Single Versus Multiple Deployment of Metallic Stents for Inoperable Malignant Hilar Biliary Obstruction

Klatskin Tumor Clinical Trial

Official title:

Single Versus Multiple Deployment of Metallic Stents for Inoperable Malignant Hilar Biliary Obstruction: A Multicenter Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02166970
• Other study ID #: Hilar stenting
• Status: Completed
• Phase: N/A
• First received: June 13, 2014
• Last updated: February 27, 2017
• Start date: March 1, 2014
• Est. completion date: October 30, 2016

Study information

• Verified date: February 2017
• Source: Soon Chun Hyang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness. However, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. The optimal endoscopic management strategy is contentious. The investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents.

Description:

In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness.

However, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. The optimal endoscopic management strategy is contentious.

The investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents.

First as an unilateral or bilateral stent will be deployed according to criteria.

In bilateral group, stent-in-stent or side-by-side deployment will be included.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: October 30, 2016
• Est. primary completion date: February 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18 years

• inoperable hilar malignancy

Exclusion Criteria:

• age under 18 years

• uncontrolled coagulopathy

• inability to provide informed consent

Related Conditions & MeSH terms

• Klatskin Tumor

Intervention

Device:
• Metallic stent deployment in hilar obstruction
Single stent insertion: metal stent deployment to right or left intrahepatic duct Multiple stenting: Stent-in-stent or side-by-side deployment

Locations

Country	Name	City	State
Korea, Republic of	Tae Hoon Lee	Cheonan

Sponsors (1)

Lead Sponsor	Collaborator
Soon Chun Hyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reintervention rate when stents occluded	When the stents occluded after successful single or multiple stent deployment, the outcome measure is assessed.	2 years
Secondary	Technical success of single or multiple stents	When the bilirubin level decrease more than 50% within one week or 75% within one month.	1 month