- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02941861
Factors Influencing the 3-Year Recurrence of Liver Carcinoma After Surgery
October 20, 2016 updated by: Ruechuta Molek
Objective:
- To study the factors that influence the 3- year recurrence of liver carcinoma after surgery
- To study the related factors affecting recurrence of liver carcinoma after surgery
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
67
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
There were 33 and 34 patients underwent liver resection for Hepatocellular carcinoma and Cholangiocarcinoma respectively between February 2010 to December 2013.
All patients were staged according to the tumor-node metastasis (TNM) system and appraised by the hospital tumor board conference.
After surgery, an attending physician followed up patients by tumor marker and imaging as standard treatment as well as diagnosed its recurrence.
In addition, all recurrence cases had standard treatments till the end of life.
The survival was classified as the dates between the operation and the death.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
recurrence rate of HCC after surgery
There were 33 for Hepatocellular carcinoma between February 2010 to December 2013.
All patients were staged according to the tumor-node metastasis (TNM) system and appraised by the hospital tumor board conference.
After surgery, an attending physician followed up patients by tumor marker and imaging as standard treatment as well as diagnosed its recurrence.
In addition, all recurrence cases had standard treatments till the end of life.
The survival was classified as the dates between the operation and the death.
|
Recurrence Rate of HCC after surgery
|
recurrence rate of CCA after surgery
There were 34 patients underwent liver resection for Cholangiocarcinoma between February 2010 to December 2013.
All patients were staged according to the tumor-node metastasis (TNM) system and appraised by the hospital tumor board conference.
After surgery, an attending physician followed up patients by tumor marker and imaging as standard treatment as well as diagnosed its recurrence.
In addition, all recurrence cases had standard treatments till the end of life.
The survival was classified as the dates between the operation and the death.
|
Recurrence Rate of CCA after surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recurrence rate of Liver Carcinoma after surgery
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Epub 2015 Feb 4.
- 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. doi: 10.1016/s0895-4356(96)00236-3.
- 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. doi: 10.1016/s0168-8278(02)00360-4.
- 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. doi: 10.1097/00000658-199902000-00009.
- 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. doi: 10.1097/00000658-199801000-00012.
- 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. doi: 10.1097/00000658-199611000-00001.
- 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. doi: 10.1007/s00268-007-9001-y.
- 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.
- 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. doi: 10.1016/s1072-7515(00)00700-6.
- 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.
- 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. doi: 10.1097/01.sla.0000197706.21803.a1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
October 20, 2016
First Submitted That Met QC Criteria
October 20, 2016
First Posted (Estimate)
October 21, 2016
Study Record Updates
Last Update Posted (Estimate)
October 21, 2016
Last Update Submitted That Met QC Criteria
October 20, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 010/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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