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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Procedure: Endoscopic Retrograde Cholangiopancreatography Other: Standard of care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SEMS
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




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of operable peri-ampullary pancreatic cancer as determined by the Department of Surgery per their standard of care
  • Serum bilirubin > 10 mg/dl
  • Adequate birth control

Exclusion Criteria:

  • Patients with evidence of distant metastasis on computed tomography (CT) or magnetic resonance imaging (MRI)
  • Patients anticipated to require vascular reconstruction
  • Patients with cholangitis
  • Patients for whom surgery is deemed inappropriate by surgeon
  • Patients with bilirubin less than 10 mg/dL or greater than 20 mg/dL
  • Patients who previously underwent biliary decompression for cholangitis by ERCP or percutaneous transhepatic cholangiography (PTC)
  • Patients with low performance score (Karnofsky performance status scale < 50)
  • Patients with known preexisting liver disease with associated elevated bilirubin
  • Patients who are pregnant or actively breast feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820544


Locations
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United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
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Principal Investigator: Thomas Kowalski, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
  Study Documents (Full-Text)

Documents provided by Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University ):
Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03820544    
Other Study ID Numbers: 16D.759
First Posted: January 29, 2019    Key Record Dates
Results First Posted: October 10, 2019
Last Update Posted: October 10, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Jaundice
Jaundice, Obstructive
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations