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I-125 Seeds Loaded Stent Insertion for Inoperable Hilar Cholangiocarcinoma

NCT04779788 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-07-14

No results posted yet for this study

Summary

Malignant biliary obstruction usually arise in patients suffering from primary or metastatic hepatobiliary tumors. Approximately 80% of malignant biliary obstruction patients are not eligible for surgical resection, and as such palliative stent insertion is the only treatment option available for most patients. At present, I-125 seeds loaded stent has been developed to improve the stent patency and patients' survival. Hilar malignant biliary obstruction is an important part of malignant biliary obstruction. Hilar cholangiocarcinoma is the most common disease which causes hilar malignant biliary obstruction. Herein, we assessed the clinical and long-term efficacy of I-125 seeds loaded stent insertion for hilar cholangiocarcinoma patients.

Conditions

  • Hilar Cholangiocarcinoma

Interventions

DEVICE

I-125 seeds loaded stent (self-expanded metal stent with I-125 seeds, Micro-Tech, Nanjing, China)

An I-125 seeds loaded stent consisted of two overlapped parts: an inner normal bare stent and an outer seeds-loaded stent

DEVICE

Normal stent (self-expanded metal stent without I-125 seeds, Micro-Tech, Nanjing, China)

Bare self-expanded metal stent

Sponsors & Collaborators

  • Xuzhou Central Hospital

    lead OTHER

Principal Investigators

  • Xian-Chi Li, MD · Xuzhou Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2021-12-31
Completion
2022-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04779788 on ClinicalTrials.gov