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Hepatocellular carcinoma (HCC) is one of the most common malignant tumors in the world, accounting for the second leading cause of cancer death in China.Surgical treatment of hepatocellular carcinoma is the most important means for long-term survival of patients with hepatocellular carcinoma, including hepatectomy and liver transplantation.Chronic liver disease caused by hepatitis B infection is the main pathogenic factor of liver cancer in China. Meanwhile, nearly 80% of patients with hepatocellular carcinoma are complicated with cirrhosis, and the incidence of thrombocytopenia in patients with cirrhosis is reported to be as high as 78%.Many previous studies have found that thrombocytopenia is closely related to perioperative outcome of hepatocellular carcinoma.The purpose of this study was to evaluate the efficacy and safety of avatripopa in the treatment of thrombocytopenia in patients with primary hepatocellular carcinoma undergoing elective hepatectomy and its effect on perioperative outcome.
The indicators included changes in platelet count before and after drug treatment and operation, the nature and amount of postoperative drainage (ascites), duration of indwelling drainage tube, intraoperative blood loss, perioperative complications, length of hospital stay, etc.After comprehensive consideration of all perioperative indicators, we selected the total amount of drainage (ascites) multiple days after surgery as the primary outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with primary hepatocellular carcinoma undergoing elective hepatectomy | The baseline platelet count before enrollment was < 75×10^9/L and > 30×10^9/L.The primary clinical diagnosis of hepatocellular carcinoma was confirmed, and the CNLC stages were Ia and Ib.An elective hepatectomy, including laparotomy or laparoscopic hepatectomy, except hepatectomy combined with splenectomy or radiofrequency ablation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avatrombopag | Drug | On the basis of conventional treatment, Avatrombopag was added, 30×10^9/L < platelet count < 50×10^9/L patients received Avatrombopag 60mg/d, 50×10^9/L≤ platelet count < 75×10^9/L patients received Avatrombopag 40mg/d for 5 consecutive days, and waited for a period of time after drug withdrawal.Surgery is expected to take place on day 10-13 of the initial dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with a platelet count ≥75×10^9/L and an increase of platelet count more than 20% from baseline | The Percentage of patients in the treatment group with platelet count ≥75×10^9/L (the highest test value of of platelet count was taken on day 9-12 of treatment) and an increase of platelet count more than 20% from baseline before operation. | on day 9-12 of treatment |
| Comparison of total amount of postoperative drainage fluid between treatment group and control group | Comparison of total amount of postoperative drainage fluid on day 1, 3 and 5 after surgery between treatment group and control group | on day 1-5 after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of intraoperative blood loss | Comparison of intraoperative blood loss between Treatment group and control group. | During surgery |
| Proportion of patients receiving remedial treatment due to bleeding risk after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Elective hepatectomy with thrombocytopenia in adults with primary hepatocellular carcinoma
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Zhou, MD PhD | Contact | 13801914007 | zhou.jian@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jian Zhou, MD PhD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan hospital, Fudan University | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31391802 | Background | Miller JB, Figueroa EJ, Haug RM, Shah NL. Thrombocytopenia in Chronic Liver Disease and the Role of Thrombopoietin Agonists. Gastroenterol Hepatol (N Y). 2019 Jun;15(6):326-332. | |
| 29956689 | Background | Li J, Han B, Li H, Deng H, Mendez-Sanchez N, Guo X, Qi X. Association of coagulopathy with the risk of bleeding after invasive procedures in liver cirrhosis. Saudi J Gastroenterol. 2018 Jul-Aug;24(4):220-227. doi: 10.4103/sjg.SJG_486_17. |
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| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| C533238 | avatrombopag |
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Comparison of the proportion of patients receiving remedial treatment due to bleeding risk after surgery between the treatment group and the control group
| on day 0-30 after surgery |
| Indwelling time of drainage tube | Comparison of postoperative indwelling time of drainage tube between treatment group and control group | on day 0-10 after surgery |
| Red blood cell count and hemoglobin content of drainage fluid | Comparison of red blood cell count and hemoglobin content of drainage fluid between treatment group and control group on the 1st, 3rd and 5th day after operation | on day 1-5 after surgery |
| Postoperative hospitalization time | Comparison of postoperative hospitalization time between treatment group and control group | on 0-30 day after surgery |
| Preoperative platelet count increase from baseline | Preoperative platelet count increase from baseline in treatment group. | before surgery |
| The change of platelet count from baseline at different time points | The change of platelet count from baseline at different time points in the treatment group. | through study completion, an average of 1 year |
| 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 |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |