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NCT Number: NCT06713421

Effect of Premedication With Pronase on Mucosal Cleanliness During EGD

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.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Dimethicone+Pronase

Drug

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.

Dimethicone

Drug

Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder.

with Postural Exercise

Behavioral

After the premedication is administered orally approximately 15-20 minutes before EGD, patients are asked to take a 3-minute postural exercise.

without Postural Exercise.

Behavioral

After the premedication is administered orally approximately 15-20 minutes before EGD, patients sit quietly awaiting examination.

Primary outcomes

  1. Mucosal Cleanliness Scores

    Time frame: Through study completion, an average of 1 year

    The upper digestive tract is divided into 9 anatomical parts, including esophagus, squamocolumnar junction, middle-upper gastric body, lower gastric body, gastric antrum, duodenal bulb, duodenal descending, gastric angulus and gastric fundus.

    The mucosal cleanliness score of each segment is classified as 0-3. Score0: any solid food, blood or blood clots, or other content that could not be suctioned or washed, or an obstruction that prevented adequate visualization of the majority of an anatomical area.

    Score 1: mucus, bubbles, liquid content, and blood that required suctioning AND/OR washing.

    Score 2: nonadherent liquid content or blood that required ONLY suctioning but NOT washing.

    Score 3: entire mucosa well seen without the need for suctioning or washing. The sum of the mucosal cleanliness scores for the above mentioned 9 locations ranges from 0 to 27.

Secondary outcomes

  1. Procedure Time

    Time frame: Through study completion, an average of 1 year

    The procedure time of EGD is defined as the time taken from the entry of EGD into the esophagus to the withdrawal of the EGD.

  2. The Detection Rate of Diminutive Lesions

    Time frame: Through study completion, an average of 1 year

    The detection rate of diminutive lesions means the proportion of patients with diminutive lesions <5 mm.

  3. Safety of antifoam/mucus agents

    Time frame: Through study completion, an average of 1 year

    Any adverse event including gag reflex and hypoxemia during EGD examination need to be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Xin, MD

CONTACT

[email protected]

13817318134

Luowei Wang, MD

CONTACT

[email protected]

13901833088

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • Affiliated Hospital of Hebei University
  • Anqing Municipal Hospital
  • Beijing Chao-Yang Hospital, Captial Medical University
  • Beijing Friendship Hospital, Captial Medical University
  • Beijing Tiantan Hospital
  • First Affiliated Hospital of Harbin Medical University
  • First Affiliated Hospital of Kunming Medical University
  • First People's Hospital of Hangzhou
  • Fujian Provincial Hospital
  • General Hospital of Ningxia Medical University
  • Hengshui People's Hospital
  • Huadu District People's Hospital of Guangzhou
  • Huashan Hospital
  • Jining Medical University
  • Jiujiang No.1 People's Hospital
  • Kunshan Hospital of Traditional Chinese Medicine
  • Liaocheng People's Hospital
  • Longgang District People's Hospital of Shenzhen
  • Loudi Central Hospital
  • Nanjing Gaochun People's Hospital
  • Ningbo Medical Center Lihuili Hospital
  • Peking Union Medical College Hospital
  • Qilu Hospital of Shandong University
  • Red Cross Hospital, Hangzhou, China
  • Second Affiliated Hospital of Xi'an Jiaotong University
  • Subei People's Hospital of Jiangsu Province
  • Taihe Hospital
  • Taizhou First People's Hospital
  • The Affiliated Hospital Of Southwest Medical University
  • The Affiliated Hospital of Inner Mongolia Medical University
  • The First Affilated Hospital of the Medical College, Shihezi University
  • The First People's Hospital of TianMen in Hubei Province
  • The People's Hospital of JiangMen
  • The Second Affiliated Hospital of Chongqing Medical University
  • The Second Affiliated Hospital of Harbin Medical University
  • The Second Affiliated Hospital of Kunming Medical University
  • The Second Affiliated Hospital of Shandong First Medical University
  • Xinghua City People's Hospital
  • Yuebei People's Hospital
  • Yunnan Cancer Hospital
  • Zhejiang Provincial People's Hospital
  • Zhoushan Hospital, Zhejiang
  • ZhuZhou Central Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2024
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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