Clinical effect of Y combined with radioactive particle chain brachytherapy in the treatment of Klaskin tumor.

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-OON-15006655
• Date of registration: 2015-06-26
• Prospective Registration: Yes
• Primary sponsor: The First Affiliated Hospital of Zhangzhou University
• Public title: Clinical effect of Y combined with radioactive particle chain brachytherapy in the treatment of Klaskin tumor.
• Scientific title: Clinical effect of Y combined with radioactive particle chain brachytherapy in the treatment of Klaskin tumor.
• Date of first enrolment: 2015-07-01
• Target sample size: A:20;B:20;C:20;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=11309
• Study type: Observational study
• Study design: Non randomized control
• Phase: Other

Countries of recruitment

China

Contacts

• Name: Hanxinwei

• Name: Jiaodechao
• Affiliation: The First Affiliated Hospital of Zhangzhou University

Key inclusion & exclusion criteria

Inclusion criteria: 1. aged 18 years old (male or female)
2. histology and cytology confirmed
3. More than 3 hours, liver function Child grade B
4. there is evidence of typical imaging (ultrasound, CT, MRCP, PTC angiography)
5. the expected survival time over 12 weeks
In blood and liver function examination basically normal, neutrophil 1.0*10^9/L, platelet > 9* 10^9/L, serum bilirubin efficiency of 15 times the upper limit of normal value; without liver metastasis. The levels of ALT and AST is less than 15 times the upper limit of normal value; coagulation function is basic and normal, no activity of bleeding tendency;
7. the KPS score >60.
Exclusion criteria: 1. the constitution of the patients is too weak, can not be tolerated or unwilling to accept operation;
2. complicated with other malignant tumors;
3. serious heart and lung dysfunction, intolerance to percutaneous operation;
4. serious disease (diabetes and blood coagulation dysfunction) patients;
5. tumor puncture site bleeding, necrosis;
6. pregnant, lactating women and all single and nonparous young patients;
7. contrast agent, local anesthetic allergy.

Age minimum: 18
Age maximum: 100
Gender: Both

Health Condition(s) or Problem(s) studied

Klaskin tumor

Intervention(s)

A:Biliary drainage;B:Biliary drainage and biliary Y- stent implantation;C:Bile duct stent plus particle chain brachytherapy;

Primary Outcome(s)

Length of biliary tract stricture;Bile duct stricture;

Source(s) of Monetary Support

self-financing