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Biliary Injury in Laparoscopic Surgery:

Part 2. Changing the Culture of Cholecystectomy


Steven M Strasberg, MD, FACS

This article simultaneously discusses prevention of bili- Indication for cholecystectomy


ary injury and reduction of the possibility of litigation The indication for surgery should be clearly docu-
arising from nonnegligent injury. These are considered mented in the record and summarized by the surgeon in
together during the three periods of encounter with a a consultation letter, or in an admission note. In a biliary
patient having cholecystectomy: preoperative, operative, injury patient, the presence of a questionable indication
and postoperative. The goals of this article are preven- for operation (often simply a lack of documentation)
tion of biliary injury and institution of a practice ap- will reflect on the overall care that the patient received
proach that will make it apparent when injury is not (eg, “The bile duct was damaged in an operation that
from negligence. Plaintiffs’ attorneys are guided, under- was not indicated”). The most common indication for
standably, by the aphorism “Where there’s smoke there’s cholecystectomy is symptomatic cholelithiasis, and the el-
fire,” and patients may seek out attorneys when care ements of diagnosis are straightforward — biliary colic and
seems deficient even when it is not. Costly, time- demonstration of stones by medical imaging. So it is desir-
consuming legal actions, as a result, may be initiated to able to document the characteristics of the pain and the
discover evidence that might have been placed in the results of imaging. When less common indications such as
chart in the first instance. Improving the current prob- biliary dyskinesia or noncalculous gallbladder pathology
lem of steeply spiraling costs of malpractice insurance are the reason for recommending cholecystectomy, the
through actions of those outside the profession, such as symptoms and the objective evidence linking the symp-
legislatures, is a worthy goal. But to pursue only that toms to the gallbladder are the elements to be recorded.
strategy is akin to asking for a good police department in
Consent
a community, but having faulty locks at home. It is my
The purpose of the consent procedure is to permit the
opinion that we, as surgeons, can have great impact on
patient to make an autonomous decision about surgery.
malpractice litigation in this area by focusing on our
Autonomy means that the patient has reached the deci-
own actions. The following are suggestions for what I
sion to undergo an operation on his own, after being
consider “good practice.” These are within the standard
informed reasonably completely about the benefits and
of care, but they do not purport to represent the stan-
risks of the procedure. Important outcomes of taking the
dard of care in the sense that they exclude other ap-
time to provide this type of consent are a good under-
proaches from also being appropriate. General issues
standing of what to expect on the part of the patient and
such as evaluation of patients suitable for surgery based
usually, the patient’s family. An unexpected negative
on comorbidities are omitted.
event is probably the single most common occurrence
Preoperative care triggering litigation, because it causes resentment and
The initial visit is used to make the diagnosis, to deter- often results in loss of confidence in the surgeon. Con-
mine whether the patient is a candidate for laparoscopic versely, when negative outcomes occurs to a patient who
cholecystectomy, and to obtain consent for the proce- has been properly prepared for their possibility, it is
dure, even though the actual consent form may not be much less likely to initiate litigation. Like autonomy,
signed at that time. expectation is a key word in the avoidance of litigation.
Four items of information needed by a patient to
Competing Interests Declared: None. make the autonomous judgment are:
Received March 11, 2005; Accepted April 4, 2005. 1. The rationale for the procedure: how was the diagnosis arrived
From the Section of Hepatobiliary-Pancreatic and Gastrointestinal Surgery, at and how does cholecystectomy relieve symptoms and pre-
Department of Surgery, Washington University in St Louis, St Louis, MO.
Correspondence address: Steven M Strasberg, MD, Box 8109, Suite 17308 vent later consequences of cholelithiasis.
Queeny Tower, 1 Barnes Hospital Plaza, St Louis, MO 63110. 2. Description of the procedure: what is actually done by the

© 2005 by the American College of Surgeons ISSN 1072-7515/05/$30.00


Published by Elsevier Inc. 604 doi:10.1016/j.jamcollsurg.2005.04.032
Vol. 201, No. 4, October 2005 Strasberg Biliary Injury in Laparoscopic Surgery, Part 2 605

surgeon and what the patient will experience from the the consent procedure may appear as “smoke,” ie, poor
start of preparation for the operation until full recovery. practice suggesting other poor practice to a lawyer inves-
3. The risks of the procedure by type, incidence severity, and tigating a case. If members of a jury believe that the
consequences. standard of care was breached in obtaining consent, they
4. The alternatives to the proposed treatment. are probably more likely to conclude that it was also
The procedure should be explained in plain terms and breached elsewhere. Good documentation is important
from a patient’s perspective. Details such as the degree of because without it, the patient’s claim of not being in-
postoperative pain and how pain will be managed, when formed usually will take precedence over the surgeon’s
oral intake will be stopped and resumed, and when nor- claim that proper information was given, even when the
mal activity and work will be possible are important to same consent is always provided by the surgeon, ie, that
patients. Risk of complications should be described in it is custom and habit to do so.
realistic terms with approximate but accurate data. Rea- Documentation that the risk of complications and spe-
sons for conversion to open cholecystectomy should be cifically biliary injury have been discussed with the patient
discussed and the role of conversion as a safety measure may be recorded in the letter of consultation in the opera-
emphasized. When there is an increased chance of con- tive note or elsewhere. Although this is acceptable, it is my
version, as in patients with acute cholecystitis,1 the in- opinion, given the frequency of litigation arising from lapa-
creased possibility of conversion should be made clear. roscopic cholecystectomy, that a new approach should be
In providing information for consent, the surgeon is the adopted: the use of a checklist. Checklists are common
patient’s teacher and like a good teacher, should confirm safety measures in many industries including aviation. An
example is shown in Figure 1. It is suggested that a checklist
that the patient understands what has been said and
be used as a guide in the consent discussion for patients
knows what to expect. Whenever possible, explanations
being prepared for cholecystectomy and that the checklist
should be given in front of close family members, typi-
then be shown or given to the patient, with an opportunity
cally a spouse, and should be followed by the surgeon
to discuss items on the list. Such an approach will not be
initiating an opportunity to ask questions (“Did you
forgotten by the patient and the list provides proof that the
understand everything and are there any questions that
consent was obtained in an exemplary manner. The check-
you would like to ask?”). Brochures designed to explain
list shown in the table goes into moderate detail. A checklist
the procedure and its risks are very helpful and their use could be as simple as the four key points in consent listed
is encouraged. But they do not replace the need for the previously and bolded in Figure 1, or as detailed as the
surgeon to discuss the procedure with the patient. information provided in some patient information sites.2,3
Patients, some of whom are medically naïve, are often In addition, the American College of Surgeons has recently
provided with many facts by several different individuals sponsored a publication about avoidance of litigation that
(family doctor, surgeon, nurses, and others) at the time contains other useful information about the importance of
they present with symptomatic cholelithiasis. Not sur- interpersonal relationships.4
prisingly, many do not remember they were told preop-
eratively that occasionally, perhaps because of local con- The operation
ditions, such as inflammation and anatomic variation, Identification of the cystic structures
biliary injury unavoidably occurs during cholecystec- The main cause of biliary injury, as noted in the companion
tomy. Unquestionably, litigation may be initiated not article, is misidentification of the common bile duct, the
because there was actual negligence during performance common hepatic duct, or an aberrant duct (usually on the
of a procedure in which biliary injury occurred, but be- right) as the cystic duct. So the goal of dissection in chole-
cause the patient and family were not informed in such a cystectomy is the conclusive identification of the cystic
way that they retained the information that allowed structures. The surgeon has an obligation to use a method
them to know what to expect. whose purpose is to obtain conclusive identification of the
Documentation of the explanations leading to con- cystic duct (and artery), although as indicated in the com-
sent is mandatory. Negligence in obtaining consent is panion article,5 the method may not always succeed. I
usually not the key issue in litigation, but it may be a know of four such methods in current use: cholangiogra-
complicating issue. Failure of clear documentation of phy, the critical view technique, the infundibular tech-
606 Strasberg Biliary Injury in Laparoscopic Surgery, Part 2 J Am Coll Surg

Figure 1. Model laparoscopic cholecystectomy consent checklist.


Vol. 201, No. 4, October 2005 Strasberg Biliary Injury in Laparoscopic Surgery, Part 2 607

duct with the common bile duct, identification will be


hard because it is difficult to see the exact point of union
of the cystic duct with the common duct. The parallel
union was recognized as a potential danger even in the
era of open cholecystectomy.8
Cholangiography is a good means of ductal identifi-
cation, and routine cholangiography reduces biliary in-
juries,9,10 but will only succeed if the cholangiogram is
interpreted correctly. Unfortunately, ductal injuries have
occurred in the face of clear cholangiographic abnormal-
ities that should have alerted the surgeon to danger.11,12
These abnormalities often involve interpretation of the
Figure 2. The deception of the hidden cystic duct and the infundib- anatomy of the upper bile ducts. For instance, the failure
ular technique of laparoscopic cholecystectomy. Left: Appearance
to surgeon when a duct appearing to be the cystic duct is dissected to see any bile ducts above the insertion of what was
first. Note that the duct appears to flare (heavy black line), giving the believed to be the cystic duct should be taken to mean
appearance that the cystic duct has been followed onto the infun- that actually the common bile duct rather than the cystic
dibulum. Right: True anatomic situation in some cases of classic
injuries. The deceptive flaring appearance (heavy black line) is
duct has been cannulated, until proved otherwise. Up-
caused by the separation of the cystic and common hepatic ducts or per bile ducts should show a normal branching pattern,
the side of the common hepatic duct and the side of the gallbladder. with ducts going to the right and left. Also, it is not
Note that such a deception is much less likely if the dissection is
carried to the “critical view” before dividing any structure. CBD,
acceptable to rely on a cholangiogram in which impor-
common bile duct; CHD, common hepatic duct. (From: Strasberg tant details are obscured by leakage of dye. Cholangio-
SM, Eagon CJ, Drebin JA. The “hidden cystic duct” syndrome and grams may be repeated, but in the case of persistent
the infundibular technique of laparoscopic cholecystectomy—the doubt, an open exploration is desirable. A particular
danger of the false infundibulum. J Am Coll Surg 2000;191:661–
667, with permission). “system” problem with cholangiography relates to aber-
rant right ducts and is illustrated in Figure 3. Figure 3A
nique, and dissection of main bile ducts so that the com- shows a postoperative ERCP in which an aberrant duct
mon bile duct, common hepatic duct, and cystic duct are has been preserved by dissection at a earlier laparoscopic
identified at the point that they unite. All of these methods cholecystectomy. Figures 3B and 3C are reconstructions
are within current practice norms. One of these methods of Figure 3A that show what a cholangiogram would
should be used, although in my opinion, the third and look like if aberrant ducts of various types were mistak-
fourth methods have considerable disadvantages. enly cannulated under the impression they were the cys-
The problems with the infundibular technique have tic duct. We have seen a number of aberrant duct injuries
been discussed in a previous publication.6 It seems that with apparently “normal” cholangiograms, as in Figure
the infundibular technique is prone to failure in the 3B. The “critical view” method13 is my preferred tech-
presence of severe acute or chronic inflammation and nique, but it is somewhat more difficult because it re-
when the cystic duct is hidden or effaced by a large stone, quires a more complete dissection of the triangle of
or hidden because of difficulty in retracting the gallblad- Calot and additional dissection time. Whichever
der (Fig. 2). Stated in the language of human error anal- method is used, the surgeon should not clip or divide
ysis,7 we consider the infundibular technique to be a “cystic” structures (either duct or artery) until he or she
well-intentioned workaround, introduced to permit is convinced that one of these methods of ductal identi-
cholecystectomies to be done laparoscopically, a fication has been applied to its end point.
method, which, however, has actually turned out to be Changing the culture of cholecystectomy:
“an error trap”7 for competent surgeons. “stopping rules,” conversion to open
Identification by dissection of the main bile ducts cholecystectomy, and performance
laparoscopically as a routine should probably be discour- of cholecystostomy
aged because of the increased possibility of injury to the In many industries there are stopping rules. These rules
main bile ducts during dissection. Also, in the 25% of are applied in the face of dangerous conditions and are
patients who have parallel or spiral union of the cystic intended to stop a process before it continues into a zone
608 Strasberg Biliary Injury in Laparoscopic Surgery, Part 2 J Am Coll Surg

Figure 3. (A) ERCP showing aberrant right hepatic duct which has been preserved during a earlier laparoscopic cholecystectomy. The clips
beside the duct show that the cystic duct entered the aberrant duct. The aberrant duct is the duct from segment 5. (B) Reconstruction of the
image to show what a cholangiogram would look like if the aberrant duct had been cannulated. Very few surgeons would recognize that one
segmental duct was missing on the right side and an injury to the aberrant duct would probably follow. (C) Reconstruction of the image to show
what a cholangiogram would look like if the aberrant duct was actually the right main bile duct. Note the much more obvious cholangiographic
abnormality of total absence of right hepatic ducts. Arrow points to left hepatic duct.

of great risk. Good examples exist in aviation. If a flight during a laparoscopic cholecystectomy that signal the
is diverted to a secondary airport, it may be that the need to convert to open cholecystectomy. But what is
“ceiling” was too low at the primary airport. The process important is the adoption of the mindset of the stopping
in making this decision is instructive. When the altime- rule in which safety is the chief consideration that gov-
ter is at a specific value, the pilot must be able to see the erns decisions when danger is apparent. This is especially
runway clearly. If the runway cannot be seen the landing appropriate in a benign disease such as cholelithiasis,
must be aborted. There is no leeway in this decision, no particularly because there are alternatives to pushing
descending another 20 or 30 feet to take a peek. It is a ahead with a difficult dissection.
hard and fast stopping rule for certain types of aircraft. When operative difficulty is encountered during lapa-
The negative effects of diversion to a secondary airport roscopic cholecystectomy, the surgeon should pause to
are considered to be minor compared with the risk of a determine whether the operation should be continued
dangerous landing and its possible disastrous conse- laparoscopically. Local operative factors and operative
quences. Note that the principle here is not merely experience of the surgeon are key considerations. Failure
avoidance of a crash. It is avoidance of entry into a dan- of progression of the dissection, anatomic disorienta-
ger zone in which the probability of a crash begins to rise tion, difficulty in visualization of the field, and inability
to an unacceptable level. In a nuclear reactor, the core of the laparoscopic equipment to carry out usual tasks
temperature is closely monitored and there are inviolate such as grasping of the gallbladder or separation of tis-
stopping rules that shut down the reactor when certain sues, are events that might be used as triggers of the
parameters are exceeded. Again, the principle is to halt stopping rule mentality in which subsequent actions are
before a zone of great danger is entered. governed chiefly by considerations of safety. In most
The application of a stopping rule to cholecystectomy cases these events are indicators for conversion (or con-
for cholelithiasis is not as simple as that for a mechanical sultation). The negative effects of conversion are minor
device such as an airplane or a nuclear power plant. The compared with the negative effect of a biliary injury, so
human body is much more complex than these mechan- like the airplane landing, it is best to back off when the
ical systems; there are no “pop ups” on the video monitor zone of serious danger is entered rather than to deter-
Vol. 201, No. 4, October 2005 Strasberg Biliary Injury in Laparoscopic Surgery, Part 2 609

mine if the procedure can be completed under danger- nical injuries is beyond the scope or purpose of this
ous conditions. The stopping rule mentality should not article, and these subjects are very well covered in stan-
end after an incision has been made and applies equally dard texts of laparoscopic surgery.
to the difficult open cholecystectomy, in which the risk
of completing an open cholecystectomy must be bal- Intraoperative consultation
anced against the risk of injury. Cholecystostomy is a The value of intraoperative consultation with a surgical
good alternative in very difficult patients, and it is al- colleague cannot be overestimated, but that consultation
most always possible. Partial cholecystectomy is another should occur early in the period of difficulty. I have never
reasonable alternative in some cases of difficult open read an operative note, either as a surgeon who has re-
cholecystectomy.14 The worst injuries we have seen have paired biliary injuries or as an expert witness, in which a
come after conversion in patients with severe inflamma- surgical colleague was called into the operating room to
tion and have involved major vascular injuries and inju- assist in the surgery and in the decision-making before
ries to the bile ducts. Although the airplane analogies are the occurrence of an injury. It seems that the chance of
useful, they can be taken only so far. Because of variation injury is much lower when this is done, or perhaps if an
in operative experience, what constitutes the zone of injury occurs in the presence of two trained surgeons,
serious danger may differ somewhat among surgeons. the chance of litigation is reduced. A surgical colleague
In my opinion, the points made in the previous para- in the operating room may be the best stopping process.
graphs cannot be emphasized too strongly and should be
ingrained in all trainees, even though today these are in Conduct when an intraoperative injury is detected
the “ought to be” category that will require a change in If an injury is diagnosed intraoperatively, it should be
culture to achieve. There is an outlet when laparoscopic repaired at the time if the skills required for repair are
cholecystectomy is very difficult and potentially hazard- within the expertise of the surgeon or an available col-
ous: conversion. There is an outlet when open cholecys- league. Cystic duct leaks, leaks from the gallbladder bed,
tectomy is very difficult and potentially hazardous: cho- and partial lacerations to the bile duct are within the skill
lecystostomy. It is not appropriate to proceed set of most surgeons. Complete transections of major
laparoscopically when conditions are patently hazard- bile ducts or aberrant ducts usually require hepaticoje-
ous. For instance, it is inappropriate to attempt to stop junostomy. Several publications now attest to the value
bleeding laparoscopically when one cannot see well and of referral of these complex injuries to a dedicated hepa-
there is a possibility that application of clips might also tobiliary service.15-17 Most tertiary care facilities that
clip and injure bile ducts. In addition, the presence of house hepatobiliary services have doctor access lines or
clips on such a structure after operation, when it has “hotlines” that are readily reached through the main tele-
been described that they have been used to arrest hem-
phone number of the hospital. Using this form of access,
orrhage (and when other local operative conditions fall
expertise can be obtained within minutes from within
into the expected range for this procedure), is likely to
the operating room (often operating room to operating
convince most experts that the action was practice below
room).
the standard of care. The mind set of surgical trainees
should be directed to methods that result in completing Laparotomy should not be performed for diagnosis or
a large number of cholecystectomies safely, even if that drainage only. Injury can be extended by dissection,
means that fewer cholecystectomies are completed lapa- which is performed solely for diagnosis, drains can be
roscopically and that more converted laparoscopic pro- inserted laparoscopically, and the laparotomy may make
cedures are completed by cholecystostomy. subsequent repair more difficult. Above all, surgeons
Misidentification is not the only cause of biliary in- should have a plan of what to do in case of suspected or
jury. Technical causes such as cautery burns to ducts, actual biliary injury, rather than try to formulate one at
slippage of clips that have been applied to ducts, entry a time of increased stress. Poor outcomes after a repair in
into a bile duct in the gallbladder bed, and tenting of the the primary institution is “smoke.” Even if the injury
common bile duct while applying clips, can result in was not negligent and the repair was performed within
biliary injury. Injury might also complicate bile duct the standard of care, the probability of an extensive
exploration. A complete discussion of avoidance of tech- search of the evidence is high.
610 Strasberg Biliary Injury in Laparoscopic Surgery, Part 2 J Am Coll Surg

The operative note time. If the patient is to be referred to a tertiary hepato-


The operative note should describe the operative condi- biliary center, the referring surgeon should personally
tions clearly and completely but without exaggeration. speak to the accepting surgeon whenever possible, con-
When an expert witness reads an operative note that vey to the patient that this contact has been made per-
describes “severe acute inflammation” and the pathology sonally, and provide the name and area of interest of the
report notes “mild chronic cholecystitis,” the conse- accepting surgeon to the patient.
quences are obvious. The rationale for cystic duct and
artery identification should be stated clearly and com- Postoperative care
pletely. When the operative note is read later, it should Postoperative complaints
be readily apparent to the reader why the structures, The most common malpractice claim in gastrointestinal
which were divided, were believed to be the cystic duct surgery is that a biliary injury was negligent, but delay in
and artery by the surgeon. The operative note should be diagnosis of that injury is probably the second most
dictated on the day of operation. In most hospitals this is common claim. Delay in diagnosis may aggravate the
becoming a requirement. Delay in dictation is “smoke.” injury. During the delay, patients are often in varying
Before beginning the actual dictation, it is wise to take a degrees of discomfort, which is distressing to them and
moment to jot down a list of the operative conditions to equally so to their families. This is especially true if the
be dictated into the note and the points that describe the laparoscopic cholecystectomy has been described as a
rationale for ductal identification. If an intraoperative minor procedure. Then there is a “double whammy”
injury occurs, it should be described in clear terms. If the —an unexpected event and the perception that the sur-
extent of the injury is unknown, it is appropriate to state geon is not being responsive to complaints. Both cause
so. If consultations have been obtained, they should be resentment and loss confidence in the surgeon, which in
described and of course, if a repair is undertaken it turn, are the triggers for litigation. A contributing factor
should be included in the note in appropriate detail. to delay in diagnosis is that substantial volumes of he-
Under no circumstances should a medical record ever be patic bile in the peritoneal cavity may cause only minor
altered or deleted because this seriously negatively affects symptoms. Hepatic bile is an isotonic fluid, quite dilute
credibility even when done with the best intention of compared with gallbladder bile in respect to irritating
correcting an error. The appropriate step for error cor- substances such as bile salts. It might leak into the peri-
rection is to enter a note of amendment. toneal cavity and produce only relatively minor com-
Discussion of intraoperative injury with patient plaints for days. But these minor symptoms, which may
and family be feelings of fullness, distention, constipation, or vague
Occurrence of a biliary injury is very distressing for a pain should be taken seriously simply because it is un-
patient and the patient’s family. It is also an upsetting usual for patients to have a degree of malaise after a
event for a surgeon. Nonetheless, it is under these con- successful laparoscopic cholecystectomy that would
ditions that the complication must be explained. The prompt a call to the surgeon.
surgeon, as in the case of being prepared to deal with the To avoid delays and their consequences, the surgeon is
possibility of an intraoperative biliary injury, should wise to consider postoperative complaints seriously, even
have anticipated and be mentally prepared to discuss those that do not classically signal a major problem. It is
such events with a patient and a family. The process good practice to interview and examine such patients
bears similarities to the consent process except that in- and initiate investigations when indicated. In case of
formation might be necessarily incomplete. Full disclo- suspected injury, appropriate endoscopic and radiologic
sure of what is known about the injury, and about its consultation should be obtained as soon as possible.
intended or actual investigation and treatment should be Complete records should be kept. When the diagnosis is
provided in clear and realistic terms. Again, the patient made intraoperatively, the potential problem should be
should be told what to expect as much as is possible from explained in a clear and complete way to patient and
the patient’s point of view. Judgmental statements about family. The patient should be told what the investiga-
the cause of the injury should not be made because they tions involve and when they can expect to know if there
frequently will be inaccurate, especially because the ex- is a problem. In this way if injury is present, the chance
tent of the biliary injuries is frequently unclear at this of added injury from delay is minimized, patient pain
Vol. 201, No. 4, October 2005 Strasberg Biliary Injury in Laparoscopic Surgery, Part 2 611

(Fig. 4) — very good words for biliary surgeons to say to


themselves when they begin a procedure.

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