Clinical study of pronase for improving visibility and safety in colonoscopy.

BACKGROUND

This is a multicenter, randomized, double-blind, placebo-controlled interventional clinical study to evaluate the efficacy and safety of pronase in improving visibility in colonoscopy and to evaluate whether pronase can increase the detection rate of intestinal lesions and the colonoscopist's satisfaction.

METHODS

From June 2023 to December 2023, a total of 1942 patients undergoing air insufflation colonoscopy in 10 hospitals (The First Medical Center, Chinese PLA General Hospital, et al ) were selected as the study subjects. They were randomly divided into two groups: (1) the experimental group ( n = 969) was given pronase for flushing in colonoscopy; and (2) the control group ( n = 973) was given physiological saline for flushing in colonoscopy. The improvement of the visibility at the target site (region of interest) in colonoscopy was evaluated in two groups to verify the efficacy of pronase in improving visibility in colonoscopy. The safety of pronase for flushing in colonoscopy was evaluated by comparing the incidence of adverse events between the two groups.

RESULTS

After the use of pronase in colonoscopy, the patient's vital signs remained stable, without serious adverse reactions. The improvement rate of visibility in the pronase group was significantly higher than that in the physiological saline group (97.21% [942/969] vs. 86.74% [844/973], P <0.0001), and the subgroup analysis (Boston Bowel Preparation Scale ≥6 points) showed similar results to the overall ones. The physician's satisfaction score in the pronase group was significantly increased. There was no statistically significant difference in the detection rates of adenoma, colorectal cancer, minimal lesions, non-polypoid colorectal lesions, polyps, and precancerous lesions between the two groups.

CONCLUSIONS

Pronase can improve the visibility in colonoscopy and help physicians observe the lesions better. Pronase demonstrates good safety in colonoscopy, with no significant difference compared to physiological saline.

REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2300071702).