Clinical outcomes of percutaneous biliary drainage and quality of life assessment: a prospective observational study.

BACKGROUND

Percutaneous transhepatic biliary drainage (PTBD) is a widely used palliative intervention to relieve symptoms and reduce bilirubin levels to facilitate further treatments. However, data regarding its clinical outcomes and impact on quality of life (QOL), particularly in the Indian population, are limited. This prospective observational study intends to analyze the clinical outcomes, complication profile, factors affecting the clinical outcomes, and QOL assessment following PTBD in patients with malignant biliary obstruction (MBO).

METHODS

175 patients with MBO who underwent PTBD between March 2023 and August 2024 were enrolled in the study. The primary outcomes assessed included technical and clinical success following PTBD. The secondary outcomes comprised QOL evaluations using the European Organisation for Research and Treatment of Cancer Quality of Life questionnaire-BIL21, with follow-ups at 1 week, 1 month, and 3 months, as well as an examination of the factors influencing clinical success. Statistical analyses involved descriptive statistics, paired sample t-tests, bivariate and multivariate regression analyses, and Wilcoxon signed-rank tests, with p-values of less than 0.05 considered significant.

RESULTS

Technical success, defined as the correct catheter placement with bile drainage, was achieved in all cases (100%). Clinical success was observed in 81.6% of patients, with a significant reduction in median serum bilirubin from 15.67 mg/dL (IQR 8.91) at baseline to 3.9 mg/dL (IQR 2.9) at 4 weeks (p < 0.001). QOL improved significantly, particularly in eating, jaundice, tiredness, drainage tube, and weight loss scales, as measured at 1 month (p < 0.001). Complications were recorded in 76 (76/152, 50%) of cases, primarily consisting of minor complications such as peri-catheter leakage 52 (52/152, 34.2%) and major complications including cholangitis or sepsis 17(17/152, 11.2%), hemorrhage 2(2/152, 1.3%), and pancreatitis 1(1/152, 0.7%). In the multivariate regression analysis, age (p = 0.035) and liver metastases (p = 0.005) were significantly associated with clinical success. The Kaplan-Meier survival analysis indicated a median survival of 115 days (95% CI, 38.6-191.4, p = 0.025), compared to 46 days (95% CI, 0-103.4, p = 0.025) in the non-successful counterpart.

CONCLUSION

PTBD is a safe and effective option for managing MBO. Factors such as age at presentation and liver metastases status were found to be significantly associated with the clinical success of PTBD, while ECOG status, level of biliary obstruction, and unilobar or bilobar drainage were not significant. Therefore, it is advisable to consider these factors before proceeding with the PTBD procedure. There is a notable long-term difference in QOL post-PTBD, particularly regarding the jaundice and tiredness scales.