TO OPERATE OR NOT TO OPERATE ON ASYMPTOMATIC GALLSTONES IN LAPAROSCOPY ERA

(Review article)

DR Fiaz Maqbool Fazili

MBBS. MS; MAMS; FICA; FICS(USA)

Dept of General, Laparoscopy and Endocrine surgery

King Fahad Hospital Medina KSA

President WALS (World Association of Laparoscopic Surgeons. KSA.)

Copyright;

WALS (World Association of Laparoscopic Surgeons)

Department of General (Endocrine Surgery) and Gastroenterology,

King Fahad Hospital Medina Munawarh Kingdom of Saudi Arabia.

Introduction;

The days when the only means of diagnosis of gallstones was the ever faithful oral cholecystogram, the gallbladder and its diseases were domains solely reserved for the surgeons .The policies of management of its malfunctions, maladies and especially its calculi would be determined by them –rarely in their agenda was surgery omitted. The advent of ultrasonography, on the other hand, did resolve many problems but it also introduced a few of its own. Thus, not infrequently, surgeons were faced with asymptomatic gallstones detected by the overzealous internists, gastroenterologists, general practioners, gynecologists and cardiologists. This finding undoubtedly lead to the everlasting controversy of their management. Now with the establishment of laparoscopic cholecystectomy for initial treatment of gall stones the incidence of cholecystectomies has gone high. There seems to be a trend on the part of surgeons to advise cholecystectomy for all patients with gall stones irrespective of their symptoms. Present article discusses the subject of gallstones as regard their management. Are they to come out despite their seemingly inert position or should we wait for them to become aggressive before action is taken?

Asymptomatic Gallstones-Definition: The presence of gallstones detected incidentally in patients who do not have any abdominal symptoms or have symptoms that are not thought to be due to gallstones. The diagnosis is made during routine ultrasound for other abdominal conditions or, occasionally, by palpation of the gall bladder at operation. This definition implies that we know which symptoms are specific to gallstones (1)

Prevalence-;

The incidence of gallstones varies widely, being greatly influenced by dietary intake, particularly of fat. For example, in Saudi Arabia gallstone disease was virtually unheard of 50 years ago, but, with increasing affluence and a Western type diet, gall stones are now as common there as in many Western countries (2).In the United Kingdom about 8% of the population aged over 40 years have gall stones, which rises to over 20% in those aged over 60. Fortunately, 90% of these stones remain asymptomatatic but cholecystectomy is the most commonly performed abdominal procedure (1). In United States around 500,000 individuals lose their gallbladders annually. Exactly how many of those operated upon silent gallstones had is unknown, although a few reports mention a figure of 4- 7%. Many of these operations are done for symptoms as vague and complex as dyspepsia which may not necessarily be due to gallstones. (3)

 Gall stone disease management-------traditional teaching and natural course;

Traditionally we were taught that surgery is indicated in virtually all gallstones cases. This teaching was based on erroneous concept that gallstone disease progresses at a fast pace and complications are very common. These concepts were so much magnified to the patient that we ended up believing firmly our own magnified image of the monstrous and mean gallstones. In the old literature, Moynihan in 1908 and Mayo in 1911 warned of the consequences of silent stones. Mayo wrote that “the innocent gall stone is a myth.’).

However, the natural history of gallstone disease indicates that most patients with gallstones will not require treatment during the course of their life .Two thirds of gall stones remain aysmptomatic, and the yearly risk of developing biliary pain is 1-4%... In Denmark, asymptomatic gallstones were detected by ultrasound screening of a population, which was then followed up for 11 years. Complication rates (acute pancreatitis, obstructive jaundice, cholecystitis) are 0.2 - 0.8% per annum (4).  A longitudinal follow – up study of asymptomatic gallstones at the University of Michigan, showed that over a 20 year period only 18% developed biliary pain and that the mean yearly probability of the development of biliary pain is, 2% during the first 5 years; 1% during the second 5 years; 0.5% during the third 5 years; 0% during the fourth 5 years. A very important observation noted in that study, was that no person ever presented a biliary complication as an initial manifestation of his biliary disease. None of these individuals died because of gall stone disease. (5,6) Although gall stones are associated with cancer of the gall bladder, the risk of developing cancer in patients with aysmptomatic gall stones is  < 0.01%—less than the mortality associated with Cholecystectomy. The conclusion drawn from the studies that prophylactic cholecystectomy for asymptomatic gallstones could not be recommended. (2, 5-7)

Risks of Cholecystectomy in Laparoscopy era;

With increasing trend towards subjecting patients to Laparoscopic Cholecystectomy for gall stones. The treatment of patients with silent gall stones must be seen in the context of recent establishment of laparoscopic Cholecystectomy for gall bladder disease. The overall mortality risk of cholecystectomy varies from 0.14-0.5% in different series depending on the age and fitness of the patients. The concern that cholecystectomy leads to a slightly increased risk of right sided colon cancer in women after 15 years is still not over. There is also an increase in gastro-oesophageal bile reflux and of diarrhea after cholecystectomy (in patients with irritable bowel syndrome and loose stools). Although Laparoscopic cholecystectomy is established as first procedure of choice for gall bladder diseases when performed properly by surgeons skillful with laparoscopic instruments, the procedure imposes minimal pain and morbidity. However on a universal scale, the operation at this time is still associated with same mortality and perhaps greater morbidity from common bile duct injuries as compared with standard open cholecystectomy (8).How much justified is prophylactic cholecystectomy when stones are discovered incidentally by radiography or ultrasonography during the investigation of other symptoms. Doesn’t the risks of the operation outweigh the complications if the stones are left .This is another compelling argument against laparoscopic cholecystectomy for aysmptomatic gallstones (9).

 Financial implications;

On comparing the cost of each of the above strategies of treatment it became clear that the cost of expectant management was almost one fourth that of prophylactic surgery. The cost of prophylactic surgery, given the prevalence of gallstones, would be high. Calculations based on average costs in a British hospital would be almost £ 4 million / 10,000 patients with asymptomatic stones

Management of asymptomatic gallstones in special circumstances;

The general recommendation for patients with asymptomatic gallstones is expectant management unless the patient is at increased risk for cancer or complications.

However, some groups are at increased risk, and their management is controversial.

Diabetes mellitus and asymptomatic gall stones;

Patients having diabetes and asymptomatic gallstones, some controversy exists regarding whether their gall bladder should be removed prophylactically.

 (10). It has been stated that diabetic patients are particularly prone to biliary complications from their stones. This led some authors to advocate prophylactic

Cholecystectomy in asymptomatic diabetic patients (11-12). Although there is no evidence, however, that diabetes with asymptomatic stones are more likely than other patients either to become symptomatic with biliary colic or to suffer complications without first becoming symptomatic with biliary colic However, diabetic patients do not have an increased morbidity or mortality from stone disease once other co morbidities such as cardiovascular disease and renal insufficiency are taken into account (13). Recent reports comparing patients with asymptomatic gallstones over time support this view, showing no difference in the incidence of symptoms, complications and mortality comparing diabetic to non-diabetic patients (14).There is no clear benefit to prophylactic cholecystectomy in diabetic patients with asymptomatic gallstones. (15, 16).

GENETIC CONSIDERATIONS. The incidence of gallstones varies markedly among world populations. The Pima Indians of the United States, especially females, have an unusually high incidence of gallstones (17). Stones develop at a young age and complications requiring cholecystectomy occur in the majority of those who live for longer than 50 years. In contrast, the Masai of East Africa (18) have a very low incidence of cholelithiasis. Gallstone disease and gallbladder cancer are frequent among the Chilean (19),. North and South American and Indian and European –American Indian) admixed population .In this population, 3-5% of patients with aysmptomatic gall stones may develop cancer. Hence, in this subgroup, prophylactic cholecystectomy may be considered. These are special occasion’s gall stones develop at an earlier age, and data from numerous studies show that the risk of symptoms and/or complications (including gallbladder carcinoma) is cumulative. Indications for cholecystectomy can therefore be liberalized in these high-risk populations (12).

ASYMPTOMATIC STONES, GALLBLADDER CARCINOMA AND CALCIFIED GALLBLADDER.

It is very rare to find gall bladder cancer without stones except in the rare condition of Adenomatous polyps. Over 70% of patients developing gallbladder carcinoma have gallstones (20). The risk of developing carcinoma is estimated to be0.3% - 1% of calculous gallbladders 20 years (21). The risk of developing cancer in patients with aysmptomatic gall stones is < 0.01%—less than the mortality associated with cholecystectomy. A higher incidence of carcinoma has been reported in patients with larger stones than 3cm size (22). Because it would take at least 100 cholecystectomies to prevent one death from gallbladder carcinoma, most authors do not recommend prophylactic cholecystectomy in patients with asymptomatic gallstones as a measure of preventing the development of gallbladder cancer (23). The American Indian women and the Chilean Hispanic and Indian population with gallstones represent the only exceptions to this rule. Because of the early onset of gallstones in that population, there is an increased risk of gallbladder carcinoma and prophylactic cholecystectomy appears to be justified (17, 19). Patients with porcelain gall bladder (a rare occurrence of a calcified gall bladder wall) associated with carcinoma in 13–22% of patients (23).Prophylactic cholecystectomy is indicated in these cases even in the absence of symptoms because of the elevated risk of malignancy.

OTHER RISK FACTORS-Warranting prophylactic Cholecystectomy;

Patients with other hemolytic anemia's are also at risk for gallstone development many of whom will become symptomatic (24). Several arguments stand in favor of elective cholecystectomy in patients with hemolytic anemias. Biliary complications and vaso-occlusive crisis both present similarly (nausea, abdominal pain, fever, leucocytosis and cholestatic jaundice) and differentiation is not easy. The onset of gallstones at a young age in sickle-cell disease raises the lifetime risk of biliary complications. Cholecystectomy following the diagnosis of asymptomatic gallstones in patients with sickle-cell disease is therefore advisable (25).

INCIDENTAL CHOLECYSTECTOMY

Sometimes, consideration is given to perform an incidental cholecystectomy in addition to the planned operation in patients with asymptomatic gallstones. The purpose would be to prevent postoperative cholecystitis or the later development of symptoms. Of course the addition of one procedure should bear no added risks for the patient. Several investigators have tried to address this question. Several studies have confirmed a high incidence of biliary symptoms following laparotomy for unrelated conditions. Juhasz and colleagues studied patients with asymptomatic cholelithiasis who underwent operation for colorectal disease. One hundred and ninety-five (4%) had an incidental cholecystectomy while 110 (36%) did not There was no increase in operative morbidity in the cholecystectomy group. A total of 20 patients required cholecystectomy during a median follow up of 6 years in non operative group. The cumulative probability of needing a cholecystectomy at 2 and 5 years after the initial surgery was 12 and 22 %( 26).  The authors therefore recommend incidental cholecystectomy in patients with asymptomatic gallstones who undergo operation for colorectal diseases.  Simple cholecystectomy is now widely accepted as a concomitant procedure during the course of laparotomy for unrelated conditions. Its purpose is not only to prevent immediate postoperative biliary complications but also to reduce the risk of later biliary symptoms. If the gallstones are discovered preoperatively, as is most often the case, cholecystectomy should be discussed with the patient preoperatively. The discussion should emphasize the safety and the purpose of the procedure and not dismiss the possible complications—as with any additional surgical procedure. Clinical judgment and caution as to the appropriateness of the procedure remain paramount in each specific case of incidental cholecystectomy.

RECOMMENDATIONS;

A careful analysis of hepatobiliary and systemic risk factors should precede any decision regarding cholecystectomy for asymptomatic gallstones. The procedure cannot be recommended for the vast majority of the population. Because the risk factors for symptoms and possibly the complications of gallstones are cumulative (2% per year), prophylactic cholecystectomy may be considered in some populations in asymptomatic patients with genetically determined early development of gallstones and risk for gallbladder cancer. Whether patients with a life expectancy of several decades should undergo prophylactic cholecystectomy is debatable (12). At this point there is no data to support it. Cholecystectomy for asymptomatic gallstones is indicated in all patients with calcified gallbladder and in young patients with sickle-cell disease, patients with rapid weight loss, weight cyclers.Patients who are known to have gallstones and may be living in a part of the world that is very remote from medical treatment, should they get a complication. Patients with immune suppression e.g. after transplantation. These may have a far higher risk should they develop a complication such as cholangitis. But also cyclosporine A and tacrolimus (Prograf/FK 506) are prolithogenic because of decreased bile salt export pump function (BSEP).

Exceptions to this policy – of not operating on asymptomatic gallstones – may depend on whether the patient is scheduled for another abdominal operation or whether an operation is carried out specifically for the presence of gallstones... Patients with insulin-dependent diabetes do not have a higher prevalence of stones, Diabetic patients should be evaluated for cholecystectomy with the same criteria as the general population;  prophylactic cholecystectomy cannot be supported but when an elderly, have a higher risk of ischaemia of gall bladder should they develop inflammatory complications. Provided that the exposure is adequate and there are no associated hepatobiliary risk factors (abnormal liver function tests, dilated bile ducts, cirrhosis, a shrunken or scarred gallbladder), incidental cholecystectomy can be carried out safely as part of another abdominal procedure. There are individual considerations or exceptions as mentioned before like gall stones in sicklers and gall stones in children, have a relative indication for cholecystectomy even if their gall stones are aysmptomatic .The chances of developing complications on long term is high .Similarly accidental discovery of gall stones  at laparotomy some  controversy continues regarding the management amongst  proponents of prophylactic cholecystectomy and those who believe that combining surgery for a aysmptomatic disease increases morbidity. Reports are conflicting regarding both the incidence of biliary symptoms after surgery in patients in whom the gall bladder is not removed and the incidence of longer recovery time and perioperative complications in patients who do have cholecystectomy en passant currently. A role for prophylactic treatment for aysmptomatic stones discovered at major abdominal surgery remains to be demonstrated. Cholecystectomy en passant currently is clearly indicated only in symptomatic patients. It is contraindicated when vascular grafts are to be simultaneously placed in the abdomen. (27)

Summary and Conclusion; Despite wishful thinking, gall stones seldom disappear spontaneously. Statistics show that every year thousands of people have their gallbladders removed. Even today, only surgical removal of the gallbladder (laparoscopic/open   cholecystectomy is treatment of choice) guarantees that the patient will not suffer a recurrence of gall stones. The advantages of surgical removal of the gallbladder over non-surgical treatment are the elimination of gallstones, and the prevention of gallbladder cancer. Issue of the development of carcinoma of the gall bladder in patients with long standing gall stones comes up frequently. Suffice it to say, the incidence of gall bladder cancer is infrequent enough that this argument in favor of prophylactic cholecystectomy is without merit. Patients with silent gall stones must be carefully evaluated in the context of their age, symptoms, and associated conditions in order to arrive at a decision for the optimal treatment of their calculous disease. In general, most patients with aysmtomatic calculi are best managed by continued observation- and not cholecystectomy.

Did you know?

 REFERENCES:

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Links to useful websites

Society for Surgery of the Alimentary Tract

Treatment of gallstone and gallbladder disease. Inc.. 1998 Jun 3 (revised 2000 Jan). 5 pages.

Society of American Gastrointestinal Endoscopic Surgeons

Guidelines for the clinical application of laparoscopic biliary tract surgery. 1990 (updated 1999). 3 pages.

Optimed Medical Systems Clinical Development Group

Cholecystectomy. 1989 (revised 2000). The software includes over 19 menus and requires user to spend 2-5 minutes depending on the clinical information.

American College of Radiology

ACR Appropriateness Criteria for evaluation of patients with acute right upper quadrant pain. 1996 (revised 1999). 5 pages.

National Guidelines Clearing House

At the NGC site type 'cholelithiasis' in the searchbox for an overview of all guidelines which mention

 Address for Communication;

Dr Fiaz Maqbool Fazili

PoBox; 5147 Medina munawarah KSA.