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. |
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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. |
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Interventions | 122 pts. LC+LCBDE: 61 pts = 57 pts ERCP/S+LC: 61 pts = 55 pts 10 exclusions. |
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Outcomes | CBD stones cleared, complications, procedure time. | |
Notes | Sphincterotomy was performed after confirming the presence of stones. Transcystic exploration was performed for LCBDE. |
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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. |