Restrictive strategy for cholecystectomy selection does not reduce pain, but does reduce surgery

Usual care for symptomatic patients with gallstones is suboptimal and patients often suffer pain after surgery. The SECURE study demonstrated that a restrictive patient selection strategy, where only patients with specific gallstone-related symptoms undergo surgery, did not result in more pain-free patients but did reduce the number of surgeries being performed.

Prof. Joost Drenth (Radboud University Medical Center, Nijmegen, the Netherlands) started by pointing out that although laparoscopic cholecystectomy for the treatment of symptomatic cholecystolithiasis is currently the standard of care, persistent post-cholecystectomy pain occurs in 10–41% of patients [1]. The aim of the SECURE study was to compare the non-inferiority of a restrictive strategy with stepwise selection with usual care, to assess (in)efficient use of cholecystectomy in a multicentre, randomised, parallel-arm, non-inferiority study in 24 academic and non-academic hospitals in the Netherlands. The primary endpoint, powered for non-inferiority, was the proportion of patients who were pain-free at 12-month follow-up, analysed by intention-to-treat and per protocol. A 5% non-inferiority margin was chosen, based on the estimated difference that would be clinically relevant in practice. Safety analyses were also done in the intention-to treat population.

The investigators enrolled 1,067 patients aged 18–95 years with abdominal pain and gallstones or sludge identified by ultrasound. Patients were randomly assigned (1:1) to either usual care in which selection for cholecystectomy was left to the discretion of the surgeon or a restrictive strategy with stepwise selection for cholecystectomy. For the restrictive strategy, cholecystectomy was advised for patients who fulfilled 5 pre-specified criteria: (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 stratified for centre (academic vs non-academic and patient volume), gender, and body-mass index.

At baseline, patients in the restrictive strategy group reported more severe pain attacks than patients in the usual care group (83% vs 77%, respectively; P=0.008), and more patients fulfilled all 5 pre-specified restrictive strategy criteria in the restrictive strategy group than in the usual care group (38% vs 28%, respectively; P=0.001). At 12-month follow-up, 298 patients (56%; 95% CI 52.0–60.4) were pain-free in the restrictive strategy group, compared with 321 patients (60%; 95% CI 55.6–63.8) in usual care. Non-inferiority was not shown (difference 3.6%; one-sided 95% lower CI −8·6%; P_{non-inferiority}=0.316). According to a secondary endpoint analysis, the restrictive strategy resulted in significantly fewer cholecystectomies than usual care (68% vs 75%; P=0.01).

There were no between-group differences in trial-related gallstone complications (8% in usual care vs 7% in restrictive strategy; P=0.16) and surgical complications (21% vs 22%, respectively; P=0.77), or in non-trial-related serious adverse events (5% in both groups).

This study was limited by the higher proportion of patients reporting severe pain at baseline in the restrictive strategy group, and the fact that some patients in the restrictive strategy group underwent cholecystectomy despite failing to satisfy the cholecystectomy selection criteria. In summary, this study illustrates that current treatment of symptomatic gallstone disease is not improved by a restrictive strategy.

1. 1. Drenth J et al. UEG Week 2019, Abstract IP233.

Posted on 23 October, 201918 March, 2021