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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02659852
Other study ID # 4-2015-1072
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date January 2020

Study information

Verified date January 2019
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date January 2020
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Pathologically confirmed hilar malignant biliary obstruction or clinically defined malignant biliary obstruction

- older than 20 years old

Exclusion Criteria:

- Operable case

- Non-hilar biliary malignant obstruction

- Duodenal obstruction

- Other cancer except biliary malignancy

- uncontrolled infection status

- Eastern Cooperative Oncology Group = 3

- No signed informed consent

- Failed endoscopic approach to duodenum or biliary tract

Study Design


Intervention

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.
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.

Locations

Country Name City State
Korea, Republic of Severance Hospital, Yonsei University Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Kim KM, Lee KH, Chung YH, Shin JU, Lee JK, Lee KT, Shim SG. A comparison of bilateral stenting methods for malignant hilar biliary obstruction. Hepatogastroenterology. 2012 Mar-Apr;59(114):341-6. doi: 10.5754/hge11533. — View Citation

Law R, Baron TH. Bilateral metal stents for hilar biliary obstruction using a 6Fr delivery system: outcomes following bilateral and side-by-side stent deployment. Dig Dis Sci. 2013 Sep;58(9):2667-72. doi: 10.1007/s10620-013-2671-4. Epub 2013 Apr 27. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Median patency duration Median patency duration from stent insertion date to stent occlusion date or last follow up date if stent is patent 1 year after stent insertion
Secondary Overall survival 1 year
Secondary complication rate 1 year
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