New Data Show That High Quality Cleansing Improves Lesion Detection During Colonoscopy Compared to Adequate Cleansing[i]

News provided by

Norgine B.V.

21 Apr, 2018, 10:00 GMT

AMSTERDAM, April 21, 2018 /PRNewswire/ --

Norgine B.V. today announced new data showing that there is a strong correlation between higher cleansing scores and increased polyp detection rate (PDR) and adenoma detection rate (ADR).

     (Logo: http://mma.prnewswire.com/media/597589/Norgine_Logo.jpg )

The adenoma detection rate (ADR) is one of the primary quality measures of colonoscopy and an indicator of the likelihood of subsequent patient colorectal cancer.

The data were presented at the European Society for Gastrointestinal Endoscopy (ESGE) 2018, oral presentation, OP251, 21 April 2018, 11:36 to 11:48 am.

This post hoc analysis determined the relationship between BBPS* scores and adenoma and polyp detection rates in patients who had identical scores in each of the three colon segments, using pooled data from three similarly designed Phase 3, multicentre, randomised trials: NOCT, MORA and DAYB.


       Overall colon                                             High-       Odds ratio
       lesion                                                   Quality:      Adequate :
       detection         High-        Adequate    Low-Quality   Adequate     Low-Quality
       rates                                                    (95% CI)      (95% CI)
                     Quality(N=166)    (N=950)      (N=54)
                                                                [P-value]     [P-value]

                                                                     1.60          0.90
                                                               (1.14-2.24)   (0.50-1.60)
       PDR, n (%)      91 (54.8)      396 (41.7)   22 (40.7)      [0.0067]      [0.7104]

                                                                     1.97          0.75
       ADR, n (%)      71 (42.8)      247 (26.0)   15 (27.8)   (1.39-2.80)   (0.39-1.43)
                                                                  [0.0001]      [0.3829]
      LR Analysis
               of
      Association
          between                                    0.0239
     Uniform BBPS
      Score Group
         and PDR,
          P-value

      LR Analysis
               of
      Association
          between                                    0.0006
     Uniform BBPS
      Score Group
         and ADR,
          P-value

Table 1. PDR and ADR by uniform BBPS score 

Similar results were shown with the use of the Harefield Cleansing Scale** - Higher Harefield Cleansing Scale Scores are associated with improved lesion detection: post hoc analysis of three randomised and central reader-assessed phase 3 clinical trials, oral presentation, OP249, 21 April 2018, 11:12-11:24 am.[ii]

Dr Cesare Hassan, Gastroenterology and Endoscopic Unit, Nuovo Regina Margherita Hospital, Roma RM, Italy said: "For the first time, the use of two independent, validated, cleansing scales demonstrate that higher segmental cleansing quality is associated with higher lesion detection rates. As a result, patients should use a high quality bowel cleanser to facilitate early detection and removal of abnormalities in order to prevent colorectal cancer."

Colonoscopy is a vital screening procedure to detect and remove adenomas and polyps that could otherwise lead to colorectal cancer.

Colorectal cancer is the second most common cause of cancer-related mortality in Europe, with over 447,000 new diagnoses every year.[iii] Colorectal cancer is largely preventable, with early detection being associated with a 90% cure rate.[iv]

*Boston Bowel Preparation Scale (BBPS) is a 10-point scale assessing bowel preparation after all cleansing manoeuvres are completed by the endoscopist.[v] 

**Harefield Cleansing Scale is a robust, reliable, and consistent tool that has the potential to improve the effective standardization of bowel preparation assessment in both clinical and research practice.[vi] 

View the media release in full http://www.norgine.com/media.

i. Hassan C. et al. High-quality cleansing improves lesion detection during colonoscopy compared to adequate cleansing: post hoc analysis of 1170 central-reader assessed patients in three randomised phase 3 trials. Oral Presentation. ESGE 2018

ii. Manning J. et al. Higher Harefield cleansing scale scores are associated with improved lesion detection: post hoc analysis of three randomised and central reader-assessed phase 3 clinical trials. Oral presentation. ESGE 2018

iii. Epidemiology of colorectal cancer in Europe. Source: GLOBOCAN 2012

iv. American Cancer Society. https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/detection.html . Accessed 10 April 2018

v. Edwin J. Lai et al. The Boston Bowel Preparation Scale: A valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar; 69(3 Pt 2): 620-625 [ https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=19136102 ]

vi. Halphen M [ https://www.ncbi.nlm.nih.gov/pubmed/?term=Halphen%20M%5BAuthor%5D&cauthor=true&cauthor_uid=23531426 ].. Validation of the Harefield Cleansing Scale: a tool for the evaluation of bowel cleansing quality in both research and clinical practice. Gastrointest Endosc. [ https://www.ncbi.nlm.nih.gov/pubmed/23531426 ] 2013 Jul;78(1):121-31. doi: 10.1016/j.gie.2013.02.009. Epub 2013 Mar 24.

Media contact: Isabelle Jouin, ijouin@norgine.com .