A Study for Efficacy of Side-by-side Compared to Stent-in-stent Technique in the Endoscopic Management of Malignant Hilar Biliary Obstruction
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|ClinicalTrials.gov Identifier: NCT02659852|
Recruitment Status : Recruiting
First Posted : January 20, 2016
Last Update Posted : January 28, 2019
Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, GB cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with placement of self-expanding metal stent (SEMS) for palliation is the therapy of choice in these patients. On hilar biliary malignant obstruction, bilateral stent used to be inserted. There are two kinds of bilateral metal stent insertion methods in hilar biliary malignant obstruction. (Stent in stent vs. side by side) Previously, two studies was conducted to show the superiority of bilateral metal stent insertion between stent in stent and side by side. Biliary drainage and stent patency was a little superior in side by side than stent in stent. But, complication related with bilateral metal stent was increased in patients with side by side method. Another study showed that there was no significant difference between those bilateral stent insertion methods. The most important concern about side by side method is associated with portal vein thrombosis by bilateral stent diameter. Selection of proper stent insertion method in patients with hilar malignant biliary obstruction is still controversial.
The purpose of this study is to investigate the patency of stent and survival of patients in side by side method (6mm sized M type) compared to stent in stent method (10mm sized LCD type) in patient with hilar malignant biliary obstruction.
|Condition or disease||Intervention/treatment||Phase|
|Cholangiocarcinoma Gallbladder Cancer Pancreatic Cancer HCC AOV Cancer||Procedure: side by side Procedure: stent in stent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Study for Efficacy of Side-by-side Compared to Stent-in-stent Technique in the Endoscopic Management of Malignant Hilar Biliary Obstruction|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
|Experimental: Side by side group||
Procedure: side by side
Stenting generally begins with selective guidewire cannulation into the left and right intrahepatic bile ducts. Self-expandable metallic stent(SEMS) deployment is the conventional method and parallel SEMS can be inserted. SEMS deployment can be performed serially or simultaneously.
|Active Comparator: Stent in stent group||
Procedure: stent in stent
After first SEMS deployment, contralateral placement of a second SEMS through the mesh of the first deployed stent was done and it looks like a Y configuration.
- Median patency duration [ Time Frame: 1 year after stent insertion ]Median patency duration from stent insertion date to stent occlusion date or last follow up date if stent is patent
- Overall survival [ Time Frame: 1 year ]
- complication rate [ Time Frame: 1 year ]
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): NCT02659852
|Korea, Republic of|
|Severance Hospital, Yonsei University||Recruiting|
|Seoul, Korea, Republic of, 120-752|
|Contact: Seungmin Bang, MD 02-2228-5412 Bang7028@yuhs.ac|
|Contact: Moonjae Chung, MD 82-10-5058-6865 email@example.com|