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Time to revisit indications for cholecystectomy

2019; Elsevier BV; Volume: 394; Issue: 10211 Linguagem: Inglês

10.1016/s0140-6736(19)32478-x

1474-547X

Demetrios Moris, Theodore N. Pappas,

Pancreatic and Hepatic Oncology Research

Aafke van Dijk and colleagues1van Dijk AH Wennmacker SZ de Reuver PR et al.Restrictive strategy versus usual care for cholecystectomy in patients with gallstones and abdominal pain (SECURE): a multicentre, randomised, parallel-arm, non-inferiority trial.Lancet. 2019; 393: 2322-2330Summary Full Text Full Text PDF PubMed Scopus (18) Google Scholar presented the findings from their multicentre, randomised, non-inferiority trial (SECURE), designed to compare a conventional indication for cholecystectomy with a more restrictive and criteria-based strategy in patients with abdominal pain and ultrasound-proven gallstones. At 12-month follow-up, non-inferiority of restrictive strategy regarding pain improvement was not shown compared with standard of care.1van Dijk AH Wennmacker SZ de Reuver PR et al.Restrictive strategy versus usual care for cholecystectomy in patients with gallstones and abdominal pain (SECURE): a multicentre, randomised, parallel-arm, non-inferiority trial.Lancet. 2019; 393: 2322-2330Summary Full Text Full Text PDF PubMed Scopus (18) Google Scholar We have a few comments regarding the study design and some of its conclusions. The authors have implied that their restrictive indication for laparoscopic cholecystectomy is somehow better than the conventional indication because a small proportion of patients is spared a non-therapeutic procedure. We wonder about how this conclusion was drawn from the data presented because there were more than 120 protocol violations (25%) in the restrictive strategy group. Interestingly, approximately half of these violations originated from surgeons recommending laparoscopic cholecystectomy without fulfilling adequate criteria. Despite the potential bias from protocol violations, the study had interesting findings. The most important observation in both groups of the study was that patients with symptomatic biliary colic usually get better after laparoscopic cholecystectomy, whereas less than 60% of patients with gallstones and random pain (ie, non-specific abdominal symptoms, such as diffuse abdominal pain, constant pain, lower gastrointestinal symptoms, and acid reflux) are benefited. Laparoscopic cholecystectomy has been described as an easy outpatient operation associated with few complications; therefore, there is a low threshold to use it as a diagnostic test for symptoms associated with gallstones.2Escarce JJ Chen W Schwartz JS Falling cholecystectomy thresholds since the introduction of laparoscopic cholecystectomy.JAMA. 1995; 273: 1581-1585Crossref PubMed Scopus (124) Google Scholar This use has led to an increase in the number of referrals and recommendations for gallbladder removal with inadequate investigations and little discussion of a clinically driven, broad differential diagnosis. Since the introduction of laparoscopic cholecystectomy in the early 1990s,3McMahon AJ Russell IT Baxter JN et al.Laparoscopic versus minilaparotomy cholecystectomy: a randomised trial.Lancet. 1994; 343: 135-138Summary PubMed Scopus (351) Google Scholar the number of cholecystectomies has increased by an estimated 10–69%.2Escarce JJ Chen W Schwartz JS Falling cholecystectomy thresholds since the introduction of laparoscopic cholecystectomy.JAMA. 1995; 273: 1581-1585Crossref PubMed Scopus (124) Google Scholar, 4Chen AY Daley J Pappas TN Henderson WG Khuri SF Growing use of laparoscopic cholecystectomy in the national Veterans Affairs Surgical Risk Study: effects on volume, patient selection, and selected outcomes.Ann Surg. 1998; 227: 12-24Crossref PubMed Scopus (38) Google Scholar Laparoscopic cholecystectomy now has a very broad indication and even the restrictive criteria used in the study by van Dijk and colleagues1van Dijk AH Wennmacker SZ de Reuver PR et al.Restrictive strategy versus usual care for cholecystectomy in patients with gallstones and abdominal pain (SECURE): a multicentre, randomised, parallel-arm, non-inferiority trial.Lancet. 2019; 393: 2322-2330Summary Full Text Full Text PDF PubMed Scopus (18) Google Scholar are too broad. Internists and surgeons need to look carefully at the indications for cholecystectomy. Physicians should conduct careful evaluation of disease-specific symptoms, such as biliary colic, and abnormalities on imaging of the gallbladder (in addition to just finding stones). Physicians should also pursue a full investigation of other causes of abdominal pain (including endoscopy as necessary to rule out other gastrointestinal diseases), which will lead to a much lower number of patients undergoing cholecystectomy and a much higher potential for pain relief after the operation. We declare no competing interests. Restrictive strategy versus usual care for cholecystectomy in patients with gallstones and abdominal pain (SECURE): a multicentre, randomised, parallel-arm, non-inferiority trialSuboptimal 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 of patients with gallstones to rethink cholecystectomy, and to be more careful in advising a surgical approach in patients with gallstones and abdominal symptoms. Full-Text PDF Time to revisit indications for cholecystectomy – Author's replyWe thank Dimitrios Moris and Theodore Pappas for their comments and suggestions to further optimise the selection criteria for laparoscopic cholecystectomy in patients with abdominal pain and gallstones. We accept the concerns about the protocol violations. The SECURE trial1 was designed to better select patients for cholecystectomy, but it stops short of answering the question of how to treat patients with abdominal symptoms and gallstones. Full-Text PDF