Liver resection surgery versus thermal ablation for colorectal LiVer MetAstases (LAVA): study protocol for a randomised controlled trial
Abstract Background Although surgical resection has been considered the only curative option for colorectal liver metastases (CLM), thermal ablation has recently been suggested as an alternative curative treatment. A prospective randomised trial is required to define the efficacy of resection vs abl...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2018-02-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13063-018-2499-5 |
| _version_ | 1818956477257220096 |
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| author | Kurinchi Gurusamy Neil Corrigan Julie Croft Maureen Twiddy Stephen Morris Nick Woodward Steve Bandula Daniel Hochhauser Vicky Napp Alison Pullan Nicholas Jakowiw Raj Prasad Steven Olde Damink C. J. H. M. van Laarhoven Johannes H. W. de Wilt Julia Brown Brian R. Davidson |
| author_facet | Kurinchi Gurusamy Neil Corrigan Julie Croft Maureen Twiddy Stephen Morris Nick Woodward Steve Bandula Daniel Hochhauser Vicky Napp Alison Pullan Nicholas Jakowiw Raj Prasad Steven Olde Damink C. J. H. M. van Laarhoven Johannes H. W. de Wilt Julia Brown Brian R. Davidson |
| author_sort | Kurinchi Gurusamy |
| collection | DOAJ |
| description | Abstract Background Although surgical resection has been considered the only curative option for colorectal liver metastases (CLM), thermal ablation has recently been suggested as an alternative curative treatment. A prospective randomised trial is required to define the efficacy of resection vs ablation for the treatment of colorectal liver metastases. Methods Design and setting: This is a multicentre, open, randomised controlled non-inferiority trial design with internal pilot and will be performed in tertiary liver centres in UK and The Netherlands. Participants: Eligible patients will be those with colorectal liver metastases at high surgical risk because of their age, co-morbidities or tumour burden and who would be suitable for liver resection or thermal ablation. Intervention: Thermal ablation as per local policy. Control: Surgical liver resection performed as per centre protocol. Co-interventions: Further chemotherapy will be offered to patients as per current practice. Outcomes Pilot study: Same as main study and in addition patients and clinicians’ acceptability of the trial to assist in optimisation of recruitment. Primary outcome: Disease-free survival (DFS) at two years post randomisation. Secondary outcomes: Overall survival, timing and site of recurrence, additional therapy after treatment failure, quality of life, complications, length of hospital stay, costs, trial acceptability, DFS measured from end of intervention. Follow-up: 24 months from randomisation; five-year follow-up for overall survival. Sample size: 330 patients to demonstrate non-inferiority of thermal ablation. Discussion This trial will determine the effectiveness and cost-effectiveness of thermal ablation vs surgical resection for high-risk people with colorectal liver metastases, and guide the optimal treatment for these patients. Trial registration ISRCTN Registry, ISRCTN52040363. Registered on 9 March 2016. |
| first_indexed | 2024-12-20T10:54:35Z |
| format | Article |
| id | doaj.art-9d3c1cca77a44521b80eadf9b2b2c43a |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-20T10:54:35Z |
| publishDate | 2018-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-9d3c1cca77a44521b80eadf9b2b2c43a2022-12-21T19:43:11ZengBMCTrials1745-62152018-02-0119111310.1186/s13063-018-2499-5Liver resection surgery versus thermal ablation for colorectal LiVer MetAstases (LAVA): study protocol for a randomised controlled trialKurinchi Gurusamy0Neil Corrigan1Julie Croft2Maureen Twiddy3Stephen Morris4Nick Woodward5Steve Bandula6Daniel Hochhauser7Vicky Napp8Alison Pullan9Nicholas Jakowiw10Raj Prasad11Steven Olde Damink12C. J. H. M. van Laarhoven13Johannes H. W. de Wilt14Julia Brown15Brian R. Davidson16Royal Free Campus, Division of Surgery and Interventional Science, University College LondonClinical Trials Research Unit, Leeds Institute of Clinical Trials Research Unit, University of LeedsClinical Trials Research Unit, Leeds Institute of Clinical Trials Research Unit, University of LeedsInstitute of Clinical and Applied Health Research, University of HullDepartment of Applied Health Research, University College LondonDepartment of Radiology, Royal Free HospitalDepartment of Radiology, University College London HospitalCancer Institute, University College LondonClinical Trials Research Unit, Leeds Institute of Clinical Trials Research Unit, University of LeedsClinical Trials Research Unit, Leeds Institute of Clinical Trials Research Unit, University of LeedsRoyal Free Campus, Division of Surgery and Interventional Science, University College LondonDepartment of Surgery and Transplantation, Leeds Teaching HospitalDepartment of General Surgery, Maastricht UniversityDepartment of Surgery, Radboud University Medical CenterDepartment of Surgery, Radboud University Medical CenterClinical Trials Research Unit, Leeds Institute of Clinical Trials Research Unit, University of LeedsRoyal Free Campus, Division of Surgery and Interventional Science, University College LondonAbstract Background Although surgical resection has been considered the only curative option for colorectal liver metastases (CLM), thermal ablation has recently been suggested as an alternative curative treatment. A prospective randomised trial is required to define the efficacy of resection vs ablation for the treatment of colorectal liver metastases. Methods Design and setting: This is a multicentre, open, randomised controlled non-inferiority trial design with internal pilot and will be performed in tertiary liver centres in UK and The Netherlands. Participants: Eligible patients will be those with colorectal liver metastases at high surgical risk because of their age, co-morbidities or tumour burden and who would be suitable for liver resection or thermal ablation. Intervention: Thermal ablation as per local policy. Control: Surgical liver resection performed as per centre protocol. Co-interventions: Further chemotherapy will be offered to patients as per current practice. Outcomes Pilot study: Same as main study and in addition patients and clinicians’ acceptability of the trial to assist in optimisation of recruitment. Primary outcome: Disease-free survival (DFS) at two years post randomisation. Secondary outcomes: Overall survival, timing and site of recurrence, additional therapy after treatment failure, quality of life, complications, length of hospital stay, costs, trial acceptability, DFS measured from end of intervention. Follow-up: 24 months from randomisation; five-year follow-up for overall survival. Sample size: 330 patients to demonstrate non-inferiority of thermal ablation. Discussion This trial will determine the effectiveness and cost-effectiveness of thermal ablation vs surgical resection for high-risk people with colorectal liver metastases, and guide the optimal treatment for these patients. Trial registration ISRCTN Registry, ISRCTN52040363. Registered on 9 March 2016.http://link.springer.com/article/10.1186/s13063-018-2499-5Randomised controlled trialCost-benefit analysisLiverNeoplasm metastasisColorectal neoplasmsHepatectomy |
| spellingShingle | Kurinchi Gurusamy Neil Corrigan Julie Croft Maureen Twiddy Stephen Morris Nick Woodward Steve Bandula Daniel Hochhauser Vicky Napp Alison Pullan Nicholas Jakowiw Raj Prasad Steven Olde Damink C. J. H. M. van Laarhoven Johannes H. W. de Wilt Julia Brown Brian R. Davidson Liver resection surgery versus thermal ablation for colorectal LiVer MetAstases (LAVA): study protocol for a randomised controlled trial Trials Randomised controlled trial Cost-benefit analysis Liver Neoplasm metastasis Colorectal neoplasms Hepatectomy |
| title | Liver resection surgery versus thermal ablation for colorectal LiVer MetAstases (LAVA): study protocol for a randomised controlled trial |
| title_full | Liver resection surgery versus thermal ablation for colorectal LiVer MetAstases (LAVA): study protocol for a randomised controlled trial |
| title_fullStr | Liver resection surgery versus thermal ablation for colorectal LiVer MetAstases (LAVA): study protocol for a randomised controlled trial |
| title_full_unstemmed | Liver resection surgery versus thermal ablation for colorectal LiVer MetAstases (LAVA): study protocol for a randomised controlled trial |
| title_short | Liver resection surgery versus thermal ablation for colorectal LiVer MetAstases (LAVA): study protocol for a randomised controlled trial |
| title_sort | liver resection surgery versus thermal ablation for colorectal liver metastases lava study protocol for a randomised controlled trial |
| topic | Randomised controlled trial Cost-benefit analysis Liver Neoplasm metastasis Colorectal neoplasms Hepatectomy |
| url | http://link.springer.com/article/10.1186/s13063-018-2499-5 |
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