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Liver CancerNCT02941861

Factors Influencing the 3-Year Recurrence of Liver Carcinoma After Surgery

An observational study of Liver Cancer and Recurrence, run by Ruechuta Molek.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Any age
Conditions the study is for
Liver Cancer, Recurrence
What is being tested?
Recurrence Rate of HCC after surgery and Recurrence Rate of CCA after surgery
How many people
67 participants
Where
No sites listed yet
Study dates
Aug 2016to Sep 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

About this study

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
Read the 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.

Being tested
Recurrence Rate of HCC after surgery, Recurrence Rate of CCA after surgery
Keywords
Hepatocellular carcinoma, Cholangiocarcinoma, Recurrence
Medical subject headings
Liver Neoplasms, Recurrence, Carcinoma, Hepatocellular, Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recurrence Rate of HCC after surgeryOther

    Recurrence Rate of HCC after surgery

  • Recurrence Rate of CCA after surgeryOther

    Recurrence Rate of CCA after surgery

Study groups in NCT02941861
Study groupRoleWhat they receive
recurrence rate of HCC after surgeryThere 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.
Receives: Other: Recurrence Rate of HCC after surgery
recurrence rate of CCA after surgeryThere 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.
Receives: Other: Recurrence Rate of CCA after surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence rate of Liver Carcinoma after surgery

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionAug 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02941861
Sponsor's protocol ID
010/2016
Status last verified
Oct 2016
First submitted
20 Oct 2016
Last updated
21 Oct 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

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.

    PubMed 25651787

  • 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.

    PubMed 12547409

  • 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.

    PubMed 8970487

  • 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.

    PubMed 10024103

  • 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.

    PubMed 9445114

  • 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.

    PubMed 8916872

  • 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.

    PubMed 17453285

  • 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.

    PubMed 22346252

  • 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.

    PubMed 11030243

  • 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.

    PubMed 21691113

  • 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.

    PubMed 16432356

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Cancer and Recurrence, run by Ruechuta Molek.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence rate of Liver Carcinoma after surgery (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02941861, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2016.

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