Pancreatic Cancer Research

Clinical trialNATerminated

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

Outcome
Stopped earlyInterest in this study changed and it was decided to end enrollment early (Enrollment)
Phase
NA
Status
Terminated
Study type
Interventional
Start
1 September 2017
Expected end
4 April 2019
Enrollment
4 participants
Sites
1
Primary outcomes
Complication Rates of Grade III or Higher; Intraoperative Estimated Blood Loss
Sponsor
Other
Results posted
2019-10-10
Last update
30 April 2025

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Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Complication Rates of Grade III or Higher [At 30 days post-surgery].

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Intraoperative Estimated Blood Loss [At time of surgery].