Patients Undergoing Diagnostic EGDNCT04502485
Reduce Patient Discomfort With Water Exchange Method During Upper Endoscopy
A study testing Gastric water exchange and traditional air insufflation in people with Patients Undergoing Diagnostic EGD, run by Yu-Hsi hsieh at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Patients Undergoing Diagnostic EGD
- What is being tested?
- Gastric water exchange and traditional air insufflation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients will include those anticipated to undergo EGD , aged 20 to 65 at the time of enrollment
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Chiayi City, Taiwan, 622
Yu-Hsi Hsieh, MD, 886052648000 ext. 5204, hsiehyuhsi1112@gmail.com
Yu-Hsi Hsieh, MD
About this study
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.
- Conditions
- Patients Undergoing Diagnostic EGD
- Being tested
- Gastric water exchange, traditional air insufflation
- Keywords
- water exchange, upper endoscopy, discomfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric water exchangeProcedure or surgery
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.
traditional air insufflationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Gastric water exchange | Experimental | 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. Receives: Procedure: Gastric water exchange |
| Traditional air insufflation | Active comparator | 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. Receives: Procedure: traditional air insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discomfort during the procedure
A VAS discomfort score (0, no discomfort; 10, most discomfort) graded by the patient,
Measured: 5 minutes after the procedure
Secondary outcomes (3)
patient satisfaction score
A VAS score (0, not satisfied at all; 10, most satisfied) graded by the patient
Measured: 5 minutes after the procedure
mucosa cleanliness score
1, no need for irrigation; 4, need more than 50 ml of water irrigation
Measured: 1 minutes after the procedure
technique adequacy score
1, excellent; 6, very poor
Measured: 1 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 May 2019
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing Diagnostic EGDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yu-Hsi hsieh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu-Hsi hsieh, Dalin Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502485
- Sponsor's protocol ID
- A10801002
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 12145594Meining 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.
PubMed 17285514
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduce Patient Discomfort With Water Exchange Method During Upper Endoscopy
- ClinicalTrials.gov ID
- NCT04502485
- Acronym / sponsor ID
- A10801002
- Conditions
- Patients Undergoing Diagnostic EGD
- Keywords
- water exchange, upper endoscopy, discomfort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Yu-Hsi hsiehUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric water exchange | Experimental | Procedure: Gastric water exchangeAir 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. |
| Traditional air insufflation | Active comparator | Procedure: traditional air insufflationAir 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients will include those anticipated to undergo EGD , aged 20 to 65 at the time of enrollment
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric water exchangeUpon 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. | Procedure or surgery | Gastric water exchange |
| traditional air insufflationAir 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 or surgery | Traditional air insufflation |
Primary outcome
Discomfort during the procedure
Time frame: 5 minutes after the procedure
A VAS discomfort score (0, no discomfort; 10, most discomfort) graded by the patient,
3 secondary outcomes
patient satisfaction score
Time frame: 5 minutes after the procedure
mucosa cleanliness score
Time frame: 1 minutes after the procedure
technique adequacy score
Time frame: 1 minutes after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Background: PubMed 12145594Abraham 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.
- Background: PubMed 17285514Meining 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric water exchange and traditional air insufflation in people with Patients Undergoing Diagnostic EGD, run by Yu-Hsi hsieh at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Hsi Hsieh, MD (886-5-2648000 ext. 3241, hsieh.yuhsi@msa.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discomfort during the procedure (time frame: 5 minutes after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04502485, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.