Clinical trial NCT02659852: A Study for Efficacy of Side-by-side Compared to Stent-in-stent Technique in the Endoscopic Management of Malignant Hilar Biliary Obstruction
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholangiocarcinoma
Gallbladder Cancer
Pancreatic Cancer
HCC
AOV Cancer
Keywords: Hilar malignant biliary obstruction
bilateral metal stent
stent in stent
side by side
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Median patency duration
timeFrame: 1 year after stent insertion
Secondary outcomes:
measure: Overall survival
timeFrame: 1 year
measure: complication rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
Study officials:
References:
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.
citation: 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.