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202
or admission to the hospital, as surrogate starting points for comparison. This
variability complicates comparison of the available studies and limits the ability to
make recommendations for optimal timing of laparoscopic cholecystectomy .
The rationale for delayed surgery is based on the observation that acute infl ammation may lead to increased risk of surgical complications. This rationale was
reinforced in the early years after laparoscopic cholecystectomy was developed.
While the benefi ts of laparoscopic cholecystectomy (decreased hospital stay,
decreased overall morbidity , earlier return to full activity etc.) were obvious in
comparison to open surgery [ 1 ], surgery in the setting of acute infl ammation led to
higher rates of conversion to open operation [ 2 ] and rates of common bile duct
injury greater than those in the era of open cholecystectomy for acute cholecystitis
[ 3 ]. In the early years of laparoscopic cholecystectomy, acute cholecystitis was con-
sidered a relative contraindication [ 4 ]. While later prospective trials showed early
laparoscopic cholecystectomy to be as safe as open cholecystectomy for acute
cholecystitis [ 5 ], most surgeons continued to opt for initial conservative treatment
and delayed laparoscopic cholecystectomy. As late as 2004 surveys of practice
patterns in Britain and the United States showed that only 20–30 % of patients with
acute cholecystitis were operated on in the early phase [ 6 , 7 ]. While the rate of bile
duct injury has decreased with time, it has not fallen to the rates reported in the open
era [ 8 ]. Common bile duct injury remains the most signifi cant surgical complication
of laparoscopic cholecystectomy.
Retrospective Studies
The rationale for early laparoscopic cholecystectomy for acute cholecystitis is supported by a growing amount of evidence from retrospective studies. First, early
surgery avoids the risks to the patient of gallstone related complications that the
wait for a delayed operation assumes. Cheruvu and Eyre-Brook showed that 18.5 %
of patients with acute cholecystitis required readmission to the hospital in the fi rst
6 weeks after their initial presentation [ 9 ]. These risks only grow with the longer
operation is postponed. A recent Canadian study [ 10 ] followed a cohort of over
10,000 patients who did not undergo cholecystectomy on their fi rst admission for
acute cholecystitis. The probability of a gallstone related complication at 6 weeks,
12 weeks, and 1 year after discharge was 14 %, 19 %, and 29 % respectively. Of
these 30 % were for biliary tract obstruction or pancreatitis. Second, retrospective
studies from large databases have indicated that early laparoscopic cholecystectomy
is as safe and effective as delayed surgery. In a retrospective cohort study of over
14,000 patients [ 11 ] early cholecystectomy was associated with a lower risk of
common bile duct injury and of common bile duct injury or death than delayed
cholecystectomy . The rate of conversion from laparoscopic to open operation was
no different in the early group (11 %) and in the delayed group (10 %). Furthermore,
hospital stay was 2 days shorter for the early surgery group. Third, retrospective
studies suggest that the sooner laparoscopic cholecystectomy is performed during
S.G. Wyers
203
the initial hospitalization the more favorable the outcomes . In a recent retrospective
analysis from Switzerland of 4,113 patients [ 12 ] immediate surgery was found to
have statistically signifi cant advantages in conversion and reoperation rates, postoperative complications, and length of hospital stay compared to delayed cholecystectomy 1–6 days after hospital admission. Brooks et al. reviewed the course of 5,268
patients in the American College of Surgeons National Surgical Quality Improvement
Program database [ 13 ]. Patients who underwent operation later in the course of
admission (>24 h) had greater risk of open operation and longer postoperative and
overall lengths of hospitalization.
Prospective Studies
A search of the Medline database from 1987 to the present as well as a review of the
recent literature produces eight prospective randomized controlled clinical trial s
which compare early laparoscopic cholecystectomy (ELC) to delayed laparoscopic
cholecystectomy (DLC) in the setting of calculous acute cholecystitis [ 14 – 21 ]. All
of prospective surgical trials reviewed here suffer from the inability to blind participants
and investigators (Table 17.1 ).
The ACDC (Acute Cholecystitis-early laparoscopic surgery versus antibiotic
therapy and Delayed elective Cholecystectomy) trial by Gutt et al. [ 14 ] is larger than
the remaining studies combined. It specifi cally addresses the question of immediate
(<24 h) laparoscopic cholecystectomy vs. delayed (>7 days) laparoscopic
cholecystectomy .
The variable criteria used by the studies to defi ne the timing of early and delayed
cholecystectomy are given in Table 17.2 .
Not all of the studies measured the same primary and secondary outcomes . All
studies (except Macafee [ 15 ]) reported quantitative outcome data for mortality ,
morbidity , conversion to open operation and hospital stay. Bile duct injury was
Table 17.1 Characteristics of prospective randomized controlled trials comparing Early
Laparoscopic Cholecystectomy (ELC) to Delayed Laparoscopic Cholecystectomy (DLC)
Authors (Ref.) Year
Single or
multicenter
Number patients
total (ELC:DLC)
Average
age (years)
Female
(%)
Gutt et al. [
14 ] 2013 Multicenter 618 (304:314) 56.2 58.7
Macafee et al. [
15 ] a 2009 Single 72 (36:36) 52.5 65.2
Yadav et al. [
16 ] 2009 Single 50 (25:25) 41 76
Kolla et al. [
17 ] 2004 Single 40 (20:20) 40 80
Johannson et al.[
18 ] 2003 Single 145 (74:71) 57 60
Davila et al. [
19 ] 1999 Single 63 (27:36) 56 71.4
Lai et al. [
20 ] 1998 Single 104 (53:51) 56 63.5
Lo et al. [
21 ] 1998 Single 86 (45:41) 60 43.3
a
The study by Macafee et al. does not furnish outcomes of interest for this review
17 Early (<24 h) or Delayed Cholecystectomy for Acute Cholecystitis?
204
included in the morbidity for all studies and as a primary outcome in one. Most
studies reported outcomes for operative time. Only one [ 14 ] examined hospital cost
(Table 17.3 ).
Mortality The only deaths reported in the seven trials were in the largest trial [ 14 ].
There was one death in both the ELC (.3 %) and DLC (.3 %) groups. There were no
deaths reported in the smaller trials.
Common Bile Duct Injury In total in the seven trials above, there were three
common bile duct injuries. One was in the ELC group (1/523, .2 %) and two were
in the DLC groups (2/533, .4 %). In a recent meta-analysis of these seven trials [ 22 ]
these small rates did not achieve statistical signifi cance.
Other Morbidity The ACDC trial [ 14 ] showed signifi cantly lower morbidity scores
at 75 days and fewer adverse events in the ELC group compared to the DLC group.
When combined with the other studies in a meta-analysis there was a trend, albeit not
statistically signifi cant, toward decreased morbidity favoring the ELC group [ 22 ].
Conversion to Open Operation The ACDC trial [ 14 ] showed no signifi cant
difference between the two groups with respect to conversion to open operation
(ELC 30/304, 9.9 %: DLC 33/314, 11.9 % p = .44). A Cochrane meta-analysis of
Table 17.2 Timing of Early Laparoscopic Cholecystectomy (ELC) and Timing of Delayed
Laparoscopic Cholecystectomy (DLC)
Study Year Timing of ELC Timing of DLC
Gutt 2013 <24 h from admission 7–45 days
Macafee 2009 <4 days from admission 3 months
Yadav 2009 <4 days 6–8 weeks
Kolla 2004 <4 days 6–12 weeks
Johannson 2003 <7 days 6–8 weeks
Davila 1999 <4 days 8 weeks
Lai 1998 <7 days 6–8 weeks
Lo 1998 <7 days 13 weeks
Table 17.3 Outcomes measured in the prospective randomized trials of ELC vs. DLC
Study
Mortality
Morbidity
CBD
injury
Conversion
to open
Operative
time
Failure of
conservative
therapy
Hospital
stay
Hospital
costs
Gutt x x x x x x x
Yadav x x x x x
Kolla x x x x x
Johannson x x x x x
Davila x x x x
Lai x x x x x
Lo x x x x x
S.G. Wyers
205
fi ve of the six smaller trials also showed no signifi cant difference in conversion rates
between ELC and DLC [ 23 ].
Operation Time There was considerable heterogeneity in the six smaller trials. A
meta-analysis of the six smaller studies showed a trend toward longer operating
times in the ELC group [ 23 ]. This trend was not statistically signifi cant.
Failure of Conservative Therapy (DLC) In the ACDC trial [ 14 ] change of antibiot-
ics was necessary in 31 of 314 (9.9 %) patients; and, of these 31 patients premature
surgery was necessary in 17 (54.8 %).
Hospital Length of Stay All seven of the trials showed signifi cant reduction in
total length of stay in the hospital. In the ACDC trial [ 14 ] the mean length of stay
was 4.6 days less in the ELC group. This was a 50 % reduction in hospital stay.
Hospital Cost In the ACDC trial [ 14 ] the reduced hospital stay for the ELC group
(<24 h) translated directly into reduced cost (approximately 3000€/case). This was
the only prospective trial to evaluate cost.
Return to Work and Normal Activity Only one trial examined return to work and
normal activity. The study by Lo et al. [ 21 ] showed that patients in the ELC group
had shorter average total recuperation periods (7 days) and shorter average periods
of time off work (11 days).
Summary and Recommendations
Early (<24 h) laparoscopic cholecystectomy has signifi cant medical and socioeconomic benefi ts and is the recommended approach for low risk patients with acute
cholecystitis . Recommendation Grade 1C. Both ELC and DLC have very low rates
of mortality and common bile duct injury and, as a result, the prospective studies
cited here are insuffi ciently powered to show superiority with regard to these outcomes . Given these low rates it has been estimated that prospective studies would
require thousands to tens of thousands of patients in each arm in order to show signifi cant differences in bile duct injury and mortality. The overall morbidity of ELC
compared to DLC is not greater and in the ACDC trial is shown to be signifi cantly
less than DLC. The prospective studies demonstrate that ELC dramatically reduces
the length of hospital stay and total hospital cost . For a disease as common as acute
cholecystitis ELC offers signifi cant reduction in direct hospital costs and improvement in hospital effi ciency. Though only one trial demonstrated earlier return to
work and normal activity with ELC, it stands to reason that the patients who avoid
DLC have a shorter time to resolution of their illness overall given that morbidity
does not increase with ELC. Further prospective studies may improve the strength
of this recommendation.
17 Early (<24 h) or Delayed Cholecystectomy for Acute Cholecystitis?
206
A Personal View of the Data
It has been my practice to operate within 24 h on all patients with acute cholecystitis
whose symptoms are of less than 72 h duration and who are candidates for general
anesthesia. A more diffi cult decision is the management of patients whose symptoms have been present for more than 3–4 days prior to admission. (Most of the
prospective studies cited above used symptoms of greater than 7 days duration prior
to admission as an exclusion criterion.) For this group of patients a more nuanced
approach is in order. The presence of other known high risk factors (male sex, a
palpable infl ammatory mass on physical exam, extensive upper abdominal surgery ,
morbid obesity or fi ndings on imaging) would warrant a conservative approach in
my view. The Tokyo Guidelines for the surgical management of acute cholecystitis
is based on a clinical grading scale of the severity of the acute cholecystitis and
endorses this nuanced approach in this group with Grade II (moderate) acute
cholecystitis [ 24 ].
The studies reviewed above argue strongly that a policy of early laparoscopic
cholecystectomy should be adopted more broadly in acute cholecystitis . This should
be undertaken with renewed dedication to what Strasberg has called a “culture of
safety” [ 25 ]. Whether operating for biliary colic or acute cholecystitis, I dissect the
hepatocystic triangle to “the critical view of safety” which has been well defi ned in
the literature [ 26 ]. If infl ammation prohibits dissection to the “critical view of
safety”, cholangiography under fl uoroscopy is my next step. If this fails to clarify
the anatomy or reveals an injury I convert to open operation. Conversion to open
operation should never be viewed as a complication but rather a triumph of good
judgment over technical ability. Given the marked improvement in laparoscopic
cameras, angled lenses, and monitors in the past 25 years, visualization does not
necessarily improve with conversion – except in one very important respect; there is
improved ability to appreciate three dimensional anatomic relationships. Way
reviewed common bile duct injuries by experienced surgeons and attributed them to
cognitive visual spatial errors [ 27 ]. Most bile duct injuries are not recognized in
the operating room; therefore, most are due to misidentifi cation. In a diffi cult
laparoscopic or open case I don’t hesitate to get a “second set of eyes” from an
experienced colleague if one is available. Conversion to open operation allows
direct palpation to assist the dissection in densely infl amed tissue. After conversion
I will use these advantages to dissect to a critical view of safety. Only if this is
unsuccessful do I use “top down” or “fundus fi rst” approach. This also entails risk
since the normal plane between the liver and gallbladder is frequently obliterated by
the infl ammation. Getting into the hepatic parenchyma from this approach can produce signifi cant hemorrhage. This is the setup for coupling a bile duct injury with a
vascular injury. Much better options to avoid this most severe combination of injures
would be placement of an open cholecystostomy tube or partial cholecystectomy
with extraction of stones and placement of a drain.
Other than the high risk situations described above, I reserve delayed laparoscopic cholecystectomy for patients whose comorbidities place them at high risk for
S.G. Wyers
207
general anesthesia (e.g. ASA class 4 or 5) or whose symptoms are of greater than
7 days duration. In addition to intravenous antibiotics percutaneous cholecystomy
tubes may be used in this group of patients. While there are still clinical situations
which warrant delayed laparoscopic cholecystectomy , in my experience, this often
results in the performance of a diffi cult operation 6 weeks later in a patient who is
better prepared for the operating room.
References
1. The Southern Surgeons Club. A prospective analysis of 1518 laparoscopic cholecystectomies.
The Southern Surgeons Club. N Engl J Med. 1991;324(16):1073–8.
2. Cheema S, Brannigan AE, Johnson S, Delaney PV, Grace PA. Timing of laparoscopic chole-
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3. Richardson MC, Bell G, Fullarton GM. Incidence and nature of bile duct injuries following
laparoscopic cholecystectomy an audit of 5913 cases. West of Scotland Laparoscopic
Cholecystectomy Audit Group. Br J Surg. 1996;83(10):1356–60.
4. Wilson P, Leese T, Morgan WP, Kelly JF, Brigg JK. Elective laparoscopic cholecystectomy for
“all comers”. Lancet. 1991;338(8770):795–7.
5. Kiviluoto J, Siren P, Luukkonen P, Kivilaakso E. Randomised trial of laparoscopic versus open
cholecystectomy for acute and gangrenous cholecystitis. Lancet. 1998;351(9099):321–5.
6. Livingston EH, Rege RV. A nationwide study of conversion from laparoscopic to open chole-
cystectomy. Am J Surg. 2004;188(3):205–11.
7. Senapati PS, Bhattarcharya D, Harinath G, Ammori BJ. A survey of the timing and approach
to the surgical management of cholelithiasis in patients with acute biliary pancreatitis and
acute cholecystitis in the UK. Ann R Coll Surg Engl. 2003;85(3):306–12.
8. Dolan JP, Diggs BS, Sheppard BC, Hunter JG. Ten-year trend in the national volume of bile
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9. Cheruvu CV, Eyre-Brooke IA. Consequences of a prolonged wait before gallbladder surgery.
Ann R Coll Surg Engl. 2002;84(1):20–2.
10. deMestral C, Rotstein OD, Laupacis A, Hoch JS, Zagorski B, Nathens AB. A population- based
analysis of the clinical course of 10,304 patients with acute cholecystitis, discharged without
cholecystectomy. J Trauma Acute Care Surg. 2013;74(1):26–30; discussion 30–1.
11. deMestral C, Rotstein OD, Laupacis A, Hoch JS, Zagorski B, Alali AS, Nathens
AB. Comparative outcomes of early and delayed cholecystectomy for acute cholecystitis: a
population-based propensity score analysis. Ann Surg. 2014;259(1):10–5.
12. Banz V, Gsponer T, Candinas D, Guller U. Population based analysis of 4113 patients with
acute cholecystitis: defi ning the optimal time point for laparoscopic cholecystectomy. Ann
Surg. 2011;254(6):964–70.
13. Brooks KR, Scarborough JE, Vaslef SN, Shapiro ML. No need to wait: an analysis of the tim-
ing of cholecystectomy during admission for acute cholecystitis using the American College
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2013;74(1):167–73.
14. Gutt CN, Enke J, Koninger J, Harnoss JC, Weigand K, Kipfmuller, Schunter O, Gotze T,
Golling MT, Menges M, Klar E, Feilhauer K, Zoller WG, Ridwelski K, Ackmann S, Baron A,
Schon MR, Seitz HK, Daniel D, Stremmel W, Buchler MW. Acute Cholecystitis: early versus
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15. Macafee DA, Humes DJ, Bouliotis G, Beckingham IJ, Whynes DK, Lobo DN. Prospective
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208
16. Yadav RP, Adhikary S, Agrawal CS, Bhattarai B, Gupta RK, Ghimire A. A comparative study
of early vs. delayed laparoscopic cholecystectomy in acute cholecystitis. Kathmandu Univ
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laparoscopic cholecystectomy for acute cholecystitis. Surg Endosc. 2004;18:1323–7.
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(early vs. delayed) of acute cholecystitis via laparoscopy. Cir Esp. 1999;66 Suppl 1:233.
20. Lai PBS, Kwong KH, Leung KL. Randomized trial of early versus delayed laparoscopic
cholecystectomy for acute cholecystitis. Br J Surg. 1998;85(6):764–7.
21. Lo C, Liu C, Fan S, Lai ECS, Wong J. Prospective randomized trial of early versus delayed
laparoscopic cholecystectomy for acute cholecystitis. Ann Surg. 1998;227(4):461–7.
22. Zhou MW, Gu XD, Xiang JB, Chen ZY. Comparison of clinical safety and outcomes of early
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C, Windsor JA, Kim SW, deSantibanes E, Padbury R, Chen XP, Chan AC, Fan ST, Jagannath
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25. Strasberg SM. Biliary injury in laparoscopic surgery: part 2. Changing the culture of cholecys-
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S.G. Wyers
209© 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_18
Chapter 18
Primary Closure or T-Tube Drainage After
Open or Laparoscopic Common Bile Duct
Exploration?
Ezra N. Teitelbaum , Anthony D. Yang , and David M. Mahvi
Abstract Common bile duct exploration (CBDE) is an operation that can be per-
formed either laparoscopically or open in order to treat choledocholithiasis by
removing stones from the common bile duct. CBDE can be performing via either a
transcystic approach or a transcholedochal one, in which an incision (or choledochotomy) is made directly into the common bile duct in order to access the stones
within it. Traditionally this cholecdochotomy have been closed around an external
drain, or “T-tube”, at the end of CBDE operations, in order to drain the biliary system and allow access for future interventions should the need arise. However, recent
data suggesting that primary closure of the choledochotomy may in fact be a superior technique have challenged the surgical dogma of routine T-tube placement after
CBDE.
In this chapter we summarize and evaluate the available evidence comparing
T-tube drainage with primary choledochotomy closure after CBDE. Six randomized
trials have compared these strategies after open CBDE, and four such trials have
been performed for laparoscopic CBDE. The existing literature mostly examines
perioperative and short-term postoperative outcomes, such as operative time, 30-day
postoperative morbidity and mortality, hospital length of stay, and need for reinterventions during the immediate postoperative period. Long-term implications of
using or foregoing T-tube drainage have not been as well studied.
Based on these studies, there is a high level of evidence that primary choledochotomy closure after CBDE (both open and laparoscopic) results in shorter operative times and shorter hospital length of stay when compared with t-tube drainage.
There is moderate evidence that primary closure and t-tube drainage after CBDE
result in equivalent rates of serious complications in the perioperative period. Due
to insuffi cient data, there is a very low level of evidence that the two techniques
result in equivalent rates of long-term recurrent choledocholithiasis and biliary
stricture. Based on the sum of this evidence, we make a moderate strength recom-
E. N. Teitelbaum • A. D. Yang • D. M. Mahvi (*)
Department of Surgery , Northwestern University ,
251 E. Huron St., Galter Room 3-710 , Chicago , IL 60611 , USA
e-mail:
dmahvi@nm.org
210
mendation that primary choledochotomy closure should be the preferred technique
in uncomplicated cases of both open and laparoscopic CBDE.
Keywords Common bile duct exploration • Choledocholithiasis • T-tube •
Choledochotomy closure • Bile duct surgery • Hepatobiliary
Introduction
Choledocholithiasis, or stones within the common bile duct , occurs in between 3.4
and 17 % of patients with symptomatic gallstone disease [ 1 , 2 ]. Currently, two
standard- of-care approaches exist for treating patients with choledocholithiasis . The
fi rst involves performing an endoscopic retrograde cholangiopancreatography
( ERCP ) in order to remove the stone or stones from the common bile duct. However,
with this approach, a cholecystectomy must also be subsequently performed in
order to eliminate the source of the stones and thus prevent disease recurrence.
Alternatively, a surgical common bile duct exploration (CBDE) can be performed in
either an open or laparoscopic fashion at the time of cholecystectomy, in order treat
the patient’s current problem and prevent future episodes, all with a single procedure. CBDE was fi rst performed in 1890 by Courvoisier and in the early 1990s with
the widespread adoption of laparoscopic cholecystectomy , CBDE was fi rst performed in a laparoscopic, minimally invasive fashion. CBDE at the time of cholecystectomy, especially when performed laparoscopically, has been shown to result
in a shorter hospital length of stay, less hospital costs, and possibly fewer complications, when compared with the two-stage approach of ERCP and cholecystectomy
[ 3 , 4 ].
Two primary methods exist for performing CBDE: transcystic and transcholedochal. In the transcystic approach, a fl exible choledochoscope or fl uoroscopicallydirected instruments are inserted through a ductotomy in the cystic duct (similar to
that through which a standard intraoperative cholangiogram is performed). In the
transcholedochal method, a longitudinal ductotomy is made into the common duct
itself, through which a choledochoscope and/or other instruments are passed in
order to capture the stones within. At the conclusion of a transcholedochal CBDE,
the choledochotomy can be dealt with in two ways: (1) it can be closed primarily or
(2) a “ T-tube ” can be placed into the choledochotomy, the ductomy then closed
around the tube, and opposite end of the tube externalized to bag drainage (Fig. 18.1 ).
Placing a T-tube drain after CBDE offers several theoretical advantages and is
still considered to be the standard of care by many surgeons. A T-tube allows for
external drainage of the biliary system in the case of residual biliary obstruction
from retained stones, ampullary edema, or stenosis. Additionally, the biliary system
can be instrumented through the T-tube under fl uoroscopic guidance, in order to
treat the postoperative conditions mentioned previously without the need for additional procedures or operations. Finally, a T-tube is thought to prevent stricture of
E.N. Teitelbaum et al.
211
the common bile duct , although this is a theoretical advantage without comparative
data to either support or refute it.
Conversely, T-tube placement at the conclusion of an otherwise successful CBDE
carries its own set of risks. The tube offers an avenue for infection of the biliary
system and it can become dislodged prematurely in the postoperative period, resulting in a biliary leak. A leak can also occur when the T-tube is eventually removed
intentionally, if an adequate tract to the skin has not formed.
Since T-tube drainage after CBDE confers both potential advantages and disadvantages, this operative strategy has been compared with primary choledochotomy
closure in several well-designed studies. This chapter will deal exclusively with the
clinical decision of whether to place a T-tube or perform a primary choledocotomy
closure after transcholedochal CBDE. We will discuss the results of trials examining these alternative operative strategies, summarize the existing evidence, make
recommendations regarding the evidence supporting the best answer to this clinical
question, and discuss the limitations to those recommendations.
Search Strategy
A search of English language publications was performed to assess existing evidence comparing the use of T-tube drainage and primary closure after CBDE using
the PICO outline shown in Table 18.1 . Databases searched were PubMed, Ovid
MEDLINE, and Cochrane Evidence Based Medicine . Search terms used were
To drainage collection
Duodenum
T-tube in comman bile duct
Cystic duct tied off
Hepatic duct
Fig. 18.1 A cartoon
depicting the anatomy of
placement of a T-tube after
open transcholedochal
CBDE and concurrent
cholecystectomy for
treatment of
choledocholithiais. The
opposite end of the tube
exits through a stabincision in the abdominal
wall and is placed either to
bag drainage or occluded
(Figure used with
permission from O’Toole
MT [
21 ] )
18 Primary Closure or T-Tube Drainage After Open or Laparoscopic Common Bile...