I-125 Seeds Loaded Stent Insertion for Inoperable Hilar Cholangiocarcinoma

NCT04779788 | Unknown DMC

• 1 other identifier: 20210218015
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

I-125 seeds loaded stent group

EXPERIMENTAL

Patients who receive the I-125 seeds loaded stent insertion

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

Normal stent group

ACTIVE COMPARATOR

Patients who receive the normal stent insertion

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

Interventions

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

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

I-125 seeds loaded stent group

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

Bare self-expanded metal stent

Normal stent group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosed hilar Cholangiocarcinoma; Inoperable cases; Patients showed evidence of obstructive jaundice; Eastern Cooperative Oncology Group performance status \< 4.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuzhou Central Hospital: lead

Study Sites (1)

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China

Location

Related 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. 2021 Dec;30(6):356-362. doi: 10.1080/13645706.2020.1735446. Epub 2020 Mar 3.

  PMID: 32125207 BACKGROUND

• 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.

  PMID: 32769739 BACKGROUND

MeSH Terms

Conditions

Klatskin Tumor

Condition Hierarchy (Ancestors)

Cholangiocarcinoma; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Xian-Chi Li, MD

  Xuzhou Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2021
• First Posted: March 3, 2021
• Study Start: April 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: July 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)