The patient’s unmet needs (PUNs)
A 40-year-old woman attends to discuss her recent ultrasound report. She had previously attended with episodes of epigastric and right subcostal colicky pains, which had sounded like biliary colic. In total, she has now had three attacks over the last year or so, each lasting a few hours.
She has a past history of irritable bowel syndrome and asthma and is overweight. She is dismayed to hear that the ultrasound confirms gallstones. “I was hoping it was just severe attacks of my IBS”, she says. “Is there no treatment short of an operation? Can’t you just give me some pills to ease each attack?”
The doctor’s unmet needs (DENs)
What are the risks of not treating symptomatic gallstones – how likely are complications?
Approximately 10% of patients who have symptomatic gallstones and are having episodes of biliary colic will go on to develop acute cholecystitis. Of those who do develop acute cholecystitis, approximately 20% may fail to respond to medical management and eventually require emergency intervention.
Gallstones may be expelled from the gallbladder, migrate through the cystic duct and into the common bile duct. Approximately 15% of patients will have common bile duct stones in combination with gallbladder stones. It is estimated that most of these will pass spontaneously into the duodenum.
But in some the stones remain in the common bile duct, and such patients may present with obstructive jaundice, cholangitis or, worse, acute pancreatitis. It is estimated that approximately 2% of patients will develop complications from their gallstone disease each year and, over 10 years, one can estimate that this would be between 15% and 20%.
Remember that the risk of acute gallstone pancreatitis is significant with a mortality of approximately 10% to 15% and a significant morbidity. The overall morbidity of this condition is much underestimated as some patients may spend months in hospital having numerous interventions, such as percutaneous pancreatic necrosectomy and drainage of collections.
The British Society of Gastroenterology guidelines on acute pancreatitis state that all patients with gallstone pancreatitis should have definitive surgical treatment for their gallstones either during the same admission or within four weeks of discharge.
Is the situation different if gallstones are discovered coincidentally in an asymptomatic patient in the course of a private screening medical, for example?
It is estimated that the risk of developing a complication of gallstone disease, for example acute pancreatitis, is 0.2% per anum or 2% over 10 years.
The risk of surgical intervention exceeds the risk of leaving gallstones untreated. The overall mortality of laparoscopic cholecystectomy varies from 0.14% to 0.5% in different series, depending on the age and fitness of patients. The incidence of bile duct injury from laparoscopic cholecystectomy is 0.3% to 0.5% and thus there is a strong argument for avoiding laparoscopic cholecystectomy in asymptomatic patients.
However, there are always exceptions:
- Young patients with multiple small gallstones should be considered for laparoscopic cholecystectomy because of the risks of stone migration.
- Patients who are diabetic and would have a higher risk, should they develop a complication of gallstones, should be considered for surgery.
- Patients with a calcified porcelain gallbladder, at risk of developing gallbladder cancer, should be considered for surgery.
Given that conditions such as gallstones and IBS are very common and will often co-exist, how easy is it to be certain that the patient’s symptoms are actually due to the gallstones?
Evaluating patients’ symptoms is always challenging, and you must rely on the patient’s description of the pain to try and distinguish the difference between biliary pain and IBS.
The term “biliary colic” is a misnomer. Biliary pain is a steady, non-paroxysmal pain, often in the right upper quadrant or epigastrium. The pain rapidly increases in intensity, plateaus and lasts for several hours before easing. It often radiates to the right subscapular area. These symptoms are quite different from intestinal colic and IBS. Nevertheless, even in those patients with classical biliary colic, only 92% will be cured by laparoscopic cholecystectomy.
How effective are conservative measures, such as weight loss and avoiding fatty foods?
Unfortunately, weight loss predisposes to the development of gallstones, and this is especially marked in those losing weight rapidly – a weight loss of more than 1.5 kg a week has been associated with a higher rate of gallstone formation, compared with rates of less than 1.5 kg per week.
Avoiding fatty foods following the development of symptomatic gallstones reduces the incidence of biliary colic, but does not stop it completely. It is important to emphasise weight loss in primary care as a sensible part of improving a patient’s overall fitness.
What medication should the patient have for use in an acute episode?
In terms of managing episodes of biliary colic, NSAIDs such as diclofenac may be effective, and it is reasonable to try antispasmodics as the pain from biliary colic is related to smooth muscle spasm. Alternatively, if very severe, patients may require opiate treatment as an inpatient. Acute cholecystitis may be managed with fluids, analgesics and oral antibiotics initially.
What are the risks of surgery?
The major risk of cholecystectomy is injury to the common bile duct. With open cholecystectomy, this varies between 0.2% and 0.3%, but since the advent of laparoscopic cholecystectomy this has increased to between 0.3% and 0.5% depending on the series.
Bile duct injury is a major life-threatening injury and should be managed in a tertiary hepatobiliary centre.
The risk of conversion for laparoscopic cholecystectomy to open cholecystectomy should be less than 2-3%.
Specialist surgeons may have a conversion rate that is less that 1% overall whilst some generalists have conversion rates of between 10-20%. The mortality of laparoscopic cholecystectomy overall varies from 0.14% to 0.5% in different series, depending on the age and fitness of the patient.
What are the non-surgical options, when might they be appropriate and what are their pros and cons?
Oral dissolution treatment using bile acids has successfully dissolved gallstones, but in an extremely limited patient population. Patients need to have symptomatic radiolucent stones smaller than 15 mm and within a functioning gallbladder. In such a group, 55% developed a reduction in biliary pain and approximately 60% had dissolution of their stones after 12 months of treatment with 10mg/kg of ursodeoxycholic acid. Unfortunately, at least 25% of patients develop recurrent gallstones within five years and so this treatment is not used presently.
In high risk elderly patients gallstones may be left untreated if it is estimated that the risks of surgery are too high. Overall laparoscopic cholecystectomy is an extremely safe operation and can be offered even in extreme old age if necessary.
For elderly, frail patients with gallstone pancreatitis an ERCP, sphincterotomy and common bile duct stone clearance may be considered preferable to having a laparoscopic cholecystectomy although the logic of this has to be questioned as ERCP is not without significant risk.
Professor Nariman Karanjia is professor of hepato-pancreatico-biliary surgery at Royal Surrey County Hospital NHS Foundation Trust, and has been a surgical tutor for the Royal College of Surgeons.
References
1. Karanjia ND, Ali T. Gallstones. Surgery 2006; 24: 16-21
2. Bellows CF, Crass RA. Management of Gallstones. American Family Physician 2005; 72(4): 637-42.
3. Johnson AG, Fried M, Tytgat GNJ, Krabshuis JH. WGO Practice Guideline; Asymptomatic Gallstone Disease. World Gastroenterology Organisation. 28th Sept 2007.
