- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04779788
I-125 Seeds Loaded Stent Insertion for Inoperable Hilar Cholangiocarcinoma
Study Overview
Status
Conditions
Detailed Description
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 interventions are the only treatment option available for most patients. Of the available palliative treatments, percutaneous or endoscopic stent insertion is the most frequently used to treat malignant biliary obstruction patients.
Although stent insertion can achieve the good short-term outcomes for patients with malignant biliary obstruction, stent dysfunction remains a common outcome in these treated patients, limiting the long-term efficacy of this treatment strategy. In order to overcome this shortcoming of the normal stent insertion, many researchers have developed a novel biliary I-125 seeds loaded stent. The I-125 seeds loaded stents not only can effectively relieve the jaundice, but also can provide the brachytherapy to the tumor. Previous meta-analyses also indicated that showed that relative to normal stent insertion, I-125 seeds loaded stent insertion was associated with longer survival and stent patency in inoperable malignant biliary obstruction patients. However, most previous studies included malignant biliary obstruction patients with different cancer types and malignant biliary obstruction sites, and therefore, the risk of bias did exist. Therefore, there is a clear need for a study comparing these two stent types in patients with a single type of cancer.
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Jiangsu
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Xuzhou, Jiangsu, China, 221009
- Xuzhou Central Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients with a diagnosed hilar Cholangiocarcinoma; Inoperable cases; Patients showed evidence of obstructive jaundice; Eastern Cooperative Oncology Group performance status < 4.
Exclusion Criteria:
Patients who underwent post-operative external radiotherapy; Patients in whom prior biliary stent insertion or drainage were performed; Patients suffering from serious dysfunction of the pulmonary, renal, cardiac, or coagulatory systems.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: I-125 seeds loaded stent group
Patients who receive the I-125 seeds loaded stent insertion
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An I-125 seeds loaded stent consisted of two overlapped parts: an inner normal bare stent and an outer seeds-loaded stent
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Active Comparator: Normal stent group
Patients who receive the normal stent insertion
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Bare self-expanded metal stent
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: From the date of randomization until the date of first documented death from any cause, assessed up to 12 months
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From the date of randomization until the date of first documented death from any cause.
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From the date of randomization until the date of first documented death from any cause, assessed up to 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xian-Chi Li, MD, Xuzhou Central Hospital
Publications and helpful links
General Publications
- Chen G, Zhang M, Sheng YG, Yang F, Li ZQ, Liu TG, Fu YF. Stent with radioactive seeds strand insertion for malignant hilar biliary obstruction. Minim Invasive Ther Allied Technol. 2021 Dec;30(6):356-362. doi: 10.1080/13645706.2020.1735446. Epub 2020 Mar 3.
- Yang S, Liu Y, Teng F, Wu AL, Lin J, Xian YT, Xu YS. Radioactive Stent Insertion for Inoperable Malignant Common Biliary Obstruction. Surg Laparosc Endosc Percutan Tech. 2020 Aug 5;31(1):61-65. doi: 10.1097/SLE.0000000000000848.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20210218015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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