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

NCT03820544 | Terminated Results DMC

• 2 other identifiers: 16D.759JT 10199
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

SEMS

EXPERIMENTAL

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

Procedure: Endoscopic Retrograde Cholangiopancreatography

Standard of care surgical resection

ACTIVE COMPARATOR

Patients undergo standard of care surgical resection.

Other: Standard of care

Interventions

Endoscopic Retrograde Cholangiopancreatography PROCEDURE

Undergo ERCP with SEMS placement

Also known as: ERCP

SEMS

Standard of care OTHER

Undergo standard of care surgical resection

Standard of care surgical resection

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cholangiopancreatography, Endoscopic Retrograde; Standard of Care

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Thomas Kowalski, MD
• Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University

Thomas.Kowalski@jefferson.edu

215-955-9396

Study Officials

• Thomas Kowalski, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 29, 2019
• Study Start: September 1, 2017
• Primary Completion: July 24, 2018
• Study Completion: April 4, 2019
• Last Updated: April 30, 2025
• Results First Posted: October 10, 2019

Record last verified: 2025-04

Locations

US (1)