drugset / Trial / NCT06713421

Effect of Premedication With Pronase on Mucosal Cleanliness During EGD

NCT06713421

Recruiting 3000 enrolled Changhai Hospital Affiliated Hospital of Hebei University · collabAnqing Municipal Hospital · collabBeijing Chao-Yang Hospital, Captial Medical University · collabBeijing Friendship Hospital, Captial Medical University · collabBeijing Tiantan Hospital · collabFirst Affiliated Hospital of Harbin Medical University · collabFirst Affiliated Hospital of Kunming Medical University · collabFirst People's Hospital of Hangzhou · collabFujian Provincial Hospital · collabGeneral Hospital of Ningxia Medical University · collabHengshui People's Hospital · collabHuadu District People's Hospital of Guangzhou · collabHuashan Hospital · collabJining Medical University · collabJiujiang No.1 People's Hospital · collabKunshan Hospital of Traditional Chinese Medicine · collabLiaocheng People's Hospital · collabLonggang District People's Hospital of Shenzhen · collabLoudi Central Hospital · collabNanjing Gaochun People's Hospital · collabNingbo Medical Center Lihuili Hospital · collabPeking Union Medical College Hospital · collabQilu Hospital of Shandong University · collabRed Cross Hospital, Hangzhou, China · collabSecond Affiliated Hospital of Xi'an Jiaotong University · collabSubei People's Hospital of Jiangsu Province · collabTaihe Hospital · collabTaizhou First People's Hospital · collabThe Affiliated Hospital Of Southwest Medical University · collabThe Affiliated Hospital of Inner Mongolia Medical University · collabThe First Affilated Hospital of the Medical College, Shihezi University · collabThe First People's Hospital of TianMen in Hubei Province · collabThe People's Hospital of JiangMen · collabThe Second Affiliated Hospital of Chongqing Medical University · collabThe Second Affiliated Hospital of Harbin Medical University · collabThe Second Affiliated Hospital of Kunming Medical University · collabThe Second Affiliated Hospital of Shandong First Medical University · collabXinghua City People's Hospital · collabYuebei People's Hospital · collabYunnan Cancer Hospital · collabZhejiang Provincial People's Hospital · collabZhoushan Hospital, Zhejiang · collabZhuZhou Central Hospital · collab
RandomizedFactorialOpen-labelOther

Summary

Gastric cancer and esophageal cancer are common malignant tumors that threaten people's life and health. Esophagogastroduodenoscopy (EGD) is an important tool for screening upper gastrointestinal tumors, especially early tumors, and an effective method for detecting other upper gastrointestinal lesions, including ulcers and polyps. However, during EGD examination, mucus and foam can reduce the cleanliness of the mucosa and limit the operator's visual field, resulting in missed lesions and misdiagnosis. Previous studies have shown that preoperative medication with pronase and dimeticone is correlated with the improvement of upper gastrointestinal mucosal cleanliness. However, the number of samples in such studies is limited, and the artificial judgment is not objective enough to evaluate the cleanliness of upper digestive tract mucosa. And, whether a postural exercise is necessary for premedication with pronase or dimeticone remains unclear. Our team design this experiment to examine the efficacy of using premedication of dimeticone/pronase with a postural exercise on visualization of the mucosa before painless EGD. The investigators aim to provide new evidence to optimize the use of premedication with EGD.

Timeline

Start
2024-12-01
Primary completion
2025-09-01
Completion
2025-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Promethazine Small molecule 20000 iu Oral
Comparator Dimethicone Unknown 5 g Oral