Prospective Randomized Trial of LC+LCBDE vs ERCP/S+LC for Common Bile Duct Stone Disease

• Published in: Archives of surgery (Chicago. 1960) Vol. 145; no. 1; pp. 28 - 33
• Main Authors: Rogers, Stanley J, Cello, John P, Horn, Jan K, Siperstein, Allan E, Schecter, William P, Campbell, Andre R, Mackersie, Robert C, Rodas, Alex, Kreuwel, Huub T. C, Harris, Hobart W
• Format: Journal Article
• Language: English
• Published: Chicago, IL American Medical Association 01.01.2010
• Subjects: Adult; Bile; Biliary Tract Surgical Procedures - methods; Biological and medical sciences; Cholangiopancreatography, Endoscopic Retrograde; Cholecystectomy, Laparoscopic; Cholecystolithiasis - surgery; Choledocholithiasis - surgery; Clinical outcomes; Common Bile Duct - surgery; Digestive system; Female; Gallstones; Gallstones - surgery; Gallstones - therapy; Gastroenterology. Liver. Pancreas. Abdomen; General aspects; Humans; Investigative techniques, diagnostic techniques (general aspects); Liver. Biliary tract. Portal circulation. Exocrine pancreas; Male; Medical research; Medical sciences; Middle Aged; Other diseases. Semiology; Prospective Studies; Radiodiagnosis. Nmr imagery. Nmr spectrometry; Sphincterotomy, Endoscopic; Surgery; San Francisco California; Cholangiopancreatography; Choledocolithiasis; Radiodiagnosis; Disease; Biliary tract disease; Medicine; Prospective; Randomization; Treatment; Surgery; Digestive diseases; Clinical trial; Endoscopy; Main biliary tract; Comparative study
• ISSN: 0004-0010; 2168-6254; 1538-3644; 2168-6262
• DOI: 10.1001/archsurg.2009.226

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). DESIGN Our study was a prospective trial conducted following written informed consent, with randomization by the serially numbered, opaque envelope technique. SETTING Our institution is an academic teaching hospital and the central receiving and trauma center for the City and County of San Francisco, California. PATIENTS 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. INTERVENTIONS Treatment was preoperative ERCP/S followed by LC, or LC+LCBDE. MAIN OUTCOME MEASURES 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. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00807729Arch Surg. 2010;145(1):28-33-->