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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral stent-in-stent insertion | Experimental | The passage of the bilateral metal stent across the stricture, stent-in-stent method. |
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| Bilateral side-by-side insertion | Active Comparator | The passage of the bilateral metal stent across the stricture, side-by-side method. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral stent-in-stent insertion | Procedure | Following negotiation of both IHD by two guidewires, inserted 1st stent to left IHD side. After deployment of the 1st stent across the hilar stricture, the remaining guide wire across the 1st stent was carefully withdrawn using an ERCP catheter without pulling it back completely. Then that guidewie was inserted under fluoroscopic guidance into the undrained right IHD through the central portion of the 1st stent. The 2nd cross-wired stent was then introduced over a guidewire through the central open mesh and then was deployed into the right IHD, so that the central portion of the 2nd stent overlapped the central portion of the 1st stent, forming a Y-shape. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Passage of the double stent across the stricture,along with flow of contrast medium and/or bile through the stent. Adequate expansion: 70% of maximal expanded diameter was dilated within 24 hr. | within 24 hr |
| Measure | Description | Time Frame |
|---|---|---|
| Early complications | Early complications such as pancreatitis, cholecystitis, cholangitis, jaundice, or external or internal stent migration within 30 days after stent insertion. | within 30 days after stent insertion |
| Late complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jong Ho Moon, MD, PhD | Contact | +82-32-621-5083 | jhmoon@schbc.ac.kr | |
| Tae Hoon Lee, MD | Contact | +82-41-570-3662 | thlee9@lycos.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Jong Ho Moon, MD, PhD | Soon Chun Hyang University College of Medicine, Bucheon Hospital, Bucheon, South Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soon Chun Hyang University College of Medicine, Bucheon Hospital | Recruiting | Bucheon-si | 420-767 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30905729 | Derived | Lee 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. |
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| Bilateral side-by-side insertion | Procedure | Following the introduction of two guidewires, the first stent was pushed and deployed into the left hepatic duct as possible, and then subsequently the second stent was pushed and deployed into the right hepatic duct, using the same method. In tight stricture during a guidewire manipulation, pneumatic biliary balloon dilation prior to insertion of first stent was performed. All stents were positioned above the level of the papilla, with their distal ends at the same level as possible. The diameter of the stent used in each case (8 or 10 mm) depended on the maximum diameter of the common bile duct (CBD). |
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Late complications were defines as complications such as pancreatitis, cholecystitis, cholangitis, jaundice, or stent migration after 30 days following stent insertion.
| after 30 days following stent insertion |
| Median stent patency | up to 1 year, from stent insertion to the occlusion of the stent |
| Median survival | 1 year, from stent insertion to the death of the patient |
| Soon Chun Hyang University College of Medicine, Cheonan Hospital | Recruiting | Cheonan | 330-721 | South Korea |
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