NCT02014025|CompletedDMC
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Sponsor study identifier
Secondary identifiers
REGISTRY · Zhengshuguo
interventional
335
1 country
1
Study Start
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)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㎝.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
December 8, 2013
Actual (reported)December 17, 2013
Actual (reported)May 2015
Actual (reported)May 2015
Actual (reported)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
intraoperative parameters
during the operation
postoperative complications
Duration hospitalization(an expected average of 7 days)
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.
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.
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.
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.
Southwest Hospital
Chongqing, Chongqing Municipality, 400038, China
Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74.
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. doi: 10.1007/s00432-003-0446-6. Epub 2003 Jul 30.
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. doi: 10.1007/s00464-005-0694-4. Epub 2006 Oct 5.
Shuguo Zheng
Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
335 participants (actual enrollment reported by the registry).
First Submitted
December 8, 2013
First Posted
December 17, 2013
Study Start
March 2013
Date type not reportedRegistry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Agostini A, Robin F, Jais JP, Aggerbeck M, Vilde F, Blanc B, Lecuru 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. doi: 10.1007/s004640090081. Epub 2001 Nov 16.
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.
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.
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.
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.
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. doi: 10.1097/00000658-200107000-00010.
Zhou XD. Recurrence and metastasis of hepatocellular carcinoma: progress and prospects. Hepatobiliary Pancreat Dis Int. 2002 Feb;1(1):35-41.
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.
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. doi: 10.1053/ejso.2002.1292.
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. doi: 10.1111/j.1572-0241.2000.02028.x.
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.
This date has not been verified as actual or estimated.
Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)Last Updated
August 11, 2015
Record last verified: 2015-08
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