Metal Versus Plastic Stent in Malignant Hilar Biliary Obstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-15

Study Completion Date

2021-06-30

Brief Summary

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The purpose of this study was to compare the difference in the stent patency duration between side-by-side fully covered self-expanding metal stents (SEMS) and side-by-side plastic stents in patients with malignant hilar biliary obstruction.

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Detailed Description

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In the case of distal common bile duct obstruction, the SEMS was reported to be clinically superior to the plastic stent in previous studies. However, there are few studies comparing the two methods in patients with malignant hilar biliary obstruction. In contrast to the distal common bile duct obstruction, the advantage of plastic stents over SEMSs exists, and plastic stents are used commonly in real clinical practice.

Conditions

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Malignant Hepatobiliary Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FCSEMS

In patients with malignant hilar biliary obstruction, endoscopic drainage is performed for biliary drainage. Since intrahepatic bile ducts are separated, it is preferable to insert a stent into bilateral intrahepatic bile ducts for bile drainage if possible. In FCSEMS group, patients are inserted with Fully covered self-expandable metal stent (FCSEMS) bilaterally for malignant hilar biliary stricture via endoscopic retrograde cholangio-pancreatography.

Group Type EXPERIMENTAL

endoscopic retrograde cholangio-pancreatography

Intervention Type PROCEDURE

In patients who were identified to have malignant hilar biliary obstruction, bilateral stents insertion is attempted via ERCP. There will be two groups divided by stent material; FCSEMS and Plastic stent.

Plastic stent

In patients with malignant hilar biliary obstruction, endoscopic drainage is performed for biliary drainage. Since intrahepatic bile ducts are separated, it is preferable to insert a stent into bilateral intrahepatic bile ducts for bile drainage if possible. In plastic stent group, patients are inserted with plastic stents bilaterally for malignant hilar biliary stricture.

Group Type ACTIVE_COMPARATOR

endoscopic retrograde cholangio-pancreatography

Intervention Type PROCEDURE

In patients who were identified to have malignant hilar biliary obstruction, bilateral stents insertion is attempted via ERCP. There will be two groups divided by stent material; FCSEMS and Plastic stent.

Interventions

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endoscopic retrograde cholangio-pancreatography

In patients who were identified to have malignant hilar biliary obstruction, bilateral stents insertion is attempted via ERCP. There will be two groups divided by stent material; FCSEMS and Plastic stent.

Intervention Type PROCEDURE

Other Intervention Names

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Plastic stent FCSEMS

Eligibility Criteria

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Inclusion Criteria

* Unresectable malignant hilar biliary stricture requiring biliary drainage through endoscopic procedure

Exclusion Criteria

* If endoscopy is not possible based on the judgement of the researcher
* Life expectancy less than 6 months
* Acute cholecystitis
* Previous history of percutaneous transhepatic biliary drainage
* Previous history of metal stent placement for malignant biliary stricture

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes