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Percutaneous Bilateral Versus Unilateral Metal Stent for Hilar Cholangiocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02108145
Recruitment Status : Recruiting
First Posted : April 9, 2014
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Guohong Han, Fourth Military Medical University

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.


Condition or disease Intervention/treatment Phase
Hilar Cholangiocarcinoma Procedure: bilateral metal stent insertion Procedure: unilateral metal stent insertion Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Percutaneous Bilateral Versus Unilateral Metal Stent Placement for Hilar Cholangiocarcinoma : A Prospective Open-label Randomized Controlled Trial
Study Start Date : July 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: unilateral metal stent insertion
unilateral metal stent insertion was performed either left or right hepatic lobe as can be drainage more liver volume
Procedure: unilateral metal stent insertion
Experimental: bilateral metal stent insertion
percutaneous transhepatic biliary drainage plus bilateral metal stent.The bare stents were used for PTBS
Procedure: bilateral metal stent insertion



Primary Outcome Measures :
  1. 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 Measures :
  1. Median survival [ Time Frame: up to 1 year ]

Other Outcome Measures:
  1. Stent patency [ Time Frame: up to 1year ]
    Stent patency is a secondary endpoint of this study. Cumulative stent patency rate is compared between the two groups.

  2. Early major complications [ Time Frame: 30 days within treatment ]
    Early major complications is a secondary endpoint of this study.Early major complications rate is compared between the two groups

  3. 30-day mortality [ Time Frame: 30 days within treatment ]
    30-day mortality is a secondary endpoint of this study. 30-day mortality rate is compared between the two groups.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108145


Contacts
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Contact: Guohong Han, MD,Ph.D 86-29-84771528 hangh@fmmu.edu.cn
Contact: MingWu Li, MD lmw_jack@china.com.cn

Locations
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China, Shanxi
Han Guo Hong Recruiting
Xi'an, Shanxi, China, 710032
Contact: guohong han, M.D.    +86-29-84771537 ext +86-29-8253904    hangh2009@gmail.com   
Sub-Investigator: mingwu Li, M.D.         
Sponsors and Collaborators
Fourth Military Medical University
Investigators
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Principal Investigator: Guohong Han, MD,Ph.D Fourth Military Medical University
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Responsible Party: Guohong Han, Head of Department of Digestive Interventional Radiology, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT02108145    
Other Study ID Numbers: XHDD-004
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: August 2019
Keywords provided by Guohong Han, Fourth Military Medical University:
cholangiocarcinoma
jaundice
metal stent
PTBS
Additional relevant MeSH terms:
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Cholangiocarcinoma
Klatskin Tumor
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms