Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012ZX10002016-004 | Other Grant/Funding Number | The State Key Project on Inflection Disease of China |
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
This clinical trial aims to compare infrahepatic inferior vena cava clamping (IIVCC) with selective hepatic vascular exclusion (SHVE) involving the portal triad clamping (PTC) in complex cirrhotic liver resection. One group will receive IIVCC plus PTC, while an another equivalent group patients will be operated using SHVE and PTC.
Intraoperative blood loss is significantly associated with clinical outcomes of patients undergoing hepatectomy. There have been various hepatic vascular control techniques, including infrahepatic inferior vena cava clamping (IIVCC) and selective hepatic vascular exclusion (SHVE).The propose of this study is to compare these two surgical techniques combined with the portal triad clamping (PTC) in hepatic cirrhotic patients. All patients being performed hepatectomy at the center are scanned according to inclusion and exclusion criteria. After intraoperative exploration, patients are randomized into two interventional groups. PTC, IIVCC or SHVE is performed at the specified timepoint in liver parenchymal transection in two different groups. All data are collected prospectively.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IIVCC group | Experimental | The portal triad and infrahepatic inferior vena cava are dissected and taped with a vessel loop, respectively. During liver parenchymal resection，portal triad and infrahepatic inferior vena cava clampings are performed at the specified transection depth from liver surface successively. |
|
| SHVE group | Active Comparator | In this group, the portal triad clamping and selective hepatic vascular exclusion of major hepatic veins are used. Different major hepatic veins are occluded by clamping forcep depending on the site of tumors. The clamping timepoints are same as the IIVCC group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infrahepatic inferior vena cava clamping | Procedure | Infrahepatic inferior vena cava is clamped in hepatectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative blood loss | blood loss from incision to closure | Intraoperative period |
| Normalized transection-related blood loss | Intraoperative blood loss normalized by transection surface area | Intraoperative period |
| Measure | Description | Time Frame |
|---|---|---|
| Time of infrahepatic inferior vena cava or selected hepatic vein dissection | Time cost of dissection | Intraoperative period |
| Variations of intraoperative infrahepatic inferior vena cava pressure or hepatic vein pressure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoping Chen, M.D. | Contact | +86 27 83662851 | chenxp@medmail.com.cn | |
| Chao Wu, M.M. | Contact | +8618986136006 | dr_wuchao@hust.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoping Chen, M.D. | Tongji Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Recruiting | Wuhan | Hubei | 430030 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| Selective hepatic vascular exclusion | Procedure | Selected major hepatic vein is clamped in hepatectomy. |
|
|
| Portal triad clamping | Procedure | Portal triad are clamped in hepatectomy. |
|
|
| Intraoperative period |
| Drop of hemoglobin level | Drop of hemoglobin level will be measured during liver parenchymal transection period(neither the specific time point nor expected average could be given prospectively because of different surgical situations) |
| Postrecovery of liver function | Liver function evaluation is composite of liver enzyme ，total bilirubin, prothrombin activity, etc. | postoperative days 1, 3, 5, 7 |
| Postrecovery of renal function | Renal function evaluation is composite of blood urea nitrogen, creatinine, etc. | postoperative days 1, 3, 5, 7 |
| Morbidity of postoperative complications | 90 days after surgery |
| Postoperative mortality | 90 days after surgery |
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D008103 | Liver Cirrhosis |
| D006528 | Carcinoma, Hepatocellular |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided