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


Phase 2
18 Years
80 Years
Not Enrolling
Both
Cholangiocellular Carcinoma, Pancreatic Cancer, Gallbladder Cancer, Metastatic Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Overall Mean Survival and Median Survival

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Gao-jun Teng, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zhong-Da Hospital, Southeast University

Authority:

China: Ministry of Health

Study ID:

320924197612177170-BS

NCT ID:

NCT01320241

Start Date:

November 2008

Completion Date:

March 2012

Related Keywords:

  • Cholangiocellular Carcinoma
  • Pancreatic Cancer
  • Gallbladder Cancer
  • Metastatic Carcinoma
  • Carcinoma
  • Pancreatic Neoplasms
  • Gallbladder Neoplasms
  • Cholangiocarcinoma
  • Cholestasis
  • Constriction, Pathologic

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