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In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness. However, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. The optimal endoscopic management strategy is contentious. The investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents.
In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness.
However, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. The optimal endoscopic management strategy is contentious.
The investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents.
First as an unilateral or bilateral stent will be deployed according to criteria.
In bilateral group, stent-in-stent or side-by-side deployment will be included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single stent deployment | Experimental | Metallic stent deployment in hilar obstruction. Insertion of metallic stent to the dominant targeted duct such as right anterior (segments V and VIII), right posterior (segments VI and VII) or left (segments II-IV). |
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| Multiple stent deployment | Active Comparator | Metallic stent deployment in hilar obstruction. Insertion of multiple metallic stent to the dominant targeted duct such as right anterior (segments V and VIII), right posterior (segments VI and VII) or left (segments II-IV). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metallic stent deployment in hilar obstruction | Device | Single stent insertion: metal stent deployment to right or left intrahepatic duct Multiple stenting: Stent-in-stent or side-by-side deployment |
| Measure | Description | Time Frame |
|---|---|---|
| Reintervention rate when stents occluded | When the stents occluded after successful single or multiple stent deployment, the outcome measure is assessed. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success of single or multiple stents | When the bilirubin level decrease more than 50% within one week or 75% within one month. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tae Hoon Lee, MD, PhD | Soonchunhyang University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tae Hoon Lee | Cheonan | 330721 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28479493 | Derived | Lee TH, Kim TH, Moon JH, Lee SH, Choi HJ, Hwangbo Y, Hyun JJ, Choi JH, Jeong S, Kim JH, Park DH, Han JH, Park SH. Bilateral versus unilateral placement of metal stents for inoperable high-grade malignant hilar biliary strictures: a multicenter, prospective, randomized study (with video). Gastrointest Endosc. 2017 Nov;86(5):817-827. doi: 10.1016/j.gie.2017.04.037. Epub 2017 May 4. |
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| ID | Term |
|---|---|
| D018285 | Klatskin Tumor |
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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|
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |