Randomized trial in malignant biliary obstruction: plastic vs partially covered metal stents

Area of Science:

• Gastroenterology
• Interventional Endoscopy
• Oncology

Background:

• Malignant infrahilar biliary obstruction presents a significant challenge in palliative care.
• Standard treatment involves biliary stenting, with various stent types available.

Purpose of the Study:

• To compare the efficacy and complication rates of partially covered self-expandable metal stents (pcSEMS) versus plastic stents (PS).
• To evaluate stent failure, survival, adverse events, and quality of life in patients with malignant biliary obstruction.

Main Methods:

• A multicenter prospective randomized clinical trial comparing pcSEMS (Wallstent) to 10 French PS.
• Inclusion criteria: palliative patients, ≥18 years, infrahilar malignant biliary obstruction, Karnofsky score >60%.
• Primary endpoint: time to stent failure. Secondary endpoints: survival, adverse events, performance, and quality of life.

Main Results:

• Eighty-five patients were randomized; 42 to SEMS and 43 to PS.
• Time to stent failure was significantly longer for SEMS (385.3 days) compared to PS (153.3 days), P=0.006.
• No significant difference in survival (P=0.70). Cholangitis was more frequent in the PS group (24.5% vs 4.9%, P=0.029).

Conclusions:

• Partially covered SEMS provide longer stent patency for malignant biliary obstruction compared to PS.
• No significant improvement in survival, performance, or quality of life was observed with pcSEMS.
• pcSEMS can be considered for patients requiring longer stent patency without increased complication rates.