Clinical trial NCT02649712: Unilateral Stenting Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction
Official title: Unilateral Stenting Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholangiocarcinoma
Gallbladder Carcinoma
Hepatocellular Carcinoma
Lead sponsor: Xuzhou Central Hospital
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the clinical effectiveness and long-term outcomes between patients with malignant hilar biliary obstruction who are treated by unilateral or bilateral stenting.

Detailed description: Malignant hilar biliary obstruction is a common clinical manifestation and it can be caused by cholangiocarcinoma, gallbladder carcinoma, liver cancer, or other metastatic carcinoma. Most patients with malignant hilar biliary obstruction are unresectable at diagnosis. Biliary stenting has been widely used in palliative treatment of malignant hilar biliary obstruction.

Hilar biliary obstruction usually involves the bifurcation of the biliary tract. Some researchers recommended unilateral stenting for malignant hilar biliary obstruction because drainage of 25% of entire liver can achieve the clinical success of biliary drainage. However, some researchers recommended bilateral stenting for malignant hilar biliary obstruction because some researches demonstrated that bilateral stenting can achieve a longer stent patency.In addition, there was no significant difference in post stenting survival between patients who were treated by unilateral or bilateral stenting. Therefore, it remains under debate whether unilateral or bilateral stenting is better in the treatment of malignant hilar biliary obstruction.

The purpose of this study is to compare the clinical effectiveness and long-term outcomes between patients with malignant hilar biliary obstruction who are treated by unilateral or bilateral stenting.

Eligibility criteria: Inclusion Criteria:

1. Malignant hilar biliary obstruction;
2. Unresectable cases

Exclusion Criteria:

1. Bismuth I patients;
2. inability to obtain informed consent;
3. Eastern Cooperative Oncology Group performance status of 4;
4. severe dysfunction in other organs.

Primary outcomes:
measure: Stent patency (Stent dysfunction is suspected when the patient experiences recurrence of jaundice)
timeFrame: From the date of randomization until the date of first documented stent dysfunction, assessed up to 10 months
Secondary outcomes:
measure: Overall survival
timeFrame: From the date of randomization until the date of first documented death from any cause, assessed up to 12 months
measure: Stent dysfunction free-patient survival
timeFrame: From the date of randomization until the date of first documented stent dysfunction or the date of death from any cause, whichever came first, assessed up to 10 months.
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
Study officials:
affiliation: Xuzhou Central Hospital
name: Chi Cao, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Bulajic M, Panic N, Radunovic M, Scepanovic R, Perunovic R, Stevanovic P, Ille T, Zilli M, Bulajic M. Clinical outcome in patients with hilar malignant strictures type II Bismuth-Corlette treated by minimally invasive unilateral versus bilateral endoscopic biliary drainage. Hepatobiliary Pancreat Dis Int. 2012 Apr;11(2):209-14. doi: 10.1016/s1499-3872(12)60150-7.
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citation: Naitoh I, Ohara H, Nakazawa T, Ando T, Hayashi K, Okumura F, Okayama Y, Sano H, Kitajima Y, Hirai M, Ban T, Miyabe K, Ueno K, Yamashita H, Joh T. Unilateral versus bilateral endoscopic metal stenting for malignant hilar biliary obstruction. J Gastroenterol Hepatol. 2009 Apr;24(4):552-7. doi: 10.1111/j.1440-1746.2008.05750.x. Epub 2009 Feb 12.
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