Pillcam COLON 2 for Investigation of the COLON Through Direct Visualization: A Systematic Review
Author(s)
Gamze Nalbant, PhD1, Sue Harnan, MSc1, Sarah Ren, PhD1, Mark Clowes, BA, MSc1, Abdullah Pandor, MSc1, Matthew Kurien, PGDipMedSci2, Kevin Monahan, PhD3, Janine Tappenden, PhD4, Paul Tappenden, BA, MSc, PhD1.
1ScHARR, The University of Sheffield, Sheffield, United Kingdom, 2Clinical Medicine, The University of Sheffield, Sheffield, United Kingdom, 3St Mark’s Hospital and Imperial College London, London, United Kingdom, 4North Lincolnshire and Goole NHS Foundation Trust, Scunthorpe, United Kingdom.
1ScHARR, The University of Sheffield, Sheffield, United Kingdom, 2Clinical Medicine, The University of Sheffield, Sheffield, United Kingdom, 3St Mark’s Hospital and Imperial College London, London, United Kingdom, 4North Lincolnshire and Goole NHS Foundation Trust, Scunthorpe, United Kingdom.
OBJECTIVES: Colorectal cancer (CRC) is the fourth most common cancer and the second leading cause of cancer deaths in England. Most cases arise from a prior adenomatous polyp. The gold standard for the diagnosis is Colonoscopy (COL) but waiting times may be long and the procedure is unpleasant. Colon capsule endoscopy (CCE) may offer a less-invasive alternative for detecting polyps or CRC. This systematic review aimed to evaluate the clinical effectiveness and diagnostic test accuracy of CCE using PillCam COLON 2 for detecting colorectal polyps, adenomas and CRC.
METHODS: Six databases and eight conference proceedings were searched in August 2024. Randomised Controlled Trials (RCTs) or diagnostic test accuracy (DTA) studies of PillCam COLON 2 in symptomatic or polyp surveillance patients were sought. Narrative synthesis was conducted, and Bayesian meta-analysis was used to pool sensitivity and specificity where ≥2 studies reported test accuracy. The Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool was used.
RESULTS: The review included 6 DTA studies in relevant populations (1 study) or mixed populations (5 studies). Amongst the five DTA studies in mixed populations, for polyps of any size (2 studies), ≥6mm (4 studies) and ≥10mm (4 studies), pooled sensitivities were 0.78 (95% credible interval [CrI] 0.51, 0.90), 0.83 (95% CrI 0.70, 0.91) and 0.85 (95% CrI 0.70, 0.94), respectively. Specificities were 0.60 (95% CrI 0.27, 0.88), 0.69 (95% CrI 0.52, 0.81) and 0.90 (95% CrI 0.82, 0.95), respectively. Data on adenomas and CRC were limited. Inclusion criteria, target condition prevalence and 95% prediction intervals indicate moderate to high between-study clinical and statistical heterogeneity.
CONCLUSIONS: The generalisability of the DTA data to symptomatic and polyp surveillance patients was unclear. While CCE may miss some polyps, fewer COLs would be required. However, patients with positive findings would need both CCE and COL, which may increase costs.
METHODS: Six databases and eight conference proceedings were searched in August 2024. Randomised Controlled Trials (RCTs) or diagnostic test accuracy (DTA) studies of PillCam COLON 2 in symptomatic or polyp surveillance patients were sought. Narrative synthesis was conducted, and Bayesian meta-analysis was used to pool sensitivity and specificity where ≥2 studies reported test accuracy. The Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool was used.
RESULTS: The review included 6 DTA studies in relevant populations (1 study) or mixed populations (5 studies). Amongst the five DTA studies in mixed populations, for polyps of any size (2 studies), ≥6mm (4 studies) and ≥10mm (4 studies), pooled sensitivities were 0.78 (95% credible interval [CrI] 0.51, 0.90), 0.83 (95% CrI 0.70, 0.91) and 0.85 (95% CrI 0.70, 0.94), respectively. Specificities were 0.60 (95% CrI 0.27, 0.88), 0.69 (95% CrI 0.52, 0.81) and 0.90 (95% CrI 0.82, 0.95), respectively. Data on adenomas and CRC were limited. Inclusion criteria, target condition prevalence and 95% prediction intervals indicate moderate to high between-study clinical and statistical heterogeneity.
CONCLUSIONS: The generalisability of the DTA data to symptomatic and polyp surveillance patients was unclear. While CCE may miss some polyps, fewer COLs would be required. However, patients with positive findings would need both CCE and COL, which may increase costs.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO180
Topic
Clinical Outcomes, Medical Technologies
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Oncology