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I-125 Seeds Loaded Stent Insertion for Inoperable Hilar Cholangiocarcinoma

Primary Purpose

Hilar Cholangiocarcinoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
I-125 seeds loaded stent (self-expanded metal stent with I-125 seeds, Micro-Tech, Nanjing, China)
Normal stent (self-expanded metal stent without I-125 seeds, Micro-Tech, Nanjing, China)
Sponsored by
Xuzhou Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hilar Cholangiocarcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Xuzhou Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

I-125 seeds loaded stent group

Normal stent group

Arm Description

Patients who receive the I-125 seeds loaded stent insertion

Patients who receive the normal stent insertion

Outcomes

Primary Outcome Measures

Overall survival
From the date of randomization until the date of first documented death from any cause.

Secondary Outcome Measures

Full Information

First Posted
February 28, 2021
Last Updated
July 12, 2021
Sponsor
Xuzhou Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04779788
Brief Title
I-125 Seeds Loaded Stent Insertion for Inoperable Hilar Cholangiocarcinoma
Official Title
I-125 Seeds Loaded Stent Insertion for Inoperable Hilar Cholangiocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuzhou Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hilar Cholangiocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I-125 seeds loaded stent group
Arm Type
Experimental
Arm Description
Patients who receive the I-125 seeds loaded stent insertion
Arm Title
Normal stent group
Arm Type
Active Comparator
Arm Description
Patients who receive the normal stent insertion
Intervention Type
Device
Intervention Name(s)
I-125 seeds loaded stent (self-expanded metal stent with I-125 seeds, Micro-Tech, Nanjing, China)
Intervention Description
An I-125 seeds loaded stent consisted of two overlapped parts: an inner normal bare stent and an outer seeds-loaded stent
Intervention Type
Device
Intervention Name(s)
Normal stent (self-expanded metal stent without I-125 seeds, Micro-Tech, Nanjing, China)
Intervention Description
Bare self-expanded metal stent
Primary Outcome Measure Information:
Title
Overall survival
Description
From the date of randomization until the date of first documented death from any cause.
Time Frame
From the date of randomization until the date of first documented death from any cause, assessed up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xian-Chi Li, MD
Organizational Affiliation
Xuzhou Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuzhou Central Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221009
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make individual participant data available.
Citations:
PubMed Identifier
32125207
Citation
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.
Results Reference
background
PubMed Identifier
32769739
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.
Results Reference
background

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I-125 Seeds Loaded Stent Insertion for Inoperable Hilar Cholangiocarcinoma

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