Kapoor 1996.
Methods | Randomised clinical trial of pts with CBD stones found at ERCP randomised to either ERCP/ES and extraction followed by open cholecystectomy (ES + S group), or open cholecystectomy and CBDE (Surgery group).
Single centre.
Drop‐outs: ES + S group ‐ 2 failures to complete treatment, 1 carcinoma of gallbladder; SA group 1 carcinoma of gallbladder. Sample size calculations: no. Exclusions: unfit (1), cholangitis (9), unable to perform ERCP (3), large stone (12), no stone (2). |
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Participants | Lucknow, India. Commenced July 1991 and completed October 1993. 33 pts randomised. Inclusion criteria: Pts proven to have CBD stones at ERCP, i.e, ERCP achieved. Fit for surgery. Exclusion criteria: Pregnancy, cholangitis/septicaemia, CBD cannulation failed at ERCP, stone larger than 15 mm. Essential investigations: USS, serum biochemistry. 420 pts seen with gallstones, 60 suspected of having BDS (bilirubin > 34.2 umol/l, ALP > 235 IU/l, CBD diameter > 10 mm or BDS on USS), all underwent ERCP. |
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Interventions | ES + S group:
CBD cleared at time of ERCP by basket or spontaneous passage.
Subsequent surgery scheduled within 6 weeks. SA group: Following ERCP, surgery undertaken on next available elective list. Choledochoscopy optional. |
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Outcomes | Mortality, morbidity, clearance rates, hospital stay. | |
Notes | "good risk" pt not defined. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random assignments. |
Allocation concealment (selection bias) | Low risk | Sealed 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. |