Prospective randomized trial of LC+LCBDE vs ERCP/S+LC for common bile duct stone disease.
OBJECTIVE
To compare outcome parameters for good-risk patients with classic signs, symptoms, and laboratory and abdominal imaging features of cholecystolithiasis and choledocholithiasis randomized to either laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC+LCBDE) or endoscopic retrograde cholangiopancreatography sphincterotomy plus laparoscopic cholecystectomy (ERCP/S+LC).


METHODS
Our study was a prospective trial conducted following written informed consent, with randomization by the serially numbered, opaque envelope technique.


METHODS
Our institution is an academic teaching hospital and the central receiving and trauma center for the City and County of San Francisco, California.


METHODS
We randomized 122 patients (American Society of Anesthesiologists grade 1 or 2) meeting entry criteria. Ten of these patients, excluded from outcome analysis, were protocol violators having signed out of the hospital against medical advice before 1 or both procedures were completed.


METHODS
Treatment was preoperative ERCP/S followed by LC, or LC+LCBDE.


METHODS
The primary outcome measure was efficacy of stone clearance from the common bile duct. Secondary end points were length of hospital stay, cost of index hospitalization, professional fees, hospital charges, morbidity and mortality, and patient acceptance and quality of life scores.


RESULTS
The baseline characteristics of the 2 randomized groups were similar. Efficacy of stone clearance was likewise equivalent for both groups. The time from first procedure to discharge was significantly shorter for LC+LCBDE (mean [SD], 55 [45] hours vs 98 [83] hours; P < .001). Hospital service and total charges for index hospitalization were likewise lower for LC+LCBDE, but the differences were not statistically significant. The professional fee charges for LC+LCBDE were significantly lower than those for ERCP/S+LC (median [SD], $4820 [1637] vs $6139 [1583]; P < .001). Patient acceptance and quality of life scores were equivalent for both groups.


CONCLUSIONS
Both ERCP/S+LC and LC+LCBDE were highly effective in detecting and removing common bile duct stones and were equivalent in overall cost and patient acceptance. However, the overall duration of hospitalization was shorter and physician fees lower for LC+LCBDE.


BACKGROUND
clinicaltrials.gov Identifier: NCT00807729.
Rogers
Stanley J
SJ
San Francisco General Hospital, Department of Surgery, University of California, 94110, USA. stan.rogers@ucsfmedctr.org
Cello
John P
JP
Horn
Jan K
JK
Siperstein
Allan E
AE
Schecter
William P
WP
Campbell
Andre R
AR
Mackersie
Robert C
RC
Rodas
Alex
A
Kreuwel
Huub T C
HT
Harris
Hobart W
HW
D000328:Adult; D001662:Biliary Tract Surgical Procedures / Q000379:methods; D002760:Cholangiopancreatography, Endoscopic Retrograde; D017081:Cholecystectomy, Laparoscopic; D041761:Cholecystolithiasis / Q000601:surgery*; D042883:Choledocholithiasis / Q000601:surgery*; D003135:Common Bile Duct / Q000601:surgery*; D005260:Female; D042882:Gallstones / Q000601:surgery* / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016717:Sphincterotomy, Endoscopic