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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status: Terminated

Conditions: Pancreatic Cancer

Treatments: Procedure: Endoscopic Retrograde Cholangiopancreatography; Other: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT03820544

JT 10199 (Other Identifier)

16D.759

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

SEMS

Experimental group

Description:

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

Treatment:

Procedure: Endoscopic Retrograde Cholangiopancreatography

Standard of care surgical resection

Active Comparator group

Description:

Patients undergo standard of care surgical resection.

Treatment:

Other: Standard of care