Prospective controlled trial of transhepatic biliary endoprosthesis versus bypass surgery for incurable carcinoma of head of pancreas.

53 patients with obstructive jaundice due to incurable carcinoma of the head of the pancreas were randomly allocated to percutaneous transhepatic placement of a permanent biliary endoprosthesis (PTE) or bypass surgery. After exclusions 25 patients in each group were treated. Technical success was achieved in 21 patients (84%) in the PTE group and 19 (76%) in the surgery group. The incidence of postprocedural complications (PTE 7, surgery 8) and 30-day mortality (PTE 2, surgery 5) were similar. Recurrent jaundice occurred more often in the PTE (8/21) than the surgery group (3/19). Duodenal obstruction developed in 3 patients in the PTE group. Although the initial median postprocedural hospital stay was significantly shorter in the PTE than the surgery group, the difference was no longer significant when readmissions for blocked endoprosthesis and gastric outlet obstruction were taken into account. There was no difference in the median survival time in the two groups (PTE 19 weeks, surgery 15 weeks).

RCT Entities:   Population Interventions Outcomes