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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02659852
• Other study ID #: 4-2015-1072
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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