I-125 Seeds Loaded Stent Insertion for Inoperable Hilar Cholangiocarcinoma

Hilar Cholangiocarcinoma Clinical Trial

Official title:

I-125 Seeds Loaded Stent Insertion for Inoperable Hilar Cholangiocarcinoma

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04779788
• Other study ID #: 20210218015
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2021
• Source: Xuzhou Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Hilar Cholangiocarcinoma
• Klatskin Tumor

Intervention

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

Locations

Country	Name	City	State
China	Xuzhou Central Hospital	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. 2020 Mar 3:1-7. doi: 10.1080/13645706.2020.1735446. [Epub ahead of print] — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	From the date of randomization until the date of first documented death from any cause.	From the date of randomization until the date of first documented death from any cause, assessed up to 12 months