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OpenTrials
Completed

NCT Number: NCT01905384

Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction

The purpose of this study is to compare the rate of long-term stent failure, defined as need for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction.

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Key information

Conditions

Distal Bile Duct Obstruction Adenocarcinoma Carcinoma Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hyperbilirubinemia Jaundice Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • distal bile obstruction referred for ERCP with intended palliative metal stent placement for palliation of jaundice
  • 18 years of age or older
  • serum bilirubin > 2mg/dL

Exclusion criteria

  • prior endoscopic or percutaneous biliary drainage
  • post-surgical anatomy
  • primary site of biliary obstruction involving the common hepatic duct or hilum
  • tumor involving gastric outlet, duodenum, or ampulla either precluding endoscopic access to the papilla or otherwise preventing endoscopic biliary cannulation

Treatment and study plan

Covered Self-expanding metal biliary stents (C-SEMS)

Device

Used for palliation of inoperable malignant distal bile duct obstruction.

Uncovered Self-expanding metal biliary stents (U-SEMS)

Device

Used for palliation of inoperable malignant distal bile duct obstructions.

Primary outcomes

  1. Rate of Long-term Stent Failure

    Time frame: One year

    Compare the rate of long-term stent failure, defined as need for repeat biliary intervention (endoscopic, percutaneous, or surgical) following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction.

Secondary outcomes

  1. Rates of Adverse Stent-related or Intervention-related Outcomes

    Time frame: One Year

    Participants will be monitored for adverse stent-related or intervention-related outcomes such as pancreatitis, cholangitis, cholecystitis, perforation.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Randomized Controlled Trial Comparing Covered Versus Uncovered Metal Stents for Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 23, 2013
Registry last updated
Mar 31, 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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