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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_1209_Библиотеки_им_академика_М_И_Перельмана.pdf
253© 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_22
Chapter 22
Immediate or Delayed Repair for Bile Duct
Injury Recognized Postoperatively?
Zhi Ven Fong and Keith D. Lillemoe
Abstract Bile duct injuries occurring during laparoscopic cholecystectomy are
rare, but result in considerable morbidity, rare mortality and major health care costs.
Signifi cant debate and controversy, however, remains regarding the optimal timing
of repair of bile duct injury recognized in the postoperative period. Delayed bile
duct injury repair has been associated with superior clinical outcomes when compared to immediate repair. Repair via a Roux-en-Y hepaticojejunostomy approach
has been shown to have higher success rates when compared to direct repair of these
injuries. Repair of bile duct injuries is feasible with no long-term physical quality of
life impairments, but with deterioration in mental health that improves over time
after repair.
Keywords Bile duct injury • Cholecystectomy • Immediate repair • Delayed repair
• Success rate
Introduction
Since the introduction of laparoscopic cholecystectomy (LC) for symptomatic gallstones in the 1980s, the procedure has evolved into one of the most common operations performed in Europe and the US [ 1 ]. Although less morbid than its open
approach [ 2 , 3 ], the incidence of a major complication, bile duct injury (BDI), is
higher, ranging from 0.15 to 0.6 % (1 per 200) [ 1 , 4 – 8 ] versus 0.1–0.3 % (1 per 500
cases) [ 9 ] as observed in the open approach cohort (OC). Additionally, BDIs associ-
ated with LC tends to be more complex (more proximal injuries involving bifurcation) when compared to injuries sustained during OC [ 10 – 12 ]. It is now accepted
that the majority of bile duct injuries occur due to a misidentifi cation of the bile duct
Z. V. Fong • K. D. Lillemoe (*)
Department of Surgery, Massachusetts General Hospital , Harvard Medical School ,
15 Parkman Street , Boston , MA 02114-3117 , USA
e-mail:
klillemoe@partners.org
254
often due to visual-perception illusion and/or inadequate visualization [ 13 ].
Irrespective of etiology, bile duct injury represents a signifi cant health and fi nancial
burden to both the patient and the healthcare industry [ 8 , 14 – 16 ].
In the recent decade, increased experience and regionalization have led to the
improved outcomes of BDIs [ 17 , 18 ]. Multidisciplinary teams comprising of inter-
ventional radiologists, gastrointestinal endoscopists and hepatopancreaticobiliary
surgeons enable successful repair of BDIs at varying levels of injury and treatment
of its long-term sequelaes [ 4 , 17 , 19 ]. While the majority of bile leak s can be man-
aged successfully by endoscopists, the long-term outcomes for major bile duct injuries are still best with surgical intervention, with long-term success rate s in excess
of 80 % [ 4 , 20 , 21 ]. Questions, however, remain regarding the optimal timing of
surgical intervention in BDIs. This chapter compares the outcomes of immediate
versus delayed repair for BDIs recognized postoperatively, specifi cally addressing
long-term success rates, mortality , health-related quality of life (HRQoL) and cost .
It is important to emphasize, however, that the ultimate decision to delay or undergo
repair is based on the surgeon’s clinical judgment, weighing in variables such as the
presence of vascular injury, biliary leak and local/systemic infl ammation.
Search Strategy
A systematic literature search of the English language publications from 2000 to
2014 was performed to identify studies analyzing the outcomes of immediate versus
delayed BDI repairs using the PICO outline (Table 22.1 . The databases searched
were PubMed, EMBASE and Cochrane Review. Terms used in the search were
“ bile duct injury / immediate repair ”, “bile duct injury/early repair”, “bile duct
injury/ delayed repair ”, “ laparoscopic cholecystectomy injury/immediate repair”,
“laparoscopic cholecystectomy /delayed repair” AND (“postoperative morbidity ”
OR “postoperative mortality ” OR “ biliary stricture ” OR “reintervention”). Articles
were excluded if they addressed bile leak s from cystic stump or accessory hepatic
ducts rather than common bile duct injury or if intervention focused on endoscopy
and interventional therapy rather than surgical. Articles analyzing BDIs discovered
intraoperatively were also excluded. Nine retrospective cohort studies were included
in our analysis. The data was classifi ed using the GRADE system.
Table 22.1 PICO table for immediate versus delayed repair of bile duct injuries recognized
postoperatively
P (Patients) I (Intervention) C (Comparator group) O (Outcomes measured)
Patients with bile
duct injuries from
cholecystectomies
Immediate
surgical repair
Delayed surgical repair Postoperative morbidity,
stricture rate, mortality, quality
of life, cost and return to work
Z.V. Fong and K.D. Lillemoe
255
Results
Long-Term Success Rate
Long-term success rate , defi ned as not needing subsequent interventions after the
index reconstructive procedure (most commonly for strictures) is the most commonly utilized metric to defi ne the success of the restorative operation. There were
nine retrospective cohort studies identifi ed that compared immediate versus delayed
repair of postoperatively found BDIs. There were no prospective, randomized controlled trial performed and will likely not be feasible given the rarity and complexity
of BDIs. Given the lack of level I data, our current understanding and clinical algorithm for managing postoperatively discovered BDIs are based on retrospective
cohort studies, which heavily favors delayed repair of these injuries (all quality of
evidence : low, Table 22.2 ).
Of the nine studies, six demonstrated higher long-term success rate s when
delayed repair was undertaken versus immediate repair of BDIs diagnosed postoperatively. In the largest cohort study, Iannelli and colleagues conducted a national
French survey involving 47 surgical centers encompassing 543 patients and reported
that delayed repair (≥45 days) of BDIs was associated with a higher success rate
when compared to immediate repair (<45 days, 93.2 % vs 59.3 %, p < 0.001) [ 22 ].
However, long-term follow-up is required to accurately evaluate success rate of the
intervention and none was reported in the study. In the study with the longest follow- up of 72 months, Sahajpal et al. reported that success rates was higher when
delayed repair was undertaken (>6 weeks, 100 %) as compared to repair in the intermediate period (72 h to 6 weeks, 91 %, p = 0.03) [ 23 ].
The limitation to this review is that all studies utilize different time thresholds
when comparing immediate versus delayed repair of postoperatively diagnosed
BDIs. The summary in Table 22.2 suggests that a delayed repair of at least >6 weeks
is ideal to achieve long-term success rate s ranging from 90 to 100 %, and that repair
anytime before that was associated with a higher rate of the need for
reintervention.
There were no studies reporting superior outcomes with immediate repair of
BDIs. Of the three studies that reported no difference between both approaches,
Sicklick et al. dichotomized the timing interval to <1 month, 1–12 months and
>12 months [
24 ]. Another compared outcomes when repair was undertaken
<2 weeks from BDI versus 2 weeks to 6 months after injury [
25 ]. Assuming the
above review holds true that a higher success rate is achieved if postoperatively
found BDI repairs were delayed for at least 6 weeks, the aforementioned time
frames will not appropriately portray an accurate comparison of immediate versus
delayed repair of postoperatively diagnosed BDIs.
22 Immediate or Delayed Repair for Bile Duct Injury Recognized Postoperatively?
256
Table 22.2 Long-term success and mortality rate of immediate versus delayed repair of postoperatively recognized bile duct injury after cholecystectomy
1st author, year n
Follow-up
(months) Timing defi nition Level of injury Method of repair
Success rate
(%)
a
Mortality (%)
Pitt, 2013 98 54 <2 weeks Strasberg: RYBE, 98 % <2 weeks: 90 –
2–4 weeks B–C, 3 % End-to-end, 1 % 2–4 weeks: 43*
6–8 weeks D, 3 % Transplant, 1 % 6–8 weeks: 100
E1–E5, 93 %
Iannelli, 2013 543 – <45 days All defi ned as
extrahepatic
injuries
RYBE, 48 % <45 days: 59* <45 days: 3.9
≥45 days End-to-end, 52 % ≥45 days: 93.2 ≥45 days: 0.8*
Sahajpal, 2010 69 72 0–72 h Strasberg: RYBE: 94 % 0–72 h: 98 0–72 h: 0
72 h to 6 weeks A–C, 1 % Hepatectomy: 4 % 72 h to 6 weeks:
91*
72 h to 6 weeks: 1
>6 weeks D –E5, 99 % End-to-end: 1 % >6 weeks: 100 >6 weeks: 0
Stewart, 2009 137 40 1 week Stewart-Way: – 1 week: 90 –
2 weeks I, 5 % 2 weeks: 93
3–6 weeks II, 24 % 3–6 weeks: 91
>6 weeks III, 61 % >6 weeks: 95
IV, 10 %
Goykhman, 2008 29 24 24–72 h CHD, 55 % RYBE: 100 % 24–72 h: 0* –
>8 weeks RHD, 17 % >8 weeks: 90
RPHD, 10 %
Walsh, 2007 144 67 <7 days Strasberg: RYBE: 87 % <7 days: 81* –
>79 days B–C, 12 % >79 days: 92
E1–E2, 27 %
E3, 38 %
E4, 20 %
E5, 1 %
Z.V. Fong and K.D. Lillemoe
257
1st author, year n
Follow-up
(months) Timing defi nition Level of injury Method of repair
Success rate
(%)
a
Mortality (%)
De Reuver, 2007 151 54 <6 weeks Amsterdam: – <6 weeks: 67* <6 weeks: 0
≥6 weeks A, 0.7 ≥6 weeks: 95 ≥6 weeks: 0
B, 8.6
C, 9.9
D, 80.7
Thomson, 2005 68 33 <2 weeks Strasberg: RYBE: 85 % <2 weeks: 86 <2 weeks: 8*
2 weeks to
6 months
B, 1 % End-to-end: 9 % 2 weeks to
6 months: 88
2 weeks to
6 months: 0
D, 2 %
E1, 8 %
E2, 30 %
E3, 25 %
E4, 18 %
E5, 3 %
Sicklick, 2005 175 – <1 month Bismuth: RYBE: 98 % p > 0.05 p > 0.05
1–12 months 1, 6 % End-to-end: 2 %
>12 months 2, 31 %
3, 26 %
4, 12 %
5, 22 %
RYBE roux-en y biliary-enteric, CHD common hepatic duct, RHD right hepatic duct, RPHD right posterior hepatic duct
*Denotes statistical signifi cance at the p < 0.05 level
a
Success defi ned as no need for further intervention after primary repair
22 Immediate or Delayed Repair for Bile Duct Injury Recognized Postoperatively?
258
Method of Repair
The most common methods of repairing BDI are direct repair with primary anastomosis (DR) and a Roux-en-Y hepaticojejunostomy (RYHJ). Historically, DR outside of the immediate setting if BDI was discovered intraoperatively has been
associated with poor outcomes , with failure rates ranging from 64 to 78 % [ 22 , 25 ,
26 ]. Thermal injuries that jeopardizes the microvascular supply to the biliary tree
and right hepatic artery injury have all been theorized to lead to the ultimate failure
of DR. Additionally, DR is diffi cult to perform in a tension-free fashion secondary
to retraction of the proximal transected bile duct proximally if repair is delayed.
Ianelli et al. demonstrated that the timing of surgical repair was a stronger predictor
of success than the method of repair: DR was associated with success rate s of 36 %
when performed at the time of LC, and 57 % when performed within 45 days (none
reported >45 days); RYHJ was associated with success rates of 37 % when performed at time of LC, but improved to 54 % and 93 % when performed within
45 days and >45 days post-BDI respectively [ 22 ].
Mortality
Of the nine cohort studies analyzed, only four studies provided mortality data. Of
the four studies, three reported a higher mortality rate in the immediate repair
(<6 weeks) group but only two achieved statistical signifi cance (Table 22.2 ). The
studies are likely underpowered for a mortality analysis, and the discrepancy
between mortality rates in both groups would likely be more apparent favoring
delayed repair of postoperatively found BDIs if the sample size were larger.
Health-Related Quality of Life and Cost
While clinical outcomes of BDI repair have been well described and compared,
patient reported outcomes like HRQoL arguably plays a larger role in defi ning the
success of the index repair. The Vanderbilt group recently performed a meta- analysis
of six studies (581 patients), which compared the HRQoL of patients with BDIs
with patients who underwent an uncomplicated LC. After controlling for follow-up
time, BDI patients were not more likely to have a reduced physical HRQoL than LC
patients ( p = 0.993), but were about 38 times more likely to have a reduced mental
HRQoL (OR = 38.4, 95 % C.I. 19.14–77.10, p < 0.001) [ 14 ]. More recently, the
Hopkins group assessed patients after BDI repair with a median follow-up of
169 months. Their study corroborated the fi ndings of the aforementioned metaanalysis, with 49 % of patients reporting a depressed mood and 40 % reporting low
energy level but unchanged levels of physical activity and general health [ 27 ].
Z.V. Fong and K.D. Lillemoe
259
Unique to their study, however, was a pre- versus post-intervention analysis, which
showed that the detrimental effect on mental health signifi cantly improved over
time after BDI repair (49 % depressed mood before repair, vs 18 % after repair,
p < 0.001; 40 % low energy before repair, vs 18 % after repair, p = 0.01).
The impact of BDI on healthcare cost , on the other hand, is dramatic secondary
to the need for complex repair and long-term multidisciplinary management of
complications (i.e. endoscopic balloon dilatation, interventional radiology guided
biliary drains). The cost of repair of BDIs can run 5–26 times the cost of an uncomplicated LC, costing over $50,000 for all its related care. These increased cost are
especially apparent in postoperatively discovered BDIs versus those recognized
intraoperatively, with the former group’s care costing 43–83 % less than the latter
group [ 8 , 28 ]. The tremendous expenses incurred holds true in Europe as well, with
a Swedish group reporting costs from 473,690 EUR to 608,789 EUR per million
inhabitants annually [ 29 ]. When discussing the fi nancial burden of BDIs, cost asso-
ciated with litigation should be considered as well. Up to 19–31 % of patients suffering BDIs seek litigation [ 15 , 30 ], with half of them settling out of court (mean
payment $469,711). Of those that proceeded to trial, about 20 % concludes with
plaintiff jury verdicts with mean payment of $188,772 [ 31 ].
A Personal View of the Data
The incidence of BDI after LC is uncommon, but results in signifi cant added morbidity , mortality and represents a fi nancial burden on healthcare cost . While there
are no level I evidence in the BDI literature, considerable retrospective data indicate
that delayed repair of postoperatively found BDIs have been found to result in superior outcomes when compared to immediate repair , achieving a signifi cantly higher
long-term success rate and lower mortality rates. The decision to perform or delay
repair of BDI must also be driven by the surgeon’s clinical judgment (eradication of
local and systemic sepsis and infl ammation). Repair via a RYHJ reconstruction is
associated with a higher success rate when compared to DR, with DR likely anatomically impossible to perform secondary to traction of the transected bile duct s.
Patients suffering BDIs have no long-term impairment in physical HRQoL but
experienced worse mental health as compared to patients undergoing uncomplicated LC. However, this impairment in mental HRQoL improves over time after
BDI repair.
Recommendation Based on the Data
• For patients with postoperatively found BDI, we recommend delayed repair of
up to 6 weeks after the index injury to achieve optimal long-term success rate s
(evidence quality low; strong recommendation).
22 Immediate or Delayed Repair for Bile Duct Injury Recognized Postoperatively?
260
• Postoperatively found BDIs should be repaired via a RYHJJ approach, as DR
results in a higher failure rate (evidence quality low; strong recommendation).
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22 Immediate or Delayed Repair for Bile Duct Injury Recognized Postoperatively?
263© 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_23
Chapter 23
Management of Suspected Choledocholithiasis
on Intraoperative Cholangiography
B. Fernando Santos and Eric S. Hungness
Abstract Choledocholithiasis is a frequently encountered problem on intraopera-
tive cholangiography at the time of laparoscopic cholecystectomy. While numerous
strategies have been described for dealing with this intraoperative scenario, most
surgeons employ laparoscopic common bile duct exploration (LCBDE), open common bile duct exploration, or postoperative endoscopic retrograde cholangiopancreatography (ERCP) in this situation. It is important to understand the relative
outcomes of each of these strategies in terms of stone clearance rates, morbidity, the
need for secondary procedures, and other outcomes such as hospital length of stay.
Although the data are limited, the initial procedure of choice may be LCBDE
through a transcystic approach, followed by either transcholedochal exploration
(laparoscopic or open) or postoperative ERCP depending on anatomic factors and
available expertise.
Keywords Choledocholithiasis • Bile duct exploration • Open • Laparoscopic •
Sphincterotomy • Endoscopic retrograde cholangiopancreatography •
Cholangiography
Introduction
Choledocholithiasis is a common problem, occurring in approximately 10–15 % of
all patients undergoing cholecystectomy [ 1 ]. In the “ open ” surgical era, the standard
of care for choledocholithiasis was open cholecystectomy with concurrent common
bile duct exploration . The introduction of laparoscopic cholecystectomy , however,
B. F. Santos (*)
Geisel School of Medicine at Dartmouth , White River Junction Veterans Affairs Medical
Center , 215 N. Main Street, Building 31-269, White River Junction ,
Hartford , VT 05009 , USA
e-mail:
Byron.Santos-Aleman@va.gov
E. S. Hungness
Northwestern University , Chicago , IL , USA
e-mail:
ehungnes@nmh.org