부산대학교 도서관

Background International guidelines advise laparoscopic cholecystectomy to treat symptomatic, uncomplicated gallstones. Usual care regarding cholecystectomy is associated with practice variation and persistent post-cholecystectomy pain in 10-41% o f patients. We aimed to compare the non-inferiority o f a restrictive strategy with stepwise selection with usual care to assess (in)efficient use o f cholecystectomy. Methods We did a multicentre, randomised, parallel-arm, non-inferiority study in 24 academic and non-academic hospitals in the Netherlands. We enrolled patients aged 18-95 years with abdominal pain and ultrasound-proven gallstones or sludge. Patients were randomly assigned (1:1) to either usual care in which selection for cholecystectomy was left to the discretion o f the surgeon, or a restrictive strategy with stepwise selection for cholecystectomy. For the restrictive strategy, cholecystectomy was advised for patients who fulfilled all five pre-specified criteria o f the triage instrument: 1) severe pain attacks, 2) pain lasting 15-30 min or longer, 3) pain located in epigastrium or right upper quadrant, 4) pain radiating to the back, and 5) a positive pain response to simple analgesics. Randomisation was done with an online program, implemented into a web-based application using blocks o f variable sizes, and stratified for centre (academic versus non-academic and a high vs low number o f patients), sex, and body-mass index. Physicians and patients were masked for study-arm allocation until after completion o f the triage instrument. The primary, non-inferiority, patient-reported endpoint was the proportion o f patients who were pain-free at 12 months’ follow-up, analysed by intention to treat and per protocol. A 5% non-inferiority margin was chosen, based on the estimated clinically relevant difference. Safety analyses were also done in the intention-to treat population. This trial is registered at the Netherlands National Trial Register, number NTR4022. Findings Between Feb 5, 2014, and April 25, 2017, we included 1067 patients for analysis: 537 assigned to usual care and 530 to the restrictive strategy. At 12 months’ follow-up 298 patients (56%; 95% Cl, 52-0-60-4) were pain-free in the restrictive strategy group, compared with 321 patients (60%, 55.6—63.8) in usual care. Non-inferiority was not shown (difference 3-6%; one-sided 95% lower Cl -8-6%; pnon-inferiority=0.316). According to a secondary endpoint analysis, the restrictive strategy resulted in significantly fewer cholecystectomies than usual care (358 [68%] o f 529 vs 404 [75%] o f 536; p=0-01). There were no between-group differences in trial-related gallstone complications (40 patients [8%] of 529 in usual care vs 38 [7%] o f 536 in restrictive strategy; p=0 -16) and surgical complications (74 [21%] o f 358 vs 88 [22%] o f 404, p=0.77), or in non-trial-related serious adverse events (27 [5%] of 529 vs 29 [5%] of 526). Interpretation Suboptimal pain reduction in patients with gallstones and abdominal pain was noted with both usual care and following a restrictive strategy for selection for cholecystectomy. However, the restrictive strategy was associated with fewer cholecystectomies. The findings should encourage physicians involved in the care o f patients with gallstones to rethink cholecystectomy, and to be more careful in advising a surgical approach in patients with gallstones and abdominal symptoms. [ABSTRACT FROM AUTHOR]