Safety of biliary drainage with 6-mm metallic stent for preoperative obstructive jaundice in pancreatic cancer: PURPLE SIX STUDY
Contact us if these videos are not relevant.
Contact us if these videos are not relevant.
View abstract on PubMed
Summary
This summary is machine-generated.A 6-mm fully covered self-expandable metal stent (FCSEMS) demonstrated high safety for preoperative biliary drainage in pancreatic cancer patients. This stent is optimal for preventing recurrent biliary obstruction during chemotherapy.
Area Of Science
- Gastroenterology
- Oncology
- Medical Devices
Background
- The 10-mm self-expandable metal stent (SEMS) is standard for biliary drainage before pancreatic cancer surgery.
- Efficacy of thinner stents (<10 mm) requires validation for distal malignant biliary obstruction (DMBO).
Purpose Of The Study
- Evaluate the safety of a 6-mm fully covered SEMS (FCSEMS).
- Assess FCSEMS for DMBO during preoperative chemotherapy in pancreatic cancer.
Main Methods
- Single-arm, prospective phase II study.
- Enrolled 32 patients with resectable (R) and borderline resectable (BR) pancreatic cancer.
- Primary endpoint: stent-related adverse events; Secondary endpoint: non-recurrent biliary obstruction (non-RBO) rate.
Main Results
- Technical success (97.0%) and clinical success (90.1%) rates were high.
- Stent-related adverse event rate was 3.1% (one case of acute pancreatitis), confirming safety.
- Overall non-RBO rate was 78.1% (82.6% for R, 66.7% for BR) over a median 96-day observation.
Conclusions
- 6-mm FCSEMS is extremely safe for preoperative biliary drainage in pancreatic cancer.
- Offers a low adverse event rate (3.1%) and optimal non-RBO rates.
- Considered the optimal stent choice for preoperative biliary drainage.
Contact us if these videos are not relevant.
Contact us if these videos are not relevant.
