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

NCT01320241 | Completed Phase 2 DMC

• 1 other identifier: 320924197612177170-BS
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholangiocellular Carcinoma; Pancreatic Cancer; Gallbladder Cancer; Metastatic Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Mean Survival and Median Survival

  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.

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

Study Arms (2)

novel radiation stent

ACTIVE COMPARATOR

Patients undergo placement of a novel biliary stent loaded with 125I seeds on day 1. Intervention: Device: self-expandable 125I radioactive seeds-loaded-stent

Device: self-expandable 125I radioactive seeds-loaded-stent

conventional stent

EXPERIMENTAL

Patients undergo placement of a conventional nitinol SEMS on day1. Intervention: Device: self-expandable biliary nitinol alloys stent

Device: self-expandable biliary nitinol alloys stent

Interventions

self-expandable 125I radioactive seeds-loaded-stent DEVICE

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

Also known as: irradiation biliary stent

novel radiation stent

self-expandable biliary nitinol alloys stent DEVICE

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

Also known as: conventional SEMS

conventional stent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda Hospital,Southeast University

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Pancreatic Neoplasms; Gallbladder Neoplasms; Carcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Neoplasms; Biliary Tract Diseases; Gallbladder Diseases

Study Officials

• Gao-jun Teng, MD, PhD

  Zhong-Da Hospital, Southeast University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Radiology

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: March 22, 2011
• Study Start: November 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 2, 2012

Record last verified: 2011-03

Locations

CN (1)