Common Bile Duct Injury - Negligence

The Condition

One of the most common complications of cholecystectomy leading to litigation, whether done laparoscopically or open, is an injury to the Common Bile Duct (CBD) or Common Hepatic Duct. Though bile duct injury is associated with cholecystectomy, it is given its own section because it is a common cause of litigation. The reader can refer to the “Cholecystectomy” and “Common Bile Duct Exploration” sections for more information.

During the process of cholecystectomy (removal of the gallbladder) there are two structures that must be safely ligated and cut. One of these structures is the cystic duct, which is the tube draining the bile from the gallbladder into the common bile duct. The other structure is the cystic artery, which is the vessel supplying the gallbladder with blood. The gallbladder is then dissected off of the liver and removed from the abdomen.

The biliary tree is composed of the Right and Left Hepatic Ducts, which drain the right and left lobes of the liver of bile, respectively. These then join to form the Common Hepatic Duct. The Common Hepatic Duct then becomes the Common Bile Duct after the junction with the Cystic Duct. The CBD then connects to the duodenum, which is the first portion of the small intestine. Any part of the biliary tree can be injured during the process of Cholecystectomy, regardless whether done open or laparoscopically.

The Mechanism of Injury of the Bile Duct

The most common mechanism of injury to the CBD is misidentification of the CBD as the cystic duct. This is usually due to uncertain anatomy, or misidentified anatomy, and insufficient dissection in this area. Occasionally the inflammation present can cause the CBD to become adhered to the gallbladder itself, thus further making the anatomy unclear. The dissection of the cystic duct, however, needs to be carefully performed to prevent damage of the CBD. The dissection is often complex in cases of acute inflammation of the gallbladder.

There are several ways to decrease likelihood of CBD injury. These include applying appropriate traction on the gallbladder to help open up the area of the cystic duct - CBD junction to better visualize these structures. The surgeon needs to actually visualize the cystic duct and cystic artery entering the gallbladder itself. This area, bordered by the liver, the cystic duct, and the common hepatic duct, is known as the “Triangle of Calot”. The cystic artery normally traverses the Triangle of Calot, and also needs to be identified and cut during cholecystectomy.

In addition, dissection of the Triangle of Calot should be started close to the gallbladder wall and continued down the cystic duct to prevent injury of the CBD or Common Hepatic Duct.

Diagnosis

One way to determine if there has been an injury to the CBD is to perform an Intraoperative Cholangiogram (IOC). This involves inserting a catheter (small plastic tube) into the cystic duct, and then injecting a contrast solution that appears on x-ray. If there has been an injury of the CBD, this will usually show up on the IOC.

Cholangiography

There has been a longstanding debate for many years as to whether Intraoperative Cholangiogram should be performed at every cholecystectomy (routine IOC), or only on selective instances (selective IOC). The indications for IOC in the selective group include jaundice, abnormal liver function tests (a blood test), uncertain anatomy, ultrasound evidence of gallstones in the CBD, or a recent history of pancreatitis (inflammation of the pancreas). The proponents of selective IOC argue that there is a monetary cost, as well as a risk of complications from the performance of the IOC itself. Therefore performing an IOC on every patient may be unwise in that it exposes the patient to unnecessary risks and increases the cost. The proponents of routine IOC argue, however, that the relative cost is very small and the performance of this test can prevent biliary injuries. However, if the CBD has been misidentified as the Cystic Duct, the performance of the IOC will not prevent the injury (that has already occurred with the placement of the cholangiography catheter), but may prevent further injury to the biliary tree, and may also make the diagnosis intra-operatively. A biliary injury that is diagnosed intra-operatively can often be addressed during the same procedure.

Despite this ongoing debate, surgeons agree that there are certain indications for IOC, as described above. Unfortunately, there are certain circumstances when it is impossible to perform the IOC without undue risk to the patient and becomes a judgment call of the surgeon. If the gallbladder is severely inflamed, making dissection difficult, an IOC should be attempted. If the surgeon, despite his/her best attempts, is unable to technically place the catheter into the cystic duct due to the inflammation, it is not below the standard of care to abort the IOC and simply remove the gallbladder, assuming the anatomy is clear. Another option would be to convert to an open procedure, although this does not necessarily protect against a CBD injury. After surgery, if there was an unrecognized bile duct injury, the patient would likely be having significant pain in the right upper side of the abdomen, (much more than the usual postoperative pain). The patient may have fever, and be jaundiced. The surgeon may want to obtain certain tests, such as ultrasound or CT, looking for fluid (bile) collection. Other tests that may be considered include a screening blood test, such as total bilirubin and alkaline phosphatase, as well as radiographic studies such as MRCP (magnetic resonance cholangiopancreatography) and HIDA scan (hepatobiliary iminodiacetic acid), as well as endoscopy and ERCP (endoscopic retrograde cholangiopancreatography).

In litigation concerning CBD injury in which an Intra-operative Cholangiogram was not performed, surgeons often state that they had no doubt about the anatomy. However, if there was no doubt about the anatomy, one could question how the injury occurred in the first place. If there was significant inflammation, an IOC should probably have been performed, or at least attempted. If the inflammation was so severe that the IOC could not be performed, but was at least attempted, there was no breach of the standard of care. If however, the surgery was described as straight forward, with minimal inflammation, easy dissection of the gallbladder, with unremarkable pathologic findings, any kind of injury to the CBD would constitute a deviation from the standard of care.

Treatment

The treatment of bile duct injury is often very complicated, and usually the patient is transferred to a major tertiary care center. A Roux –en- y choledochojejunostomy is then performed. This involves a segment of small intestine being brought up and connected to the bile ducts as they are leaving the liver. The other end of the segment of small intestine is then connected to the small intestine further distally. The bile then has a drainage path from the liver, through the attached segment of intestine, and then on to the remaining small bowel. This reconstruction is a major surgery and can be associated with complications. Patients are more likely to sue the surgeon who performed the cholecystectomy if the reconstructive surgery is met with complications and the patient’s recovery is protracted. These complications include:

• Stricture of the anastomosis (connection) of the bile duct to the intestine
• Infection of the bile ducts (cholangitis)

If the patient does well for the first five years after reconstructive surgery, then the patient most likely will continue to do well.

Medical Negligence:

As with any surgical procedure, there are certain risks and potential complications that are known to occur, and such complications do not necessarily constitute a deviation from the standard of care. Studies on bile duct injuries that resulted in litigation have shown that the main reasons for lawsuits are:

• Delayed diagnosis and treatment
• Complications as a result of delayed diagnosis
• Misinterpretation of radiologic images
• Delayed referral to a specialized center for reconstruction/ correction

Other instances of deviation from the standard of care include:

• Uncertainty about the anatomy, and no IOC was done, or at least attempted
• No preoperative testing, including an imaging test such as ultrasound, and blood tests including liver function tests
• If the patient presents with any of the signs and symptoms of a bile duct injury described above, and no postoperative examination is done, or the surgeon does not act on the abnormal results of the examination and tests
• An inexperienced surgeon embarking on a complicated reconstruction of the injured bile ducts