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The informed patient What you should know about gallstone treatment Publisher www.falkfoundation.org © 2016 Falk Foundation e.V. All rights reserved. 14th edition 2016 The informed patient What you should know about gallstone treatment Compiled by Prof. Dr. Michael Sackmann Bamberg (Germany) Author’s address: Prof. Dr. M. Sackmann Medizinische Klinik II Klinikum der Sozialstiftung Bamberg Buger Str. 80 96049 Bamberg Germany The informed patient Contents Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 The gallbladder: Where it is and what it does . . . 6 How do gallstones develop? . . . . . . . . . . . . . . . . 10 Not all gallstones are alike . . . . . . . . . . . . . . . . . . 13 Treatment options for gallstones . . . . . . . . . . . . . – Oral dissolution of gallstones using drugs . . . . . . – Shockwave lithotripsy (ESWL) . . . . . . . . . . . . . . . – Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . – Bile duct stones . . . . . . . . . . . . . . . . . . . . . . . . . . 15 16 22 25 27 Can gallstone recurrence be prevented? . . . . . . 28 Dietary advice . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 A final word . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 3 Foreword Dear patient, Gallstones are much more common than you might think: In fact, about one in five adults living in Western industrial nations will at some point in their lives develop stones in the gallbladder or elsewhere in the biliary system. Many people affected by gallstones are completely unaware of this fact as only about 20% experience typical symptoms. These so-called “silent gallstones” may, however, become “loud” – cramping abdominal pain, colic and potential derangements in the function of the gallbladder, liver or pancreas demand an accurate diagnosis and, in some cases, prompt treatment. 4 The informed patient Gallstones: How they form and – what can be done? Surgery: Removing the gallbladder together with the gallstones? Fragmenting the stones with shockwaves or dissolving them with drugs – or both? Can the recurrence of gallstones be prevented? This brochure will answer these and other questions, and update you on the latest advances in gallstone therapy. You will not only learn about the function of your gallbladder but also come to better understand the therapeutic options. If, after reading this brochure, you still have questions, please consult your physician who will provide further assistance. Falk Foundation e.V. Patient Service 5 The gallbladder: Where it is and what it does The gallbladder lies in the upper right corner of the abdomen, just beneath the liver. Its function is easy to describe: It collects and concentrates the bile that is produced by the cells in the liver and drains through the ducts of the biliary tract into the gallbladder. When we take our meals, the gallbladder then doses this concentrated digestive juice, releasing it into the duodenum (the first segment of the small bowel or intestine) to aid in digestion. Liver Gallbladder Position of the gallbladder and liver. 6 Bile and gallbladder Liver Stomach Gallbladder Stones Bile duct Duodenum Entrance to duodenum Schematic representation of the gallbladder, stomach and liver. 7 Why do we need the gallbladder’s reservoir function? Each day, the liver produces about a liter of bile. The gallbladder functions to collect, thicken and store this bile. As omnivores, humans have developed a complex system to digest our food, from adequate mastication (chewing) to gastric juice and intact intestinal function. The bile fluid is another crucial component of this system. Liver: 500–1100 ml/day Bile Oral cavity: 1000–1500 ml/day Saliva Stomach: 2000 ml/day Gastric juice Duodenum Pancreas: 1000–1500 ml/day Pacreatic juice Small intestine Colon 8 Bile and gallbladder Because we eat at different times and in different amounts, we require an adequately large supply of bile and other digestive juices to meet the varying needs of our digestive system. The bile is especially important in helping the body absorb dietary fats and fat-soluble vitamins. When we eat, the gallbladder contracts, expelling the concentrated bile through the common bile duct into the duodenum. Here, the bile mixes with the chyme or partially digested food exiting the stomach. The result is a mixture of chyme and bile in which the nutrients from the food more completely dissolve and can thus be more thoroughly digested. Bile is rich in substances known as emulsifiers that assist in dissolving the food, including bile acids as well as cholesterol, pigments, proteins, lecithin, salts and water. 9 How do gallstones develop? The answer to this question is also quite simple. Gallstones are the result of an imbalance in the composition of the bile, which may, however, have many causes. Bile is a complex solution containing many individual components. These substances remain dissolved only as long as cholesterol, bile acids and other components of the bile remain in exact balance and the gallbladder, by contracting regularly, keeps these substances well mixed and empties normally into the duodenum. Many factors can lead to an imbalance between the individual components: – Disturbances in the production or transport of the bile in the liver, e.g. by high-calorie diets too rich in fat – Disturbances in the gallbladder’s function of concentrating the bile or poor mixing of the bile fluid, e.g. in diabetes mellitus or other metabolic disorders – Loss of bile acids in other disorders, e.g. after surgery on the small bowel or Crohn’s disease – Congenital (inborn or genetic) changes As a result of these disorders, microscopic crystals begin to deposit in the gallbladder. Once formed, these small gallstone crystals may continue to grow over the ensuing months and years. Usually, you are not even aware that this is happening. Only when the gallbladder can no longer contract normally or when its outlet is partially or completely blocked by a stone is there a backup in bile flow. This is when the painful symptoms begin. 10 Gallstone formation Who is at increased risk of developing gallstones? Persons consuming a high-calorie diet and especially those whose diets are rich in fat have a significantly higher risk of developing stones. Conversely, an increased amount of cholesterol in the bile also occurs during periods of prolonged fasting. A diet low in fat less often triggers emptying of the gallbladder, resulting in further “thickening” of the bile fluid. The tendency for gallstone formation is generally increased when a high cholesterol concentration in the bile is not balanced by the increased synthesis of bile acids. Bile acids are normally re-absorbed in the bowel. Thus, chronic diseases of the small bowel or colon, such as Crohn’s disease or ulcerative colitis, or surgical removal of sections of bowel may result in increased loss of these important substances. The following groups have an increased risk of developing gallstones: – – – – – – Overweight or obese persons Patients with metabolic disorders Patients with diabetes mellitus Patients with liver diseases (cirrhosis, hepatitis) Patients with disorders of the small bowel or colon Persons participating in a strict weight reduction diet An increased risk of developing gallstones also exists during pregnancy. 11 This is probably due to the profound metabolic changes during pregnancy, such as: – Changes in the woman’s hormonal status – Restrictions in the contractility of the gallbladder due to the increasing size of the unborn child Women in general have a higher risk of developing gallstones than do men. This is again probably due to hormonal differences. Over the past few years, researchers have identified clear genetic factors that may serve to explain a familial tendency to developing gallstones. We have now covered the many different causes for the development of gallstones. The next chapter will discuss the different types of gallstones and how these affect the range of therapeutic options. . 12 Gallstone composition Not all gallstones are alike As we discussed above, gallstones form as a result of an imbalance in the composition of the bile. The exact nature of this imbalance determines whether the resulting stones are made up predominantly of cholesterol or pigments (bilirubin). In addition, stones may contain different amounts of salts (e.g. calcium), components of mucus (mucins) and proteins. Stones may also be of mixed composition, yielding a wide range of intermediate stone varieties that differ from patient to patient. The following table and illustrations provide an overview of the main gallstone types: Type Main component Frequency Cholesterol stone Cholesterol 70–90% Mixed stone Cholesterol, pigments 10–30% Pigment stone Pigments, calcium, mucins 5–10% 13 External view Cross-section Radial stone “Bucket stone” Faceted stones “Mulberry stone” Pigment stones Gallbladder sludge Different types of human gallstones. Differences in gallstone composition have therapeutic consequences, which we will now discuss. 14 Gallstone treatment Treatment options for gallstones Treatment options depend on the composition of a patient’s gallstones and the severity of the disease. In individual cases, the patient’s physical constitution will be decisive in selecting the most appropriate treatment option. As you will learn in the following sections, there are a variety of effective options available today for treatment of gallstones: – – – – Oral dissolution therapy (drugs) Shockwave lithotripsy Surgery Adjuvant dietary measures “Silent” gallbladder stones, i.e. those that have never caused any symptoms, it is important to note, are observed but, as a general rule, do not require treatment. It is only when gallbladder stones become symptomatic that they are treated. With few exceptions, stones located in the bile ducts require immediate treatment. 15 Oral dissolution of gallstones using drugs The principle: Gallstone formation in reverse Bile acids, an important component of the bile, are produced by the liver to emulsify cholesterol, making it more soluble. Stones consisting predominantly of cholesterol crystals can dissolve if litholytic (“stone-dissolving”) bile acids are administered regularly in highly purified form, thus reversing the process of stone formation. One bile acid, ursodeoxycholic acid (UDCA), has been shown to be particularly suitable for this treatment method. Which stones are most suitable for oral dissolution therapy? Patients whose gallstones consist predominantly of cholesterol respond particularly well to treatment with UDCA. Because they contain little or no calcium, these gallstones are seen either very faintly or not at all on conventional x-rays, but they can be easily visualized and located using ultrasound. 16 Oral dissolution therapy Cholesterol gallstone: Light in color and somewhat translucent. Multiple floating gallstones (less than 5 mm in diameter) in the fluid-filled gallbladder (x-ray image). 17 Ideally suited for oral dissolution therapy are the so-called “floating” gallstones. Composed mainly of cholesterol, their density corresponds to that of the bile itself. Hence, these stones do not sink to the bottom of the gallbladder. The success of oral dissolution therapy with UDCA has been shown to be highest when certain pre-requisites are met: – Maximum stone diameter should not exceed five millimeters – Total stone mass should not exceed one-third of the volume of the gallbladder – The gallbladder must be fully functional (complete contraction after a test meal) – The bile ducts must be free of obstruction – Patients should not be taking certain medications (clofibrate, antacids, colestyramine, estrogen preparations) Important facts to know about the oral dissolution of gallstones First, patience is a virtue: Just as the development of gallstones takes months or even years, dissolution of gallstones with the help of bile acids does not occur overnight. Duration of oral dissolution therapy Depending on the size, type and number of gallstones, therapy may take between three months and one year. Maximum stone size is the main determinant of the duration of therapy. 18 Drug therapy Regular and consequent compliance with your medication is the key requirement for successful stone dissolution. You will take most of your medication in the evening, since it is especially at night that the liver produces bile fluid of a type that promotes the formation of gallstones. Severe abdominal pain, fever or chills, as well as dark urine may point to a stone trapped in the bile duct that obstructs the outflow of the bile. This causes a back-up of bile into the liver. If you experience these symptoms, you must seek medical attention immediately! No-fat “crash” diets, though they produce rapid weight loss, are accompanied by an increased risk of gallstone formation. Ask your doctor about reducing this risk with UDCA. This treatment is normally continued at least until weight stabilization has occurred. 19 Advantages of oral dissolution therapy Therapy with ursodeoxycholic acid (UDCA) is practically free of side effects and has been proven safe and effective in many international clinical studies. It is certainly the gentlest method of treating gallbladder stones. Compared to other forms of therapy, especially surgery, oral dissolution with UDCA offers patients a number of important advantages: – Preservation of the gallbladder and normal bile flow – Avoidance of surgery – Avoidance of its associated risks and consequences (anesthesia, complications, scars, dietary restrictions) – No pain, no time off from work Success rates and follow-up examinations during oral dissolution therapy Patients who meet the above selection criteria and regularly take their prescribed medication can expect successful oral dissolution of gallstones in about 30–70% of cases. Female patients should avoid becoming pregnant during therapy. 20 Drug therapy The efficacy of oral dissolution therapy, measured by reduction in stone size, is normally monitored after three to six months by ultrasound. Treatment is continued only if there has been a significant reduction in stone size. Before beginning oral dissolution treatment, patients and their doctors should discuss alternatives, such as surgery, which remains the standard treatment. Because the gallbladder is preserved, patients should be fully aware of the risk of stone recurrence following successful oral dissolution therapy with UDCA. A final request: Oral dissolution therapy for gallstones is only successful when you take your medication regularly and as prescribed. Please do not alter with the dosage and never simply discontinue therapy without first consulting your physician. In such cases, gallstones will continue to grow and may result in severe, acute symptoms that may even require surgery! 21 Treating gallstones with shockwaves (lithotripsy, ESWL) In Germany, extracorporeal shockwave lithotripsy (ESWL) has been used in the treatment of gallstones since 1985. The method was initially introduced in 1980 for the treatment of kidney stones. The aim of this method is to reduce the size of gallstones without resorting to surgical intervention. One very effective way of doing this is by the use of special shockwaves originating from a generator located outside the body, hence “extracorporeal”. The principle: Precisely-focused shockwaves shatter the gallstone into tiny fragments. Schematic representation of shockwave therapy.The patient lies on a water cushion above the shockwave reflector. Shockwaves are generated following precise placement of the stone in the shockwave focus. 22 Shockwave lithotripsy Ultrasound image of the gallbladder with a solitary stone (image center) in the gallbladder. The treatment: A treatment session takes about 30–60 minutes. During treatment, the patient lies atop a shockwave reflector that focuses the shockwaves exactly on the stone. With the stone under constant monitoring, shockwaves are generated. The disintegration of the stone is observed using either ultrasound or radiological methods. Depending on stone type, size and number, one or sometimes several treatments may be necessary before the stone is pulverized. 23 Which stones are suitable for shockwave treatment? The technique is especially suitable for patients with large stones trapped in the bile ducts that have not been amenable to treatment with other methods, such as endoscopic stone removal. This may apply especially in the case of stones trapped high in the liver or unable to pass a narrow point in the bile duct. Because of the very high rate of recurrent stone formation, this method is no longer recommended for the treatment of gallbladder stones. 24 Surgery Surgical treatment of gallbladder stones This is what you should know about the surgical treatment of gallstones: – The surgical removal of the gallbladder (cholecystectomy) is today considered the treatment of choice for gallbladder stones. – The surgical removal of the gallbladder is one of the most frequently performed and safest surgical procedures. – For patients presenting with highly acute symptoms, surgical removal of the gallbladder may often be the only feasible and life-saving option. Thus, surgery has retained its pre-eminent position in the treatment of gallstone disease. Nearly 100,000 cholecystectomies are performed each year in Germany, making this a “routine” procedure of modern surgery. As with any surgical procedure, however, problems or complications may occur in individual cases. Before making any decision, an open and frank discussion between you and your doctor will comprehensively address your questions and concerns before undergoing this surgical procedure. Your doctor will also discuss with you the necessity of surgery and answer any questions you may have regarding the procedure itself. 25 Today, most operations to remove the gallbladder are performed using an endoscopic (“laparoscopic”) surgical technique. This requires several very small incisions through the abdominal wall and the navel (“keyhole surgery”). Most patients are therefore spared the unpleasant large scars left after conventional open cholecystectomy. The required length of inpatient hospitalization following the surgery has also been significantly shortened and usually lasts no more than a few days. The surgical risk associated with laparoscopic gallbladder operations depends to a great extent on patients’ general health and other disorders. Damage to the bile ducts, a feared complication, occurs only rarely. 26 Bile duct stones Removing stones from the bile ducts Gallstones in the bile ducts are today typically removed using endoscopic techniques. The basic technique may already be familiar to you from experience with endoscopic examinations of the stomach (gastroscopy) or bowel (colonoscopy). When the objective is to treat a stone in the bile duct, the endoscope is advanced into the small bowel and, having opened the mouth of the bile duct (papillotomy), a tiny basket is inserted to “capture” and remove the stone. The stone is then released into the small bowel and allowed to pass with the stool. The determination of the stone’s position and whether all stones have been successfully removed is performed using a radiological method known as fluoroscopy. Large stones, as well as those that are trapped or located high in the liver itself or at a narrow point in the bile duct can also in many cases be safely and effectively fragmented using shockwaves or lasers (highenergy light beams) and then removed using the above-described method. X-ray image showing the endoscope and stones in the bile duct. 27 Can gallstone recurrence be prevented? One serious problem remains: Even after successful treatment and compete disappearance of the gallbladder stone the underlying process of stone formation cannot be prevented. As we have discussed above, the ultimate cause of stone formation to a great extent lies in metabolic disturbances in the liver. The exact molecular and biochemical processes in the liver cells that are responsible for the production of bile fluid of a type that promotes stone formation have long been the subject of intense scientific research but are still far from being adequately understood. More recently, a number of important genetic factors that play a role in gallstone formation have been identified. Comprehensive studies of stone recurrence in patients following successful stone clearance have repeatedly shown that 30–50% of successfully treated patients will again develop gallbladder stones within 5 years. Of these, however, only a minority again developed pain. The high recurrence rate may partially be explained by the fact that very small stones are often “invisible” to diagnostic imaging and may thus be overlooked. These patients are therefore erroneously declared stone-free and their therapy terminated prematurely. 28 Stone recurrence Continuing oral dissolution therapy This leads to the logical next conclusion: Treatment with UDCA should be continued for a period of about 3–6 months after clear evidence of complete stone clearance at ultrasound. It is currently being studied whether longer-term, reduceddose treatment with drugs can reduce the risk of stone recurrence. Long-term findings, however, remain unavailable at this time. Patients with a strong tendency to stone recurrence are usually advised to consider surgical removal of the gallbladder. 29 Nutrition tips to prevent stone recurrence Certain dietary measures may reduce your risk of gallstone recurrence: – Avoid becoming overweight: Overweight patients are at higher risk of stone recurrence. – Reduce your dietary intake of cholesterol. By consuming a diet low in cholesterol, patients can do much to extend their freedom from gallstones as long as possible. – Eat several small meals distributed throughout the whole day, including a light late meal (such as a glass of milk). This helps the gallbladder mix and empty the bile and hinders the formation of stones. – A high-fiber diet, rich in vegetables, facilitates the digestive process and also counteracts the formation of gallstones. Therefore: Consult your physician and follow his or her advice on diet and lifestyle! 30 The informed patient A final word Supporting patients and physicians in treating disorders of the liver, stomach, bowel and biliary tract is the main mission of the Falk Foundation e.V. We hope that this brochure has increased yout understanding of modern therapeutic options. This, in turn, should serve to deepen the understanding between physicians, patients, medical researchers, the pharmaceutical industry and the general public. Falk Foundation e.V. Patient Service 31 U85e 14-4/2016 POP