Effect of Premedication With Pronase on Mucosal Cleanliness During EGD

NCT06713421 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2025-02-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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.

DRUG

Dimethicone

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

BEHAVIORAL

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.

BEHAVIORAL

without Postural Exercise.

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

Sponsors & Collaborators

  • Fujian Provincial Hospital

    collaborator OTHER
  • Huashan Hospital

    collaborator OTHER
  • The Second Affiliated Hospital of Harbin Medical University

    collaborator OTHER
  • First Affiliated Hospital of Harbin Medical University

    collaborator OTHER
  • Red Cross Hospital, Hangzhou, China

    collaborator OTHER
  • The Affiliated Hospital of Inner Mongolia Medical University

    collaborator OTHER
  • Yuebei People's Hospital

    collaborator OTHER
  • Longgang District People's Hospital of Shenzhen

    collaborator OTHER
  • Huadu District People's Hospital of Guangzhou

    collaborator OTHER
  • Liaocheng People's Hospital

    collaborator OTHER
  • Qilu Hospital of Shandong University

    collaborator OTHER
  • The Second Affiliated Hospital of Shandong First Medical University

    collaborator OTHER
  • Anqing Municipal Hospital

    collaborator OTHER
  • Jiujiang No.1 People's Hospital

    collaborator OTHER
  • Kunshan Hospital of Traditional Chinese Medicine

    collaborator UNKNOWN
  • Nanjing Gaochun People's Hospital

    collaborator OTHER
  • Taizhou First People's Hospital

    collaborator OTHER
  • Hengshui People's Hospital

    collaborator OTHER
  • Affiliated Hospital of Hebei University

    collaborator OTHER
  • Second Affiliated Hospital of Xi'an Jiaotong University

    collaborator OTHER
  • Taihe Hospital

    collaborator OTHER
  • ZhuZhou Central Hospital

    collaborator OTHER
  • The Second Affiliated Hospital of Kunming Medical University

    collaborator OTHER
  • First Affiliated Hospital of Kunming Medical University

    collaborator OTHER
  • Subei People's Hospital of Jiangsu Province

    collaborator OTHER
  • The Affiliated Hospital Of Southwest Medical University

    collaborator OTHER
  • The Second Affiliated Hospital of Chongqing Medical University

    collaborator OTHER
  • Loudi Central Hospital

    collaborator OTHER
  • Beijing Tiantan Hospital

    collaborator OTHER
  • Peking Union Medical College Hospital

    collaborator OTHER
  • The First People's Hospital of Lin'an District, Hangzhou

    collaborator UNKNOWN
  • Zhejiang Provincial People's Hospital

    collaborator OTHER
  • Jining Medical University

    collaborator OTHER
  • Ningbo Medical Center Lihuili Hospital

    collaborator OTHER_GOV
  • Zhoushan Hospital, Zhejiang

    collaborator UNKNOWN
  • General Hospital of Ningxia Medical University

    collaborator OTHER
  • Yunnan Cancer Hospital

    collaborator OTHER
  • Xinghua City People's Hospital

    collaborator UNKNOWN
  • Beijing Friendship Hospital, Captial Medical University

    collaborator UNKNOWN
  • Beijing Chao-Yang Hospital, Captial Medical University

    collaborator UNKNOWN
  • The People's Hospital of JiangMen

    collaborator UNKNOWN
  • The First People's Hospital of TianMen in Hubei Province

    collaborator UNKNOWN
  • THE FIRST AFFILIATED HOSPITAL OF SHIHEZI UNIVERSITY

    collaborator UNKNOWN
  • Changhai Hospital

    lead OTHER

Principal Investigators

  • Luowei Wang, MD · Changhai hosipital, Shanghai

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06713421 on ClinicalTrials.gov