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Treatment for patients at intermediate risk of a common duct stone--reply.

Treatment for Patients at Intermediate Risk of a Common Duct Stone To the Editor The randomized clinical trial (RCT) by Dr Iranmanesh and colleagues1 compared 2 commonly used clinical strategies for the evaluation of suspected choledocholithiasis in patients at intermediate risk and found that initial cholecystectomy, compared with sequential endoscopy and surgery, decreased the length of stay and number of common duct investigations. We believe that the results of this study, and their implications, should be considered in the context of 2 important caveats. First, the reasons for the hospital length of stay advantage observed in the cholecystectomy-first group were not fully explained but may reflect processes specific to the study institution, the unblinded nature of the trial, or both. Patients assigned to the cholecystectomy-first group underwent the study intervention at a median half day before patients in the endoscopic ultrasound (EUS) group, suggesting more efficient delivery of surgical compared with endoscopic services at the study center. Furthermore, diagnostic EUS is simple and safe; therefore, it is unclear why randomization to the EUS-first group increased hospital length of stay by 3 days. Because the study was unblinded, it is plausible that surgeons’ awareness of a negative EUS result reduced the perceived urgency of cholecystectomy and delayed operation, biasing against the sequential treatment group. It would be informative for the authors to comment on potential reasons for the increased length of stay in the endoscopy-first group. Second, this RCT was underpowered to evaluate concrete clinical outcomes, which are important in this context because the performance characteristics of EUS and intraoperative cholangiography cannot be assumed to be universally equivalent. For example, hyperopacification of the bile duct during contrast injection may obscure a stone, whereas gas bubbles within the duct may mimic stones, compromising accuracy. Indeed, the sensitivity of cholangiography has been reported to be as low as 60%2 and its use in surgical training and practice is diminishing, especially when endoscopic expertise is readily available.3,4 Alternatively, the performance characteristics of EUS are operator dependent; sensitivity varies from 85% to 100%, even in expert hands.5 Given the potentially adverse consequences of a missed bile duct stone (ie, cholangitis or necrotizing pancreatitis), differences in diagnostic accuracy between tests may translate into important differences in clinical outcomes that could eclipse or reverse any length of stay advantages. Large multicenter RCTs that are adequately powered to assess medium-term clinical outcomes, in which the endoscopy-first group is expected to undergo cholecystectomy within 1 day after endoscopic evaluation, will further elucidate the optimal approach to this common condition.