Journal of Gastrointestinal Surgery | 2021
Cholecystectomy Is Superior to Medical Management for Biliary Pain in Pediatric Patients
Abstract
Dear Drs. Hodin and Pawlik, As pediatric surgeons with an interest in biliary diseases, we eagerly read the article by Gao and colleagues titled “A Multicenter Randomized Prospective Study of Early Cholecystectomy for Pediatric Patients with Biliary Colic”. The authors should be commended for addressing a question that is not answered in the pediatric surgery literature: does prompt cholecystectomy for biliary colic in children improve outcomes? They argue that “[for] biliary colic, early cholecystectomy, despite the normalization of laboratory values or clinical progress, exerted a beneficial effect on biliary pain or complication reduction compared with conservative management.” The implication of this study is that patients presenting with biliary colic are best served with an operation within three days of initial surgical evaluation. While the authors were able to randomize a reasonably large number of patients, their methodology left us with concerns about the study’s conclusions. First, we contend that the conservative management arm of this study is not appropriate to fulfill the authors’ objective. The choice of “early cholecystectomy” in the title implies that participants randomized to “early” surgery were compared to a group of patients who underwent a delayed operation, when in fact, many patients in the comparison group underwent no operation. The non-operative arm of the study received a lowfat diet and ursodeoxycholic acid, without mention of planned elective cholecystectomy at a later date. While roughly half (56.7%) of patients in the conservative management group did require an operation for recurrence or progression of biliary symptoms during the follow-up period, no substantive comparison of surgical outcomes or health care costs between the early, delayed, and no cholecystectomy groups was provided. Furthermore, the study population included a considerable number of patients with inflammatory or obstructive sequelae of gallstones, as evidenced by the fact that a majority exhibited leukocytosis, roughly one-third had an elevated serum bilirubin and nearly half were diagnosed with acute cholecystitis. We believe that patients with the aforementioned findings would not be considered good candidates for medical management at most centers. It is particularly telling that 21 patients initially randomized to the conservative management arm subsequently underwent an “emergency cholecystectomy” during their index hospitalization, due to progression of biliary symptoms. This nearly immediate crossover between groups makes us concerned that the results favoring “early” cholecystectomy reflect a study population skewed toward more advanced biliary disease, rather than simple biliary colic. To accurately study patients with true biliary colic, narrower inclusion criteria should have been used to limit the severity of participants’ conditions. Finally, we question the decision to include and randomize patients with biliary dyskinesia in this study. A randomized trial of “early” cholecystectomy versus medical management in children with functional gallbladder disorders is needed, as data for ideal management of this problem are sparse. However, the results of the current study indicate that 100% of participants had cholelithiasis or biliary sludge, despite approximately 30% being diagnosed with biliary dyskinesia. It is unclear how to reconcile these numbers, since biliary dyskinesia is by definition an acalculous gallbladder disorder. By grouping patients with biliary dyskinesia, acute cholecystitis, and symptomatic cholelithiasis together, the authors introduced heterogeneity in the study population related to underlying pathophysiology and surgical indications. As a result, we find it difficult to confidently apply these findings to children with either calculous or acalculous conditions. A subgroup analysis where patients with these specific diagnoses were considered separately would have aided in interpretation of the data. In summary, while this study included an impressive number of children across multiple centers, we believe the authors’ * Robert A. Cowles [email protected]