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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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 ]
- Median survival [ Time Frame: up to 1 year ]
- 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.
- 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
- 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.
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
|Contact: Guohong Han, MD,Ph.Demail@example.com|
|Contact: MingWu Li, MDfirstname.lastname@example.org|
|Han Guo Hong||Recruiting|
|Xi'an, Shanxi, China, 710032|
|Contact: guohong han, M.D. +86-29-84771537 ext +86-29-8253904 email@example.com|
|Sub-Investigator: mingwu Li, M.D.|
|Principal Investigator:||Guohong Han, MD,Ph.D||Fourth Military Medical University|