ClinicalTrials.Veeva

Menu

I-125 Seeds Loaded Stent Insertion for Inoperable Hilar Cholangiocarcinoma

X

Xuzhou Central Hospital (Xuzhou Fourth People's Hospital)

Status

Unknown

Conditions

Hilar Cholangiocarcinoma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04779788
20210218015

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

I-125 seeds loaded stent group
Experimental group
Description:
Patients who receive the I-125 seeds loaded stent insertion
Treatment:
Device: I-125 seeds loaded stent (self-expanded metal stent with I-125 seeds, Micro-Tech, Nanjing, China)
Normal stent group
Active Comparator group
Description:
Patients who receive the normal stent insertion
Treatment:
Device: Normal stent (self-expanded metal stent without I-125 seeds, Micro-Tech, Nanjing, China)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems