Suc 1998.
Methods | Randomised clinical trial.
Open cholecystectomy +/‐ ECD versus ERCP/ES. Cholecystectomy not necessarily performed in ERCP group. Multicentre. Exclusions ‐ none listed. Protocol violations ‐ 9, all withdrawn. Other withdrawals ‐ 9, due to incorrect diagnosis (malignant biliary obstruction). Sample size calculations: yes. Power analysis based on primary outcome variable of additional procedures required, with 95 pts per group required with a power of 90% at the 0.05 level. |
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Participants | France. Commenced September 1989 and completed September 1994. 220 consecutive adult pts randomised. Inclusion criteria: Adult (> 18 yrs). One of: jaundice, mild AP, mild cholangitis, biliary colic + raised ALP, CDS or dilated CD on USS. Exclusion criteria: Cholecystitis (thick gallbladder wall on USS). No stones on USS and CBD < 1 cm. Pts unable to have ERCP (previous total or B2 gastrectomy, or choledochoenterostomy). |
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Interventions | All cholecystectomies by surgeons, all ERCPs by gastroenterologists. Surgical group: OC (if not performed previously ‐ 3 pts). CBDE +/‐ choledochoscopy. Duct closure either primary, +/‐ T‐tube, or choledochoenterostomy. Endoscopic group: ERCP and cholangiogram. Basket extraction of stones OC subsequently only if cholecystitis or cholangitis developed. |
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Outcomes | Retained stones, additional procedures, mortality, morbidity, total duration of hospital stay. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number tables. |
Allocation concealment (selection bias) | Low risk | Telephone call to co‐ordinating centre. |
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. |