IMPROVED REAL-WORLD LESION DETECTION WITH HIGH-QUALITY VERSUS ADEQUATE LEVEL COLON CLEANSING: POST HOC ANALYSIS OF RANDOMISED CLINICAL TRIALS USING THE BOSTON BOWEL PREPARATION SCALE

Aims:

Adequate colon cleansing permits detection of small (> 5 mm) polyps and is defined as a segmental Boston Bowel Preparation Scale (BBPS) score of at least 2 (overall 6). Minimal targeted lesion sizes may however vary by practice. This post hoc analysis of three randomised clinical trials assessed real-world lesion detection versus BBPS scores assessed with academic rigor.

Methods:

Three similar phase 3 randomised clinical trials assessed the colon cleansing 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 BBPS. This pooled analysis excluded patients with missing segmental cleansing score or lesion count data. Polyp- (PDR) and adenoma (ADR) detection rates plus the mean number of polyps (MPP) and adenomas (MAP) per patient were calculated. One-sided t-tests assuming equal variance compared the lesion detection in BBPS 7 – 9 (high-quality) versus lower score groups.

Results:

Out of 1985 randomised patients, 1749 were included (Table). High-quality cleansing improved lesion detection versus adequate cleansing for PDR (52% vs. 42%; P < 0.001), ADR (36% vs. 26%; P < 0.001), MPP (1.38 vs. 1.02; P = 0.003) and MAP (0.81 vs. 0.52; P = 0.001). High-quality cleansing also increased lesion detection versus cleansing failures for PDR (52% vs. 41%; P = 0.002), ADR (36% vs. 28%; P = 0.008), and MAP (0.81 vs. 0.51; P = 0.011).

Tab. 1:

Overall colon cleansing quality vs. lesion detection using the BBPS; P-values vs. high-quality cleansing (BBPS 7 – 9)

Overall BBPS scores assessed by treatment-blinded central readers	High-quality BBPS 7 – 9 (N = 463)	Adequate BBPS 6 (N = 958)	Failure BBPS 0 – 5 (N = 328)
Polyp detection rate: patients, n/N (%); P-value vs. BBPS 7 – 9	240/463 (52)	399/958 (42) P < 0.001	135/328 (41) P = 0.002
Adenoma detection rate: patients, n/N (%); P-value vs. BBPS 7 – 9	168/463 (36)	249/958 (26) P < 0.001	92/328 (28) P = 0.008
Polyps per patient, Mean (SD); P-value vs. BBPS 7 – 9	1.38 (2.86)	1.02 (1.98) P = 0.003	1.09 (2.42) P = 0.066
Adenomas per patient, Mean (SD); P-value vs. BBPS 7 – 9	0.81 (2.21)	0.52 (1.28) P = 0.001	0.51 (1.13) P = 0.011

Conclusions:

High-quality cleansing on the BBPS enables a greater real-world detection of polyps, adenomas, mean number of polyps per patient, and mean number of adenomas per patient than adequate-only cleansing quality.