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NCT Number: NCT01320241

Radiation Stent Versus Self-expanding Metallic Stents (SEMS) for Palliative Treatment of Malignant Biliary Stricture

Malignant biliary obstruction is a common clinical condition caused by various malignancies. Currently,biliary stent implantation guided either by fluoroscopy or endoscopy has become the most important methods for relieving malignant biliary obstruction. However, the benefit for the survival of the patients with palliation of the stent treatment is limited because no therapeutic effects on process of the tumor itself by a stent implantation. Encouraged by the success of 125I esophageal stent in esophageal carcinoma, a novel biliary stent loaded with 125I radioactive seeds has been developed in our institute. After ex vivo and in vivo evaluations for the delivery system, the investigators prospectively compare the responses to treatment with this radiation biliary stent, versus the conventional biliary SEMS in patient with malignant biliary obstruction.

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Key information

Conditions

Cholangiocellular Carcinoma Adenocarcinoma Biliary Tract Diseases Biliary Tract Neoplasms Carcinoma Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gallbladder Cancer Gallbladder Diseases Gallbladder Neoplasms Metastatic Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zhongda Hospital,Southeast University

Nanjing, Jiangsu, 210009, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years old or older
  • Biliary obstruction by any malignant process with histologically or cytologically confirmed by biopsy or previous surgical procedures
  • Clinical symptoms of biliary obstruction
  • Unresectable or refused to be surgically treated biliary obstruction by any malignant process
  • Willing and able to comply with the study procedures and provide written informed consent to participate in the study

Exclusion criteria

  • Suspected benign bile duct stricture
  • Strictures that can not be dilated enough to pass the delivery system
  • Perforation of any duct within the biliary tree
  • Presence metallic biliary stent or bile duct surgery
  • Patients for whom PTC procedures are contraindicated
  • Patients with active hepatitis or intrahepatic metastases that extensively involves both lobes of the liver
  • Noncooperation or no authorization and signature

Treatment and study plan

self-expandable 125I radioactive seeds-loaded-stent

Device

Patients undergo placement of a self-expandable 125I radioactive seeds-loaded-stent on day 1.

Other names: irradiation biliary stent

self-expandable biliary nitinol alloys stent

Device

Patients undergo placement of a conventional self-expandable biliary nitinol alloys stent on day 1.

Other names: conventional SEMS

Primary outcomes

  1. Overall Mean Survival and Median Survival

    Time frame: follow-up in interval of stent insertion and death (3 years)

Secondary outcomes

  1. Number of Participants with Adverse Events as a Measure of Technical Success, Clinical Success, Safety (including WBC and Immunological changes of lab, Leakage of the radioactive seeds and Complications related to the procedure.

    Time frame: follow-up in interval of stent insertion and death (3 years)

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

An Unicentric RCT About Novel Radiation Stent Versus Nitinol SEMS for Palliative Treatment of Malignant Biliary Stricture

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Mar 22, 2011
Registry last updated
Apr 2, 2012

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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