Effect of Palliative Biliary Stenting Versus Conservative Treatment on the Quality of Life (QOL) of Patients With Unresectable Carcinoma of the Gallbladder With Hiliar Block: A Randomised Controlled Trial

For most patients with gallbladder cancer, cure is not possible and treatment should be therefore aimed at palliation of symptoms and maintaining quality of life (QOL) in the few months between diagnosis and death. Most of these patients suffer from intractable pruritis, pain, anorexia and general debility. Biliary stenting leads to a reduction in pruritis and jaundice, and is commonly offered to many unresectable patients. However stenting related complications like cholangitis, rescue percutaneous treatment and need for prolonged hospitalization often impair the remaining short survival of these patients. In these patients improving the QOL should be the primary focus, and survival a secondary end point in disease management. No study has addressed the issue of QOL of patients with gallbladder cancer, post stenting.

Three clinical studies have evaluated the change in the QOL of patients with malignant biliary obstruction after of endoscopic stenting. Ballinger et al evaluated 19 patients with unresectable pancreatic carcinoma before stenting and upto 12 weeks or death after stenting. The Rotterdam Symptom Checklist and the Hospital Anxiety and Depression Scale were used. Significant improvements were seen in the parameters of mood, indigestion, appetite and level of activity. Luman et al studied 47 inoperable patients with malignant biliary strictures. The European Organisation for Research and Treatment of Cancer QOL questionnaire (EORTC QLQ-C30) was used at baseline and 1 month after stenting. For patients successfully completing the follow up, significant improvement in emotional, cognitive , and global health scores was found after stenting. In addition to the expected improvement in pruritis and jaundice , anorexia, diarrhea and sleep pattern were also improved. Abraham et al studied 50 patients with malignant biliary obstruction without liver metastasis considered non surgical candidates, and undergoing palliative biliary stenting. The SF-36 Health Survey Questionnaire was used to quantify QOL at baseline and 1 month after stent insertion. Follow up data was available for only 26 patients. Among these patients a significant reduction in the bilirubin level was associated with improvement in the social function and mental health. A high baseline bilirubin (> 14mg/dL) was associated with a lack of improvement at 1 month follow up.

Hence existing data regarding improvement in the QOL of patients undergoing palliative biliary stenting is sparce and incomplete. Gallbladder cancer presenting a hilar block is the most common biliary malignancy in India. Hilar tumors are associated with more technical failure of stenting, higher cholangitis rates, earlier stent blockage, and shorter survival as compared to distal biliary tumors. Only 6 patients with Klatskin tumors were included in one of the study.8 Patients with hilar block were either not included6, or were not specified7 in the other studies.

Health related quality of life (QOL) refers to the impact of a medical condition or its treatment on a person's expected physical, psychological and social well being.

Calman states that QOL evaluations measure the difference between the "hopes and expectations" of an individual and that individual's present experience.