Effect of Premedication With Pronase on Mucosal Cleanliness During EGD

Официальное название

The Effects of Premedication With Pronase and Postural Exercise on Mucosal Cleanliness During Painless Esophagogastroduodenoscopy: A Prospective, Multicenter, Randomized Controlled Study Based on Artificial Intelligence Assessment

Обзор

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.

Вмешательства

• Препарат Dimethicone+Pronase
  Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder and 20,000 IU pronase granules combined with 1 g NaHCO3.
• Препарат Dimethicone
  Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder.
• Поведенческое with Postural Exercise
  After the premedication is administered orally approximately 15-20 minutes before EGD, patients are asked to take a 3-minute postural exercise.
• Поведенческое without Postural Exercise.
  After the premedication is administered orally approximately 15-20 minutes before EGD, patients sit quietly awaiting examination.

Первичные конечные точки

• Mucosal Cleanliness Scores [Срок оценки: Through study completion, an average of 1 year]

Вторичные конечные точки (3)

• Procedure Time [Срок оценки: Through study completion, an average of 1 year]
• The Detection Rate of Diminutive Lesions [Срок оценки: Through study completion, an average of 1 year]
• Safety of antifoam/mucus agents [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

• Male or female aged ≥18 years and ≤70 years;
• Voluntarily participate in the trial and sign the informed consent.

Критерии исключения

• active gastrointestinal bleeding;
• esophageal stricture, complete pyloric obstruction and gastroparesis caused by various reasons;
• diagnosed malignant tumors of the upper digestive tract;
• a history of upper gastrointestinal surgery;
• severe heart, liver and kidney diseases, and the doctor judges that it is not suitable for painless gastroscopy;
• serious mental illness;
• pregnancy or breastfeeding;
• an allergy to pronase or dimeticone;
• current participation in other clinical trials and in the follow-up or drug washout period;
• patients considered by the investigator to be unsuitable for this study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Китай · 1 центр

• Changhai hosipital — Шанхай

Идентификаторы

NCT: NCT06713421 · EPPMC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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