Reduce Patient Discomfort With Water Exchange Method During Upper Endoscopy

Yu-Hsi hsieh

Status: Unknown

Conditions: Patients Undergoing Diagnostic EGD

Treatments: Procedure: Gastric water exchange; Procedure: traditional air insufflation

Study type: Interventional

Funder types: Other

Identifiers

NCT04502485

A10801002

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups

Gastric water exchange

Experimental group

Description:

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.

Treatment:

Procedure: Gastric water exchange

Traditional air insufflation

Active Comparator group

Description:

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.

Treatment:

Procedure: traditional air insufflation