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Screening for colorectal cancer and advanced colorectal neoplasia in kidney transplant recipients: cross sectional prevalence and diagnostic accuracy study of faecal immunochemical testing for haemoglobin and colonoscopy

BMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e4657 (Published 25 July 2012) Cite this as: BMJ 2012;345:e4657
  1. Michael G Collins, nephrologist and clinical senior lecturer12,
  2. Edward Teo, gastroenterologist3,
  3. Stephen R Cole, principal medical scientist45,
  4. Choy-Yoke Chan, research nurse1,
  5. Stephen P McDonald, nephrologist and associate professor126,
  6. Graeme R Russ, nephrologist and professor12,
  7. Graeme P Young, gastroenterologist and professor457,
  8. Peter A Bampton, gastroenterologist and associate professor57,
  9. P Toby Coates, transplant nephrologist and associate professor12
  1. 1Central Northern Adelaide Renal and Transplantation Service, Royal Adelaide Hospital, Adelaide, SA 5000, Australia
  2. 2School of Medicine, University of Adelaide, SA 5005, Australia
  3. 3Department of Gastroenterology, Queen Elizabeth Hospital, Woodville, SA 5011, Australia
  4. 4Bowel Health Service, Repatriation General Hospital, Daw Park, SA 5041, Australia
  5. 5Flinders Clinical and Molecular Medicine, Flinders University, Bedford Park, SA 5042, Australia
  6. 6School of Population Health and Clinical Practice, University of Adelaide
  7. 7Department of Gastroenterology and Hepatology, Flinders Medical Centre, Bedford Park, SA 5042
  1. Correspondence to: P T Coates toby.coates{at}health.sa.gov.au
  • Accepted 15 June 2012

Abstract

Objective To investigate whether screening kidney transplant recipients aged over 50 years for colorectal cancer with a faecal immunochemical test for haemoglobin might be justified, by determining the prevalence of advanced colorectal neoplasia and evaluating the diagnostic accuracy of faecal haemoglobin testing compared with colonoscopy in a population of kidney transplant recipients at otherwise average risk.

Design Cross sectional prevalence and diagnostic accuracy study with index test of faecal haemoglobin and reference standard of colonoscopy.

Setting Outpatient clinics in metropolitan and regional hospitals in South Australia.

Participants 229 kidney transplant recipients aged 50 years and over, who were at least 6 months (mean 9.0 (SD 8.4) years) post-transplant and otherwise at average risk of colorectal cancer, completed the study between June 2008 and October 2011.

Interventions Faecal immunochemical testing (Enterix Insure) for human haemoglobin, followed by colonoscopy with histological evaluation of retrieved samples.

Main outcome measures Prevalence of advanced colorectal neoplasia, defined as an adenoma at least 10 mm in diameter, villous features, high grade dysplasia, or colorectal cancer; sensitivity, specificity, and predictive values of faecal haemoglobin testing for advanced neoplasia compared with colonoscopy.

Results Advanced colorectal neoplasia was found in 29 (13%, 95% confidence interval 9% to 18%) participants, including 2% (n=4) with high grade dysplasia and 2% (n=5) with colorectal cancer. Faecal testing for haemoglobin was positive in 12% (n=28); sensitivity, specificity, and positive and negative predictive values for advanced neoplasia were 31.0% (15.3% to 50.8%), 90.5% (85.6% to 94.2%), 32.1% (15.9% to 52.4%), and 90.1% (85.1% to 93.8%). Colonoscopy was well tolerated, with no significant adverse outcomes. To identify one case of advanced neoplasia, 8 (6 to 12) colonoscopies were needed.

Conclusions Kidney transplant recipients aged over 50 years have a high prevalence of advanced colorectal neoplasia. Faecal haemoglobin screening for colorectal neoplasia has similar performance characteristics in transplant recipients to those reported in general population studies, with poor sensitivity but reasonable specificity. Surveillance colonoscopy might be a more appropriate approach in this population.

Trial registration Australian New Zealand Clinical Trials Registry ACTRN12608000154303.

Footnotes

  • We thank the physicians, surgeons, nurses, and kidney transplant recipients who took part in this study. We also thank Enterix Australia for providing faecal immunochemical testing at no cost and Nancy Briggs (from the Australian and New Zealand Dialysis and Transplant Registry) who provided statistical advice.

  • Investigators and participating centres were as follows. Nephrologists: Queen Elizabeth Hospital and Royal Adelaide Hospital—Michael Collins, P Toby Coates, Stephen McDonald, and Graeme Russ (all principal investigators); Kym Bannister, Robert Carroll, Ghee Chew, Duncan Cooke, Susan Crail, Alex Disney, Tony Elias, Randall Faull (co-investigator), Lisa Jeffs, Shilpa Jesudason, Chen Au Peh, Natasha Rogers, and Shaundeep Sen; Flinders Medical Centre—Jeffrey Barbara, Jonathan Gleadle, Rajiv Juneja (co-investigator), Caroline Milton, and George Passaris. Gastroenterologists/colorectal surgeons: Queen Elizabeth Hospital—Edward Teo (principal investigator, 104 colonoscopies); Flinders Medical Centre and Tennyson Cancer Centre—Peter Bampton (principal investigator, 48); Mt Gambier Hospital—Matthias Wichmann (co-investigator, 14); Royal Adelaide Hospital—Mark Schoeman (co-investigator, 13); others who performed or assisted at two or more colonoscopies—Judith Gapasin (8), Kate Muller (6), John Bate (4), M Yee (4), Basile Alexander (3), Michael Damp (3), Nam Nguyen (3), Sam Hall (2), Peter Hewett (2), Richard Holloway (2), Matthew Lawrence (2), Kenneth Lim (2), Venkat Mahesh (2), Michelle Thomas (2), and Daniel Van Langenberg (2). In addition, another 31 gastroenterologists/surgeons performed or assisted at a single colonoscopy (not listed here).

  • Contributors: MGC, PTC, PAB, SPMcD, GRR, SRC, and GPY contributed to the research design. MGC, GPY, PAB, and PTC obtained funding for the study. MGC, C-YC, and PTC coordinated the study; C-YC provided administrative and technical support. PTC, GRR, SPMcD, MGC, and other nephrologists listed above as investigators were responsible for recruitment. SRC and GPY provided access to faecal haemoglobin screening. ET and PAB had primary responsibility for colonoscopy performance and data acquisition; investigators listed above also did colonoscopies. MGC analysed the data, including statistical analysis; all authors contributed to the interpretation of the data. MGC drafted the manuscript; all authors reviewed it and approved the final manuscript. PAB and PTC are joint senior authors of this study; MGC and PTC are the guarantors.

  • Funding: This study was funded by the Queen Elizabeth Hospital Research Foundation and also by Roche Products Pty Australia through the CellCept Australia Research Grants (CARG). Enterix Australia generously supplied the Insure kits and processed the faecal samples at no cost. Most colonoscopy procedures were done through the public healthcare system as “standard of care,” where such procedures are available for colorectal cancer screening of patients thought to be at increased risk. None of the sponsors had any role in study design, data collection, analysis, interpretation, or the writing of the manuscript. This research was conducted completely independently from funders.

  • Competing interests: All authors have completed the Unified Competing Interest form at http://www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: all authors received support from Roche Products Australia, Queen Elizabeth Hospital Research Foundation, and Enterix Australia for the submitted work as described above; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

  • Ethical approval: This study was approved by human research ethics committees at the Queen Elizabeth Hospital, Royal Adelaide Hospital, and Flinders Medical Centre. All participants provided written informed consent.

  • Data sharing: No additional data available.

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