NCT02659852

A Study for Efficacy of Side-by-side Compared to Stent-in-stent Technique in the Endoscopic Management of Malignant Hilar Biliary Obstruction

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cholangiocarcinoma
• Gallbladder Cancer
• Pancreatic Cancer
• HCC
• AOV Cancer

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2016-01-20
• Last updated: 2019-01-28

Locations

1 site across 1 country: South Korea