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

Primary Purpose

Pancreatic Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endoscopic Retrograde Cholangiopancreatography
Standard of care
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pancreatic Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SEMS

Standard of care surgical resection

Arm Description

Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection.

Patients undergo standard of care surgical resection.

Outcomes

Primary Outcome Measures

Complication Rates of Grade III or Higher
The risk difference will be calculated (stent minus control) with a one-sided 95% confidence interval.
Intraoperative Estimated Blood Loss
Group comparisons will be performed using two sample t-tests or Wilcoxon rank sum tests.

Secondary Outcome Measures

Full Information

First Posted
January 25, 2019
Last Updated
September 20, 2019
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT03820544
Brief Title
SEMS Placement Before Surgery in Unblocking Bile Duct in Patients With Periampullary Pancreatic Cancer With Severe Obstructive Jaundice
Official Title
Preoperative Endoscopic Biliary Drainage With Self Expanding Metal Stents (SEMS) vs. Direct Surgical Resection for Patients With Severe Obstructive Jaundice
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Interest in this study changed and it was decided to end enrollment early
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
July 24, 2018 (Actual)
Study Completion Date
April 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SEMS
Arm Type
Experimental
Arm Description
Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection.
Arm Title
Standard of care surgical resection
Arm Type
Active Comparator
Arm Description
Patients undergo standard of care surgical resection.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Retrograde Cholangiopancreatography
Other Intervention Name(s)
ERCP
Intervention Description
Undergo ERCP with SEMS placement
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Undergo standard of care surgical resection
Primary Outcome Measure Information:
Title
Complication Rates of Grade III or Higher
Description
The risk difference will be calculated (stent minus control) with a one-sided 95% confidence interval.
Time Frame
At 30 days post-surgery
Title
Intraoperative Estimated Blood Loss
Description
Group comparisons will be performed using two sample t-tests or Wilcoxon rank sum tests.
Time Frame
At time of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Kowalski, MD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital

Learn more about this trial

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

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