Back to resultsPercutaneous Bilateral Versus Unilateral Metal Stent for Hilar Cholangiocarcinoma
Primary Purpose
Hilar Cholangiocarcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
bilateral metal stent insertion
unilateral metal stent insertion
Sponsored by
About this trial
This is an interventional treatment trial for Hilar Cholangiocarcinoma focused on measuring cholangiocarcinoma, jaundice, metal stent, PTBS
Eligibility Criteria
Inclusion Criteria:
Written informed consent; Jaundice duo to biliary obstruction; The diagnosis is based on typical features on MRI and magnetic resonance cholangiopancreatography or histologic and cytologic confirmation is established by percutaneous biopsy (X ray-guided) or exploratory laparotomy; Bismuth type Ⅱ、Ⅲ、Ⅳobstruction; Performance status (eastern cooperative oncology group, ECOG) 0-2; All patients were considered unsuitable or refuse for resection on the basis of general medical condition and/or tumor extent.
Exclusion Criteria:
Refuse to participate and provide informed consent; Bismuth Ⅰtype obstruction; Performance status (eastern cooperative oncology group, ECOG) 3-4. Portal Vein involvement; Prior history of stent; Concomitant renal insufficiency; Severe cardiopulmonary diseases; Uncontrolled systemic infection or sepsis; Accompany other malignancy or serious medical illness which may reduce the life expectancy.
Contraindications for PTBS.
Sites / Locations
- Han Guo HongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
unilateral metal stent insertion
bilateral metal stent insertion
Arm Description
unilateral metal stent insertion was performed either left or right hepatic lobe as can be drainage more liver volume
percutaneous transhepatic biliary drainage plus bilateral metal stent.The bare stents were used for PTBS
Outcomes
Primary Outcome Measures
Failure to control jaundice or failure to prevent stent occlusion or re-jaundice within three month after stent implantation
Secondary Outcome Measures
Median survival
Full Information
NCT ID
NCT02108145
First Posted
March 31, 2014
Last Updated
July 31, 2019
Sponsor
Air Force Military Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT02108145
Brief Title
Percutaneous Bilateral Versus Unilateral Metal Stent for Hilar Cholangiocarcinoma
Official Title
Percutaneous Bilateral Versus Unilateral Metal Stent Placement for Hilar Cholangiocarcinoma : A Prospective Open-label Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common hepatic malignancy after hepatocellular carcinoma (HCC). A majority of the CCA (50-70%) was presented in the area of the biliary duct bifurcation. Recent retrospective study included heterogeneous group of malignant diseases demonstrate that draining more than 50% of was associated with a longer median survival.
However, in recent European Society of Gastrointestinal Endoscopy (ESGE) biliary stenting clinical guideline and Asia-Pacific consensus recommendations for endoscopic and interventional management of hilar cholangiocarcinoma (HCCA), whether we should deployment bilateral or unilateral metal stent for patients with HCCA was not clearly recommended due to the absence of randomized controlled trials.
Detailed Description
Patients with advanced hilar obstruction (Bismuth III and IV), PTBS had a higher success rate of cholestasis palliation and a low rate of post cholangitis when compared with endoscopic retrograde cholangiopancreatography(ERCP). The advantage of percutaneous approach is the precise lobar selection for drainage and this approach should yield a lower rate of cholangitis.
Guideline recommendation European Society of Gastrointestinal Endoscopy (ESGE) biliary stenting clinical guideline and Asia-Pacific consensus recommendations the goal of palliative stenting of HCCA is drainage of adequate liver volume (50% or more), irrespective of unilateral, bilateral, or multi-segmental stenting was based on heterogeneous group of malignancy by ERCP in retrospective study.There are no randomized clinical trials compared with these two internal biliary drainage methods in HCCA using metal stent.
The aim of the present study was to compare the effect and safety of bilateral versus unilateral stenting in patients with HCCA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hilar Cholangiocarcinoma
Keywords
cholangiocarcinoma, jaundice, metal stent, PTBS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
unilateral metal stent insertion
Arm Type
Active Comparator
Arm Description
unilateral metal stent insertion was performed either left or right hepatic lobe as can be drainage more liver volume
Arm Title
bilateral metal stent insertion
Arm Type
Experimental
Arm Description
percutaneous transhepatic biliary drainage plus bilateral metal stent.The bare stents were used for PTBS
Intervention Type
Procedure
Intervention Name(s)
bilateral metal stent insertion
Intervention Type
Procedure
Intervention Name(s)
unilateral metal stent insertion
Primary Outcome Measure Information:
Title
Failure to control jaundice or failure to prevent stent occlusion or re-jaundice within three month after stent implantation
Time Frame
From stent insertion to three months
Secondary Outcome Measure Information:
Title
Median survival
Time Frame
up to 1 year
Other Pre-specified Outcome Measures:
Title
Stent patency
Description
Stent patency is a secondary endpoint of this study. Cumulative stent patency rate is compared between the two groups.
Time Frame
up to 1year
Title
Early major complications
Description
Early major complications is a secondary endpoint of this study.Early major complications rate is compared between the two groups
Time Frame
30 days within treatment
Title
30-day mortality
Description
30-day mortality is a secondary endpoint of this study. 30-day mortality rate is compared between the two groups.
Time Frame
30 days within treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent; Jaundice duo to biliary obstruction; The diagnosis is based on typical features on MRI and magnetic resonance cholangiopancreatography or histologic and cytologic confirmation is established by percutaneous biopsy (X ray-guided) or exploratory laparotomy; Bismuth type Ⅱ、Ⅲ、Ⅳobstruction; Performance status (eastern cooperative oncology group, ECOG) 0-2; All patients were considered unsuitable or refuse for resection on the basis of general medical condition and/or tumor extent.
Exclusion Criteria:
Refuse to participate and provide informed consent; Bismuth Ⅰtype obstruction; Performance status (eastern cooperative oncology group, ECOG) 3-4. Portal Vein involvement; Prior history of stent; Concomitant renal insufficiency; Severe cardiopulmonary diseases; Uncontrolled systemic infection or sepsis; Accompany other malignancy or serious medical illness which may reduce the life expectancy.
Contraindications for PTBS.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guohong Han, MD,Ph.D
Phone
86-29-84771528
Email
hangh@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
MingWu Li, MD
Email
lmw_jack@china.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guohong Han, MD,Ph.D
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Han Guo Hong
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
guohong han, M.D.
Phone
+86-29-84771537
Ext
+86-29-8253904
Email
hangh2009@gmail.com
First Name & Middle Initial & Last Name & Degree
mingwu Li, M.D.
12. IPD Sharing Statement
Learn more about this trial
Percutaneous Bilateral Versus Unilateral Metal Stent for Hilar Cholangiocarcinoma
We'll reach out to this number within 24 hrs