NCT02941861

Brief Summary

Objective:

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
Last Updated

October 21, 2016

Status Verified

October 1, 2016

Enrollment Period

Same day

First QC Date

October 20, 2016

Last Update Submit

October 20, 2016

Conditions

Keywords

Hepatocellular carcinomaCholangiocarcinomaRecurrence

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate of Liver Carcinoma after surgery

    3 years

Study Arms (2)

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.

Other: 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.

Other: Recurrence Rate of CCA after surgery

Interventions

Recurrence Rate of HCC after surgery

recurrence rate of HCC after surgery

Recurrence Rate of CCA after surgery

recurrence rate of CCA after surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • All patients having no pathology results were not included.
  • All patients having no show for follow up recording were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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.

    PMID: 25651787BACKGROUND
  • 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.

    PMID: 12547409BACKGROUND
  • 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.

    PMID: 8970487BACKGROUND
  • 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.

    PMID: 10024103BACKGROUND
  • 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.

    PMID: 9445114BACKGROUND
  • 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.

    PMID: 8916872BACKGROUND
  • 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.

    PMID: 17453285BACKGROUND
  • 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.

    PMID: 22346252BACKGROUND
  • 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.

    PMID: 11030243BACKGROUND
  • 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.

    PMID: 21691113BACKGROUND
  • 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.

    PMID: 16432356BACKGROUND

MeSH Terms

Conditions

Liver NeoplasmsRecurrenceCarcinoma, HepatocellularCholangiocarcinoma

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ms Ruechuta Molek (rmolek)

Study Record Dates

First Submitted

October 20, 2016

First Posted

October 21, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

October 21, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share