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Standard forward-viewing colonoscopy versus full-spectrum endoscopy: an international, multicentre, randomised, tandem colonoscopy trial.

ABSTRACT: Although colonoscopy is the accepted standard for detection of colorectal adenomas and cancers, many adenomas and some cancers are missed. To avoid interval colorectal cancer, the adenoma miss rate of colonoscopy needs to be reduced by improvement of colonoscopy technique and imaging capability. We aimed to compare the adenoma miss rates of full-spectrum endoscopy colonoscopy with those of standard forward-viewing colonoscopy.We did an international, multicentre, randomised trial at three sites in Israel, one site in the Netherlands, and two sites in the USA between Feb 1, 2012, and March 31, 2013. Patients aged 18-70 years referred for colorectal cancer screening, polyp surveillance, or diagnostic assessment underwent same-day, back-to-back tandem colonoscopy with standard forward-viewing colonoscope and the full-spectrum endoscopy colonoscope. The patients were randomly assigned (1:1), via computer-generated randomisation with block size of 20, to which procedure was done first. The endoscopist was masked to group allocation until immediately before the start of colonoscopy examinations; patients were not masked. The primary endpoint was adenoma miss rates. We did per-protocol analyses. This trial is registered with ClinicalTrials.gov, number NCT01549535.197 participants were enrolled. 185 participants were included in the per-protocol analyses: 88 (48%) were randomly assigned to receive standard forward-viewing colonoscopy first, and 97 (52%) to receive full-spectrum endoscopy colonoscopy first. By per-lesion analysis, the adenoma miss rate was significantly lower in patients in the full-spectrum endoscopy group than in those in the standard forward-viewing procedure group: five (7%) of 67 vs 20 (41%) of 49 adenomas were missed (p<0·0001). Standard forward-viewing colonoscopy missed 20 adenomas in 15 patients; of those, three (15%) were advanced adenomas. Full-spectrum endoscopy missed five adenomas in five patients in whom an adenoma had already been detected with first-pass standard forward-viewing colonoscopy; none of these missed adenomas were advanced. One patient was admitted to hospital for colitis detected at colonoscopy, whereas five minor adverse events were reported including vomiting, diarrhoea, cystitis, gastroenteritis, and bleeding.Full-spectrum endoscopy represents a technology advancement for colonoscopy and could improve the efficacy of colorectal cancer screening and surveillance.EndoChoice.

SUBMITTER: Gralnek IM

PROVIDER: S-EPMC4062184 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

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Standard forward-viewing colonoscopy versus full-spectrum endoscopy: an international, multicentre, randomised, tandem colonoscopy trial.

Gralnek Ian M IM Siersema Peter D PD Halpern Zamir Z Segol Ori O Melhem Alaa A Suissa Alain A Santo Erwin E Sloyer Alan A Fenster Jay J Moons Leon M G LM Dik Vincent K VK D'Agostino Ralph B RB Rex Douglas K DK

The Lancet. Oncology 20140220 3

<h4>Background</h4>Although colonoscopy is the accepted standard for detection of colorectal adenomas and cancers, many adenomas and some cancers are missed. To avoid interval colorectal cancer, the adenoma miss rate of colonoscopy needs to be reduced by improvement of colonoscopy technique and imaging capability. We aimed to compare the adenoma miss rates of full-spectrum endoscopy colonoscopy with those of standard forward-viewing colonoscopy.<h4>Methods</h4>We did an international, multicentr ...[more]

PMID: 24560453

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Project description:Interventions: Randomized order of colonoscopy type (conventional versus FUSE colonoscopy) to determine the miss rates of colonoscopy type. The intervention is the use of the FUSE colonoscope which is a colonoscope that incorporates 3 cameras on the colonoscope tip to provide a panoramic 330-degree field of view. .The size and function of the FUSE colonoscope is otherwise the same as the conventional colonoscope (control). Both instruments visualise the internal lining of the bowel and permit the identification and removal of neoplasia. All subjects will have both procedures performed back-to-back (crossover tandem colonoscopy) but the order of the procedure will be randomized. The effect is that the second procedure will determine if lesions were missed during the first procedure, and which colonoscope can identify more neoplasia. Both colonoscopies are expected to be equivalent in duration, taking 15-25 minutes. Quality indicator is that colonoscopy withdrawal should be of at least 6 minutes to improve the chances of not missing pathology. Both colonoscopies are conducted by investigators who are experienced in surveillance colonoscopies and accredited endoscopists. The histopathologists are from the Department of Pathology and familiar with the identification and interpretation of IBD dysplasia. Where dysplasia is found, a second gastrointestinal pathologist will assist with the grading through consensus. Both pathologists are blinded to the order of the colonoscopy (which is coded). There is no need for a wash out, as this is not a drug trial. The second colonoscopy is inserted as soon as the processor is connected and switched on, which usually takes 4-5 minutes. The patient remains under sedation during the intervening period and we wish to keep that as brief a Primary outcome(s): Dysplasia miss rates on a per-lesion analysis [Following completion of both colonoscopies and histological confirmation of the lesions removed during the procedures. ] Study Design: Purpose: Diagnosis; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Safety/efficacy

Project description:Although evidence suggests frequent gastrointestinal (GI) involvement during coronavirus disease 2019 (COVID-19), endoscopic findings are scarcely reported. We aimed at registering endoscopic abnormalities and potentially associated risk factors among patients with COVID-19. All consecutive patients with COVID-19 undergoing endoscopy in 16 institutions from high-prevalence regions were enrolled. Mann-Whitney U, χ2 or Fisher's exact test were used to compare patients with major abnormalities to those with negative procedures, and multivariate logistic regression to identify independent predictors. Between February and May 2020, during the first pandemic outbreak with severely restricted endoscopy activity, 114 endoscopies on 106 patients with COVID-19 were performed in 16 institutions (men=70.8%, median age=68 (58-74); 33% admitted in intensive care unit; 44.4% reporting GI symptoms). 66.7% endoscopies were urgent, mainly for overt GI bleeding. 52 (45.6%) patients had major abnormalities, whereas 13 bled from previous conditions. The most prevalent upper GI abnormalities were ulcers (25.3%), erosive/ulcerative gastro-duodenopathy (16.1%) and petechial/haemorrhagic gastropathy (9.2%). Among lower GI endoscopies, 33.3% showed an ischaemic-like colitis.Receiver operating curve analysis identified D-dimers >1850 ng/mL as predicting major abnormalities. Only D-dimers >1850 ng/mL (OR=12.12 (1.69-86.87)) and presence of GI symptoms (OR=6.17 (1.13-33.67)) were independently associated with major abnormalities at multivariate analysis. In this highly selected cohort of hospitalised patients with COVID-19 requiring endoscopy, almost half showed acute mucosal injuries and more than one-third of lower GI endoscopies had features of ischaemic colitis. Among the hospitalisation-related and patient-related variables evaluated in this study, D-dimers above 1850 ng/mL was the most useful at predicting major mucosal abnormalities at endoscopy. ClinicalTrial.gov (ID: NCT04318366).

Dataset Information

Standard forward-viewing colonoscopy versus full-spectrum endoscopy: an international, multicentre, randomised, tandem colonoscopy trial.

Publications

Standard forward-viewing colonoscopy versus full-spectrum endoscopy: an international, multicentre, randomised, tandem colonoscopy trial.

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