Condition category
Cancer
Date applied
08/12/2004
Date assigned
24/01/2005
Last edited
11/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Markus W Büchler

ORCID ID

Contact details

University of Heidelberg Medical School
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 6221 56 6200
markus.buechler@med.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KSC 05/2003

Study information

Scientific title

Influence of two different resection techniques of liver metastases from colorectal cancer on haematogenous tumour cell dissemination: a prospective randomised multicentre trial

Acronym

Anterior Approach Study

Study hypothesis

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

Ethics approval

Added 11/02/2009: Ethics Committee of University of Heidelberg Medical School gave approval in October 2002.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Liver cancer

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

01/02/2003

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

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).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

Patients with positive extrahepatic spread (including positive lymph nodes) routinely do not undergo liver resection, these patients will therefore be excluded from the study.

Recruitment start date

01/02/2003

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Germany, United States of America

Trial participating centre

University of Heidelberg Medical School
Heidelberg
69120
Germany

Sponsor information

Organisation

University of Heidelberg Medical School (Germany)

Sponsor details

Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 6221 56 6200
markus.buechler@med.uni-heidelberg.de

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Heidelberg (Germany) - Medical School

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Jung Stiftung (Germany)

Alternative name(s)

Jung Foundation for Science and Research, Jung-Stiftung

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Germany

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Protocol in http://www.ncbi.nlm.nih.gov/pubmed/18321372

Publication citations

  1. Protocol

    Schmidt T, Koch M, Antolovic D, Reissfelder C, Schmitz-Winnenthal FH, Rahbari NN, Schmidt J, Seiler CM, Büchler MW, Weitz J, Influence of two different resection techniques (conventional liver resection versus anterior approach) of liver metastases from colorectal cancer on hematogenous tumor cell dissemination - prospective randomized multicenter trial., BMC Surg, 2008, 8, 6, doi: 10.1186/1471-2482-8-6.

Additional files

Editorial Notes