Reduce Patient Discomfort With Water Exchange Method During Upper Endoscopy

The aim of the study was to evaluate the application of water exchange method to upper endoscopy. We hypothesize that water exchange during upper endoscopy could reduce patient discomfort. The primary outcome will be the patient discomfort score during upper endoscopy. The secondary outcomes will include cleanliness score, techniques adequacy score, findings of the EGD, and willing to repeat the procedure, as well as the patient and endoscopist satisfaction score with the method.

Study Overview

• Status: Unknown
• Conditions: Patients Undergoing Diagnostic EGD
• Intervention / Treatment: Procedure: Gastric water exchange; Procedure: traditional air insufflation

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Chiayi, Taiwan, 622
    • Recruiting
    • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
    • Principal Investigator: Yu-Hsi Hsieh, MD
    • Contact: Yu-Hsi Hsieh, MD; Phone Number: 5204 886052648000; Email: hsiehyuhsi1112@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Eligible patients will include those anticipated to undergo EGD , aged 20 to 65 at the time of enrollment

Exclusion Criteria:

• a therapeutic EGD
• sedation with other agents
• American Society of Anesthesiology (ASA) risk Class 3 or higher, renal failure
• age less than 20 years or more than 65 years
• pregnancy
• refusal to provide written informed consent. All participants signed written informed consents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gastric water exchange; Air will be minimally insufflated to partially open the lumen and any residual fluid will be suctioned when the scope passes through the esophagus. Upon entering the fundus of the stomach the air button will be turned off. Air pocket and gastric fluids will be removed by suctioning. Distilled water, delivered by a 50-ml syringe in 10ml-to-20 ml increments, will be infused to dislodge debris and air bubbles adhering the gastric mucosa and open the lumen. The infused water will be removed to keep the lumen almost completely collapsed before the scope advance further. Air will be opened when the scope enter the prepylorus area where there is usually an air pocket. The scope will enter the duodenal bulb and 2nd portion of duodenum where withdrawal inspection will start.	Procedure: Gastric water exchange; Upon entering the fundus of the stomach the air button will be turned off. Air pocket and gastric fluids will be removed by suctioning. Distilled water, delivered by a 50-ml syringe in 10ml-to-20 ml increments, will be infused to dislodge debris and air bubbles adhering the gastric mucosa and open the lumen. The infused water will be removed to keep the lumen almost completely collapsed before the scope advance further.
Active Comparator: Traditional air insufflation; Air will be minimally insufflated and residual fluid suctioned during the entire insertion process. Usually, no water will be infused to cleanse the mucosa until the withdrawal phase.	Procedure: traditional air insufflation; Air will be minimally insufflated and residual fluid suctioned during the entire insertion process. Usually, no water will be infused to cleanse the mucosa until the withdrawal phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discomfort during the procedure	A VAS discomfort score (0, no discomfort; 10, most discomfort) graded by the patient,	5 minutes after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction score	A VAS score (0, not satisfied at all; 10, most satisfied) graded by the patient	5 minutes after the procedure
mucosa cleanliness score	1, no need for irrigation; 4, need more than 50 ml of water irrigation	1 minutes after the procedure
technique adequacy score	1, excellent; 6, very poor	1 minutes after the procedure

Collaborators and Investigators

• Sponsor: Yu-Hsi hsieh

Publications and helpful links

General Publications

• Abraham N, Barkun A, Larocque M, Fallone C, Mayrand S, Baffis V, Cohen A, Daly D, Daoud H, Joseph L. Predicting which patients can undergo upper endoscopy comfortably without conscious sedation. Gastrointest Endosc. 2002 Aug;56(2):180-9. doi: 10.1016/s0016-5107(02)70175-2.
• Meining A, Semmler V, Kassem AM, Sander R, Frankenberger U, Burzin M, Reichenberger J, Bajbouj M, Prinz C, Schmid RM. The effect of sedation on the quality of upper gastrointestinal endoscopy: an investigator-blinded, randomized study comparing propofol with midazolam. Endoscopy. 2007 Apr;39(4):345-9. doi: 10.1055/s-2006-945195. Epub 2007 Feb 7.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 6, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: water exchange; discomfort; upper endoscopy
• Other Study ID Numbers: A10801002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No