A randomized, clinical trial to compare endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy with primary laparoscopic bile duct exploration during cholecystectomy in higher risk patients with choledocholithiasis.
BACKGROUND
Outcomes after endoscopic sphincterotomy (ES) and subsequent laparoscopic cholecystectomy (LC) versus laparoscopic bile duct exploration (LBDE) during LC are comparable in fit patients with choledocholithiasis. This randomized, clinical trial aimed to determine the optimum treatment in patients with higher medical risk.


METHODS
Ninety-one higher risk patients with evidence of bile duct stones were randomized to ES/LC (group A) or LBDE during LC (group B). The primary outcome measure was duct clearance. Secondary outcome measures were complications, number of procedures per patient, conversion, and postoperative hospital stay (POS).


RESULTS
Forty-seven patients were randomized to ES/LC and 44 to LBDE. The median age was 74.56 years. On an intention-to-treat basis, duct clearance was achieved in 29 of 47 of group A and 44 of 44 of Group B patients (P < 0.001). Clavien Grade II-V complications occurred in 8 of 47 and 8 of 44 patients (P = 0.884), the median number of procedures was 2 (2-3) and 1 (1-1) (P < 0.001), 2 of 47 and 4 of 44 patients required conversion (P = 0.676), and the median POS was 3 (2-7) and 5 (2-7) days (P = 0.825), respectively.


CONCLUSIONS
There was no difference between approaches to duct clearance in terms of postoperative stay, complications, or conversion in higher risk patients, but the laparoscopic approach was more effective and efficient and avoided unnecessary procedures.
Department of Surgery, Southmead Hospital, Westbury-on-Trym, Bristol, UK. mail@hamishnoble.com
Hamish
H
Noble
Sheena
S
Tranter
Tim
T
Chesworth
Sally
S
Norton
Michael
M
Thompson
D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D002760:Cholangiopancreatography, Endoscopic Retrograde; D017081:Cholecystectomy, Laparoscopic; D042883:Choledocholithiasis / Q000000981:diagnostic imaging / Q000473:pathology* / Q000601:surgery*; D005260:Female; D006801:Humans; D007902:Length of Stay; D008297:Male; D011183:Postoperative Complications; D012307:Risk Factors; D016717:Sphincterotomy, Endoscopic; D016896:Treatment Outcome