Noble 2009.
Methods | ES followed by LC (Grp A) vs LCBDE during LC (Grp B). Randomised clinical trial. Sample size calculation: yes. Median length of follow‐up: 1.88 (IQR, 1.38 to 3.15) yrs. |
|
Participants | Single centre. Southmead Hospital, Bristol, UK Higher‐risk pts: defined as being > 70 yrs age, > 60 with comorbidity, or > 50 with a BMI greater than 40. Pts with proven CBD stones on imaging or those with strong evidence of CBD stones (15 pts). Strong evidence of those with CBD stones was defined as those with a dilated CBD on transabdominal USS (5 mm in a 50‐yr old and 5+1 mm per decade) in addition to abnormal lLFTs. 2000 to 2006 Exclusion criteria: Pts with previous sphincterotomy, previous Bilroth II gastrectomy, pts unfit for general anaesthesia. |
|
Interventions | Total of 91 pts. Group A ‐ 47 pts and Group B ‐ 44 pts. |
|
Outcomes | Morbidity, bile duct clearance, conversion to open surgery, median postoperative stay. | |
Notes | If stones were confirmed on cholangiogram, sphincterotomy was performed and stones retrieved using balloon, basket, mechanical lithotripsy. During post‐ERCP LC, lap USS or cholangiography was performed. If stones were present, proceeded to LCBDE. LCBDE group: Transcystic/transcholedochal approach was decided by intra‐operative USS or cholangiogram. Choledochoscope was used. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was by an independent computer‐generated random number system. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
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. |