Effect of Premedication With Pronase on Mucosal Cleanliness During EGD

NCT ID: NCT06713421

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Cancer Gastric Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A1:Dimeticone+Pronase+Postural Exercise group

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. Then the patients are asked to take a 3-minute postural exercise.

Group Type EXPERIMENTAL

Dimethicone+Pronase

Intervention Type 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.

with Postural Exercise

Intervention Type BEHAVIORAL

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

A2:Dimeticone+Pronase group

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. Then the patients sit quietly awaiting examination.

Group Type EXPERIMENTAL

Dimethicone+Pronase

Intervention Type 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.

without Postural Exercise.

Intervention Type BEHAVIORAL

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

B1:Dimeticone+Postural Exercise group

Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder. Then the patients are asked to take a 3-minute postural exercise.

Group Type ACTIVE_COMPARATOR

Dimethicone

Intervention Type DRUG

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

with Postural Exercise

Intervention Type BEHAVIORAL

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

B2:Dimeticone group

Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder. Then the patients sit quietly awaiting examination.

Group Type ACTIVE_COMPARATOR

Dimethicone

Intervention Type DRUG

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

without Postural Exercise.

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Dimethicone

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

Intervention Type DRUG

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.

Intervention Type BEHAVIORAL

without Postural Exercise.

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fujian Provincial Hospital

OTHER

Sponsor Role collaborator

Huashan Hospital

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Red Cross Hospital, Hangzhou, China

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Inner Mongolia Medical University

OTHER

Sponsor Role collaborator

Yuebei People's Hospital

OTHER

Sponsor Role collaborator

Longgang District People's Hospital of Shenzhen

OTHER

Sponsor Role collaborator

Huadu District People's Hospital of Guangzhou

OTHER

Sponsor Role collaborator

Liaocheng People's Hospital

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Shandong First Medical University

OTHER

Sponsor Role collaborator

Anqing Municipal Hospital

OTHER

Sponsor Role collaborator

Jiujiang No.1 People's Hospital

OTHER

Sponsor Role collaborator

Kunshan Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Nanjing Gaochun People's Hospital

OTHER

Sponsor Role collaborator

Taizhou First People's Hospital

OTHER

Sponsor Role collaborator

Hengshui People's Hospital

OTHER

Sponsor Role collaborator

Affiliated Hospital of Hebei University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Taihe Hospital

OTHER

Sponsor Role collaborator

ZhuZhou Central Hospital

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role collaborator

Subei People's Hospital of Jiangsu Province

OTHER

Sponsor Role collaborator

The Affiliated Hospital Of Southwest Medical University

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Loudi Central Hospital

OTHER

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

Zhejiang Provincial People's Hospital

OTHER

Sponsor Role collaborator

Jining Medical University

OTHER

Sponsor Role collaborator

Ningbo Medical Center Lihuili Hospital

OTHER_GOV

Sponsor Role collaborator

Zhoushan Hospital, Zhejiang

UNKNOWN

Sponsor Role collaborator

General Hospital of Ningxia Medical University

OTHER

Sponsor Role collaborator

Yunnan Cancer Hospital

OTHER

Sponsor Role collaborator

Xinghua City People's Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Friendship Hospital, Captial Medical University

UNKNOWN

Sponsor Role collaborator

Beijing Chao-Yang Hospital, Captial Medical University

UNKNOWN

Sponsor Role collaborator

The People's Hospital of JiangMen

UNKNOWN

Sponsor Role collaborator

The First People's Hospital of TianMen in Hubei Province

UNKNOWN

Sponsor Role collaborator

THE FIRST AFFILIATED HOSPITAL OF SHIHEZI UNIVERSITY

UNKNOWN

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Luowei Wang, MD

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Luowei Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Changhai hosipital, Shanghai

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Changhai hosipital

Shanghai, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Luowei Wang, MD

Role: CONTACT

13901833088

Lei Xin, MD

Role: CONTACT

13817318134

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Chu Chu

Role: primary

13817318134

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EPPMC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.