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. 2013 Dec 12;2013(12):CD003327. doi: 10.1002/14651858.CD003327.pub4

Rogers 2010.

Methods LC+LCBDE vs ERCP/S+LC.
Randomised trial.
Follow‐up: 10 protocol violators were excluded. Duration: 24 months.
Pre‐study power analysis conducted, but not detailed.
Participants University of California, San Francisco.
1997 to 2003.
Inclusion criteria:
Age > 18 yrs, ability to consent, classic biliary pain, USS‐cholecystolithiasis, platelet count/prothrombin time ‐ normal, ASA grade 1 or 2, 'Likely' choledocholithiasis suggested by one of the following: CBD ≥ 6 mm by USS or CT scan, intrahepatic duct dilation as determined by USS or CT scan, serum bilirubin ≥ 2 mg/dl, ALP and/or lipase levels ≥ 1.5 times upper limit of normal within 48 hrs of intended procedure.
Exclusion criteria:
History of bleeding disorders, uraemia, USS/CT evidence of cirrhosis, intrahepatic gallbladder, liver mass or abscess or periampullary neoplasm, clinical or sonographic evidence of suppurative or necrotising cholecystitis, gallbladder empyema or perforation, IDDM, multiple prior laparotomies/morbid obesity/portal vein thrombosis, pregnancy.
Interventions 122 pts.
LC+LCBDE: 61 pts = 57 pts
ERCP/S+LC: 61 pts = 55 pts
10 exclusions.
Outcomes CBD stones cleared, complications, procedure time.
Notes Sphincterotomy was performed after confirming the presence of stones.
Transcystic exploration was performed for LCBDE.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised according to serially numbered, sealed, opaque envelopes.
Allocation concealment (selection bias) Low risk Sealed, opaque envelopes.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not possible.
Selective reporting (reporting bias) Low risk None.
Incomplete outcome data Low risk No missing data.
For‐profit bias Low risk Appears free of for‐profit support.
Other bias Low risk None.