One-step versus two-step distal self-expandable metal stent placement: A multicenter prospective randomized trial

Area of Science:

• Gastroenterology
• Interventional Endoscopy
• Oncology

Background:

• Distal malignant biliary obstruction (MBO) management often involves transpapillary covered self-expandable metal stent (SEMS) placement.
• Two techniques exist: a one-step method without prior drainage and a two-step method with initial plastic stent drainage.

Purpose of the Study:

• To compare the efficacy and safety of one-step versus two-step SEMS placement for distal MBO in patients with unresectable pancreatic cancer.
• To evaluate outcomes including time to recurrent biliary obstruction (TRBO), adverse events, survival, and cost-effectiveness.

Main Methods:

• A prospective multicenter randomized study enrolled 90 patients with unresectable pancreatic cancer and distal MBO.
• Patients were allocated to either the one-step (n=45) or two-step (n=45) SEMS placement group.
• Primary outcome was TRBO; secondary outcomes included adverse events, survival, bilirubin reduction time, and cost.

Main Results:

• Median TRBO did not differ significantly between groups (not available vs. 314 days, P=0.134).
• SEMS migration was significantly higher in the two-step group (14.3% vs. 0%, P=0.026).
• No significant differences in other adverse events, survival, or bilirubin reduction time were observed. The one-step group had significantly lower total costs ($3347 vs. $5465, P<0.001).

Conclusions:

• The two-step SEMS placement method did not demonstrate superiority in preventing recurrent biliary obstruction.
• One-step SEMS placement is a promising, potentially less invasive, and more cost-effective approach for managing distal MBO.
• This finding supports the one-step method as a viable alternative in clinical practice.