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

Study Overview

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

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.

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.

Pancreatic Cancer

PROCEDURE: Endoscopic Retrograde Cholangiopancreatography
OTHER: Standard of care

16D.759
JT 10199 (OTHER Identifier) (OTHER: JeffTrial Number)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-01-25	Results First Submitted 2019-08-08	Last Update Submitted that met QC Criteria 2025-04-28
First Submitted that Met QC Criteria 2019-01-25	Results First Submitted that Met QC Criteria 2019-09-20	Last Update Posted (ACTUAL) 2025-04-30
First Posted (ACTUAL) 2019-01-29	Results First Posted 2019-10-10	Last Verified 2025-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/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
ACTIVE_COMPARATOR: Standard of care surgical resection Patients undergo standard of care surgical resection.	OTHER: Standard of care Undergo standard of care surgical resection

Participant Group/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

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	Measure Description	Time Frame
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
Intraoperative Estimated Blood Loss	Group comparisons will be performed using two sample t-tests or Wilcoxon rank sum tests.	At time of surgery

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Thomas Kowalski, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record