Higher Adenoma Detection Rates with Endocuff-Assisted Colonoscopy – A Randomized Controlled Multicenter Trial

<div><p>Objectives</p><p>The Endocuff is a device mounted on the tip of the colonoscope to help flatten the colonic folds during withdrawal. This study aimed to compare the adenoma detection rates between Endocuff-assisted (EC) colonoscopy and standard colonoscopy (SC).</p><p>Methods</p><p>This randomized prospective multicenter trial was conducted at four academic endoscopy units in Germany. Participants: 500 patients (235 males, median age 64[IQR 54–73]) for colon adenoma detection purposes were included in the study. All patients were either allocated to EC or SC. The primary outcome measure was the determination of the adenoma detection rates (ADR).</p><p>Results</p><p>The ADR significantly increased with the use of the Endocuff compared to standard colonoscopy (35.4%[95% confidence interval{CI} 29–41%] vs. 20.7%[95%CI 15–26%], p<0.0001). Significantly more sessile polyps were detected by EC. Overall procedure time and withdrawal time did not differ. Caecal and ileum intubation rates were similar. No major adverse events occurred in both groups. In multivariate analysis, age (odds ratio [OR] 1.03; 95%[CI] 1.01–1.05), male sex (OR 1.74; 95%CI 1.10–2.73), withdrawal time (OR 1.16; 95%CI 1.05–1.30), procedure time (OR 1.07; 95%CI 1.04–1.10), colon cleanliness (OR 0.60; 95%CI 0.39–0.94) and use of Endocuff (OR 2.09; 95%CI 1.34–3.27) were independent predictors of adenoma detection rates.</p><p>Conclusions</p><p>EC increases the adenoma detection rate by 14.7%(95%CI 6.9–22.5%). EC is safe, effective, easy to handle and might reduce colorectal interval carcinomas.</p><p>Trial Registration</p><p>ClinicalTrials.gov <a href="https://clinicaltrials.gov/ct2/results?term=NCT02034929" target="_blank">NCT02034929</a>.</p></div

Polyp and adenoma detection analysis.

<p>*only patients considered in whom at least one adenoma or polyp, respectively were detected.</p>#<p>3 polyps (EC) and two polyps (SC) not retrieved endoscopically.</p><p>Polyp and adenoma detection analysis.</p

Main outcomes of endoscopic procedures.

<p>IQR: interquartile range.</p><p>Main outcomes of endoscopic procedures.</p

Forest plot showing the results of multivariate regression analysis for adenoma detection.

<p>The x-axis represents the Odds ratio on a log scale with the reference line (dashed), Odds ratios (diamond) and 95% CI (whiskers).</p

Baseline demographic and clinical characteristics.

<p>ASS = acetylsalicylate; IQR = interquartile range.</p><p>Baseline demographic and clinical characteristics.</p

Enrollment flow chart.

<p>Enrollment flow chart.</p

Overall Survival (OS) and Relapse-Free Survival (RFS) in 349 patients with cytogenetically normal acute myeloid leukemia and <i>NPM1</i> mutation treated in the AMLCG99 study.

<p>(A) OS in patients with <i>NPM1</i> type A mutation versus <i>NPM1</i> rare type mutation. (B) OS in patients with <i>NPM1</i> type A mutation versus <i>NPM1</i> rare type mutation with or without an additional <i>FLT3-ITD</i>. (C) RFS in patients with <i>NPM1</i> type A mutation versus <i>NPM1</i> rare type mutation. (D) RFS in patients with <i>NPM1</i> type A mutation versus <i>NPM1</i> rare type mutation with or without an additional <i>FLT3-ITD</i>. <b>Abbreviations</b>: CR, complete remission; <i>FLT3-ITD</i>+, presence of an internal tandem duplication in the fms-related tyrosine 3 gene; <i>FLT3-ITD</i>-, absence of an internal tandem duplication in the fms-related tyrosine 3 gene; <i>NPM1-A</i>, mutation in the nucleophosmin gene consisting of an insertion of the tetranucleotide TCTG; <i>NPM1-RA</i>, mutation in the nucleophosmin gene other than type A.</p

Multivariable Cox regression models for OS and RFS in 349 <i>NPM1</i>-mutated patients.

<p>White blood cell count, platelet count, hemoglobin level, lactase dehydrogenase level, bone marrow blasts, de novo AML versus non de novo AML, performance status, sex, age, type A versus rare type <i>NPM1</i> mutation, <i>FLT3-ITD</i>, monoallelic <i>CEBPA</i> mutations, biallelic <i>CEBPA</i> mutations were included in the Cox regression models for OS and RFS with backward elimination. The analyses were performed using 313 patients for OS and 227 RFS who had data for all these variables. A p-value of <0.05 was considered as indicating significant differences. All parameters that did not have a significant impact on OS or RFS are not shown in the table, except for the <i>NPM1</i> mutation type.</p><p><b>Abbreviations</b>: <i>CEBPA</i>, CCAAT/enhancer-binding protein alpha gene; CI, confidence interval; <i>FLT3-ITD</i>, internal tandem duplication of the <i>FLT3</i> gene; HR, hazard ratio; negative, absence of <i>FLT3-ITD</i>; <i>NPM1</i>, nucleophosmin gene; <i>NPM1-A</i>, mutation in the nucleophosmin gene leading to the insertion of the tetranucleotide TCTG; <i>NPM1-RA</i>, mutation in the nucleophosmin gene other than type A; OS, Overall survival; p, p value; positive, presence of <i>FLT3-ITD</i>; RFS, Relapse-free survival; WBC, white blood cell count.</p><p>Multivariable Cox regression models for OS and RFS in 349 <i>NPM1</i>-mutated patients.</p