Improved detection of colorectal adenomas by high-quality colon cleansing

Hassan, Cesare; Manning, Jonathan; González, Marco Antonio Álvarez; Sharma, Prateek; Epstein, Michael; Bisschops, Raf

doi:10.1055/a-1167-1359

Cited by 21 publications

(15 citation statements)

References 28 publications

(49 reference statements)

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“…However, the grading by site endoscopists reflects what the clinical practitioners experience in their daily work when detecting adenomas. 38 There was also a comparatively small number of patients in each treatment group who met all three risk factors in both the MORA and NOCT studies. Rates of high-quality cleansing in the multiple risk factor group were similar to the site colonoscopists’ assessments in the original populations of MORA (68.0%) and NOCT (69.9%).…”

Section: Discussionmentioning

confidence: 94%

Bowel-cleansing efficacy of the 1L polyethylene glycol-based bowel preparation NER1006 (PLENVU) in patient subgroups in two phase III trials

Baile-Maxía

Amlani

Martínez

2021

Therap Adv Gastroenterol

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Background: Adequate bowel preparation prior to colonoscopy is essential for visualization of the colonic mucosa to maximize adenoma and polyp detection. The risk of inadequate bowel cleansing is heightened if the patient is older, male, overweight, and has comorbidities, such as diabetes. This post hoc analysis of the combined MORA and NOCT clinical trials explores the efficacy of evening/morning split-dose regimens of NER1006 (PLENVU®, Norgine Ltd), a 1-liter polyethylene glycol (PEG) bowel preparation, to evaluate its bowel-cleansing efficacy in patients at risk for inadequate cleansing. Methods: Patients requiring colonoscopy were randomized to receive evening/morning split-dosing of either NER1006, 2-liter (2L) PEG and ascorbate, or oral sulfate solution (OSS). Bowel-cleansing efficacy was assessed by treatment-blinded central readers using the validated Harefield Cleansing Scale (HCS). Results: Split-dose NER1006 was associated with high levels of cleansing, ranging between 87.0% and 94.0% across all patient subtypes ( n = 551), including patients with obesity or diabetes. However, patients aged >65 years and <45 years showed significantly greater rates of successful cleansing than patients aged 45–65 years (94.0% versus 94.2% versus 87.0%, p = 0.002). The high-risk patient subgroup, which included obese males aged ⩾60 years, had significantly improved overall and high-quality bowel-cleansing success rates of 100% (33/33) and 72.7% (27/33) on the HCS with NER1006, compared with 86.7% (26/30) and 50% (15/30) with the comparator solutions ( p = 0.015 and p = 0.033, respectively). In this high-risk subgroup, adenoma detection was greater per patient receiving NER1006 versus the comparator group (1.82 versus 0.93, p = 0.041). NER1006 was the only treatment that enabled the detection of patients with ⩾5 adenomas [9.1% (3/33) versus 0/30, p = 0.047]. Conclusion: NER1006 effectively cleansed a broad range of patients and offered superior bowel cleansing versus 2LPEG/OSS in patients at increased risk of colorectal cancer. Future research should establish whether more effective cleansing also enables improved adenoma detection. Plain language summary A low-volume bowel preparation solution to better detect lesions associated with colorectal cancer during colonoscopy Colorectal cancer (CRC) is the fourth most commonly diagnosed cancer in the world. Obese men over the age of 65 years are at particularly increased risk of developing CRC. If the changes in their large intestine (colon) could be seen more clearly during a colonoscopy (where a small camera is inserted via the anus to examine the bowels from the inside), patients who need treatment would be diagnosed earlier, thus improving their chances of survival. In this paper we discuss the use of a bowel preparation solution that is more convenient for patients (less to drink) but also cleans bowels more effectively, meaning more lesions are detected than when other solutions are used. This improved cleansing, and thus better visualization, occurred in a range of patients, including those at higher risk of CRC, such as older, overweight men.

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Section: Discussionmentioning

confidence: 94%

Bowel-cleansing efficacy of the 1L polyethylene glycol-based bowel preparation NER1006 (PLENVU) in patient subgroups in two phase III trials

Baile-Maxía

Amlani

Martínez

2021

Therap Adv Gastroenterol

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“…The attainment of overall adequate or HQ cleansing was assessed by comparing the percentage of patients who attained Grade AB or A, respectively, on the validated HCS 20 . As a more detailed measure, segmental cleansing success was assessed as the number of HQ cleansed colon segments per treatment group, given that adenomas are more likely to be detected in HQ than adequate-quality cleansed colon segments 7 . We included in our analyses the cleansing scores rated by site colonoscopists and central readers.…”

Section: Methodsmentioning

confidence: 99%

“…Diminutive adenomas may be present but not always detected in bowels where cleansing is classified as only adequate on the Boston Bowel Preparation Scale (BBPS) and the Harefield Cleansing Scale (HCS), as stool-free high-quality (HQ) cleansing has been shown to improve both the adenoma detection rate and the mean number of adenomas detected per patient 7 .…”

Section: Introductionmentioning

confidence: 99%

Bowel preparation with 1L polyethylene glycol and ascorbate NER1006 doubles the chance to detect three or more adenomas in overweight or obese males

Epstein¹,

Halonen

Sharma

2021

Endosc Int Open

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Background and study aims Men have more colon cleansing failures, colorectal adenomas, and colorectal cancers than women. We analyzed whether 1-liter (1 L) polyethylene glycol (PEG) NER1006 improves high-quality (HQ) colon cleansing and adenoma detection in males versus two mid-volume alternatives. Patients and methods The analysis of 1028 adult patients in two randomized clinical trials was performed. Adenoma detection and HQ cleansing were compared for overnight split dosing regimens with NER1006 (n = 513) versus combined oral sulfate solution or 2 L PEG + ascorbate (OSS/2 L PEG) (n = 515). Analyses included males versus females, overweight or obese (OO) males versus lean males, and NER1006 versus OSS/2 L PEG. In male patients, the adenoma detection rate of at least 3 (ADR3 +) was predicted with multiple logistic regression and statistical comparisons used the two-sided t-test. Results ADR3 + was greater in males versus females (10.7 % [56/524] versus 5.8 % [29/504]; P = 0.004) despite comparable adequate cleansing success rates (93.2 % [479/514] versus 93.0 % [466/501]; P = 0.912) and more HQ-scores in females (41.6 % [1069/2570] versus 45.3 % [1134/2505]; P = 0.008). ADR was almost twice as high in OO versus lean males (43.4 % [184/424] versus 23.1 % [21/91]; P < 0.001). Multivariate logistic regression predicted ADR3 + detection to be twice as likely in OO males using NER1006 versus OSS/2 L PEG (odds ratio (95 % confidence interval [CI]) = 2.049 (1.082–3.973); P = 0.030) and 90 % more likely in all males (1.902 (1.045–3.526); P = 0.037). In males, including OO males, NER1006 attained more HQ-scores per trial than OSS or 2 L PEG (P ≤ 0.017 for all comparisons). Conclusions NER1006 predicted the detection of more males for frequent surveillance than OSS/2 L PEG.

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“…This increases the osmotic activity of the preparation relative to 2LPEG and also enables delivery in a total preparation volume of 1L [ 14 ]. This enhanced osmotic activity may contribute to improved cleansing of the right colon, as seen in the original studies and detailed in these post hoc analyses [ 14 – 16 , 27 , 29 – 31 ].…”

Section: Discussionmentioning

confidence: 81%

“…High-quality cleansing, as assessed by the HCS, is associated with numerically improved adenoma detection in the right colon and significantly improved adenoma detection in the overall colon [ 27 ]. In its Phase III clinical development programme, NER1006 demonstrated numerically improved high-quality cleansing success rates in the right colon versus all of its comparators and a statistically significant improvement over 2LPEG [ 14 , 15 ].…”

Section: Discussionmentioning

confidence: 99%

1L NER1006 can improve rates of adequate and high-quality bowel cleansing in the right colon: a post hoc analysis of two randomised clinical trials

et al. 2022

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Background The right colon is difficult to cleanse compared with other colon segments. This post hoc analysis of two randomised clinical trials (MORA and NOCT) examined whether 1L polyethylene glycol (PEG) NER1006 and two mid-volume alternatives could improve adequate and high-quality cleansing in the right colon among patients with complete cleansing assessments. Methods Patients received NER1006 (N2D), 2L PEG plus ascorbate (2LPEG) or oral sulphate solution (OSS) as a 2-day evening/morning split-dosing regimen or NER1006 as a same-day morning-only dosing regimen (N1D). Patients had full segmental scoring assigned by treatment-blinded central readers using the Harefield Cleansing Scale. The right colon adequate (score ≥ 2) and high-quality (score ≥ 3) cleansing success of NER1006 (N2D and N1D) versus 2LPEG and OSS was analysed individually and as pooled groups (N2D vs. 2LPEG/OSS). We assessed the comparative right colon cleansing rates of the N2D versus 2LPEG/OSS in overweight males. We also performed a multivariable regression analysis to examine factors affecting cleansing in the right colon. Results A total of 1307 patients were included. Pooled N2D showed significantly improved rates of adequate-level cleansing in the right colon compared with 2LPEG (97.5% [504/517] vs. 94.6% [246/260]; p = 0.020) and OSS (97.5% [504/517] vs. 93.8% [244/260]; p = 0.006). In MORA, the rate of adequate right colon cleansing did not significantly differ between N1D and 2LPEG (95.2% [257/270] vs. 94.6% [246/260]; p = 0.383). The rate of right colon high-quality cleansing was significantly improved with N2D or N1D vs. 2LPEG (p < 0.001 for both), and was numerically higher with N2D versus OSS (p = 0.11). In overweight males, NER1006 delivered numerically higher adequate (p = 0.398) and superior high-quality (p = 0.024) cleansing rates versus 2LPEG/OSS. Multivariable regression analysis showed NER1006 was associated with adequate and high-quality cleansing (p = 0.031 and p < 0.001), while time between preparation and colonoscopy was negatively associated (p = 0.034 and p = 0.006). Conclusions NER1006 delivered improved rates of adequate and high-quality right colon cleansing compared with 2LPEG and OSS. The increased rate of high-quality cleansing with NER1006 versus its comparators was also seen in overweight males.

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Improved detection of colorectal adenomas by high-quality colon cleansing

Cited by 21 publications

References 28 publications

Bowel-cleansing efficacy of the 1L polyethylene glycol-based bowel preparation NER1006 (PLENVU) in patient subgroups in two phase III trials

Bowel-cleansing efficacy of the 1L polyethylene glycol-based bowel preparation NER1006 (PLENVU) in patient subgroups in two phase III trials

Bowel preparation with 1L polyethylene glycol and ascorbate NER1006 doubles the chance to detect three or more adenomas in overweight or obese males

1L NER1006 can improve rates of adequate and high-quality bowel cleansing in the right colon: a post hoc analysis of two randomised clinical trials

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