Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

Obstructive Jaundice Clinical Trial

Official title:

Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01622803
• Other study ID #: KH0LEE
• Status: Withdrawn
• Phase: Phase 3
• First received: June 12, 2012
• Last updated: April 24, 2016
• Start date: August 2011
• Est. completion date: August 2013

Study information

• Verified date: April 2016
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Internal biliary drainage using stent is used for malignant hilar obstruction such as cholangiocarcinoma, hepatocellular carcinoma and other malignancy including metastasis.

Bilateral drainage is more physiologic and have more long patency than unilateral drainage.

There are two methods of bilateral drainage: Y-stent and side by side.

However there are no clinical data about comparing the effectiveness of these two methods.

Therefore the investigators want to compare the clinical outcomes of two methods:

Y-stent and side by side.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age = 18 years

• patient who have obstructive jaundice (bilirubin > 2.0mg/dl) due to hilar malignancy

Exclusion Criteria:

• patients with endoscopic retrograde cholangiogram is not possible

• bleeding tendency (PT INR > 1.5, platelet < 50,000)

• poor general condition (ECOG 3-4) or cardiopulmonary deterioration

• pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Neoplasm
• Bile Duct Neoplasms
• Jaundice, Obstructive
• Obstructive Jaundice

Intervention

Procedure:
• parallel stent
bilateral parallel stent insertion (right and left side)

Device:
• Y-stent (BONASTENT M-Hilar)
Bilateral Y-stent insertion (stent in stent type)

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time taken to insert bilateral stent		After the ERCP procedure	Yes