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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02941861
Other study ID # 010/2016
Secondary ID
Status Completed
Phase N/A
First received October 20, 2016
Last updated October 20, 2016
Start date August 2016
Est. completion date September 2016

Study information

Verified date October 2016
Source Chulabhorn Hospital
Contact n/a
Is FDA regulated No
Health authority Thailand: Institutional Review Board
Study type Observational

Clinical Trial Summary

Objective:

1. To study the factors that influence the 3- year recurrence of liver carcinoma after surgery

2. To study the related factors affecting recurrence of liver carcinoma after surgery


Description:

Liver carcinoma including 80% Hepatocellular carcinoma (HCC) and 20% Cholangiocarcinoma (CCA) becomes the leading causes of death in East and South-East Asia. Though hepatectomy is the treatment of choice for early stage cancer, the recurrence has been reported as 30%, 62% and 79% in 1st, 3rd and 5th year respectively. Chulabhorn hospital, a cancer institute established in 2011, has been performing a 3-years retrospective study on the influencing factors and its correlation to liver carcinoma after surgery.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date September 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients underwent liver resection for Hepatiocellular carcinoma and Cholangiocarcinoma respectively including having pathology results between February 2010 to December 2013. Data was received from Cholabhron Hospital's patient database.

Exclusion Criteria:

- All patients having no pathology results were not included.

- All patients having no show for follow up recording were excluded.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Intervention

Other:
Recurrence Rate of HCC after surgery
Recurrence Rate of HCC after surgery
Recurrence Rate of CCA after surgery
Recurrence Rate of CCA after surgery

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ruechuta Molek

References & Publications (11)

Hanazaki K, Kajikawa S, Shimozawa N, Mihara M, Shimada K, Hiraguri M, Koide N, Adachi W, Amano J. Survival and recurrence after hepatic resection of 386 consecutive patients with hepatocellular carcinoma. J Am Coll Surg. 2000 Oct;191(4):381-8. — View Citation

Hasegawa S, Ikai I, Fujii H, Hatano E, Shimahara Y. Surgical resection of hilar cholangiocarcinoma: analysis of survival and postoperative complications. World J Surg. 2007 Jun;31(6):1256-63. — View Citation

Imamura H, Matsuyama Y, Tanaka E, Ohkubo T, Hasegawa K, Miyagawa S, Sugawara Y, Minagawa M, Takayama T, Kawasaki S, Makuuchi M. Risk factors contributing to early and late phase intrahepatic recurrence of hepatocellular carcinoma after hepatectomy. J Hepatol. 2003 Feb;38(2):200-7. — View Citation

Ko S, Nakajima Y, Kanehiro H, Hisanaga M, Aomatsu Y, Kin T, Yagura K, Ohyama T, Nishio K, Ohashi K, Sho M, Yamada T, Nakano H. Significant influence of accompanying chronic hepatitis status on recurrence of hepatocellular carcinoma after hepatectomy. Result of multivariate analysis. Ann Surg. 1996 Nov;224(5):591-5. — View Citation

Peduzzi P, Concato J, Kemper E, Holford TR, Feinstein AR. A simulation study of the number of events per variable in logistic regression analysis. J Clin Epidemiol. 1996 Dec;49(12):1373-9. — View Citation

Poon RT, Fan ST, Lo CM, Liu CL, Wong J. Intrahepatic recurrence after curative resection of hepatocellular carcinoma: long-term results of treatment and prognostic factors. Ann Surg. 1999 Feb;229(2):216-22. — View Citation

Portolani N, Coniglio A, Ghidoni S, Giovanelli M, Benetti A, Tiberio GA, Giulini SM. Early and late recurrence after liver resection for hepatocellular carcinoma: prognostic and therapeutic implications. Ann Surg. 2006 Feb;243(2):229-35. — View Citation

Shimada M, Takenaka K, Taguchi K, Fujiwara Y, Gion T, Kajiyama K, Maeda T, Shirabe K, Yanaga K, Sugimachi K. Prognostic factors after repeat hepatectomy for recurrent hepatocellular carcinoma. Ann Surg. 1998 Jan;227(1):80-5. — View Citation

Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. — View Citation

Wadsworth CA, Dixon PH, Wong JH, Chapman MH, McKay SC, Sharif A, Spalding DR, Pereira SP, Thomas HC, Taylor-Robinson SD, Whittaker J, Williamson C, Khan SA. Genetic factors in the pathogenesis of cholangiocarcinoma. Dig Dis. 2011;29(1):93-7. doi: 10.1159/000324688. Epub 2011 Jun 17. — View Citation

Yusoff AR, Razak MM, Yoong BK, Vijeyasingam R, Siti ZM. Survival analysis of cholangiocarcinoma: a 10-year experience in Malaysia. World J Gastroenterol. 2012 Feb 7;18(5):458-65. doi: 10.3748/wjg.v18.i5.458. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence rate of Liver Carcinoma after surgery 3 years Yes
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