NCT03820544

SEMS Placement Before Surgery in Unblocking Bile Duct in Patients With Periampullary Pancreatic Cancer With Severe Obstructive Jaundice

Preoperative Endoscopic Biliary Drainage With Self Expanding Metal Stents (SEMS) vs. Direct Surgical Resection for Patients With Severe Obstructive Jaundice

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This trial studies the side effects of self expanding metal stent (SEMS) placement before surgery in unblocking the bile duct in patients with periampullary pancreatic cancer with severe obstructive jaundice. SEMS placement unblocks the bile duct and may help in improving bile drainage prior to surgery in patients with periampullary pancreatic cancer with severe obstructive jaundice.

Detailed description

PRIMARY OBJECTIVES: I. To compare the 30-day overall complication rates between patients with severe obstructive jaundice undergoing preoperative endoscopic biliary drainage with self expanding metal stents (SEMS) and patients undergoing direct surgical resection.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
PROCEDURE	Endoscopic Retrograde Cholangiopancreatography	Undergo ERCP with SEMS placement
OTHER	Standard of care	Undergo standard of care surgical resection

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-07-24
• Completion: 2019-04-04
• First posted: 2019-01-29
• Last updated: 2025-04-30
• Results posted: 2019-10-10

Locations

1 site across 1 country: United States