Influence of two different resection techniques of liver metastases from colorectal cancer on haematogenous tumour cell dissemination

ISRCTN	ISRCTN45066244
DOI	https://doi.org/10.1186/ISRCTN45066244
Protocol serial number	KSC 05/2003
Sponsor	University of Heidelberg Medical School (Germany)
Funders	University of Heidelberg (Germany) - Medical School, Jung Stiftung (Germany)

Submission date: 08/12/2004
Registration date: 24/01/2005
Last edited: 05/11/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Markus W Büchler
Scientific

University of Heidelberg Medical School
Im Neuenheimer Feld 110
Heidelberg
69120
Germany

Phone	+49 6221 56 6200
Email	markus.buechler@med.uni-heidelberg.de

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Influence of two different resection techniques of liver metastases from colorectal cancer on haematogenous tumour cell dissemination: a prospective randomised multicentre trial
Study acronym	Anterior Approach Study
Study objectives	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(s)	Added 11/02/2009: Ethics Committee of University of Heidelberg Medical School gave approval in October 2002.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	150
Total final enrolment	80
Key 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).
Key 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.
Date of first enrolment	01/02/2003
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Germany
United States of America

Study participating centre

University of Heidelberg Medical School

Heidelberg
69120
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2021	05/11/2020	Yes	No
Protocol article	Protocol	05/03/2008		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

05/11/2020: Publication reference and total final enrolment number added.