Clinical trial · Interventional
Two Bilateral Metal Stenting in Hilar Malignancy
Clinical Outcomes of Endoscopic Bilateral Stent-in-stent Placement Versus Side-by-side Method With Newly Designed Metallic Stent for Malignant Hilar Biliary
- 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 overall median survival of nonresectable malignant hilar obstruction in most series has been less than 6 months. Most patients with malignant hilar obstruction present with advanced disease, making allative endoscopic drainage the principal therapeutic option. However, the optimal endoscopic management strategy is contentious. In malignant hilar obstruction, exclusively endoscopic placement of bilateral metal stents has been considered very difficult and complex, and it may require multiple procedures, with an increased risk of complications and mortality. To overcome this difficulty and strategize plan of management, the investigators evaluated the technical and clinical efficacy of endoscopic bilateral placement of newly designed stents, Y-configuration, followed by side-by-side insertion in failure of stent-in-stent method for the management of malignant hilar obstruction.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bilateral Stent Insertion | — | UNRESOLVED | — |
| Malignant Hilar Stricture | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bilateral side-by-side insertion | Procedure | — | UNRESOLVED |
| Bilateral stent-in-stent insertion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bilateral stent-in-stent insertion
- description
- The passage of the bilateral metal stent across the stricture, stent-in-stent method.
- interventionNames
- Procedure: Bilateral stent-in-stent insertion
- Procedure: Bilateral side-by-side insertion
- type
- ACTIVE_COMPARATOR
- label
- Bilateral side-by-side insertion
- description
- The passage of the bilateral metal stent across the stricture, side-by-side method.
- interventionNames
- Procedure: Bilateral stent-in-stent insertion
- Procedure: Bilateral side-by-side insertion
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient over 18 years old * patient with malignant hilar obstruction Exclusion Criteria: * refuse to participate in this study * refuse to provide informed consent * Karnofsky score \< 60% * physically unfit for endoscopic procedure
References
Publications (1)
- DERIVEDLee TH, Moon JH, Choi JH, Lee SH, Lee YN, Paik WH, Jang DK, Cho BW, Yang JK, Hwangbo Y, Park SH. Prospective comparison of endoscopic bilateral stent-in-stent versus stent-by-stent deployment for inoperable advanced malignant hilar biliary stricture. Gastrointest Endosc. 2019 Aug;90(2):222-230. doi: 10.1016/j.gie.2019.03.011. Epub 2019 Mar 21. PMID 30905729