HIGH-QUALITY COLON CLEANSING IMPROVES REAL-WORLD IDENTIFICATION OF HIGH-RISK PATIENTS: POST HOC ANALYSIS OF RANDOMISED CLINICAL TRIALS USING TWO VALIDATED CLEANSING SCALES

Aims:

Clinical guidelines classify colonoscopy patients with three or more detected adenomas as being at high risk for advanced neoplasia. These patients have a recommended follow-up after 3 years. Our post hoc analysis of three phase 3 randomised clinical trials assessed whether increased colon cleansing quality could improve the real-world identification of high-risk patients.

Methods:

Three similarly designed phase 3 trials assessed the efficacy and safety of 1L NER1006 (PLENVU) versus standard bowel preparations. Polyps were detected by site endoscopists as per local practice. Cleansing quality was assessed by treatment-blinded central readers using the validated Harefield Cleansing Scale (HCS) and Boston Bowel Preparation Scale (BBPS). This pooled analysis assessed the identification of high-risk patients with three or more adenomas versus attained colon cleansing quality.

Results:

At total of 1749 patients were included (Table). Three or more adenomas/patient were observed more frequently when the overall cleansing quality increased from failure to high-quality (HCS grade A vs. C: 8.7% vs. 3.9%; P = 0.022, and BBPS overall score 7 – 9 vs. 0 – 5: 8.6% vs. 4.6%; P = 0.013). When the cleansing quality improved from adequate to high, a numerical trend towards increased detection was observed with both scales, and statistical significance was established with BBPS 7 – 9 vs. 6 at 8.6% vs. 5.6%; P < 0.001.

Tab. 1:

Overall colon cleansing quality versus detection of high-risk patients with three or more adenomas per patient

Overall colon cleansing quality	High-quality	Adequate/Successful	Failure
BBPS overall score	7 – 9 (N = 463)	6 (N = 958)	0 – 5 (N = 328)
High-risk patients, n/N (%); P-value vs. High-quality	40/463 (8.6)	54/958 (5.6) P < 0.001	15/328 (4.6) P = 0.013
HCS Grade	A (N = 242)	B (N = 1229)	C (N = 203)	D (N = 75)
High-risk patients, n/N (%); P-value vs. High-quality	21/242 (8.7)	74/1229 (6.0) P = 0.062	8/203 (3.9) P = 0.022	6/75 (8.0) P = 0.427

Conclusions:

With high- versus adequate only colon cleansing quality, more patients were identified as being at high-risk for advanced neoplasia. This trend was numerically consistent across both HCS and BBPS, but reached statistical significance only with the more balanced sample sizes in the BBPS analysis.