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| ID | Type | Description | Link |
|---|---|---|---|
| NO. 2012BAI06B01 | Other Grant/Funding Number | National Key Technology R&D Program of China | |
| NO. 2012ZX10002-017 | Other Grant/Funding Number | National S&T Major Project for Infectious Diseases of China |
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The study aims to compare the perioperative and long-term outcomes of liver resection for HBV-related HCC with versus without hepatic inflow occlusion.
High prevalence of hepatitis B virus (HBV) imposes a huge burden of hepatocellular carcinoma (HCC) in Asia. Liver resection remains the mainstay of treatment for HCC. Hepatic inflow occlusion, known as the Pringle maneuver, is most commonly used to reduce blood loss during liver parenchymal transection. A major issue about this maneuver is the ischemia-reperfusion injury to the remnant liver. And the hemodynamic disturbance to the tumor-bearing liver remains an oncologic concern. Given the technical advances in living donor liver transplantation, vascular occlusion can be avoided in liver resection by experienced hands. This study aims to compare the perioperative and long-term outcomes of liver resection for HBV-related HCC without versus with hepatic inflow occlusion.
This study will include eligible patients with HBV-related HCC elected for liver resection. 57 patients will be enrolled in each randomized arm to detect a 20% difference in the serum level of total bilirubin on postoperative day 5 (80% power and α = 0.05). The secondary endpoints include procedural parameters, perioperative liver function and inflammatory response, postoperative morbidity and mortality, and long-term outcomes. Patients will be followed for up to five years. Data will be statistically analyzed on an intention-to-treat basis.
This prospective randomized controlled trial is designed to evaluate the feasibility of liver resections for HBV-related HCC without vascular occlusion. Clinical implication of its outcomes may change the present surgical practice and fill the oncologic gaps therein.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hx with hepatic inflow occlusion | No Intervention | Hepatectomy is carried out using Pringle maneuver in cycles of 15 minutes clamping + 5 minutes unclamping of the hepatoduodenal ligament. | |
| Hx with non-occlusion technique | Experimental | Hepatectomy without hepatic inflow occlusion (non-occlusion technique) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-occlusion technique | Procedure | Hepatectomy is carried out without hepatic inflow control. (non-occlusion technique) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum total bilirubin on postoperative day 5 | Postoperative liver insufficiency characterized by the serum total bilirubin on POD 5. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative blood loss | Total blood loss from the incision to the closure of abdomen | Entire operation duration |
| Requirement of blood transfusion | The amount of intraoperative blood transfusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shichun Lu, MD, PhD | Contact | +86 10 68160801 | sclu_301@163.com | |
| Yinzhe Xu, MD, PhD | Contact | +1 617 818 4081 | james_hbp@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shichun Lu, MD, PhD | Department of Hepatobiliary Surgery, Chinese PLA General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14762851 | Result | Llovet JM, Fuster J, Bruix J; Barcelona-Clinic Liver Cancer Group. The Barcelona approach: diagnosis, staging, and treatment of hepatocellular carcinoma. Liver Transpl. 2004 Feb;10(2 Suppl 1):S115-20. doi: 10.1002/lt.20034. | |
| 20137393 | Result | Dong JH, Yang SZ, Duan WD, Ji WB, Cai SW, Wang J, Shi XJ, Jiang K, Xia HT, He L, Zhang WZ, Huang XQ, Huang ZQ. [Clinical application of precise liver resection techniques in patients with complicated liver space-occupying lesions]. Zhonghua Wai Ke Za Zhi. 2009 Nov 1;47(21):1610-5. Chinese. |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D006498 | Hepatectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Entire operation duration |
| Operative time | The time from induction of anesthesia to the closure of abdomen | Entire operation duration |
| Postoperative intensive-care unit (ICU) stay | Duration of stay in ICU | Duration of stay in ICU |
| Hospital stay | Duration of hospital stay | Duration of hospital stay |
| Total hospital expenditure | Total costs during hospital stay | Duration of hospital stay |
| Perioperative systemic inflammatory response | Perioperative systemic inflammatory response is characterized by elevated serum level of tumor necrosis factor-α (TNF-α), interleukins (IL)-1α, 2, 6, 8 and 10, procalcitonin (PCT) and C-reactive protein (CRP) at different time points. | an expected average of 7 days |
| Postoperative morbi-mortality | Postoperative morbi-mortality is characterized by postoperative complication and its severity based on Clavien-Dindo classification and in-hospital mortality | an expected average of 12 days in hospital |
| Long-term oncologic outcomes | 1, 3, 5-year tumor recurrence rate | 5 years after operation |
| Long-term survival | 1, 3, 5-year overall survival (OS) and disease (tumor)-free survival (DFS) | 5 years after operation |
| 19094562 | Result | Huang ZQ, Xu LN, Yang T, Zhang WZ, Huang XQ, Liu R, Cai SW, Zhang AQ, Feng YQ, Zhou NX, Dong JH. [Liver resection: single center experiences of 2008 consecutive resections in 20 years]. Zhonghua Wai Ke Za Zhi. 2008 Sep 1;46(17):1314-21. Chinese. |
| 23943100 | Result | Dong J, Yang S, Zeng J, Cai S, Ji W, Duan W, Zhang A, Ren W, Xu Y, Tan J, Bu X, Zhang N, Wang X, Wang X, Meng X, Jiang K, Gu W, Huang Z. Precision in liver surgery. Semin Liver Dis. 2013 Aug;33(3):189-203. doi: 10.1055/s-0033-1351781. Epub 2013 Aug 13. Danish, English. |
| 20632273 | Result | Sugiyama Y, Ishizaki Y, Imamura H, Sugo H, Yoshimoto J, Kawasaki S. Effects of intermittent Pringle's manoeuvre on cirrhotic compared with normal liver. Br J Surg. 2010 Jul;97(7):1062-9. doi: 10.1002/bjs.7039. |
| 12143206 | Result | Kim YI, Song KE, Ryeon HK, Hwang YJ, Yun YK, Lee JW, Chun BY. Enhanced inflammatory cytokine production at ischemia/reperfusion in human liver resection. Hepatogastroenterology. 2002 Jul-Aug;49(46):1077-82. |
| 19300227 | Result | Katz SC, Shia J, Liau KH, Gonen M, Ruo L, Jarnagin WR, Fong Y, D'Angelica MI, Blumgart LH, Dematteo RP. Operative blood loss independently predicts recurrence and survival after resection of hepatocellular carcinoma. Ann Surg. 2009 Apr;249(4):617-23. doi: 10.1097/SLA.0b013e31819ed22f. |
| 20409520 | Result | Fu SY, Lau WY, Li GG, Tang QH, Li AJ, Pan ZY, Huang G, Yin L, Wu MC, Lai EC, Zhou WP. A prospective randomized controlled trial to compare Pringle maneuver, hemihepatic vascular inflow occlusion, and main portal vein inflow occlusion in partial hepatectomy. Am J Surg. 2011 Jan;201(1):62-9. doi: 10.1016/j.amjsurg.2009.09.029. Epub 2010 Apr 20. |
| 27724929 | Derived | Xu Y, Chen J, Wang H, Zheng H, Feng D, Zhang A, Leng J, Duan W, Yang Z, Chen M, Shi X, Cai S, Ji W, Jiang K, Zhang W, Chen Y, Gu W, Dong J, Lu S. Perioperative and long-term outcomes of liver resection for hepatitis B virus-related hepatocellular carcinoma without versus with hepatic inflow occlusion: study protocol for a prospective randomized controlled trial. Trials. 2016 Oct 11;17(1):492. doi: 10.1186/s13063-016-1621-9. |
| D008107 |
| Liver Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |