Mo1433 Prototype Extra Wide Angle View Colonoscope: A Pilot Study to Assess Safety and Efficacy for Colorectal Polyp Detection

Abstract Objective This metanalysis aimed to evaluate the sensitivity and specificity of computed tomography colonography in colorectal polyp detection. Methods A literature search was performed in the PubMed and Web of Science databases. Results A total of 1,872 patients (males 57.2%, females 42.8%) aged 49 to 82 years old (mean age 59.7 ± 5.3 years) were included in this metanalysis. The estimated sensitivity of computed tomography colonography was 88.4% (46.3–95.7%, coefficient of variation [CV] = 28.5%) and the estimated specificity was 73.6% (47.4–100.0%, CV = 37.5%). For lesions up to 9 mm, the sensitivity was 82.5% (62.0–99.9%, CV = 25.1%) and the specificity was 79.2% (32.0–98.0%, CV = 22.9%). For lesions > 9 mm, the sensitivity was 90.2% (64.0–100.0%, CV = 7.4%) and the specificity was 94.7% (80.0–100.0%, CV = 6.2%). No statistically significant differences in sensitivity according to the size of the lesion were found (p = 0.0958); however, the specificity was higher for lesions > 9 mm (p < 0.0001). Conclusions Most of the studies analyzed in the present work were conducted before 2010, which is about a decade after computed tomography colonography started being indicated as a screening method by European and American guidelines. Therefore, more studies aimed at analyzing the technique after further technological advancements are necessary, which could lead to the development of more modern devices.

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Safety and efficacy of faecal microbiota transplantation by Anaerobic Cultivated Human Intestinal Microbiome (ACHIM) in patients with systemic sclerosis: study protocol for the randomised controlled phase II ReSScue trial

BMJ Open ◽

10.1136/bmjopen-2020-048541 ◽

2021 ◽

Vol 11 (6) ◽

pp. e048541

Author(s):

Anna-Maria Hoffmann-Vold ◽

Håvard H Fretheim ◽

Vikas K Sarna ◽

Imon Barua ◽

Maylen N Carstens ◽

...

Keyword(s):

Systemic Sclerosis ◽

Pilot Study ◽

Phase Ii ◽

Intestinal Microbiome ◽

Induction Phase ◽

Inflammatory Disorder ◽

Faecal Microbiota ◽

Safety And Efficacy ◽

Faecal Microbiota Transplantation ◽

Patient Reported

IntroductionIn the multisystem inflammatory disorder systemic sclerosis (SSc), gastrointestinal tract (GIT) affliction is highly prevalent. There are no known disease modifying therapies and the negative impact is substantial. Aiming for a new therapeutic principle, and inspired by recent work showing associations between gut microbiota changes and GIT symptoms in SSc, we performed a pilot study on faecal microbiota transplantation (FMT) with the single-donor bacterial culture ‘Anaerobic Cultivated Human Intestinal Microbiome (ACHIM)’. Motivated by positive pilot study signals, we designed the ReSScue trial as a phase II multicentre, placebo-controlled, randomised 20-week trial to evaluate safety and efficacy on lower GIT symptoms of FMT by ACHIM in SSc.Methods and analysesWe aim to include 70 SSc participants with moderate to severe lower GIT symptoms, defined by the validated patient-reported University of California Los Angeles Scleroderma Clinical Trial Consortium GIT 2.0 2.0 questionnaire. The trial includes three parts. In part A1 (induction phase) lasting from week 0 to week 12, participants will be randomised 1:1 to repeat infusions of 30 mL ACHIM or placebo at week 0 and 2 by gastroduodenoscopy. In part A2, which is an 8-week subsequent maintenance phase, all study participants will receive 30 mL ACHIM at week 12 and followed until week 20 on continued blind. In part B, which will last until the last participant completes part A2, the participants will be followed through a maximum 16-week extended monitoring period, for longer-term data on safety and intervention effects. Primary endpoint is change from baseline to week 12 in UCLA GIT subscale scores of diarrhoea or bloating, depending on the worst symptom at baseline evaluated separately for each patient. Secondary endpoints are safety measures and changes in UCLA GIT scores (total, diarrhoea and bloating).Ethics and disseminationThis protocol was approved by the Northern Norwegian Committee for Medical Ethics. Study findings will be published.Trial registration numberNCT04300426; Pre-results.Protocol versionV.3.1.

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