Exploration of the optimal regimen of gastric mucosal cleansing medication for the population before ME-NBI screening: study protocol for a single-center, single-blind, randomized controlled trial.

OBJECTIVE

Magnifying endoscopy combined with narrow-band imaging endoscopy is an emerging method for early gastric cancer screening and diagnosis However, its effectiveness is closely related to the cleaning quality of the gastric mucosal preparation. infection is a major risk factor for inadequate gastric mucosa cleaning quality preparation. Multiple medications are useful in helping patients with gastric mucosal cleansing preparations. This randomized controlled trial study protocol aims to investigate the effect of different combinations of medications on the quality of gastric mucosal cleansing in an -infected population.

METHODS

This study is a prospective, randomized, single-blind, single-center trial. The subjects are patients who require magnifying endoscopy combined with narrow-band imaging and have evidence of infection (a non-invasive diagnostic C urea breath test was used to examine the study subjects). These patients will be randomly assigned to the control group (Group A) and the experimental groups (Groups B, C, D, E, and F). Each group will consist of 44 patients, with a total of 264 patients expected to be enrolled. The core content of the drug preparation regimen for each group is as follows: Group A (control group) will take 10 ml of simethicone before the examination; Group B (experimental group) will take 20,000 units of pronase before the examination; Group C (experimental group) will take 600 mg of N-acetylcysteine before the examination; Group D (experimental group) will take 10 ml of simethicone +20,000 units of pronase before the examination; Group E (experimental group) will take 10 ml of simethicone + 600 mg of N-acetylcysteine before the examination; Group F (experimental group) will take 10 ml of simethicone + 20,000 units of pronase + 1 g of sodium bicarbonate before the examination. All group medications will be dissolved in 50 ml of warm water at 20-40°C. All patients will fast for ≥6 h and abstain from drinking for 2 h before the examination. The primary endpoint is the gastric mucosa cleanliness score. Secondary endpoints include the early detection rate of gastric cancer, polyp detection rate, adenoma detection rate, procedure time, number of irrigations, patient medication compliance, preoperative anxiety, incidence of adverse reactions, overall patient satisfaction, and willingness to undergo the examination again.

IMPLICATIONS

The results of this research project are aimed at improving the quality of gastric mucosal cleansing preparations in the population to meet the demand for early diagnosis and treatment prevention screening for early gastric cancer screening. The implementation of the results of the study and their inclusion in the guidelines may reduce economic expenditures by reflecting a reduced need for social and health care services.

CLINICAL TRIAL REGISTRATION

Chinese Clinical Trial Registry (ChiCTR). Number of identification: (ChiCTR2400087510).