Effect of premedication on lesion detection rate and visualization of the mucosa during upper gastrointestinal endoscopy: a multicenter large sample randomized controlled double-blind study

Abstract

BackgroundPremedication in upper gastrointestinal endoscopy for higher lesions detection rate has not been well studied so far. This study aimed to confirm whether premedication could improve the detection rate of early cancer or precancerous lesions and mucosal visibility.MethodFrom July 2015 to December 2015, 7200 participants from 6 centers were screened by endoscopy with one of the 4 following premedications randomly: (1) water (group D); (2) pronase (group A); (3) simethicone (group B); (4) pronase and simethicone (group C). Early cancer and precancerous lesions detection rates were taken as the primary endpoints, and mucosal visibility was taken as the secondary endpoint. They were compared among four groups to determine different premedication effects in terms of different anatomical sites. Trial was registered at Chinese Clinical Trial Registry; the registration number is ChiCTR-IOR-17010985.ResultsThe upper gastrointestinal overall precancerous lesion detection rates among four groups were 8.7, 8.4, 10.0, and 10.3%, the overall early cancer detection rates were 1.3, 1.4%, 1.5, and 1.6%, both without significant difference (p = 0.138 and 0.878). However, the visibility score distributions between control group (D) and premedication groups (A, B, and C) were all statistically significant, with all anatomical sites p values < 0.001. Subgroup analyses, from 2 centers without screening before, also showed significant difference in esophageal (3.9, 3.3, 4.5, and 8.4% with p = 0.004) and overall (7.0, 5.5, 7.3, and 12.0% with p = 0.004) precancerous lesion detection rate.ConclusionsPremedication with pronase and simethicone may not increase lesion detection rates but could significantly increase the upper gastrointestinal mucosal visibility.

Use of N-acetylcysteine plus simethicone to improve mucosal visibility during upper GI endoscopy

“…We agree with their concerns based on reports of crystallization in the endoscope channels when simethicone is used in the water pump. 3 The concentration of simethicone used varies and is not standardized, but frequently 10 to 20 mL (1-2 g) are poured into 1 liter of water. Then the water is flushed; applied on the mucosa covered with bubbles, mucus, or both; and directly suctioned.…”

Prevention of White Flocculate Precipitation with Simethicone During Upper Gastrointestinal Endoscopy: A Double‐Blinded, Multi‐Center, Randomized Study

“…Published data from institutions in the United Kingdom have shown that 10-14% of gastric cancer patients had undergone EGD in the preceding 3 years [2,3]. Impaired visibility may be a paramount factor for missing diagnosis of EGD [4].…”

“…It is generally accepted that premedication with antifoam/mucus agent before EGD can improve operation visibility [5][6][7]. Premedication with pronase [7][8], N-acetylcysteine [9] or simethicone [4] before EGD improves procedural visibility. In addition, combining different antifoam/mucus agents might be more effective [4].…”

“…Premedication with pronase [7][8], N-acetylcysteine [9] or simethicone [4] before EGD improves procedural visibility. In addition, combining different antifoam/mucus agents might be more effective [4]. Premedication before EGD with sedation has proven to be safe [7].…”

“…It is effective in eliminating foam and mucus by decreasing the surface tension of bubbles or foam [11]. Moreover, simethicone was proven effective in improving mucosal visibility when used as a premedication for EGD [4]. The latest Asian consensus on standards of diagnostic upper endoscopy for neoplasia has strongly recommended premedication with simethicone before EGD, classifying it as a level A recommendation [12].…”