Effect of Premedication With Pronase on Mucosal Cleanliness During EGD

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06713421

Enrollment

3000

Registered

2024-12-03

Start date

2024-12-01

Completion date

2025-09-01

Last updated

2025-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer, Gastric Cancer

Keywords

EGD, Pronase, Postural exercise, Mucosal cleanliness

Brief 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.

Interventions

DRUGDimethicone+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.

DRUGDimethicone

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

BEHAVIORALwith Postural Exercise

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

BEHAVIORALwithout Postural Exercise.

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

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Mucosal Cleanliness Scores	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

Measure	Time frame	Description
Procedure Time	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.
The Detection Rate of Diminutive Lesions	Through study completion, an average of 1 year	The detection rate of diminutive lesions means the proportion of patients with diminutive lesions <5 mm.
Safety of antifoam/mucus agents	Through study completion, an average of 1 year	Any adverse event including gag reflex and hypoxemia during EGD examination need to be recorded.

Countries

China

Contacts

Primary ContactLuowei Wang, MD

wangluoweimd@126.com13901833088

Backup ContactLei Xin, MD

aip_xin@163.com13817318134

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026