Sinai Hospital of Baltimore , 2435 W Belvedere Avenue, Hoffberger Building Suite 42 , Baltimore , MD 21215 , USA e-mail:
brianbello@gmail.com
312
reserved for those patients with risk for common bile duct stones or diffi cult anat­omy. Differences in training and personal experience have led to varied practices in the use of IOC and remain a matter of surgeon preference. Some surgeons believe that obtaining a “critical view of safety” is suffi cient for identifi cation of vital struc­tures while other surgeons see routine IOC as the gold standard for biliary identifi ­cation and imaging [ 5 , 6 ]. Selective IOC users believe it changes management in relatively few cases and apply it only in cases where choledocholithiasis is sus­pected or among patients at high risk for common bile duct injury . Another argu­ment against routine IOC is that cholangiography may be misinterpreted by surgeons over half of the time [ 7 ].
This chapter is an evidenced-based review of recent literature focusing on the potential advantages and disadvantages of routine cholangiography compared to selective cholangiography in patients undergoing elective laparoscopic cholecystec­tomy . Outcomes such as morbidity , secondary procedures, and cost will be specifi ­cally examined. We will also address the newer techniques of near-infrared fl uorescence cholangiography that may become an alternative to traditional IOC.

Search Strategy

A literature search of English language publications from 2005 to 2014 was used to identify published data on intraoperative cholangiogram using the PICO outline (Table 27.1 ). Databases searched were PubMed, Medline, Cochrane Evidence Based Medicine , and TRIP database. Terms used in the search were “cholangio­gram, routine, selective,” “cholangiogram, bile duct injury ,” “cholangiogram, com­plications,” and “cholangiogram, cost .” Randomized controlled studies were reviewed as well as comparative studies with greater than 400 patients. All studies regarding near-infrared cholangiography were reviewed. The data was classifi ed using the GRADE system.
Table 27.1 PICO table for routine versus selective cholangiography for elective laparoscopic cholecystectomy
P (patients) I (intervention) C (comparator) O ( outcomes) Patients
undergoing elective laparoscopic cholecystectomy
Routine intraoperative cholangiography
Selective intraoperative cholangiography
Bile duct injury, retained stones, operating time, secondary procedures, false positives, cost
S. Svoboda and B.L. Bello
313

Results

Routine Versus Selective Cholangiography

The role of routine intraoperative cholangiography in laparoscopic cholecystectomy is controversial. When surveyed by the American College of Surgeons, general sur­geons had varying opinions. Twenty seven percent identifi ed themselves as “routine users” using IOC in more than 75 % of their cases. “Selective users” tended to be low-volume surgeons with less than 20 LC per year. “Routine users” responded more favorably regarding IOC believing that routine use was overall less costly and more protective of injury [ 8 ]. Part of the lack of consensus on this topic among surgeons is the confl icting evidence in the literature.
In the 1990s, there were few randomized, prospective trials conducted compar­ing routine IOC versus no IOC. Soper and Dunnegan found an increased operative time of 16 min in patients undergoing routine IOC with an increase in total charges by $700 [ 9 ]. Nies et al. found no difference in morbidity or mortality between the two groups, and the operations with routine IOC lasted signifi cantly longer (92 vs. 77 min) [ 10 ]. Each trial concluded that routine IOC was not justifi ed.
Two more recent randomized controlled trials are summarized in Tables 27.2 and 27.3 . Like the two previous trials, Khan et al. in 2011 studied the difference between routine IOC versus no IOC. They studied 190 patients that were at low risk of common duct stones and found a longer operative time (66 vs. 54 min; p < 0.001) with no statistical difference in readmission rates and morbidity including retained stones or common bile duct injury . The authors concluded that routine cholangiog­raphy was not indicated [ 11 ]. In contrast, Amott et al. in 2005 randomized 303 patients to undergo routine or selective IOC. There was no difference in operating time, retained stones or common bile duct injury. However, the authors still changed their practice to performing routine IOC because seven of eight patients who pre­sented with a retained common bile duct stone postoperatively did not undergo IOC. Three of the seven had normal LFTs and a normal ultrasound preoperatively and would have been missed with a selective approach. They also argued an unplanned IOC may lead to a signifi cant increase in operative time versus a routine and planned IOC because the operating room staff would already have the equip­ment in place [ 12 ].
These aforementioned randomized trials were limited by having relatively low numbers at a single center. In fact, due to the low incidence of bile duct injury , the number of patients needed to conduct a randomized, controlled trial with adequate power in order to avoid a type II error would be greater than 30,000 [ 13 ].
Despite the lack of randomized trials, it is possible to garner some information from other types of comparative studies. There are several, large prospective regis­tries that examine bile duct injuries in routine IOC versus no IOC. In the Swiss prospective registry, 36.6 % of 31,838 patients underwent IOC which is a similar rate as in the United States. The rate of biliary injuries was 0.3 % in each of the two groups suggesting no effect of IOC on the prevention and detection of biliary
27 Routine or Selective Cholangiography for Elective Laparoscopic Cholecystectomy?
314
Table 27.2 Routine intraoperative cholangiography versus no intraoperative cholangiography
Author
(date)
N (pts)
Bile duct
injury (%)
Intraoperative
retained stones
(%)
Postoperative
retained stones
(%)
Operating
time (min)
Secondary
procedures
(%)
False
positives
(%)
Cost
($) Study type IOC No IOC IOC
No
IOC IOC
No
IOC IOC
No
IOC IOC
No
IOC IOC
No
IOC
Khan (2011)
[
11 ]
91 99 0 (0) 1 (0)
a
3 (3) 0 (0)
a
0 (0) 0 (0)
a
66 ± 2 54 ± 3 NR NR 0 (0) NR RCT level
1B
Giger
(2012) [
15 ]
11,642 20,196 40
(0.3)
61
(0.3)
a
NR NR NR NR NR NR NR NR NR NR Prospective
registry level
III
Törnqvist
(2012) [
15 ]
51,041 747 (1.5 %),
incidence of
BDI in IOC
group 29 %
lower (exact
number not
reported)
NR NR NR NR NR NR NR NR NR NR Prospective
registry level
III
RCT Randomized clinical trial , NR not reported
a
No statistical difference
S. Svoboda and B.L. Bello
Table 27.3 Routine intraoperative cholangiography versus selective intraoperative cholangiography
Author
(date)
N (pts) Bile duct injury (%)
Intraoperative
retained stones (%)
Postoperative
retained stones (%)
Operating time
(min)
Secondary
procedures (%)
False
positives
(%)
Cost ($)
Study type
Routine
IOC
Selective
IOC
Routine
IOC
Selective
IOC
Routine
IOC
Selective
IOC
Routine
IOC
Selective
IOC
Routine
IOC
Selective
IOC
Routine
IOC
Selective
IOC
Routine
IOC
Selective
IOC
Amott
(2005) [
12 ]
148 155 1 (0.68) 1 (0.64)
a
12 (8.1) 5 (3.2)
a
3 (2.0) 5 (3.2)
a
56 61
a
12 (8.1
%)
NR 0
NR
RCT level 1B
Nuzzo
(2005) [ 2 ]
56,591 (Routine IOC
done in 10.3 %
general surgery
units; selective IOC
done in 89.7 %
general surgery
units)
25 (0.32) 210
(0.43)
a
NR NR NR NR NR NR NR NR NR NR Retrospective
study level III
Ragulin-
Coyne
(2013) [ 16 ]
111,815 (Routine
IOC surgeons 10.8
%; Selective IOC
surgeons 89.2 %)
(0.25) (0.26)
a
NR NR NR NR NR NR (15.8) (12.7) NR 10425 9495 Retrospective
study level III
Buddingh
(2011) [ 17 ]
435 (60 %
had IOC)
421 11 (2.5);
major
BDI 0
(0)
15 (3.5)
a
;
major
BDI 8
(1.9 %)
21 (4.8) 4 (1.0) NR NR 110 ± 44 100 ± 47 83
(19.1)
102
(24.2)
a
NR NR Retrospective
study level III
Nickkholgh
(2006) [
18 ]
1,330 800 0 (0) 2 (0.25)
a
37 (2.8) 9 (1.1) NR NR NR NR NR NR 0 NR Retrospective
study level III
RCT Randomized clinical trial , NR not reported
a
No statistical difference
316
injuries [ 14 ]. The Swedish prospective registry found 747 bile duct injuries in 51,041 laparoscopic cholecystectomies for a rate of 1.5 %. This relatively high number was likely due to the inclusion of minor bile duct injuries. The incidence of a bile duct injury (BDI) was 29 % lower when IOC was successfully performed or attempted suggesting a possible protective effect [ 15 ]. These studies are included Table 27.2 . A large, retrospective national survey from Italy examined 56,591 patients in different general surgery units that underwent LC and demonstrated no statistical difference in BDI between routine and selective IOC (0.32 % vs. 0.43 %). However, only 10.3 % of general surgery units surveyed underwent routine IOC much lower than other countries [ 2 ]. This study is included in Table 27.3 . These sizeable studies are good because of the large numbers but have to be interpreted with caution as the frequency of IOC may be considerably different from other stud­ies and there are very few listed specifi cs regarding the context of surgery.
Ragulin-Coyne and colleagues queried Nationwide Inpatient Sample data and found 111,815 patients who presented with acute biliary disease who underwent laparoscopic cholecystectomy . They dichotomized surgeons into a routine IOC sur­geons and selective IOC surgeons. Their data suggested no signifi cant difference between the rates of biliary injury and the use of routine cholangiography . They found no protective effect of routine IOC with signifi cantly increased cost ($930 more) and slightly higher incidence in morbidity (7.3 vs. 6.8 %; p = 0.04). Routine IOC was also associated with increased endoscopic retrograde cholangiopancrea­tography ( ERCP ) use (15.8 % vs. 12.7 % p <0.0001) and higher common bile duct exploration (2.6 % vs. 1.6 %; p < 0.0001) [ 16 ]. This study is summarized in Table
27.3 .
A retrospective review by Buddingh et al. examined medical records 3 years prior and following implementation of a routine IOC approach in a university hos­pital in The Netherlands. Four hundred twenty one patients underwent cholecystec­tomy with selective IOC prior to the start of the study and this was compared to 435 patients that underwent routine IOC after the study began. In this study, the policy of routine IOC was deliberately not strictly enforced at fi rst. Instead, a period of gradual introduction allowed the surgical team to become more familiar with the technique. Thus, compliance with IOC in the rouine approach was relatively low immediately after introduction. Six percent of the selective IOC group received IOC, and only 60 % of the routine group had IOC both lower than expected limiting this study. They did demonstrate, however, a signifi cant decrease in major BDI in the routine group (0 % versus 1.9 %; p = 0.004) but no difference in total BDI (major and minor). An increase in intraoperative management of common bile duct stones was also noted (2.8 % vs. 0.7 %; p = 0.023) [ 17 ]. Similarly in Iran, Nickkholgh and colleagues implemented a routine IOC approach and compared 1330 patients that underwent routine IOC versus 800 patients that underwent selective IOC prior to the start of the study. They found an increased rate of retained stones (2.8 % vs.
1.1 %; p = 0.01) with no signifi cant difference in BDI. These two studies are sum- marized in Table 27.3 .
Literature focused on cost associated with routine intraoperative cholangiogra­phy has been sparse. One of the fi rst studies proposed was by Flum et al. in 2003.
S. Svoboda and B.L. Bello
317
They created decision analytic models to calculate costs and benefi ts of routine IOC. They noted that it would cost approximately $100 more per each case. However, they found that routine IOC would prevent 2.5 deaths for every 10,000 patients at a cost of $390,000 per life saved or $13,900/quality life-year (well below the standard benchmark of <$50,000/quality life-year to be deemed cost-effective). Cost per common bile duct injury avoided ranged from approximately $61,000 to $87,100. These estimates do not consider the high price of litigation costs which many argue that any cost of IOC is worthwhile [ 13 ]. Brown et al. designed another decision model to examine patients with symptomatic cholelithiasis with possible common bile duct stones including fi ve different strategies: (1) LC alone, (2) preop­erative ERCP followed by LC, (3) LC with IOC ± common bile duct exploration , (4) LC followed by ERCP, (5) and LC with IOC ± postoperative ERCP. Across a common bile duct stone probability range of 4–100 %, LC with IOC ± ERCP was the most cost-effective [ 19 ].
Livingston et al. argued against routine IOC when cost and utilization were examined. They reviewed the 2001 Nationwide Inpatient Survey database for IOC utilization and associated charges. IOCs were associated with $706–739 additional charges [ 20 ]. This is consistent with the increased cost of $930 of the previously discussed NIS study [ 16 ]. Livingston projected a cost of $371,356 to prevent one single bile duct injury by using a routine IOC approach [ 20 ].

Near Infrared Fluorescent Cholangiography

Fluorescence cholangiography is a feasible alternative to contrast-dye cholangiog­raphy and may have a cost benefi t although reduction in bile duct injury has not been proven. A study by Schools and colleagues demonstrated safety and feasibility of near-infrared fl uorescence cholangiography (NIRF-C) in patients receiving indo­cyanine green (ICG) just after induction of anesthesia in 15 patients. Fluorescence imaging was performed with no adverse reactions to the injected ICG with identifi ­cation of the cystic duct in an average of 23 min [ 21 ]. A prospective study that demonstrated the feasibility of NIRF-C was done recently. Eighty two patients underwent elective LC with NIRF-C with successful identifi cation of the cystic duct in 95.1 %, common bile duct in 76.8 % and common hepatic duct in 69.5 %. This was followed by IOC with successful identifi cation of the cystic duct in 72.0 %, common bile duct in 75.6 % and common hepatic duct in 74.3 %. The procedure times were signifi cantly different with NIRF-C and IOC (1.9 min vs. 11.8 min; p < 0.001). There were no adverse events [ 22 ].
A recent study examined cost analysis and effectiveness of fl uorescent cholangi­ography . Identifi cation with fl uorescence was successful in 100 % of 43 patients and signifi cantly less costly than IOC ($14.10 vs. $778.43; p < 0.0001), and was faster than IOC (0.71 vs. 7.15 min; p < 0.0001) [ 23 ]. Prevot and colleagues found in a prospective cohort of 23 patients that identifi cation of the biliary tract was more effective with fl uorescence imaging than with IOC after dissection. Analyzability
27 Routine or Selective Cholangiography for Elective Laparoscopic Cholecystectomy?