Evaluation of a national digital pre-implantation biopsy service for deceased-donor kidney transplantation in the UK (Pithia trial); a stepped-wedge cluster randomised registry trialResearch in context
Summary: Background: Pre-implantation biopsy may help select kidneys retrieved from elderly deceased donors for transplantation, but concerns persist that it may cause unnecessary discard of kidneys that would have provided acceptable transplant function. The PITHIA trial tested the hypothesis that...
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2025-09-01
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| author | Dominic M. Summers John O.O. Ayorinde Desley A. Neil Karla Hemming Laura Smith Jennifer Mehew Helen Thomas Rosie Brown Suzie Phillips Emma Laing Anna Sidders Alison J. Deary Rachel J. Johnson Victoria Bardsley Sathia Thiru Meryl H. Griffiths Ranmith Perera Owen Cain Candice Roufosse Naomi Simmonds Michael Sheaff Natalie Brearley Bindu Vydianath Anna Paterson Kishore Gopalakrishnan Anastasios Chatzitolios Chris J. Callaghan Richard Jarvis Frank J.M.F. Dor Smarajit Dutta Atul Bagul Colin Wilson Dan Ridgway Adam Barlow Richard Baker Adnan Sharif James McDaid John Terrace Lorna Marson Debabrata Roy James Hunter Laszlo Szabo Simon Knight Karen Stevenson Patrick Mark Samuel Turner Zia Moinuddin Abbas Ghazanfar Rajesh Sivaprakasam Reza Motallebzadeh Nicholas Torpey Gareth Jones Catherine Boffa Paul Gibbs Andrew Connor Imran Saif Badri Shrestha Harry Hill James Fotheringham Gavin J. Pettigrew |
| author_facet | Dominic M. Summers John O.O. Ayorinde Desley A. Neil Karla Hemming Laura Smith Jennifer Mehew Helen Thomas Rosie Brown Suzie Phillips Emma Laing Anna Sidders Alison J. Deary Rachel J. Johnson Victoria Bardsley Sathia Thiru Meryl H. Griffiths Ranmith Perera Owen Cain Candice Roufosse Naomi Simmonds Michael Sheaff Natalie Brearley Bindu Vydianath Anna Paterson Kishore Gopalakrishnan Anastasios Chatzitolios Chris J. Callaghan Richard Jarvis Frank J.M.F. Dor Smarajit Dutta Atul Bagul Colin Wilson Dan Ridgway Adam Barlow Richard Baker Adnan Sharif James McDaid John Terrace Lorna Marson Debabrata Roy James Hunter Laszlo Szabo Simon Knight Karen Stevenson Patrick Mark Samuel Turner Zia Moinuddin Abbas Ghazanfar Rajesh Sivaprakasam Reza Motallebzadeh Nicholas Torpey Gareth Jones Catherine Boffa Paul Gibbs Andrew Connor Imran Saif Badri Shrestha Harry Hill James Fotheringham Gavin J. Pettigrew |
| author_sort | Dominic M. Summers |
| collection | DOAJ |
| description | Summary: Background: Pre-implantation biopsy may help select kidneys retrieved from elderly deceased donors for transplantation, but concerns persist that it may cause unnecessary discard of kidneys that would have provided acceptable transplant function. The PITHIA trial tested the hypothesis that introduction of a National Digital Pathology Service (NDPS) would increase the proportion of kidneys transplanted from elderly donors and/or improve their function. Methods: A stepped-wedge cluster randomised controlled registry trial delivered the NDPS to 22 UK kidney transplant centres (clusters) in 5 sequences at four-monthly intervals, using a restricted randomisation technique to ensure similar cluster sizes in the intervention and control status. Upon access to the intervention, centres could request urgent pre-implantation biopsy on kidneys from deceased donors aged 60 years or older. Co-primary outcome measures were the proportion of kidneys transplanted upon first offer according to whether the centre had access or not to the biopsy service, and the 1-year eGFR of the kidneys that were transplanted. Analysis adjusts for clustering and underlying secular trends, with 97.5% Confidence Intervals (CI) reported to reflect the two co-primary outcomes. The trial is complete (Trial Registration Number: ISRCTN 11708741). Findings: The trial commenced on 1st October 2018 and ended on 31st January 2022. Of the 2502 eligible kidneys offered, 1355 single and 67 dual transplants were performed. Regarding the first primary endpoint, a non-significantly lower proportion of those kidneys first offered to centres with access to the biopsy service were transplanted compared with those offered to centres without access (295 of 1241 (23.8%) vs. 377 of 1261 (29.9%): adjusted Odds Ratio (97.5% CI) 0.91 (0.60–1.39); p = 0.6083). For the second primary endpoint, the adjusted mean (SE) 1-year eGFR of the transplant kidneys was similar, irrespective of whether the implanting centre had access to the biopsy service or not (43.7 (1.3) ml/min/1.73 m2 vs. 42.2 (1.3) ml/min/1.73 m2; adjusted mean difference (97.5% CI) 1.53 (−2.33 to 5.40); p = 0.37). Secondary outcome analysis of how the biopsy service was adopted revealed that biopsies were performed on 287 of the 1493 (19.2%) kidneys offered to at least one centre with access to the biopsy service, with marked variation between transplant centres in requests for biopsy, and in implantation rates of biopsied kidneys. Nevertheless, 191 (66.6%) of biopsied kidneys were transplanted, compared with 643 of the 1009 (63.7%) kidneys only ever offered to centres without biopsy access, and 588 of the 1206 (48.8%) kidneys that were not biopsied, despite being offered to at least one centre with biopsy access. Interpretation: Implementation of the NDPS did not significantly increase transplantation rates of elderly deceased donor kidneys upon first offer, nor improve 1-year eGFR of the transplanted kidneys. This may reflect inter-centre variation in adoption and application of the biopsy service; such variations would need to be considered when designing future studies of pre-implantation biopsy analysis. Funding: NIHR Research for Patient Benefit programme (RfPB PB-PG-1215-20033). |
| format | Article |
| id | doaj-art-0bb3450a98574c1298c35c56ee84e05e |
| institution | DOAJ |
| issn | 2666-7762 |
| language | English |
| publishDate | 2025-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | The Lancet Regional Health. Europe |
| spelling | doaj-art-0bb3450a98574c1298c35c56ee84e05e2025-08-20T02:47:49ZengElsevierThe Lancet Regional Health. Europe2666-77622025-09-015610139010.1016/j.lanepe.2025.101390Evaluation of a national digital pre-implantation biopsy service for deceased-donor kidney transplantation in the UK (Pithia trial); a stepped-wedge cluster randomised registry trialResearch in contextDominic M. Summers0John O.O. Ayorinde1Desley A. Neil2Karla Hemming3Laura Smith4Jennifer Mehew5Helen Thomas6Rosie Brown7Suzie Phillips8Emma Laing9Anna Sidders10Alison J. Deary11Rachel J. Johnson12Victoria Bardsley13Sathia Thiru14Meryl H. Griffiths15Ranmith Perera16Owen Cain17Candice Roufosse18Naomi Simmonds19Michael Sheaff20Natalie Brearley21Bindu Vydianath22Anna Paterson23Kishore Gopalakrishnan24Anastasios Chatzitolios25Chris J. Callaghan26Richard Jarvis27Frank J.M.F. Dor28Smarajit Dutta29Atul Bagul30Colin Wilson31Dan Ridgway32Adam Barlow33Richard Baker34Adnan Sharif35James McDaid36John Terrace37Lorna Marson38Debabrata Roy39James Hunter40Laszlo Szabo41Simon Knight42Karen Stevenson43Patrick Mark44Samuel Turner45Zia Moinuddin46Abbas Ghazanfar47Rajesh Sivaprakasam48Reza Motallebzadeh49Nicholas Torpey50Gareth Jones51Catherine Boffa52Paul Gibbs53Andrew Connor54Imran Saif55Badri Shrestha56Harry Hill57James Fotheringham58Gavin J. Pettigrew59Department of Surgery, School of Clinical Medicine, University of Cambridge, Cambridge, UKNIHR Clinical Lecturer, University College London, UKDepartment of Cellular Pathology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UKInstitute of Applied Health Research, University of Birmingham, Birmingham, UKClinical Trials Unit, NHS Blood and Transplant, UKClinical Trials Unit, NHS Blood and Transplant, UKClinical Trials Unit, NHS Blood and Transplant, UKClinical Trials Unit, NHS Blood and Transplant, UKClinical Trials Unit, NHS Blood and Transplant, UKIntensive Care National Audit and Research Centre, London, UKClinical Trials Unit, NHS Blood and Transplant, UKClinical Trials Unit, NHS Blood and Transplant, UKClinical Trials Unit, NHS Blood and Transplant, UKDepartment of Histopathology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UKDepartment of Histopathology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UKDepartment of Histopathology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UKDepartment of Pathology, Guy's and St Thomas' NHS Foundation Trust, London, UKDepartment of Cellular Pathology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UKDepartment of Immunology and Inflammation, Faculty of Medicine, Imperial College London, London, UKDepartment of Pathology, Guy's and St Thomas' NHS Foundation Trust, London, UKBarts Health NHS Trust, London, UKDepartment of Pathology, Portsmouth Hospitals University NHS Trust, Portsmouth, UKDepartment of Cellular Pathology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UKDepartment of Histopathology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UKDepartment of Cellular Pathology, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UKDepartment of Cellular Pathology, North Bristol NHS Trust, Bristol, UKTransplant Unit, Guy's and St Thomas' NHS Foundation Trust, London, UKTransplant Patient, Cambridge, UKErasmus MC Transplant Institute, Rotterdam, the NetherlandsNottingham University Hospitals NHS Trust, Nottingham, UKUniversity Hospitals of Leicester NHS Trust, Leicester, UKNewcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle, UKLiverpool University Hospitals NHS Foundation Trust, Liverpool, UKLeeds Teaching Hospitals NHS Trust, Leeds, UKLeeds Teaching Hospitals NHS Trust, Leeds, UKUniversity Hospitals Birmingham NHS Foundation Trust, Birmingham, UKDepartment of Renal Surgery, Belfast Health and Social Care Trust, Belfast, UKDepartment of Surgery, Royal Edinburgh Infirmary, Edinburgh, UKNHS Blood and Transplant, UKUniversity Hospitals Coventry and Warwickshire NHS Trust, Coventry, UKNuffield Department of Surgical Sciences, University of Oxford, Oxford, UKCardiff and Vale University Health Board, Cardiff, UKNuffield Department of Surgical Sciences, University of Oxford, Oxford, UKDepartment of Surgery, NHS Greater Glasgow and Clyde, Glasgow, UKSchool of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UKRenal and Transplant Service, North Bristol NHS Trust, Bristol, UKRenal Transplant Unit, Manchester University NHS Foundation Trust, Manchester, UKSt George's University Hospitals NHS Foundation Trust, London, UKBarts Health NHS Trust, London, UKDepartment of Surgical Biotechnology, University College London, London, UKCambridge University Hospitals NHS Foundation Trust, Cambridge, UKRoyal Free London NHS Foundation Trust, London, UKPortsmouth University Hospitals NHS Trust, Portsmouth, UKPortsmouth University Hospitals NHS Trust, Portsmouth, UKUniversity Hospitals Plymouth NHS Trust, Plymouth, UKUniversity Hospitals Plymouth NHS Trust, Plymouth, UKSheffield Teaching Hospitals NHS Trust, Sheffield, UKSchool of Medicine and Population Health, University of Sheffield, Sheffield, UKSchool of Medicine and Population Health, University of Sheffield, Sheffield, UKDepartment of Surgery, School of Clinical Medicine, University of Cambridge, Cambridge, UK; Corresponding author. Department of Surgery, University of Cambridge School of Clinical Medicine, Cambridge, CB2 0QQ, UK.Summary: Background: Pre-implantation biopsy may help select kidneys retrieved from elderly deceased donors for transplantation, but concerns persist that it may cause unnecessary discard of kidneys that would have provided acceptable transplant function. The PITHIA trial tested the hypothesis that introduction of a National Digital Pathology Service (NDPS) would increase the proportion of kidneys transplanted from elderly donors and/or improve their function. Methods: A stepped-wedge cluster randomised controlled registry trial delivered the NDPS to 22 UK kidney transplant centres (clusters) in 5 sequences at four-monthly intervals, using a restricted randomisation technique to ensure similar cluster sizes in the intervention and control status. Upon access to the intervention, centres could request urgent pre-implantation biopsy on kidneys from deceased donors aged 60 years or older. Co-primary outcome measures were the proportion of kidneys transplanted upon first offer according to whether the centre had access or not to the biopsy service, and the 1-year eGFR of the kidneys that were transplanted. Analysis adjusts for clustering and underlying secular trends, with 97.5% Confidence Intervals (CI) reported to reflect the two co-primary outcomes. The trial is complete (Trial Registration Number: ISRCTN 11708741). Findings: The trial commenced on 1st October 2018 and ended on 31st January 2022. Of the 2502 eligible kidneys offered, 1355 single and 67 dual transplants were performed. Regarding the first primary endpoint, a non-significantly lower proportion of those kidneys first offered to centres with access to the biopsy service were transplanted compared with those offered to centres without access (295 of 1241 (23.8%) vs. 377 of 1261 (29.9%): adjusted Odds Ratio (97.5% CI) 0.91 (0.60–1.39); p = 0.6083). For the second primary endpoint, the adjusted mean (SE) 1-year eGFR of the transplant kidneys was similar, irrespective of whether the implanting centre had access to the biopsy service or not (43.7 (1.3) ml/min/1.73 m2 vs. 42.2 (1.3) ml/min/1.73 m2; adjusted mean difference (97.5% CI) 1.53 (−2.33 to 5.40); p = 0.37). Secondary outcome analysis of how the biopsy service was adopted revealed that biopsies were performed on 287 of the 1493 (19.2%) kidneys offered to at least one centre with access to the biopsy service, with marked variation between transplant centres in requests for biopsy, and in implantation rates of biopsied kidneys. Nevertheless, 191 (66.6%) of biopsied kidneys were transplanted, compared with 643 of the 1009 (63.7%) kidneys only ever offered to centres without biopsy access, and 588 of the 1206 (48.8%) kidneys that were not biopsied, despite being offered to at least one centre with biopsy access. Interpretation: Implementation of the NDPS did not significantly increase transplantation rates of elderly deceased donor kidneys upon first offer, nor improve 1-year eGFR of the transplanted kidneys. This may reflect inter-centre variation in adoption and application of the biopsy service; such variations would need to be considered when designing future studies of pre-implantation biopsy analysis. Funding: NIHR Research for Patient Benefit programme (RfPB PB-PG-1215-20033).http://www.sciencedirect.com/science/article/pii/S2666776225001826Pre-implantation biopsy analysisDeceased donor kidney transplantationStepped wedge cluster randomised trialNational digital pathology service |
| spellingShingle | Dominic M. Summers John O.O. Ayorinde Desley A. Neil Karla Hemming Laura Smith Jennifer Mehew Helen Thomas Rosie Brown Suzie Phillips Emma Laing Anna Sidders Alison J. Deary Rachel J. Johnson Victoria Bardsley Sathia Thiru Meryl H. Griffiths Ranmith Perera Owen Cain Candice Roufosse Naomi Simmonds Michael Sheaff Natalie Brearley Bindu Vydianath Anna Paterson Kishore Gopalakrishnan Anastasios Chatzitolios Chris J. Callaghan Richard Jarvis Frank J.M.F. Dor Smarajit Dutta Atul Bagul Colin Wilson Dan Ridgway Adam Barlow Richard Baker Adnan Sharif James McDaid John Terrace Lorna Marson Debabrata Roy James Hunter Laszlo Szabo Simon Knight Karen Stevenson Patrick Mark Samuel Turner Zia Moinuddin Abbas Ghazanfar Rajesh Sivaprakasam Reza Motallebzadeh Nicholas Torpey Gareth Jones Catherine Boffa Paul Gibbs Andrew Connor Imran Saif Badri Shrestha Harry Hill James Fotheringham Gavin J. Pettigrew Evaluation of a national digital pre-implantation biopsy service for deceased-donor kidney transplantation in the UK (Pithia trial); a stepped-wedge cluster randomised registry trialResearch in context The Lancet Regional Health. Europe Pre-implantation biopsy analysis Deceased donor kidney transplantation Stepped wedge cluster randomised trial National digital pathology service |
| title | Evaluation of a national digital pre-implantation biopsy service for deceased-donor kidney transplantation in the UK (Pithia trial); a stepped-wedge cluster randomised registry trialResearch in context |
| title_full | Evaluation of a national digital pre-implantation biopsy service for deceased-donor kidney transplantation in the UK (Pithia trial); a stepped-wedge cluster randomised registry trialResearch in context |
| title_fullStr | Evaluation of a national digital pre-implantation biopsy service for deceased-donor kidney transplantation in the UK (Pithia trial); a stepped-wedge cluster randomised registry trialResearch in context |
| title_full_unstemmed | Evaluation of a national digital pre-implantation biopsy service for deceased-donor kidney transplantation in the UK (Pithia trial); a stepped-wedge cluster randomised registry trialResearch in context |
| title_short | Evaluation of a national digital pre-implantation biopsy service for deceased-donor kidney transplantation in the UK (Pithia trial); a stepped-wedge cluster randomised registry trialResearch in context |
| title_sort | evaluation of a national digital pre implantation biopsy service for deceased donor kidney transplantation in the uk pithia trial a stepped wedge cluster randomised registry trialresearch in context |
| topic | Pre-implantation biopsy analysis Deceased donor kidney transplantation Stepped wedge cluster randomised trial National digital pathology service |
| url | http://www.sciencedirect.com/science/article/pii/S2666776225001826 |
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