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 |
| Secondary identifying numbers | KSC 05/2003 |
- 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
Not provided at time of registration
Contact information
Prof Markus W Büchler
Scientific
Scientific
University of Heidelberg Medical School
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
| Phone | +49 6221 56 6200 |
|---|---|
| markus.buechler@med.uni-heidelberg.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 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(s) | Added 11/02/2009: Ethics Committee of University of Heidelberg Medical School gave approval in October 2002. |
| 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 |
| Primary outcome measure | 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 study start date | 01/02/2003 |
| Overall study end date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Total final enrolment | 80 |
| 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 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
Study participating centre
University of Heidelberg Medical School
Heidelberg
69120
Germany
69120
Germany
Sponsor information
University of Heidelberg Medical School (Germany)
University/education
University/education
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
| Phone | +49 6221 56 6200 |
|---|---|
| markus.buechler@med.uni-heidelberg.de | |
"ROR" |
https://ror.org/038t36y30 |
Funders
Funder type
University/education
University of Heidelberg (Germany) - Medical School
No information available
Jung Stiftung (Germany)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Jung Foundation for Science and Research, Jung-Stiftung
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 05/03/2008 | Yes | No | |
| Results article | results | 01/01/2021 | 05/11/2020 | Yes | No |
Editorial Notes
05/11/2020: Publication reference and total final enrolment number added.
