Clinical trial · Interventional
Unilateral Stenting Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction
NCT02649712CI-TRIAL-00035882completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gallbladder Carcinoma | Gallbladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biliary stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Unilateral stent
- description
- Patients undergo placement of unilateral biliary stent on day 1.
- interventionNames
- Device: biliary stent
- type
- ACTIVE_COMPARATOR
- label
- Bilateral stents
- description
- Patients undergo placement of bilateral biliary stents on day 1.
- interventionNames
- Device: biliary stent
Primary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (10)
- BACKGROUNDIwano 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. PMID 21198916
- BACKGROUNDYasuda 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. PMID 23617655
- BACKGROUNDLiberato 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. PMID 22873816
- BACKGROUNDGwon 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. PMID 21940566
- BACKGROUNDMukai 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. PMID 22415652
- BACKGROUNDBulajic 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. PMID 22484591