麻豆传媒

While disposable electronic gastroscopes were comparable to reusable gastroscopes for capturing images, the image quality was lower and the operating time was longer, a randomized non-inferiority trial in China found.

In an analysis involving 110 patients, both types of gastroscopes had a 100% success rate for capturing routine anatomical images, which met criteria for non-inferiority (margin of -8%), reported Peng Li, MD, of the Beijing Friendship Hospital in China, and colleagues, writing in .

But average image quality score was significantly lower and operating time was significantly longer for disposable gastroscopes versus reusable gastroscopes (P<0.001 for all):

• Mean image score: 37.0 vs 39.5 (out of 40)
• Total operating time: 7.7 vs 4.9 minutes
• Insertion time: 3.9 vs 2.4 minutes
• Withdrawal time: 3.8 vs 2.5 minutes

There were no significant differences in safety, maneuverability, gastroscopy completion rate, or device failure/defect rate, the authors noted.

"The performance of the disposable gastroscope was not quite as good as that of the reusable gastroscope," the group wrote. "However, improvements can be made to the image quality and maneuverability in the future."

Interestingly, the authors noted that the shorter operating time, time for insertion, and time for withdrawal may have been "related to the investigators' familiarity with the reusable endoscopes."

Since reusable gastroscopes can increase the risk of infection, disposable gastroscopes were developed to eliminate this risk, Li's group said. The FDA cleared the first disposable duodenoscope in late 2019; the EndoFresh Disposable Digestive Endoscopy System, used in the current study, .

Li's group noted that "this study is the first to compare disposable and reusable gastroscopes."

They enrolled 110 patients at Beijing Friendship Hospital from June to December 2020. Patients were randomized 1:1 to either the disposable or . Adults up to age 75, who required a gastroscopy for upper gastrointestinal (GI) symptoms or a screening gastroscopy were included.

Patients with systemic bleeding, corrosive ingestion, giant upper GI diverticulum, intolerance or contraindications to gastroscopy, or who had another endoscopy on the same day or an emergency endoscopy were excluded. Fasting for a minimum of 6 hours prior to the procedure was required.

Mean patient age was 36-39, about two-thirds were women, and none had prior upper GI surgery.

There were no adverse events in either group, and no significant fluctuations in blood pressure or heart rate, "indirectly demonstrating good operational stability" of both gastroscopes, Li's team noted.

They suggested that disposable gastroscopes had a place in the clinical arsenal as an "acceptable bedside tool" for certain populations, such as patients with severe immune deficiency disorder and hypoimmunity, as well as in various other settings: the emergency department, intensive care units, in disaster areas, remote regions, field and model hospitals, and infectious disease wards, especially during the COVID pandemic.

The authors acknowledged several limitations, including the cost and potential environmental impact of disposable gastroscopes.

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