Treatment of Patients with Uncomplicated Gallbladder Stones?

Abstract

International recommendations agree that pain is the main indication for treating patients with gallbladder stones (1), but what kind of pain and when is it severe enough to warrant treatment? These questions have puzzled clinicians for many years. Between 15% and 30% of patients still suffer the same symptoms after cholecystectomy; there are substantial regional variations in cholecystectomy rates; and studies comparing abdominal symptoms in persons with and without stones in the gallbladder show no conclusive result (2). The father of cholecystectomy—Langenbuch—is quoted as saying: ‘In my opinion, cholecystectomy should be used in cases where both patient and doctor have exhausted their patience’. The literature thus indicates a considerable lack of agreement on who should have their gallbladder removed. This was clearly illustrated when laparoscopic cholecystectomy was introduced, giving rise to a rapid increase in the rate of cholecystectomy (2) without any parallel increase in disease incidence. One reason for early cholecystectomy is to prevent uncomplicated gallstone disease turning into a complicated condition, but observational studies in selected groups of patients with untreated symptomatic gallbladder stones show a yearly rate of complication to thegallbladder disease of only 0.7%‐2.0% (2, 3). A randomized trial comparing watchful waiting with cholecystectomy in symptomatic patients with stones in the gallbladder was therefore very much warranted. In this issue of the Journal, Vetrhus and co-workers present the erst results of such a randomized trial (4) of patients referred to three Norwegian hospitals with well-dee ned catchment areas. The process of including and randomizing patients showed how dife cult it is to perform such a study in a situation with strong patient treatment preferences and a dominant treatment preference expressed by the medical profession. All in all, 47% of the eligible patients were randomized. After randomization, 12% randomized to surgery did not undergo operation, while 51% randomized to watchful waiting later had their gallbladder removed during a 7-year follow-up period. The cholecystectomy rate levelled off after 4 years in the observation group. Among 54 eligible patients who were excluded from randomization because of severe symptoms, 15% did not have a cholecystectomy. The hard facts from this randomized study are that signie cantly fewer were cholecystectomized in the observation group without any overall increase in complications due to either the gallstone disease itself or surgery. The rate of cholecystectomy in the observation group was in accordance with the results from an observational study (5) showing a cholecystectomy rate of 44% with a mean follow-up of 7 years. Unfortunately the authors give very few data on symptoms and no data on quality of life. A substantial number of patients were re-admitted due to pain in the observation group, but more data are needed on symptoms in general in the two groups. We hope that these data will be published in a forthcoming article. Otherwise it will not be possible fully to answer whether to prefer watchful waiting or early cholecystectomy. The randomized clinical trial is widely accepted as the ‘gold standard’ in evidence-based medicine. Given the abovementioned problems with indication for cholecystectomy, it is surprising that nearly 120 years have passed before a randomized trial was performed. Vetrhus and colleagues have taken the e rst step, but further studies are needed and more data on symptoms and quality of life should be forwarded. Through randomized trials it should be possible to elucidate the symptoms specie c for uncomplicated gallbladder stone. In the meanwhile, however, the lesson learned from the present randomized clinical trial and former observational trials is: It is safe to observe patients with symptomatic, non-complicated gallbladder stone disease. Some patients will need an operation within the e rst few years, but far from everybody will.