Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the clinical benefits in the patients receiving Viatorr CX over a period of 12 months of structured Follow-up (before TIPS, at TIPS, 1 week after TIPS, at 6 weeks, 4 months, 6 months, 9 months, 12 months), regarding clinical endpoints, such as HE, readmission, liver injury, cardiac function, response to TIPS and the passive expansion of the stents in real life.
Case-control study using the patients in the University Clinic Bonn receiving Viatorr CX (n=40), using a comparison ration 1:1:1 to Viatorr and bare metal stents.
Of these patients, 20 patients will receive Viatorr CX and the assessement of the width of the stent as outlined in the JVIR-paper published this year.
The Viatorr and BMS controls with similar age, gender, Child, MELD and indication for TIPS.
A total of 125 patients with the primary composite-endpoint HE/readmission will be investigated Secondary endpoints are liver injury, cardiac function, response to TIPS and the passive expansion of the stents in real life.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bare metal stent (BMS) TIPS | retrospective patients receiving BMS-TIPS for treatment of complications of portal hypertension. |
| |
| Regular Viatorr (RV) TIPS | retrospective patients receiving RV-TIPS for treatment of complications of portal hypertension. |
| |
| Viatorr Control Expansion (VCX)TIPS | prospective patients receiving VCX-TIPS for treatment of complications of portal hypertension. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIPS | Device | Transjugular Intrahepatic Portosystemic Shunt |
|
| Measure | Description | Time Frame |
|---|---|---|
| Readmissions | Number of readmissions will be documented using a structured CRF | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hepatic encephalopathy (HE) | Number of Episodes of overt HE (West Haven Criteria > Grad I) | 12 months |
| Liver injury | Increase in liver function tests |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Case-control study using the patients in our center receiving Viatorr CX (n=40), using a comparison ration 1:1:1 to Viatorr and bare metal stents (all available data from our center). Thereby, we will choose 20 patients receiving Viatorr CX and the assessement of the width of the stent as outlined in the JVIR-paper published this year. The Viatorr and BMS controls with similar age, gender, Child, MELD and indication for TIPS. We will investigate a total 125 patients with the primary composite-endpoint HE/readmission, and secondary endpoints will be liver injury, cardiac function, response to TIPS and the passive expansion of the stents in real life.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonel Trebicka, MD, PhD | Laboratory for Liver Fibrosis and Portal Hypertension | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory for Liver Fibrosis and Portal Hypertension | Bonn | 53127 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019168 | Portasystemic Shunt, Transjugular Intrahepatic |
| ID | Term |
|---|---|
| D011170 | Portasystemic Shunt, Surgical |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
Not provided
Not provided
Not provided
Not provided
Not provided
blood, stool, DNA
| 12 months |
| Response to TIPS | grade of ascites after TIPS | 12 months |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |