Laparoscopic Hepatectomy Versus Open Hepatectomy for PHC

Primary Liver Carcinoma Clinical Trial

Official title:

Laparoscopic Hepatectomy Versus Open Hepatectomy for PHC With a Tumor Size of 5-10cm:a Prospective Case-control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02014025
• Other study ID #: SWHZSG004
• Secondary ID: Zhengshuguo
• Status: Completed
• Phase: N/A
• First received: December 8, 2013
• Last updated: August 8, 2015
• Start date: March 2013
• Est. completion date: May 2015

Study information

• Verified date: August 2015
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare short-term and long-term efficacy of laparoscope hepatectomy and open hepatectomy, evaluate the safety and efficacy of laparoscope hepatectomy the PHC with a tumor size of 5～10㎝,and provide class B evidence based medicine for laparoscope hepatectomy for PHC with a tumor size of 5～10㎝.

Description:

Background:primary hepatic carcinoma( PHC) is the world's most common and one of the most malignant tumors, the incidence of malignant tumors in the top five in the world, second only to mortality in gastric cancer, ranked No. 3. surgery and comprehensive treatment is recognized by the medical profession Surgical approach, surgical methods include open and laparoscopic liver resection .The safety and efficacy of laparoscopic resection small PHC has been recognized, but the safety and efficacy of laparoscopy PHC resection is still a dispute, that with a tumor size of 5～10㎝, the clinical evidence is a C or D grade level from the standard definition of evidence-based medicine literature which has been published , for laparoscopic liver resection versus open liver resection for these hepatocellular carcinoma prospective case-control study has not been reported.

Intervention:We will let the 90 patients who meet the inclusion criteria .Patients in hepatobiliary surgery A, D district is undergo traditional open liver resection, hepatobiliary surgery E district is undergo laparoscopic liver resection. In addition to the surgery way is different, the rest treatments are same.

Results:

1. Clinical data include:operation time, intraoperative blood loss, volume of blood transfusion, Rate of blood transfusion, complications and mortality, postoperative liver function, resection margin, long-term curative effect and survival time were collected and analysed.

2. Statistical method:groups t-test ，univariate/multivariate analysis, logistic regression analysis, mixed linear regression, Cox survival analysis ，Kaplan-Meier survival analysis，Log-rank curves were used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria for the Laparoscope hepatectomy group are:

1. both male and female, aged 18 to 70;

2. PHC diagnosis is clear preoperative;

3. No active hepatitis and decompensated cirrhosis

4. tumor size of 5-10 cm,no intrahepatic or distant metastasis,no tumor thrombus in the portal vein, hepatic vein, vena cava, or bile duct; and no invasion of the diaphragm or surrounding tissues;

5. no rupture or bleeding of the tumor;

6. Child-Pugh class A or B liver function;

7. indocyanine green retention rate at 15 min of <15%, and a remnant liver volume/standard liver volume ratio of >50% in patients with liver cirrhosis and >35% in patients without liver cirrhosis;

8. upper abdominal surgery, radiofrequency ablation, Transhepatic Arterial Chemotherapy And Embolization treatment, radiotherapy and chemotherapy have not been implemented and no previous surgery that absolutely contraindicated Laparoscope hepatectomy.

9. General condition of patients and cardiopulmonary function enough to tolerate surgery

10. voluntary participation in the study, and informed consent.

• Inclusion criteria for the Open hepatectomy group are:

meet the criteria for Laparoscope hepatectomy group;

Exclusion Criteria:

• (1) age <18 years or> 70 years , pregnant or lactating women; (2) tumor size =10 cm, or tumor location that would interfere with intraoperative exposure and isolation of the hepatic hilum; (3) tumor encroaching on the hepatic hilum , the portal vein, primary bile duct or tumor adjacent to the major vascular structures ; (4) unable to tolerate a pneumoperitoneum or can't tolerate surgery duo to cardiopulmonary dysfunction; (5) severe upper abdominal adhesions; (6)Pathologically confirmed positive margins

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Primary Liver Carcinoma

Intervention

Procedure:
• Open hepatectomy
We let the 45 patients who are meet the inclusion criteria .Hospital in hepatobiliary surgery A and D district is Group A ,they will accept Open Hepatectomy: tumors are totally resected by conventional laparotomy.
• Laparoscope hepatectomy
We let the 45 patients who are meet the inclusion criteria .Hospital in hepatobiliary surgery E district is Group B ,they will accept Laparoscopic Hepatectomy: tumors are totally resected through laparoscopic.

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Shuguo Zheng, MD

Country where clinical trial is conducted

China, 

References & Publications (15)

Agostini A, Robin F, Jais JP, Aggerbeck M, Vildé F, Blanc B, Lécuru F. Impact of different gases and pneumoperitoneum pressures on tumor growth during laparoscopy in a rat model. Surg Endosc. 2002 Mar;16(3):529-32. Epub 2001 Nov 16. — View Citation

Fu C, Li GY, Liu FY, Lin QH, Fang XL. [Effect of carbon dioxide pneumoperitoneum-laparoscopic surgery on tumor seeding and metastases in endometrial cancer]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2008 Feb;33(2):130-7. Chinese. — View Citation

Hanazaki K, Kajikawa S, Shimozawa N, Matsushita A, Machida T, Shimada K, Yazawa K, Koide N, Adachi W, Amano J. Perioperative blood transfusion and survival following curative hepatic resection for hepatocellular carcinoma. Hepatogastroenterology. 2005 Mar-Apr;52(62):524-9. — View Citation

Jingli C, Rong C, Rubai X. Influence of colorectal laparoscopic surgery on dissemination and seeding of tumor cells. Surg Endosc. 2006 Nov;20(11):1759-61. Epub 2006 Oct 5. — View Citation

Kwon AH, Matsui Y, Kamiyama Y. Perioperative blood transfusion in hepatocellular carcinomas: influence of immunologic profile and recurrence free survival. Cancer. 2001 Feb 15;91(4):771-8. — View Citation

Makino Y, Yamanoi A, Kimoto T, El-Assal ON, Kohno H, Nagasue N. The influence of perioperative blood transfusion on intrahepatic recurrence after curative resection of hepatocellular carcinoma. Am J Gastroenterol. 2000 May;95(5):1294-300. — View Citation

Metzelder M, Kuebler JF, Shimotakahara A, Chang DH, Vieten G, Ure B. CO2 pneumoperitoneum increases survival in mice with polymicrobial peritonitis. Eur J Pediatr Surg. 2008 Jun;18(3):171-5. doi: 10.1055/s-2008-1038365. — View Citation

Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. — View Citation

Poon RT, Fan ST, Lo CM, Ng IO, Liu CL, Lam CM, Wong J. Improving survival results after resection of hepatocellular carcinoma: a prospective study of 377 patients over 10 years. Ann Surg. 2001 Jul;234(1):63-70. — View Citation

Rao A, Rao G, Ahmed I. Laparoscopic vs. open liver resection for malignant liver disease. A systematic review. Surgeon. 2012 Aug;10(4):194-201. doi: 10.1016/j.surge.2011.06.007. Epub 2011 Jul 30. Review. — View Citation

Toyosaka A, Okamoto E, Mitsunobu M, Oriyama T, Nakao N, Miura K. Intrahepatic metastases in hepatocellular carcinoma: evidence for spread via the portal vein as an efferent vessel. Am J Gastroenterol. 1996 Aug;91(8):1610-5. Retraction in: Am J Gastroenterol. 1998 Mar;93(3):492. — View Citation

Yeh CN, Lee WC, Jeng LB, Chen MF. Hepatic resection for hepatocellular carcinoma in Taiwan. Eur J Surg Oncol. 2002 Sep;28(6):652-6. — View Citation

Yin Z, Fan X, Ye H, Yin D, Wang J. Short- and long-term outcomes after laparoscopic and open hepatectomy for hepatocellular carcinoma: a global systematic review and meta-analysis. Ann Surg Oncol. 2013 Apr;20(4):1203-15. doi: 10.1245/s10434-012-2705-8. Epub 2012 Oct 26. Review. — View Citation

Zhou XD, Tang ZY, Ma ZC, Wu ZQ, Fan J, Qin LX, Zhang BH. Surgery for large primary liver cancer more than 10 cm in diameter. J Cancer Res Clin Oncol. 2003 Sep;129(9):543-8. Epub 2003 Jul 30. — View Citation

Zhou XD. Recurrence and metastasis of hepatocellular carcinoma: progress and prospects. Hepatobiliary Pancreat Dis Int. 2002 Feb;1(1):35-41. Review. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperative complications	ascites, pleural effusion,cardiopulmonary insufficiency,mortality, postoperative liver function failure.	Duration hospitalization(an expected average of 7 days)	Yes
Primary	survival rate	follow-up after the surgery every 3months, to understand relapse, death, statistics 1-year, 3-year overall survival rates,disease-free survival rates , recurrence and metastasis rate.	3-year	Yes
Secondary	intraoperative parameters	operation time, intraoperative blood loss, rate of blood transfusion, tumor resection margin.	during the operation	Yes