Palliation of malignant biliary obstruction: a prospective trial examining impact on quality of life.

BACKGROUND: Endoscopic decompression is used for palliation of patients with malignant biliary obstruction. Little is known of its effect on quality of life. The aims of this study were to determine clinical characteristics that have the greatest adverse impact on quality of life in patients with malignant biliary obstruction, and to quantify changes in the quality of life of patients with malignant biliary obstruction after successful decompression with a plastic stent.
METHODS: Patients with malignant biliary obstruction without liver metastases considered nonsurgical candidates and referred to a tertiary university medical center for palliative endoscopic decompression were sequentially enrolled in this prospective cohort study. The SF-36 Health Survey questionnaire at baseline and 1 month after stent insertion was used to quantify quality of life. Results were correlated to clinical and laboratory parameters. Multivariate analyses were carried out to determine independent predictors of baseline quality of life and improvement after stent insertion.
RESULTS: Fifty patients (20 men, 30 women; mean [SD] age 72.6 [10.6] years) with a mean weight of 62.4 (12.9) kg and mean body mass index of 23.4 (4.3) kg/m(2) were enrolled. Two thirds had a distal malignant lesion, 12.5% had mid bile duct obstruction, and the rest either hilar or intrahepatic cholangiocarcinoma. At baseline, 70% complained of pruritus and 98% were jaundiced (mean total bilirubin 15 [7] mg/dL). Mean duration of symptoms before decompression was 23 (25) days. Weight loss, and elevated bilirubin level had the greatest impact on baseline quality of life domains in both univariate and multivariate analysis. After biliary drainage, complete follow-up information was available for 51% of the initial cohort. Among these 26 patients, a 33% improvement in bilirubin level was documented in 84% of patients and was associated with significant improvements in social function (relative risk = 0.11; 95% CI [0.03, 0.19]) and mental health (relative risk = 0.036; 95% CI [0.011, 0.08]). A baseline bilirubin of greater than 14 mg/dL was associated with lack of improvement in social function at 1-month follow-up (p = 0.03).
CONCLUSIONS: Weight loss and hyperbilirubinemia are strongly predictive of poor quality of life before endoscopic decompression. Successful biliary drainage after stent insertion is associated with improvements in quality of life, although this is less true among patients with a baseline bilirubin over 13 mg/dL. These results may lead to better selection of patients for palliative biliary decompression and require prospective validation.