In an analysis of a procedure used to help prevent common duct injury during gallbladder removal surgery, use of radiologic examination of the ducts during gallbladder surgery was not associated with a reduced risk of common duct injury, according to a study in the August 28 issue of JAMA.
Biliary anatomy misidentification during gallbladder removal can result in injury to the common hepatic duct or common bile duct. Common duct injuries cause significant short and long-term morbidity including major operations, multiple hospitalizations, and biliary strictures. Elimination of common duct injury is desirable, but it has remained stubbornly present with rates ranging from 0.3 percent to 0.5 percent, according to information. When routinely used, intra-operative cholangiography is thought to prevent common duct injury. However, controversy exists regarding the effectiveness of routine use in the prevention of common duct injury.
Kristin M. Sheffield, Ph.D., and Taylor S. Riall, M.D., Ph.D., of the University of Texas Medical Branch, Galveston, and colleagues investigated the association between intraoperative cholangiography use during cholecystectomy and common duct injury, using instrumental variable analysis, an effective way to overcome unmeasured confounding, that is to say, factors influencing outcomes not found in the database. The researchers identified Medicare beneficiaries from Texas Medicare claims data who underwent inpatient or outpatient cholecystectomy for conditions including biliary colic or biliary dyskinesia, acute cholecystitis, or chronic cholecystitis. The percentage of intraoperative cholangiography use at the hospital and by surgeon was the instrumental variables. Patients with claims for common duct repair operations within 1 year of cholecystectomy were considered as having major common duct injury.
In a logistic regression model controlling for patient, surgeon, and hospital characteristics, the odds of common duct injury for cholecystectomies performed without intraoperative cholangiography were increased compared with those performed with it. When confounding was controlled with instrumental variable analysis, the association between cholecystectomy performed without intraoperative cholangiography and duct injury was no longer significant.
Significant controversy exists regarding the role of intraoperative cholangiography in the prevention of common duct injury during cholecystectomy. Previous population-based studies using data from Medicare claims, hospital discharge records, and national inpatient registries report nearly 2-fold higher rates of injury in cholecystectomies performed without intraoperative cholangiography. In the present study using Texas Medicare claims data, the association between intraoperative cholangiography and common duct injury was highly sensitive to the analytic method used.
Failure to account for potentially confounding variables not routinely captured in administrative databases has a major effect on the interpretation of the findings. Intraoperative cholangiography was not associated with significant reduction in common duct injury using instrumental variable analysis. Instrumental variable analysis balances unmeasured confounding variables to better align risk factors in comparator groups. With better control for unmeasured confounding variables, intraoperative cholangiography was no longer associated with common duct injury. Based on these results, routine intraoperative cholangiography should not be advocated as means for preventing common duct injury.
While this report does not definitively close the door on routine intraoperative cholangiography use, use of directed attention to an important clinical debate by using a new approach to revisit the outcomes of intraoperative cholangiography using observational data. While the true effect of intraoperative cholangiography on the safety of laparoscopic cholecystectomy remains controversial, this study undoubtedly reinvigorates the discussion.
- The difference between science-based medicine and CAM (sciencebasedmedicine.org)