Study of Liver Resection With Versus Without Hepatic Inflow Occlusion for the HBV-related HCC

Surgery Clinical Trial

— OHx-NOHx  

Official title:

Short- and Long-term Outcomes of Liver Resection With Versus Without Hepatic Inflow Occlusion for the Hepatitis B Virus-related Hepatocellular Carcinoma: a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02563158
• Other study ID #: JFJZYY-GD-15-01
• Secondary ID: NO. 2012BAI06B01
• Status: Not yet recruiting
• Phase: N/A
• First received: September 26, 2015
• Last updated: November 29, 2015
• Start date: January 2016
• Est. completion date: January 2019

Study information

• Verified date: November 2015
• Source: Chinese PLA General Hospital
• Contact: Shichun Lu, MD, PhD
• Phone: +86 10 68160801
• Email: sclu_301[@]163.com
• Is FDA regulated: No
• Health authority: China: Chinese Medical Association
• Study type: Interventional

Clinical Trial Summary

The study aims to compare the two liver resection techniques (with versus without hepatic inflow occlusion) in regards to perioperative and long-term outcomes of hepatectomy for HBV-related HCC.

Description:

Blood loss and the requirement of transfusions during liver resection have been shown to correlate well with postoperative morbidity and mortality. Total hepatic blood inflow occlusion, also known as the Pringle maneuver, is most commonly practiced for the control of bleeding during liver transection, which improves the surgical safety but also induces ischemia-reperfusion injury to the liver remnant as well as hemodynamic disturbance. These concerns are more profound in patients with hepatocellular carcinoma that are superimposed on hepatitis B cirrhosis. In the rise of living donor liver transplantation, techniques of donor liver lobe procurement without hepatic inflow occlusion have been established. This study aims to compare the outcomes of liver resection with versus without hepatic inflow occlusion.

This study will include Child-Pugh grading A patients with hepatitis B virus-related hepatocellular carcinoma scheduled for elective liver resection. 57 patients in each randomized arm will be analyzed to detect a difference in the short- and long-term outcomes (80% power and α = 0.05). The primary endpoint of the trial will be the serum level of total bilirubin on postoperative day 5. The secondary endpoints will be perioperative systemic response, procedure-related parameters, postoperative morbi-mortality and long-term patient outcomes. The statistical analysis is based on the intention-to-treat population. Patients will be followed for up to five years.

This prospective randomized controlled single-center trial is designed to evaluate liver resections with versus without the hepatic inflow occlusion with a special regard to the ischemia-reperfusion injury, perioperative systemic inflammatory response and long-term outcomes.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 114
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Elective liver resection due to HBV-related HCC with Barcelona-Clinic Liver Cancer (BCLC) staging 0 or A;

2. Child-Pugh classified A with or without cirrhosis, or reversed to A from B after conventional therapy;

3. Tumors locates either in the left or right hemiliver;

4. Resection extent was a hemi-hepatectomy or less;

5. Informed consent.

Exclusion Criteria:

1. Having comorbidity that contraindicates surgery;

2. Participation in concurrent interventional trials with interference to this study;

3. Eligible for laparoscopic hepatectomy;

4. Requiring concomitant procedures, such as digestive, vascular or biliary reconstruction;

5. Lack of compliance for treatment or future follow-up.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cancer
• Surgery

Intervention

Procedure:
• non-occlusion technique
Hepatectomy is carried out without hepatic inflow control. (non-occlusion technique)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

References & Publications (8)

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. Re — View Citation

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. — View Citation

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 hepatectom — View Citation

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. — View Citation

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: — View Citation

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. — View Citation

Llovet JM, Fuster J, Bruix J; Barcelona-Clínic Liver Cancer Group. The Barcelona approach: diagnosis, staging, and treatment of hepatocellular carcinoma. Liver Transpl. 2004 Feb;10(2 Suppl 1):S115-20. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative liver insufficiency	Postoperative liver insufficiency characterized by the serum total bilirubin on POD 5.	5 days	Yes
Secondary	Intraoperative blood loss	Total blood loss from the incision to the closure of abdomen	Entire operation duration	Yes
Secondary	Requirement of blood transfusion	The amount of intraoperative blood transfusion	Entire operation duration	Yes
Secondary	Operation time	The time from induction of anesthesia to the closure of abdomen	Entire operation duration	Yes
Secondary	Postoperative intensive-care unit (ICU) stay	Duration of stay in ICU	Duration of stay in ICU	Yes
Secondary	Hospital stay	Duration of hospital stay	Duration of hospital stay	Yes
Secondary	Total hospital expenditure	Total costs during hospital stay	Duration of hospital stay	No
Secondary	Perioperative systemic inflammatory response	Perioperative systemic inflammatory response is characterized by elevated serum level of tumor necrosis factor-a (TNF-a), interleukins (IL)-1a, 2, 6, 8 and 10, procalcitonin (PCT) and C-reactive protein (CRP) at different time points.	an expected average of 7 days	Yes
Secondary	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	Yes
Secondary	Long-term oncologic outcomes	1, 3, 5-year tumor recurrence rate	5 years after operation	No
Secondary	Long-term survival	1, 3, 5-year overall survival (OS) and disease (tumor)-free survival (DFS)	5 years after operation	No