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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03820544
• Other study ID #: 16D.759
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: April 4, 2019

Study information

• Verified date: September 2019
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 4, 2019
• Est. primary completion date: July 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Jaundice
• Jaundice, Obstructive
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Endoscopic Retrograde Cholangiopancreatography
Undergo ERCP with SEMS placement

Other:
• Standard of care
Undergo standard of care surgical resection

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication Rates of Grade III or Higher	The risk difference will be calculated (stent minus control) with a one-sided 95% confidence interval.	At 30 days post-surgery
Primary	Intraoperative Estimated Blood Loss	Group comparisons will be performed using two sample t-tests or Wilcoxon rank sum tests.	At time of surgery

External Links

•   Sidney Kimmel Cancer Center at Thomas Jefferson University
•   Thomas Jefferson University Hospital