SEMS Placement Before Surgery in Unblocking Bile Duct in Patients With Periampullary Pancreatic Cancer With Severe Obstructive Jaundice
|ClinicalTrials.gov Identifier: NCT03820544|
Recruitment Status : Terminated (Interest in this study changed and it was decided to end enrollment early)
First Posted : January 29, 2019
Results First Posted : October 10, 2019
Last Update Posted : October 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Procedure: Endoscopic Retrograde Cholangiopancreatography Other: Standard of care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Preoperative Endoscopic Biliary Drainage With Self Expanding Metal Stents (SEMS) vs. Direct Surgical Resection for Patients With Severe Obstructive Jaundice|
|Actual Study Start Date :||September 1, 2017|
|Actual Primary Completion Date :||July 24, 2018|
|Actual Study Completion Date :||April 4, 2019|
Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection.
Procedure: Endoscopic Retrograde Cholangiopancreatography
Undergo ERCP with SEMS placement
Other Name: ERCP
Active Comparator: Standard of care surgical resection
Patients undergo standard of care surgical resection.
Other: Standard of care
Undergo standard of care surgical resection
- Complication Rates of Grade III or Higher [ Time Frame: At 30 days post-surgery ]The risk difference will be calculated (stent minus control) with a one-sided 95% confidence interval.
- Intraoperative Estimated Blood Loss [ Time Frame: At time of surgery ]Group comparisons will be performed using two sample t-tests or Wilcoxon rank sum tests.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820544
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Thomas Kowalski, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|