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ISRCTN
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ISRCTN45066244
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ClinicalTrials.gov identifier
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Public title
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Influence of two different resection techniques of liver metastases from colorectal cancer on haematogenous tumour cell dissemination
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Scientific title
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Influence of two different resection techniques of liver metastases from colorectal cancer on haematogenous tumour cell dissemination: a prospective randomised multicentre trial
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Acronym
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Anterior Approach Study
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Serial number at source
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KSC 05/2003
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Study hypothesis
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We hypothesise that intraoperative haematogenous tumour cell dissemination could be reduced or prevented by using the anterior approach technique in resection of colorectal liver metastases.
Please note that as of 11/02/2009 this record was updated to include an amended end date. The initial end date at the time of registration was:
Initial anticipated end date: 28/02/2009
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Lay summary
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Ethics approval
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Added 11/02/2009: Ethics Committee of University of Heidelberg Medical School gave approval in October 2002.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany, United States of America
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Disease/condition/study domain
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Liver cancer
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Participants - inclusion criteria
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1. Hospitalised patients of the Department of Surgery, University of Heidelberg or of the Hepatobiliary Division, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, aged greater than 18 years (no upper age limit)
2. Are considered for a potentially curative (R0) right hepatectomy (removal of segments 5,6,7,8), extended right hepatectomy (removal of segments 5,6,7,8, part of segment 4) or right trisegmentectomy (removal of segments 4,5,6,7,8) for colorectal liver metastases
There will be 150 patients (75 each group) accrued in this study (excluding patients who underwent R1 resection and/or with an intraoperative blood loss of greater than or equal to 2000 cc).
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Participants - exclusion criteria
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Patients with positive extrahepatic spread (including positive lymph nodes) routinely do not undergo liver resection, these patients will therefore be excluded from the study.
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Anticipated start date
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01/02/2003
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Anticipated end date
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31/12/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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150
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Interventions
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Patients with liver metastases from colorectal cancer scheduled for a potentially curative normal or extended right hemihepactomy.
The study will be performed as a prospective randomised multicentre trial. Patients will be randomised intraoperatively in each institution: one group will undergo conventional liver resection and the other group will be operated with the anterior approach technique.
On day 0 the patient will undergo exploration. In case of suspected extrahepatic spread (including grossly involved lymph nodes) frozen sections of the suspicious areas will be performed. All these procedures are considered routine and are carried out for any patient undergoing resection of liver tumours. Patients with positive extrahepatic spread (including positive lymph nodes) routinely do not undergo liver resection, these patients will therefore be excluded from the study. After extrahepatic tumour spread is excluded, the surgeon will again evaluate whether resection of the tumour can be performed by either technique. Once this criteria is met, the patient will be randomised to one of the two groups: one group will undergo conventional liver resection and the other group will undergo resection using the anterior approach technique.
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Primary outcome measure(s)
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To compare the anterior approach to the conventional technique of hepatic resection for colorectal metastases with respect to the incidence of intraoperative haematogenous tumour cell dissemination. We hypothesise that intraoperative haematogenous tumour cell dissemination could be reduced or prevented by using the anterior approach technique in resection of colorectal liver metastases.
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Secondary outcome measure(s)
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1. Survival of the patients (overall and disease-free survival)
2. Blood loss
3. Duration time of resection
4. Transfusion requirements
5. Complication rates
Assessed between the two different liver resection techniques. Furthermore the prognostic relevance of tumor cell detection in blood and bone marrow and the comparison of tumor cell detection by different detection methods will be analysed.
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Sources of funding
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1. University of Heidelberg (Germany) - Medical School
2. Jung Stiftung (Germany)
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Trial website
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Publications
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Protocol in http://www.ncbi.nlm.nih.gov/pubmed/18321372
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Contact name
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Prof
Markus W
Büchler
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Address
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University of Heidelberg Medical School
Im Neuenheimer Feld 110
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City/town
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Heidelberg
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Zip/Postcode
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69120
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Country
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Germany
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Tel
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+49 6221 56 6200
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Fax
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+49 6221 56 6988
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Email
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markus.buechler@med.uni-heidelberg.de
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Sponsor
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University of Heidelberg Medical School (Germany)
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Address
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Im Neuenheimer Feld 110
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City/town
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Heidelberg
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Zip/Postcode
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69120
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Country
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Germany
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Tel
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+49 6221 56 6200
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Fax
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+49 6221 56 6988
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Email
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markus.buechler@med.uni-heidelberg.de
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Date applied
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08/12/2004
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Last edited
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11/02/2009
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Date ISRCTN assigned
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24/01/2005
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