麻豆传媒

Colonoscopies with a G-EYE balloon-assisted mechanical device detected more adenomas, including advanced adenomas, compared to Endocuff Vision (ECV)-assisted colonoscopies, a researcher reported.

In an analysis involving 727 patients, use of the G-EYE-assisted colonoscopy led to a higher adenoma detection rate (ADR) compared to those who had an ECV colonoscopy (61% vs 51%) and a significantly greater detection of advanced adenomas (24% vs 12%, respectively; P<0.05 for both), according to Seth Gross, MD, of NYU Langone Health in New York City.

G-EYE colonoscopy also detected significantly more adenomas per patient (APP) than ECV colonoscopy (1.21 vs 1.04), as well as twice as many advanced APP (0.242 vs 0.118), and found more larger adenomas (>10 mm) per patient (0.251 vs 0.143), he said in a presentation at the American College of Gastroenterology (ACG) annual meeting.

New colonoscopy technology aims to increase the ADR, and colonoscopy-assisted technology strives to maximize the surface area for inspection, Gross said at the presentation. During insertion, the G-EYE balloon is deflated, but then inflated once reaching the cecum. G-EYE centralizes the colonoscopy view by flattening the folds of the colon upon withdrawal, he noted.

"Adenoma detection rate is a key metric used to judge colonoscopy quality," said Christopher Velez, MD, of Massachusetts General Hospital in Boston, who was not involved in this study. "Any attempt to enhance adenoma detection has importance not only for physician practice, but also for patient care."

"The two devices studied in this trial represent credible ways to improve adenoma detection," Velez told 麻豆传媒. "There are some benefits of the reusable G-EYE device in this work, which may lead to its increased adoption in the coming years."

Gross noted that this is the first trial to provide a "head-to-head comparison" on two new mechanical attachments applied to the distal end of a colonoscope.

When asked to explain the difference between the two, Gross said, "the Endocuff does more of a fold-to-fold flattening of folds, where the G-EYE does a more segmental flattening of the folds," adding that "we're seeing much more surface area exposure on the backsides of these [colonic] folds."

Gross noted that while current AI systems identify more obvious polyps, they cannot detect those "behind folds, or blind spots at the flexures."

"This study also highlights what we have known over the last bunch of years from other studies, that mechanical enhancement appears to improve polyp detection, adenoma detection, with the whole concept of more surface area exposure on the withdrawal of the colonoscope," he said.

"We are excited to embrace new, safe technologies which help us prevent colon cancer in our patients," said Benjamin Levy, MD, of Mount Sinai Hospital in Chicago and a member of the ACG's FDA Related Matters Committee, who was not involved in the study. "These study results may help endoscopy centers and hospitals plan future technology purchases."

The multicenter study randomized 727 patients 1:1 to colonoscopy surveillance or screening with the G-EYE-assisted device (which has a reusable permanently mounted balloon) or the ECV colonoscopy (which has a disposable, single-use attachment).

The primary endpoint compared ADR between groups. Secondary endpoints assessed APP and polyp detection rates.

Both groups had similar patient characteristics and colonoscopy withdrawal times, which were greater than the recommended guidelines of 6 minutes. All extracted polyps were examined via pathology.

One study limitation was the lack of a cost comparison between the two devices. Also, the ability to perform right colon retroflexion was not assessed, but Gross said it was possible with these mechanical devices.

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