Klatskin Tumor
Conditions
Keywords
Hilar tumor, Metal stent, Single, Multiple
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMetallic stent deployment in hilar obstruction
Single stent insertion: metal stent deployment to right or left intrahepatic duct Multiple stenting: Stent-in-stent or side-by-side deployment
Sponsors
Soon Chun Hyang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \> 18 years * inoperable hilar malignancy
Exclusion criteria
* age under 18 years * uncontrolled coagulopathy * inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reintervention rate when stents occluded | 2 years | When the stents occluded after successful single or multiple stent deployment, the outcome measure is assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success of single or multiple stents | 1 month | When the bilirubin level decrease more than 50% within one week or 75% within one month. |
Countries
South Korea
Outcome results
None listed