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Completed

NCT Number: NCT01675908

Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression

Compare the performance of full covered metal stents and plastic stents for preoperative biliary decompression

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Key information

Conditions

Obstructive Jaundice Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hyperbilirubinemia Jaundice Jaundice, Obstructive Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida Hospital

Orlando, Florida, 32814, United States

About this study

Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr plastic stents. When compared to plastic stents, randomized trials have shown longer patency and fewer stent-related complications for CSEMS. The investigators hypothesize that placement of CSEMS would be a better treatment option for preoperative biliary decompression in patients with pancreatic cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with pancreatic cancer and mass in the head of pancreas causing jaundice.
  • Patients 19 yrs of age and older
  • Serum bilirubin > 2mg/dl
  • CT: No evidence of distant metastasis or local vascular invasion (tumor surrounding portal or mesenteric vessels for more than 180 degrees of their circumference or an irregular vessel margin).

Exclusion criteria

  • Karnofsky score < 60
  • Prior (ERCP or PTC) attempts at biliary decompression for the same indication
  • Tumor-related gastric outlet obstruction (vomiting and oral intake of < 1L/day)
  • Ongoing or planned neoadjuvant therapy
  • Cholangitis at presentation or coagulopathy needing reversal medication
  • Post-surgical anatomy
  • Multiple extra-hepatic biliary strictures or concomitant stricture in liver hilum
  • Failed ERCP's (Definition: Inability to deploy a biliary stent thereby requiring a PTC or surgery).

Treatment and study plan

Stent Dysfunction

Procedure

Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP.

Complications

Procedure

Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.

Primary outcomes

  1. Complications related to stent dysfunction

    Time frame: 30 days

    Evaluate the rates of complications (%) related to stent dysfunction which include persistent hyperbilirubinemia and cholangitis that warrant stent exchange by a repeat ERCP.

Secondary outcomes

  1. Procedural complications

    Time frame: 30 days

    This will be measured as proportion of patients who encounter a procedural complication (%) during ERCP that includes pancreatitis, perforation or hemorrhage.

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Collaborators

  • University of Maryland, Baltimore
  • Vanderbilt University

Registry information

Official study title

Multicenter Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Aug 30, 2012
Registry last updated
Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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