Gallbladder Disease and Medical Malpractice

Gallbladder disease encompasses a wide range of clinical conditions including cholelithiasis (gallstones in the gallbladder), choledocholithiasis (gallstones in the shared bile duct), cholecystitis (inflammation of the gallbladder from obstruction of the biliary tree), and ascending cholangitis (infection of the biliary tree). The most shared admittable presenting problem related to the gallbladder is cholecystitis. Patients present with biliary colic and fever. Cholecystitis is caused mostly by stones obstruction the cystic duct (90%) which is the duct attaching the gallbladder to the shared bile duct. The other 10% are due to stones obstructing the shared bile duct. The shared bile duct leads to the small intestine, and is also fed by the hepatic duct coming from the liver (see anatomical picture below). Risk factors for cholecystitis mirror those for cholelithiasis (simple biliary colic) and include increasing age, female sex, certain ethnic groups, obesity or rapid weight loss, drugs, and pregnancy.

Pathophysiology:

Acute calculous (stones) cholecystitis is caused by obstruction of the cystic duct, leading to distention of the gallbladder. As the gallbladder becomes distended, blood flow and lymphatic drainage are compromised, leading to mucosal ischemia and necrosis.

Acalculous cholecystitis is less shared and far more dangerous than calculous cholecystitis with a much higher mortality rate. It is caused by conditions associated with biliary stasis including basic illnesses (many), major surgery, harsh trauma and burns, sepsis, long term TPN (total parenteral nutrition), prolonged fasting, and diabetes.

Frequency/Morbidity/Mortality:

An estimated 10-20% of Americans have gallstones (cholelithiasis or choledocholithiasis), and as many as one third of these people develop acute cholecystitis. Cholecystectomy for either recurrent biliary colic or acute cholecystitis is the most shared major surgical procedure performed by general surgeons, resulting in approximately 500,000 operations yearly.

Most patients with acute cholecystitis have a complete remission within 1-4 days. However, 25-30% of patients either require surgery or develop some complication. The mortality rate for calculous cholecystitis is 4%. Perforation of the gallbladder leading to intraabdominal abscess and sepsis occurs in 10-15% of situations.

History/Physical:

The most shared presenting symptom of acute cholecystitis is classically described as upper abdominal pain, often radiating to the tip of the right scapula. Although the pain may initially be described as colicky, it becomes continued in virtually all situations. Nausea and vomiting are generally present, and patients may report fever. In elderly patients, pain and fever may be absent, and localized tenderness may be the only presenting sign. Cholecystitis is differentiated from biliary colic by the persistence of continued harsh pain for more than 6 hours and the presence of fever.

Physical examination may show fever, tachycardia, and tenderness in the RUQ or epigastric vicinity, often with guarding or rebound. A palpable gallbladder or fullness of the RUQ is present in 30-40% of situations. Jaundice (Yellowing of the eyes and skin) may be noted in approximately 15% of patients. The absence of physical findings does not rule out the diagnosis of cholecystitis. Many patients present with travel epigastric pain without localization to the RUQ. Elderly patients and patients with diabetes frequently have atypical presentations, including absence of fever and localized tenderness with only vague symptoms.

Diagnosis:

Lab studies have found that no combination of laboratory or clinical values are useful in identifying patients at high risk for acute cholecystitis. Although laboratory criteria are not reliable in identifying all patients with cholecystitis, the following findings may be useful in arriving at the diagnosis: Leukocytosis with a left shift, elevated liver function enzymes, elevated bilirubin and alkaline phosphatase, elevated amylase and lipase.

Imaging studies include plain x-rays (15% will show gallstones, air in the gallbladder wall represents emphysematous cholecystitis due to gas forming bacteria and has a very high mortality rate), ultrasound (95% sensitivity for picking up gallstones), hepatobiliary scintigraphy (HIDA examine) which is 95% accurate, CT and MRI (greater than 95% accurate), ERCP (endoscopic retrograde cholangiopancreatography) to diagnosis shared bile duct stones, intraoperative cholangiogram (for diagnosing shared bile duct stones).

Treatment:

For acute cholecystitis, initial treatment includes bowel rest, intravenous hydration, analgesia, and intravenous antibiotics. Antibiotics must cover the most shared organisms. Bacteria that are commonly associated with cholecystitis include E coli and Bacteroides fragilis and Klebsiella, Enterococcus, and Pseudomonas species.

Laparoscopic cholecystectomy is the standard of care for the surgical treatment of cholecystitis. Surgery is usually performed after symptoms have subsided but during the hospitalization for acute illness. For elective laparoscopic cholecystectomy, the rate of conversion from a laparoscopic procedure to an open surgical procedure is approximately 5%.

Complications and Prognosis:

Bacterial proliferation within the obstructed gallbladder results in empyema of the organ. Patients with empyema may have a toxic reaction and may have more marked fever and leukocytosis. The presence of empyema frequently requires conversion from laparoscopic to open cholecystectomy. In some instances, a large gallstone may erode by the gallbladder wall into the duodenum, impacting the terminal ileum and causing a gallstone ileus.

For uncomplicated cholecystitis, the prognosis is excellent, with a very low mortality rate. In patients who are critically ill with cholecystitis, the mortality rate approaches 50-60%, especially in the setting of gangrene or empyema. Once complications such as perforation/gangrene develop, the prognosis becomes less popular. In patients who are critically ill with acalculous cholecystitis and perforation or gangrene, the mortality rate can be as high as 50-60%.

Medical Legal Concerns:

The major legal liability in the treatment of gallstones rests with the surgeon and interventional endoscopist. Specific issues for the surgeon include shared bile duct injury, trocar-induced bowel damage and lost stones during laparoscopic cholecystectomy.

Delays in making the diagnosis of acute cholecystitis consequence in a higher incidence of morbidity and mortality. This is especially true for ICU patients who develop acalculous cholecystitis. The diagnosis should be considered and investigated promptly in order to prevent poor outcomes.

Surgeons must take the time to clarify and protect the shared bile duct. An intraoperative cholangiogram is useful in this regard. unexpected puncture or laceration of the shared bile duct is a extreme complication that is not easily remedied and is the most shared surgical misadventure resulting in litigation. Over 70% of lawsuits involving iatrogenic shared bile duct injury are resolved in favor of plaintiffs by verdict or by settlement. Routine cholangiography leads to intraoperative detection of such injuries.

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