<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04502485</url>
  </required_header>
  <id_info>
    <org_study_id>A10801002</org_study_id>
    <nct_id>NCT04502485</nct_id>
  </id_info>
  <brief_title>Reduce Patient Discomfort With Water Exchange Method During Upper Endoscopy</brief_title>
  <official_title>Reduce Patient Discomfort With Water Exchange Method During Upper Endoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yu-Hsi hsieh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dalin Tzu Chi General Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study was to evaluate the application of water exchange method to upper&#xD;
      endoscopy. We hypothesize that water exchange during upper endoscopy could reduce patient&#xD;
      discomfort. The primary outcome will be the patient discomfort score during upper endoscopy.&#xD;
      The secondary outcomes will include cleanliness score, techniques adequacy score, findings of&#xD;
      the EGD, and willing to repeat the procedure, as well as the patient and endoscopist&#xD;
      satisfaction score with the method.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Discomfort during the procedure</measure>
    <time_frame>5 minutes after the procedure</time_frame>
    <description>A VAS discomfort score (0, no discomfort; 10, most discomfort) graded by the patient,</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>patient satisfaction score</measure>
    <time_frame>5 minutes after the procedure</time_frame>
    <description>A VAS score (0, not satisfied at all; 10, most satisfied) graded by the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mucosa cleanliness score</measure>
    <time_frame>1 minutes after the procedure</time_frame>
    <description>1, no need for irrigation; 4, need more than 50 ml of water irrigation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>technique adequacy score</measure>
    <time_frame>1 minutes after the procedure</time_frame>
    <description>1, excellent; 6, very poor</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Patients Undergoing Diagnostic EGD</condition>
  <arm_group>
    <arm_group_label>Gastric water exchange</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional air insufflation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Gastric water exchange</intervention_name>
    <description>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.</description>
    <arm_group_label>Gastric water exchange</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>traditional air insufflation</intervention_name>
    <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.</description>
    <arm_group_label>Traditional air insufflation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible patients will include those anticipated to undergo EGD , aged 20 to 65 at the&#xD;
             time of enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a therapeutic EGD&#xD;
&#xD;
          -  sedation with other agents&#xD;
&#xD;
          -  American Society of Anesthesiology (ASA) risk Class 3 or higher, renal failure&#xD;
&#xD;
          -  age less than 20 years or more than 65 years&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  refusal to provide written informed consent. All participants signed written informed&#xD;
             consents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yu-Hsi Hsieh, MD</last_name>
    <phone>886-5-2648000</phone>
    <phone_ext>3241</phone_ext>
    <email>hsieh.yuhsi@msa.hinet.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</name>
      <address>
        <city>Chiayi</city>
        <zip>622</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yu-Hsi Hsieh, MD</last_name>
      <phone>886052648000</phone>
      <phone_ext>5204</phone_ext>
      <email>hsiehyuhsi1112@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Yu-Hsi Hsieh, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>12145594</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17285514</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Dalin Tzu Chi General Hospital</investigator_affiliation>
    <investigator_full_name>Yu-Hsi hsieh</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>water exchange</keyword>
  <keyword>upper endoscopy</keyword>
  <keyword>discomfort</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04502485
org study id: A10801002
nct id: NCT04502485
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Outcomes Assessor)
measure: Discomfort during the procedure
time frame: 5 minutes after the procedure
description: A VAS discomfort score (0, no discomfort; 10, most discomfort) graded by the patient,
measure: patient satisfaction score
time frame: 5 minutes after the procedure
description: A VAS score (0, not satisfied at all; 10, most satisfied) graded by the patient
measure: mucosa cleanliness score
time frame: 1 minutes after the procedure
description: 1, no need for irrigation; 4, need more than 50 ml of water irrigation
measure: technique adequacy score
time frame: 1 minutes after the procedure
description: 1, excellent; 6, very poor
arm group label: Gastric water exchange
arm group type: Experimental
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.
arm group label: Traditional air insufflation
arm group type: Active Comparator
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.
intervention type: Procedure
intervention name: Gastric water exchange
description: 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.
arm group label: Gastric water exchange
intervention type: Procedure
intervention name: traditional air insufflation
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.
arm group label: Traditional air insufflation
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yu-Hsi Hsieh, MD
phone: 886-5-2648000
phone ext: 3241
email: hsieh.yuhsi@msa.hinet.net
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
citation: 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.
PMID: 12145594
citation: 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.
PMID: 17285514
responsible party type: Sponsor-Investigator
investigator affiliation: Dalin Tzu Chi General Hospital
investigator full name: Yu-Hsi hsieh
investigator title: Dr.