Guidelines for the Treatment of Gallstones by itlpw9937


									CLINICAL                GUIDELINE

Guidelines for the Treatment of Gallstones
American College of Physicians*

[The square-bracketed numbers are references to the num-              20% of cholecystectomy patients. Because bile acids
bered sections in the review article in this issue ("Treatment of     must be taken daily for up to 2 years and because of
Gallstone Disease"; see pages 606-619, which support state-           their limited efficacy, their use is not widespread. A
ments made here. -The Editors./
                                                                      second option, methyl-tert-butyl-ether, is a contact sol-
Ann Intern Med. 1993;119:620-622.                                     vent that dissolves cholesterol during repeated instilla-
                                                                      tions into the gallbladder via a catheter. However, this
x roper decision making for gallstone disease necessi-                therapy is still in the investigational stage. A third ther-
tates that clinicians and patients recognize three cate-              apy, extracorporeal shock-wave lithotripsy, breaks
gories of disease. The first category encompasses silent              stones into smaller pieces using acoustic shock waves.
gallstones (asymptomatic disease). The second category                Then oral bile acid therapy dissolves these pieces.
involves disease that causes uncomplicated biliary pain               These options do bypass the risks and potential com-
(symptomatic disease). A third category involves com-                 plications of surgery. Still, the clinician and patient
plications of gallstone disease, such as acute cholecys-              should keep in mind that such nonsurgical therapies will
titis and gallbladder cancer. The present guideline fo-               neither prevent gallstone recurrence nor prevent gall-
cuses on the first two categories only.                               bladder cancer [4.1.2].
   This categorization of disease allows clinicians and                  Surgical removal of gallstones and gallbladder (chole-
patients to choose the treatment most appropriate to the              cystectomy) prevents future pain, complications, gall-
specific patient. Therapy could be expectant manage-                  stone recurrence, and gallbladder cancer. It spares the
ment, a "wait-and-see" position in which intervention                 patient the length of nonsurgical therapies and is not
is postponed until a more serious problem develops.                   limited by the size or composition of the gallstones. In
Therapy may be nonsurgical, in which only the gall-                   return, cholecystectomy is accompanied by a higher
stones, but not the gallbladder, are removed. The last                risk for mortality, the associated risks of general anes-
option, the surgical approach, involves the removal of                thesia, postoperative morbidity, and a lengthy convales-
both the gallstones and the gallbladder. To choose the                cence period (up to several months to return to full
most appropriate option requires information about the                activity) [4.1, 4.1.1]. Laparoscopic cholecystectomy de-
efficacy, safety, and benefits of each.                               creases the convalescent period, but it remains a new
                                                                      (1989) technology whose safety has not been fully as-
                                                                      sessed in large, comprehensive studies. Because of the
Therapy Choices
                                                                      absence of strict requirements for uniform, rigorous
   Because expectant management delays treatment, this                training, not all surgeons have been trained well enough
therapy poses a dilemma. Watchful waiting may avoid                   to prevent bile duct injury or bowel perforation. Subse-
an unnecessary intervention. However, delaying an in-                 quently, the complication rate for bile duct injury may
tervention is a tradeoff that could result in an adverse              be substantially higher for the laparoscopic technique
consequence by not preventing a future complication or                [4.1.1]. The laparoscopic technique has gained popular-
by requiring the intervention when the patient is in an               ity among surgeons and the public alike. Until rigorous
older, frailer state when the associated morbidity and                training becomes widespread, however, the clinician
mortality are greater [2.4].                                          and patient should determine the experience of the sur-
   Nonsurgical therapy dissolves gallstones by "solubi-               geon before choosing the laparoscopic route.
lizing" their cholesterol through various methods. This
therapy is generally limited to gallstones with a diame-
ter less than 1.5 cm and whose content is primarily                   Background, Symptoms, and Diagnosis
cholesterol. Options include oral bile acids that dissolve
cholesterol stones by increasing the cholesterol in bile.                By age 75, approximately 35% of women and 20% of
However, suitable candidates would account for only                   men have developed gallstones. Although it is a com-
                                                                      mon disease, most cases are asymptomatic and the
                                                                      patient remains unaware of its presence [2.1]. Symp-
* These guidelines were authored by David F. Ransohoff, MD; William
A. Gracie, MD; and John P. Schmittner, and were developed for the
                                                                      tomatic disease generally occurs as uncomplicated, in-
Health and Public Policy Committee by the Clinical Efficacy Assess-   frequent biliary pain; episodes appear suddenly as se-
ment Subcommittee: Ernest L. Mazzaferri, MD, Chair; John R. Feuss-    vere, steady pain that is unaffected by household
ner, MD; Edward J. Huth, MD; Gerald R. Kerby, MD; Francis J.
Klocke, MD; Albert G. Mulley, Jr., MD; George E. Thibault, MD; and    remedies, position change, or gas passage. If pain epi-
Col. Michael J. Kussman, MD. Members of the Health and Public         sodes do recur, the frequency may vary from weeks to
Policy Committee were Clifton R. Cleaveland, MD, Chair, Cecil O.      years. Gallstone disease is not indicated by pain that is
Samuelson, Jr., MD; Christine K. Cassel, MD; David J. Gullen, MD;
Ernest L. Mazzaferri, MD; Quentin D. Young, MD; Whitney Adding-       present uniformly, that frequently comes and goes, and
ton, MD; Robert A. Berenson, MD; John E. Eisenberg, MD; Nancy E.      that lasts less than 15 minutes. Belching, bloating, in-
Gary, MD; P. Preston Reynolds, MD; Gerald E. Thomson, MD; and         tolerance of fatty foods, and chronic pain are problems
Mack V. Traynor, Jr., MD. The guidelines were approved by the Board
of Regents on 29 March 1993.                                          not attributable to gallstone disease. To the patient,

620     1 October 1993 • Annals of Internal Medicine • Volume 119 • Number 7 (Part 1)
however, the first episode of biliary pain can be upset-      Asymptomatic Gallstones
ting if mistaken for a heart attack or abdominal catas-
trophe. Besides biliary colic, various complications are         Because of a benign history and a low risk for ever
attributable to gallstone disease, including acute chole-     incurring a major complication, expectant management
cystitis, acute pancreatitis, common duct obstruction,        should be recommended for patients with asymptomatic
ascending cholangitis, gallbladder cancer, and gallstone      gallstones [4.2.1, 4.3,, 4.4, 4.6]. This recommen-
ileus [2.2].                                                  dation applies to men and women of all ages. The effort
   If the clinical history suggests gallstones, ultrasonog-   and minor risks of surgical and nonsurgical intervention
raphy, oral cholecystography, or plain roentgenography        still outweigh their corresponding benefits. Expectant
can diagnose their presence. Asymptomatic gallstones          management must suffice until a perfectly safe, effec-
are discovered incidentally [2.3].                            tive, convenient, and inexpensive treatment is devel-
   Differentiation of symptoms proves important be-           oped.
cause the decision making for symptomatic gallstones             Patients with a high risk for gallbladder cancer, for
differs from that for asymptomatic gallstones. Gallstone      whom prophylactic cholecystectomy may be advisable,
disease does not impose the long-term disabilities that       are exceptions to this recommendation [4.2.1,,
accompany conditions such as congestive heart failure,, 4.6]. It remains uncertain, however, which pa-
stroke, and cancer. Therefore, the issue is not whether       tients with asymptomatic stones have an increased risk
to alleviate a chronic or debilitating condition. Rather,     for gallbladder cancer. Patients with calcified gallblad-
the clinician and patient must decide whether to prevent      ders and New World Indians, such as the Pima Indians,
(for example, by cholecystectomy) future biliary pain, a      do carry an increased risk for gallbladder cancer. This
biliary complication, gallbladder cancer, or death.           increased risk may also apply to patients with large
                                                              (more than 3 cm) stones [5].
Gallbladder Cancer
   Gallbladder cancer accounts for approximately one          Symptomatic Gallstones
third to one half of gallstone-related deaths in the
United States. The median age of persons with gallblad-          For symptomatic gallstones, the choice of treatment
der cancer is 73 years. Even though 80% of patients           proves more complicated. The following recommenda-
with gallbladder cancer have gallstones, it has not been      tions are suggested.
proved that gallstones are the cause. Alternately, a             1. The clinician should determine if the biliary pain is
common underlying factor (for example, a property of          the first episode and whether the pain indicates gall-
bile) may cause both diseases, which could account for        stone disease. From that assessment, the natural history
the association between their occurrence [4.2.1]. This        can be roughly estimated using natural history data.
alternative theory has clinically important implications.     (See Tables 4 and 5 in the corresponding background
If cancer is related to bile and not to gallstones, then      paper, pages 609 and 611) [4.2.2,, 5].
nonsurgical therapies (which leave the gallbladder in-           2. The clinician should assess the patient's treatment
tact) may not prevent gallbladder cancer. For asymp-          goals and attitudes. Specifically, the clinician should
tomatic gallstones, the potential effect of gallbladder       determine whether the patient wants to prevent another
cancer cannot be assessed easily because the incidence        episode of pain. If so, treatment should be instituted
of gallbladder cancer is not well understood. Although        [4.4, 5].
the absolute risk for gallbladder cancer is low, gallblad-       3. If the patient primarily wants to reduce the risk for
der cancer is almost uniformly fatal, so even a low rate      death from gallstones and if the pain is a first episode,
of cancer of 0.0002 per year would result in approxi-         then the patient may choose to observe the "pattern"
mately a 0.4% risk for death during a period of 20 years      of pain before deciding about therapy. The clinician
[].                                                    could advise that about 30% of patients with a pain
   For patients with symptomatic gallstones, gallbladder      episode may not incur more episodes even after pro-
cancer has a greater effect on decision making. Cohort        longed follow-up [4.2.2,].
studies suggest that patients with symptomatic stones            4. Symptomatic patients who opt for expectant man-
develop gallbladder cancer at higher rates than do pa-        agement would have to believe that the gains from
tients with asymptomatic stones []. Cholecystec-       prophylactic cholecystectomy, in terms of life expect-
tomy may be more advantageous to patients with symp-          ancy, do not warrant intervention. For such patients,
tomatic gallstones because it would remove the threat         the decision between immediate treatment or expectant
of gallbladder cancer.                                        management may be more a matter of personal choice
                                                              and convenience [,, 4.4, 5].
Recommendations                                                  5. If the patient desires intervention, open cholecys-
                                                              tectomy, or laparoscopic cholecystectomy if a skilled
   In treating gallstone disease, the clinician and patient   surgeon is available, is generally preferred [4.1.1,
should first recognize that they can focus their decision,,, 4.6].
making on two distinct goals: preventing future biliary          6. The potential problem of bile duct injury should be
pain or preventing a future biliary complication or           considered, especially for laparoscopic cholecystectomy
death. Then the decision-making process should con-           [4.1.1,]. If the patient is attracted to the reduced
sider whether the disease is asymptomatic or symptom-         recovery time associated with the laparoscopic treat-
atic [5].                                                     ment, then the clinician should determine if the surgeon

                                  1 October 1993 • Annals of Internal Medicine • Volume 119 • Number 7 (Part 1)       621
is appropriately qualified and experienced in this new         surgical approach []. Still, these patients should
technology.                                                    be made aware that nonsurgical methods may not re-
   7. Nonsurgical methods should be considered if the          duce the risk for gallbladder cancer.
patient is a good candidate. Candidates for oral bile
acids have small stones (diameter less than 0.5 cm) that       Future Research
float during oral cholecystography. The best candidates          Future gallstone research should focus on several ar-
for lithotripsy have a solitary radiolucent stone smaller      eas, including the natural history of both asymptomatic
than 2 cm, with adjuvant oral bile acids. Methyl-tert-         and symptomatic gallstones, risks for developing gall-
butyl-ether is still considered investigational [4.1.2,        bladder cancer, and issues concerning the safety of lap-,].                                             aroscopic cholecystectomy compared with that of open
   8. Because gallstone disease treatment is usually not       cholecystectomy [6].
urgent, it may be reasonable to try nonsurgical therapy
                                                               Requests for Reprints: Linda Johnson White, Director, Scientific Policy,
in certain patients. Such patients could have high mor-        American College of Physicians, Independence Mall West, Sixth Street
tality risks from surgery or may simply prefer a non-          at Race, Philadelphia, PA 19106-1572.

               To my mind, science is a means of generating new knowledge through the application of
               the scientific method. The attributes that distinguish the true scientist are curiosity, the
               power of observation (which involves a degree of skill as well as the patience and effort
               to make accurate and reliable observations), objectivity, and a form of humility that
               allows one to subject one's observations to the scrutiny of others and to accept the fact
               that one may be wrong. The scientific method provides us with a means to solve
               problems. Thus the physician-scientist is one who displays the attributes above in his
               daily work whether he is engaged in formal investigative endeavors in the laboratory and
               clinic or in the full-time care of patients.
                                                             Frederick C. Robbins, MD
                                                             "The Physician-Scientist: Reality or Myth?"
                                                             1981 Merrimon Lecture
                                                             University of North Carolina

               Submissions from readers are welcomed. If the quotation is published, the sender's name will be
               acknowledged. Please include a complete citation, as done for any reference.—The Editors

622    1 October 1993 • Annals of Internal Medicine • Volume 119 • Number 7 (Part 1)

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