Disposable gastroscopes were equally 100% successful as reusable gastroscopes for capturing images, but image quality was significantly lower and operating time was significantly longer, according to study results in Gastrointestinal Endoscopy.
Investigators assessed the image quality, operability, operating time, and safety of disposable gastroscopes compared with reusable gastroscopes.
A total of 110 patients were included from a hospital in China from June 12, 2020, to December 16, 2020. Eligible participants were aged 18 to 75 years and required gastroscopy for upper gastrointestinal symptoms or screening gastroscopy.
Patients were randomly assigned to either the disposable electronic gastroscope group (experimental group; n=55) or reusable gastroscope group (control group; n=55). The disposable gastroscope used was the XZING-W200B (Huizhou Xianzan Technology Co, Ltd, China).
The primary endpoint was acceptable image quality with a noninferiority margin of -8%. Secondary measures included image quality score, gastroscopy completion rate, acceptable clinical operability, device failure/malfunction rate, and operating time. Safety measures were also assessed.
Patients in the disposable gastroscope group had a mean age of 36.58 years, and 63.6% were women. Patients in the reusable gastroscope group had a mean age of 38.76 years, and 67.3% were women.
The rate of acceptable image quality was 100.0% (95% CI, 0.9347-1.0000) in the 2 groups. The mean image quality scores were 37.02±3.09 (95% CI, 36.18-37.85) in the experimental group and 39.47±1.92 (95% CI, 38.95-39.99) in the control group, with a statistically significant difference (P <.001). The endoscopy completion rate was 100.0% (95% CI, 0.9347-1.0000) in the 2 groups, and the rate of acceptable (rating A or B) clinical operability was 100.0% (95% CI, 0.9347-1.0000) in both groups.
The device failure/malfunction rate was 0.0% (95% CI, 0.0000-0.0653) for both groups. The experimental group had a longer total operating time, insertion time, and withdrawal time, with statistically significant differences (P <.001). No adverse events were observed in either group.
The researchers noted that their findings are based on a noninferiority trial and the disposable gastroscope’s performance was not quite as good as that of the reusable gastroscope. Also, the disposable endoscopes currently cost $800 to $1200, and the potential environmental impact of them is unknown.
“In addition to the possible contamination and high cost for maintenance and repair for conventional gastroscopes, disposable gastroscopes are an acceptable bedside tool with an important role not only in the emergency room and intensive care unit but also in certain circumstances, eg, for patients with severe immune deficiency disorder and hypoimmunity, on warships, and in disaster areas, remote regions, field hospitals, mobile hospitals and infectious disease wards, especially during the COVID-19 pandemic,” the study authors wrote.
Luo X, Ji M, Zhang S, et al. Disposable versus reusable gastroscope: a prospective randomized non-inferiority trial. Gastrointest Endosc. Published online April 2, 2022. doi:10.1016/j.gie.2022.03.024