NCT06713421

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2024

Completed
22 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

9 months

First QC Date

November 9, 2024

Last Update Submit

February 22, 2025

Conditions

Esophageal CancerGastric Cancer

Keywords

EGDPronasePostural exerciseMucosal cleanliness

Outcome Measures

Primary Outcomes (1)

  • Mucosal Cleanliness Scores

    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.

    Through study completion, an average of 1 year

Secondary Outcomes (3)

  • Procedure Time

    Through study completion, an average of 1 year

  • The Detection Rate of Diminutive Lesions

    Through study completion, an average of 1 year

  • Safety of antifoam/mucus agents

    Through study completion, an average of 1 year

Study Arms (4)

A1:Dimeticone+Pronase+Postural Exercise group

EXPERIMENTAL

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.

Drug: Dimethicone+PronaseBehavioral: with Postural Exercise

A2:Dimeticone+Pronase group

EXPERIMENTAL

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.

Drug: Dimethicone+PronaseBehavioral: without Postural Exercise.

B1:Dimeticone+Postural Exercise group

ACTIVE COMPARATOR

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.

Drug: DimethiconeBehavioral: with Postural Exercise

B2:Dimeticone group

ACTIVE COMPARATOR

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

Drug: DimethiconeBehavioral: without Postural Exercise.

Interventions

Dimethicone+PronaseDRUG

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.

A1:Dimeticone+Pronase+Postural Exercise groupA2:Dimeticone+Pronase group
DimethiconeDRUG

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

B1:Dimeticone+Postural Exercise groupB2:Dimeticone group
with Postural ExerciseBEHAVIORAL

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

A1:Dimeticone+Pronase+Postural Exercise groupB1:Dimeticone+Postural Exercise group
without Postural Exercise.BEHAVIORAL

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

A2:Dimeticone+Pronase groupB2:Dimeticone group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai hosipital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Esophageal NeoplasmsStomach Neoplasms

Interventions

dimethicone

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Luowei Wang, MD

    Changhai hosipital, Shanghai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luowei Wang, MD

CONTACT

13901833088wangluoweimd@126.com

Lei Xin, MD

CONTACT

13817318134aip_xin@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 9, 2024

First Posted

December 3, 2024

Study Start

December 1, 2024

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)