Unilateral Stenting Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction

Hepatocellular Carcinoma Clinical Trial

Official title:

Unilateral Stenting Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02649712
• Other study ID #: xzxy20160106
• Status: Completed
• Phase: N/A
• Start date: January 20, 2016
• Est. completion date: October 31, 2018

Study information

• Verified date: November 2018
• Source: Xuzhou Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Gallbladder Carcinoma
• Hepatocellular Carcinoma

Intervention

Device:
• biliary stent
Self-expandable biliary nitinol alloys stent

Locations

Country	Name	City	State
China	Xuzhou Central Hospital	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View Citation

Gwon DI, Ko GY, Sung KB, Yoon HK, Shin JH, Hyoung Kim J, Kim J, Oh JY. Percutaneous biliary metallic stent placement in patients with unilobar portal vein occlusion caused by advanced hilar malignancy: outcome of unilateral versus bilateral stenting. AJR Am J Roentgenol. 2011 Oct;197(4):795-801. doi: 10.2214/AJR.11.6424. — View Citation

Inal M, Akgül E, Aksungur E, Seydaoglu G. Percutaneous placement of biliary metallic stents in patients with malignant hilar obstruction: unilobar versus bilobar drainage. J Vasc Interv Radiol. 2003 Nov;14(11):1409-16. — View Citation

Iwano H, Ryozawa S, Ishigaki N, Taba K, Senyo M, Yoshida K, Sakaida I. Unilateral versus bilateral drainage using self-expandable metallic stent for unresectable hilar biliary obstruction. Dig Endosc. 2011 Jan;23(1):43-8. doi: 10.1111/j.1443-1661.2010.01036.x. Epub 2010 Nov 30. — View Citation

Li M, Wu W, Yin Z, Han G. [Unilateral versus bilateral biliary drainage for malignant hilar obstruction: a systematic review and meta-analysis]. Zhonghua Gan Zang Bing Za Zhi. 2015 Feb;23(2):118-23. doi: 10.3760/cma.j.issn.1007-3418.2015.02.009. Review. Chinese. — View Citation

Liberato MJ, Canena JM. Endoscopic stenting for hilar cholangiocarcinoma: efficacy of unilateral and bilateral placement of plastic and metal stents in a retrospective review of 480 patients. BMC Gastroenterol. 2012 Aug 9;12:103. doi: 10.1186/1471-230X-12-103. — View Citation

Mukai T, Yasuda I, Nakashima M, Doi S, Iwashita T, Iwata K, Kato T, Tomita E, Moriwaki H. Metallic stents are more efficacious than plastic stents in unresectable malignant hilar biliary strictures: a randomized controlled trial. J Hepatobiliary Pancreat Sci. 2013 Feb;20(2):214-22. doi: 10.1007/s00534-012-0508-8. — View 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. — View Citation

Yasuda I, Mukai T, Moriwaki H. Unilateral versus bilateral endoscopic biliary stenting for malignant hilar biliary strictures. Dig Endosc. 2013 May;25 Suppl 2:81-5. doi: 10.1111/den.12060. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stent patency (Stent dysfunction is suspected when the patient experiences recurrence of jaundice)	Stent dysfunction is suspected when the patient experiences recurrence of jaundice.	From the date of randomization until the date of first documented stent dysfunction, assessed up to 10 months
Secondary	Overall survival	From the date of randomization until the date of first documented death from any cause.	From the date of randomization until the date of first documented death from any cause, assessed up to 12 months
Secondary	Stent dysfunction free-patient survival	From the date of randomization until the date of first documented stent dysfunction or the date of death from any cause, whichever came first.	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.