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

Not Applicable

Terminated

• Conditions: Pancreatic Cancer
• Interventions: Other: Standard of care; Procedure: Endoscopic Retrograde Cholangiopancreatography

• Registration Number: NCT03820544
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2018-07-24
• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-29
• Study Completion: 2019-04-04
• Results First Submitted: 2019-08-08
• Results First Submitted QC: 2019-09-20
• Results First Posted: 2019-10-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Complication Rates of Grade III or Higher	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	At time of surgery	Group comparisons will be performed using two sample t-tests or Wilcoxon rank sum tests.

Trial Locations

Locations (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States