NCT02238613

Brief Summary

The purpose of this study is to determine whether radioactive stents and common used plastic stents are effective and safety in the treatment of unresectable biliary tract cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

1.8 years

First QC Date

August 25, 2014

Last Update Submit

September 10, 2014

Conditions

Intrahepatic CholangiocarcinomaCholangiocarcinoma of the Extrahepatic Bile DuctAmpullary CarcinomaBiliary Obstruction

Keywords

Radioactive stentsBrachytherapyBiliary obstructionIntrahepatic CholangiocarcinomaCholangiocarcinoma of the Extrahepatic Bile Ductampullary carcinoma

Outcome Measures

Primary Outcomes (1)

  • Tumor Response rate

    The investigators will conduct CT test or MRI scan after the implantation of the stents in order to measure the tumor size of each patients and evaluate the best tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.0).

    3 months

Secondary Outcomes (3)

  • Progression-free survival

    6 months

  • overall survival

    follow-up in interval of stent insertion and death (1 years)

  • Adverse events

    1 year

Study Arms (2)

radioactive stent

EXPERIMENTAL

The radioactive stent carrying seeds iodine 125 is made of Polytetrafluoroethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the irradiation group patients.

Device: radioactive stent

plastic stent

OTHER

The plastic stent is made of polyethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the conventional group patients.

Device: plastic stent

Interventions

radioactive stentDEVICE

radioactive stent carrying seed iodine 125

Also known as: brand names: carriable radioactive bile duct plastic stent, serial numbers and code name: PBS1-A/B-10/160/140
radioactive stent
plastic stentDEVICE

common plastic stent without carrying seed iodine 125

plastic stent

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients were eligible if they had received a histopathological or cytologic diagnosis of nonresectable, recurrent, or metastatic biliary tract carcinoma (intrahepatic or extrahepatic cholangiocarcinoma,or ampullary carcinoma)
  • Patients aged between 18 and 80 years
  • an estimated life expectancy of more than 3 months
  • Disease had to be measurable by computed tomography scan (as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria
  • TNM stage III-IV
  • no evidence of cancer of another organ.
  • no prior chemotherapy for advanced disease was allowed, but adjuvant/neoadjuvant therapy was allowed
  • Karnofsky index of ≥60%
  • ECOG index ≥2
  • previous technically successful stenting or ENBD derange
  • Accept of informed consent

You may not qualify if:

  • Clinically significant cardiovascular disease
  • coagulation disorders
  • contraindication of Endoscopic
  • pregnant or breastfeeding women
  • known sensitivity sensitivity to investigated agents or components
  • recent invasive procedure
  • prior chemotherapy or radiotherapy for biliary cancer
  • refusal of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

307 hospital of PLA

Beijing, Beijing Municipality, 10086, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Yan Liu, Doctor

    307 hospital of PLA, Beijing, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Liu, MD,PhD

CONTACT

86-1391179828813911798288@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MD. Chairman of Department of Gastroenterology and Hepatology, 307 Hospital of PLA

Study Record Dates

First Submitted

August 25, 2014

First Posted

September 12, 2014

Study Start

August 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2017

Last Updated

September 12, 2014

Record last verified: 2014-09

Locations

CN(1)