The operative mortality for biliary tract obstruction due to malignancy is high. In 1981 a controlled clinical trial of pre-operative percutaneous drainage was started at the Royal Postgraduate Medical School. At the time of percutaneous transhepatic cholangiography patients were randomized either to laparotomy or to pre-operative percutaneous transhepatic biliary drainage ( PTBD ) followed by laparotomy. Only patients with malignant biliary tract obstruction and serum bilirubin greater than 100 mumol/l were included. Seventy patients entered the trial, and five were withdrawn. Of the 65 remaining, 31 underwent laparotomy and 34 had pre-operative PTBD followed by laparotomy. The median duration of drainage was 18 days and during this time the median bilirubin fell from 305 to 115 mumol/l. Five patients required early surgery for complications of PTBD and two died within 30 days of surgery. The mortality for laparotomy was 19 per cent (6/31) compared with 32 per cent (11/34) for drainage plus laparotomy. This trial highlights the hazards of PTBD in high risk patients and has failed to demonstrate a reduction in mortality with the use of pre-operative PTBD .

This study is a critical prospective assessment of 37 patients with obstructive jaundice, treated by percutaneous transhepatic biliary drainage. The median duration of drainage was 18 days (range 44-55), and during this period clearance of bilirubin and improvement in creatinine clearance were obtained. Only 10 patients gained weight. Three patients required early laparotomy. Thirty-three patients underwent definitive surgery. Of these, 8 died without leaving hospital. The incidence of infection rose during drainage, and infected bile was clinically significant. Two deaths were associated with infection, arising in the drainage system, producing intrahepatic abscesses around the drain track. While the evidence for a staged approach in the severely ill patient with obstructive jaundice is substantial, the procedure of percutaneous transhepatic tubal drainage carries significant hazards, underemphasized in previous reports. Further controlled assessment is required before this technique is accepted as the initial best option for decompression of the obstructed biliary tract.

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