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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unilateral stent | Active Comparator | Patients undergo placement of unilateral biliary stent on day 1. |
|
| Bilateral stents | Active Comparator | Patients undergo placement of bilateral biliary stents on day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biliary stent | Device | Self-expandable biliary nitinol alloys stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Stent dysfunction free-patient survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chi Cao, MD | Xuzhou Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuzhou Central Hospital | Xuzhou | Jiangsu | 221009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21198916 | Background | 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. | |
| 23617655 | Background | 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. |
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There is not a plan to make individual participant data available.
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| D005706 | Gallbladder Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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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. |
| 22873816 | Background | 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. |
| 21940566 | Background | 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. |
| 22415652 | Background | 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. |
| 22484591 | Background | 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. |
| 14605106 | Background | Inal M, Akgul 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. doi: 10.1097/01.rvi.0000096762.74047.a6. |
| 19220678 | Background | 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. |
| 25880978 | Background | 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. Chinese. |
| 30968181 | Derived | Fu YF, Zhou WJ, Shi YB, Cao W, Cao C. Percutaneous stenting for malignant hilar biliary obstruction: a randomized controlled trial of unilateral versus bilateral stenting. Abdom Radiol (NY). 2019 Aug;44(8):2900-2908. doi: 10.1007/s00261-019-02010-6. |
| D009369 | Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |