- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00746538
Quality of Life in Patients With Unresectable Hilar Cholangiocarcinoma on Palliative Metallic Stent Versus Plastic Stent
Quality of Life in Patients With Unresectable Hilar Cholangiocarcinoma on Palliative Metallic Stent Versus Plastic Stent: A Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the patient with unresectable hilar cholangiocarcinoma,palliative biliary stent is the one way to help him.
The aim of palliative treatment is to improve quality of life and relief symptom,or sometime ,extended survival rate.
There are two types of biliary stent:
- plastic stent made from polyethylene or polytetrafluoroethylene
- metalic stent braided in the form of a tubular mesh from surgical-grade stainless steel alloy and designed to expand to a maximum diameter of 10mm.
The main drawback of plastic stent is relatively high occlusion rate, but its advantage is the lower cost.
In the reasons of higher occlusion rate , the lower cost of plastic stent versus metallic stent that should be stent exchange when occluded, so we would to know about quality of life in both group.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Worrarat Kongkasame, MD
- Phone Number: (66)0817259376
- Email: worrarat-eab@hotmail.com
Study Locations
-
-
KhonKaen
-
Muang, KhonKaen, Thailand
- Recruiting
- Srinagarind Hospital.KhonKaen University.
-
Principal Investigator:
- Worrarat Kongkasame, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patient with diagnosis of hilar cholangiocarcinoma and/or radiological diagnosis
- Patient considered having an unresectable tumor or unfit of operation because of advanced age or medical illness
Exclusion Criteria:
- Patient with ASA 4 or 5
- Patient who inability to comply with follow up
- Patient refused to join the research
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
metallic stent group
|
Metallic stent of plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP
Other Names:
|
Active Comparator: 2
plastic stent group
|
Metallic stent of plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assessment of the quality of life of patient with unresectable hilar cholangiocarcinoma after palliative biliary stent.
Time Frame: 2-4 weeks
|
2-4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assessment of early and late complication after palliative stent.
Time Frame: After stent insertion for sixth month and one year or until patients were expired
|
After stent insertion for sixth month and one year or until patients were expired
|
Survival rate at sixth month and one year.
Time Frame: After stent insertion for sixth month and one year or until patients were expired
|
After stent insertion for sixth month and one year or until patients were expired
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Worrarat Kongkasame, MD, Department of Medicine.Faculty of Medicine .KhonKaen University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HE500636(subproject)
- HE5OO636(sub)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Unresectable Hilar Cholangiocarcinoma
-
Zhongda HospitalCompleted
-
Hospital Vall d'HebronRecruiting
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnUnresectable Extrahepatic Bile Duct Carcinoma | Recurrent Cholangiocarcinoma | Non-Resectable Cholangiocarcinoma | Stage III Intrahepatic Cholangiocarcinoma | Stage IIIA Hilar Cholangiocarcinoma | Stage IIIB Hilar Cholangiocarcinoma | Stage IVA Hilar Cholangiocarcinoma | Stage IVA Intrahepatic Cholangiocarcinoma and other conditionsUnited States
-
University of Kansas Medical CenterNational Cancer Institute (NCI)RecruitingStage III Intrahepatic Cholangiocarcinoma AJCC v8 | Metastatic Cholangiocarcinoma | Locally Advanced Cholangiocarcinoma | Stage III Hilar Cholangiocarcinoma AJCC v8 | Stage IV Hilar Cholangiocarcinoma AJCC v8 | Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 | Recurrent CholangiocarcinomaUnited States
-
National Cancer Institute (NCI)RecruitingStage III Intrahepatic Cholangiocarcinoma AJCC v8 | Recurrent Gallbladder Carcinoma | Unresectable Gallbladder Carcinoma | Stage III Hilar Cholangiocarcinoma AJCC v8 | Stage IV Hilar Cholangiocarcinoma AJCC v8 | Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IV Distal Bile Duct Cancer... and other conditionsUnited States
-
Moscow Clinical Scientific CenterCompletedIntrahepatic Cholangiocarcinoma | Hilar Cholangiocarcinoma
-
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co...TerminatedHilar CholangiocarcinomaChina
-
Zhujiang HospitalUnknownHilar CholangiocarcinomaChina
-
Khon Kaen UniversityCompletedHilar CholangiocarcinomaThailand
-
National Cancer Institute (NCI)RecruitingMalignant Solid Neoplasm | Cholangiocarcinoma | Stage III Intrahepatic Cholangiocarcinoma AJCC v8 | Gallbladder Carcinoma | Stage III Gallbladder Cancer AJCC v8 | Stage III Hilar Cholangiocarcinoma AJCC v8 | Stage IV Gallbladder Cancer AJCC v8 | Stage IV Hilar Cholangiocarcinoma AJCC v8 | Stage IV Intrahepatic...United States
Clinical Trials on biliary stent
-
Allium, Ltd.WithdrawnMalignant Obstruction of the Common Bile DuctIsrael
-
Azienda USL 1 ImperiesePapa Giovanni XXIII Hospital; Ospedali Riuniti Marche Nord, Pesaro, Italy; NOCSAE... and other collaboratorsCompletedBiliary CancerItaly
-
Chinese University of Hong KongTerminated
-
Turku University HospitalTerminatedCholangitis | Biliary ObstructionFinland
-
Taewoong Medical Co., Ltd.CompletedBiliary Stricture | Malignant NeoplasmsKorea, Republic of
-
Helsinki University Central HospitalWithdrawn
-
Xuzhou Central HospitalCompletedHepatocellular Carcinoma | Cholangiocarcinoma | Gallbladder CarcinomaChina
-
Institut Paoli-CalmettesCompletedMalignant Biliary ObstructionFrance
-
University of Cape TownUnknownBiliary Stricture | Cancer of the Pancreas | Bile Duct Obstruction, Extrahepatic | Cancer of the Bile DuctSouth Africa
-
Xuzhou Central HospitalCompletedPancreatic Carcinoma | Biliary ObstructionChina