1999 Abstract: 3479 RANDOMIZED CONTROLLED TRIAL OF LAPAROSCOPIC CHOLECYSTECTOMY PLUS LAPAROSCOPIC COMMON BILE DUCT EXPLORATION (LC+LCBDE) VS. ERCP-SPHINCTEROTOMY PLUS LAPAROSCOPIC CHOLECYSTECTOMY (ERCP/S+LC) FOR COMMON BILE DUCT STONE DISEASE
Abstracts
|
Following informed consent, we randomized by serially-numbered sealed envelopes 31 patients (8M/23F)with ultrasonographically-defined cholecystolithiasis and "likely" CDB stones to either LC+LCBDE or ERCP/S+LC. Patients were determined to have likely CBD calculi based upon one of the following within 48 hrs of randomization:CBD diameter ³6 mm &/or intrahepatic duct dilation &/or likely CBD stone by either ultrasound or CT, bilirubin ³2 mg/dl, alkaline phosphatase ³ 1.5X normal, amylase or lipase ³ 1.5X normal. Patients randomized to ERCP/S+LC underwent ERCP (and sphincterotomy if CBD calculi detected on cholangiography) prior to LC. Patients randomized to LC+LCBDE underwent CBDE by either cholangiography and/or cholangioscopy. The following entry parameters were not significantly different between the two groups: age, white blood cell count, serum bilirubin, alkaline phosphatase, or amylase. The following outcome parameters were prospectively defined and analyzed: efficacy of primary treatment modality, hospitalization days, health care costs, standardized quality of life. The mean length of hospitalization (1.385±0.18 days for LC+LCBDE vs 1.73±0.20) and the total hospital fees (±834 vs ±378) were not different. Professional fees for the LCBDE arm were significantly lower than that in the ERCP/S+LC (±307 vs. ±267 p<0.0014). Initial efficacy of stone removal in both arms was 100% and there were no complications related to primary technique in either arm. Conclusion: LCBDE provides a valuable alternative to ERCP/S, with equivalent safety, efficacy, length of hospitalization, and hospital charges but decreased professional charges for patients with CBD stones. Copyright 1996 - 1999, SSAT, Inc. |