Novel model may decide which patient with gallstone disease will benefit from cholecystectomy: JAMA

Netherlands: Cholecystectomy is a common surgery, and it carries only a small risk of complications. Currently, no consensus on the indication for cholecystectomy in patients with uncomplicated gallstone disease has been reported. A multicenter trial by Dr. Carmen S. S. Latenstein, MD, and the team revealed that a multivariable prediction model may help predict the probability of pain reduction following cholecystectomy. This may help surgeons in making decisions on whether patients with uncomplicated cholelithiasis will benefit from cholecystectomy.

The objective of the study was to report on the development and validation of a multivariable prediction model to better select patients for surgery. The findings of the study are published in JAMA Surgery.

The study evaluated data from 2 multicenter prospective trials (the previously published Scrutinizing (In)efficient Use of Cholecystectomy: A Randomized Trial Concerning Variation in Practice [SECURE] and the Standardized Work-up for Symptomatic Cholecystolithiasis [Success] trial) collected from the outpatient clinics of 25 Dutch hospitals between April 2014 and June 2019 and including 1561 patients with symptomatic uncomplicated cholelithiasis, defined as gallstone disease without signs of complicated cholelithiasis. Data were analyzed from January 2020 to June 2020. Patient characteristics, comorbidity, surgical outcomes, pain, and symptoms were measured at baseline and at 6 months follow-up. A multivariable regression model to predict a pain-free state or a clinically relevant reduction in pain after surgery. Model performance was evaluated using calibration and discrimination.

A total of 1561 patients were included (494 patients in 7 hospitals in the development cohort and 1067 patients in 24 hospitals in the validation cohort; 6 hospitals included patients in both cohorts).

The results of the study were

• In the development cohort, 395 patients (80.0%) underwent cholecystectomy. After surgery, 225 patients (57.0%) reported that they were pain-free and 295 (74.7%) reported a clinically relevant reduction in pain.

• A multivariable prediction model showed that increased age, no history of abdominal surgery, increased visual analog scale pain score at baseline, pain radiation to the back, pain reduction with simple analgesics, nausea, and no heartburn were independent predictors of clinically relevant pain reduction after cholecystectomy.

• Both internal validation and external validation showed good discrimination were (C statistic, 0.80) (C statistic, 0.74) respectively between patients with and without clinically relevant pain reduction.

Dr Latenstein, MD, and team conveyed that model validated in this study might help predict the probability of pain reduction after cholecystectomy and thus aid surgeons in deciding whether patients with uncomplicated cholelithiasis will benefit from cholecystectomy.

Reference:

Latenstein CSS, Hannink G, van der Bilt JDW, et al. A Clinical Decision Tool for Selection of Patients With Symptomatic Cholelithiasis for Cholecystectomy Based on Reduction of Pain and a Pain-Free State Following Surgery. JAMA Surg. 2021;156(10):e213706. doi:10.1001/jamasurg.2021.3706