Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| B-0901-068-003 | Other Identifier | Seoul National University Bundang Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
For patient with liver cirrhosis who need to right or extended right hepatectomy, we will treat with autologous peripheral stem cells transplantation to facilitate liver regeneration. We will asses liver regeneration by evaluation of liver volume and liver function test.
Patients: 30 patients (10 patients in each 3 group)
Indication:
Contraindication
Allocation: We will allocate patients randomly to three group including control group.
Methods
( -> after 4 weeks, operation will be performed)
Evaluation: Change of liver volume, liver function test before and after portal vein embolization
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. CD34 | Experimental |
|
|
| 2. Mononucelar cell | Active Comparator |
|
|
| 3. Control | Other | Without infusion of G-CSF, patients will be performed just right portal vein embolization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma pheresis, Right portal vein embolization | Procedure | Plasma pheresis : With insertin of 2 intravenous line, plasmapheresis will be done with COBE BCT Inc. It will be performed under supervision of clinical laboratorians and doctors. Right portal vein : Under ultrasonography guided, left portal vein be punctured. Right portal vein will be embolized by coil or gelfoam. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and efficacy, short term outcome | After portal vein embolization, we will compare liver volume by CT and liver function test by blood test in 3 groups. (Second and forth week) | 4 weeks after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and efficacy. | After 4 weeks of portal vein embolization, hepatectomy woul be performed in indicated patients. After hepatectomy, until 12 weeks, we will compare remnant liver volume by CT and liver function test by blood test. | 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ho-Seong Han, PhD | Contact | 82-31-787-7099 | hanhs@snubh.org | |
| Keun Soo Ahn, MD | Contact | 82-31-787-7099 | ahnks@snubh.org |
| Name | Affiliation | Role |
|---|---|---|
| Ho-Seong Han, PhD | Chairman of surgery, Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ho-Seong Han | Recruiting | Seongnam-si | Gyeonggi-do | South Korea |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 5, 2013 | |
| Reset | Jan 21, 2014 | |
| Release | May 19, 2015 | |
| Unrelease | Yes | |
| Release | Jun 4, 2015 | |
| Unrelease | Yes | |
| Release | Jun 8, 2015 | |
| Reset | Jun 29, 2015 | |
| Release | Apr 27, 2016 | |
| Reset | Jun 2, 2016 | |
| Release | Oct 27, 2016 | |
| Reset | Dec 27, 2016 | |
| Release | Jan 8, 2017 | |
| Reset | Feb 24, 2017 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 5, 2013 | Jan 21, 2014 | |||
| May 19, 2015 |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D010956 | Plasmapheresis |
| ID | Term |
|---|---|
| D001781 | Blood Component Removal |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Yes |
| Jun 4, 2015 | Yes |
| Jun 8, 2015 | Jun 29, 2015 |
| Apr 27, 2016 | Jun 2, 2016 |
| Oct 27, 2016 | Dec 27, 2016 |
| Jan 8, 2017 | Feb 24, 2017 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D013514 | Surgical Procedures, Operative |