<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/NCT03829293</url>
  </required_header>
  <id_info>
    <org_study_id>CHRO-2019-01</org_study_id>
    <nct_id>NCT03829293</nct_id>
  </id_info>
  <brief_title>High-Flow Nasal Oxygenation Versus Standard Oxygenation in Gastrointestinal Endoscopy With Sedation.</brief_title>
  <acronym>ODEPHI</acronym>
  <official_title>High-Flow Nasal Oxygenation Versus Standard Oxygenation in Gastrointestinal Endoscopy With Sedation. A Prospective Multicenter Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Régional d'Orléans</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Régional d'Orléans</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized controlled trial comparing high-flow nasal oxygen therapy (HFNO)&#xD;
      versus standard oxygen therapy (nasal prongs, nasopharyngeal catheter or standard face mask)&#xD;
      during gastrointestinal (GI) endoscopy with sedation to reduce the incidence of hypoxia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypoxemia is the most common complication during a gastrointestinal endoscopy with sedation.&#xD;
      Oxygenation is usually applied during the procedure to prevent the occurrence of&#xD;
      desaturation. Conventional oxygen is typically administered by conventional nasal cannula, by&#xD;
      nasopharyngeal catheter or by a facemask with mild flow of oxygen. The flow of standard&#xD;
      oxygen is limited to 15L/min.&#xD;
&#xD;
      High-flow nasal cannula oxygenation is a new method of humidified and heated oxygenation with&#xD;
      a higher flow rates (up to 70L/min).&#xD;
&#xD;
      The primary outcome will be the incidence of hypoxia defined by pulsed saturation with oxygen&#xD;
      (SpO2) ≤92%. The investigator's hypothesis is that high-flow nasal oxygen therapy will&#xD;
      decrease the frequency of hypoxemia during gastrointestinal endoscopy under sedation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 26, 2019</start_date>
  <completion_date type="Actual">September 9, 2019</completion_date>
  <primary_completion_date type="Actual">September 9, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of hypoxia</measure>
    <time_frame>Duration of GI endoscopy procedure under sedation, an expected average of 2 hours</time_frame>
    <description>SpO2 ≤ 92%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of hypoxia in the recovery room</measure>
    <time_frame>Length of stay in the recovery room, an expected average of 2 hours</time_frame>
    <description>SpO2 ≤ 92%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of apnea during the procedure</measure>
    <time_frame>Duration of GI endoscopy procedure under sedation, an expected average of 2 hours</time_frame>
    <description>Breath rate ≤6/min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of hypoxia with SpO2 ≤ 90%</measure>
    <time_frame>Duration of GI endoscopy procedure under sedation, an expected average of 2 hours</time_frame>
    <description>SpO2 ≤ 90%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of severe hypoxia</measure>
    <time_frame>Duration of GI endoscopy procedure under sedation, an expected average of 2 hours</time_frame>
    <description>SpO2 ≤ 85%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prolonged hypoxia during the procedure</measure>
    <time_frame>Duration of GI endoscopy procedure under sedation, an expected average of 2 hours</time_frame>
    <description>SpO2 ≤ 92% for ≥60 s</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe hypoxia during the procedure</measure>
    <time_frame>Duration of GI endoscopy procedure under sedation, an expected average of 2 hours</time_frame>
    <description>SpO2 ≤ 90% and SpO2 ≤85%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modification of oxygenation during the procedure</measure>
    <time_frame>Duration of GI endoscopy procedure under sedation, an expected average of 2 hours</time_frame>
    <description>Increase of oxygen flow in conventional group or FiO2 in the interventional group to maintain an adequate oxygenation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The need of intervention by the anesthesia team</measure>
    <time_frame>Duration of GI endoscopy procedure under sedation, an expected average of 2 hours</time_frame>
    <description>Need of airway manipulation, use of noninvasive ventilation or mechanical invasive ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temporal course of SpO2</measure>
    <time_frame>Duration of GI endoscopy procedure under sedation, an expected average of 2 hours</time_frame>
    <description>Absolute changes in SpO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temporal course of respiratory rate</measure>
    <time_frame>Duration of GI endoscopy procedure under sedation, an expected average of 2 hours</time_frame>
    <description>Absolute changes in respiratory rate, in cycles/minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temporal course of heart rate</measure>
    <time_frame>Duration of GI endoscopy procedure under sedation, an expected average of 2 hours</time_frame>
    <description>Absolute changes in heart rate, in bpm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temporal course of arterial blood pressure</measure>
    <time_frame>Duration of GI endoscopy procedure under sedation, an expected average of 2 hours</time_frame>
    <description>Absolute changes arterial blood pressure, in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of bradycardia</measure>
    <time_frame>Duration of GI endoscopy procedure under sedation, an expected average of 2 hours</time_frame>
    <description>Heart rate &lt; 50 bpm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of need for mechanical respiratory support</measure>
    <time_frame>Duration of GI endoscopy procedure under sedation, an expected average of 2 hours</time_frame>
    <description>noninvasive ventilation, or ventilation through a laryngeal mask, or tracheal intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Failure of the endoscopic procedure</measure>
    <time_frame>Duration of GI endoscopy procedure under sedation, an expected average of 2 hours</time_frame>
    <description>Number of patients in whom the endoscopic procedure has to be stopped and postponed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of the endoscopic procedure</measure>
    <time_frame>Duration of GI endoscopy procedure under sedation, an expected average of 2 hours</time_frame>
    <description>From insertion of the fiberoptic endoscope to its withdrawal, in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of sedation</measure>
    <time_frame>Duration of GI endoscopy procedure under sedation, an expected average of 2 hours</time_frame>
    <description>From anaesthesia induction to the awakening of the patient, in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in the recovery room</measure>
    <time_frame>Length of stay in the recovery room, an expected average of 2 hours</time_frame>
    <description>From admission at to discharge from the recovery room, in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need of hospitalisation</measure>
    <time_frame>24 hours</time_frame>
    <description>percentage of ambulatory patients who needed to be hospitalised after the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious adverse event rate</measure>
    <time_frame>24 hours</time_frame>
    <description>Percentage of patients experiencing at least one serious adverse event</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">380</enrollment>
  <condition>Gastrointestinal Endoscopy</condition>
  <condition>Sedation</condition>
  <arm_group>
    <arm_group_label>High-flow nasal cannula oxygenation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the experimental group will receive high-flow nasal oxygen therapy (HFNO) during gastrointestinal endoscopy under sedation (with a flow at 70L/min and oxygen inspired fraction (FiO2) 50%) through a dedicated system, the THRIVETM (Fisher&amp;Paykel, New-Zealand)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Oxygenation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the current standard of care will receive standard oxygenation by nasal prongs (with a flow at 6L/min) or naropharyngeal catheter (with a flow at 5L/min) or standard face mask (with a flow at 6L/min)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High-flow nasal cannula oxygenation group</intervention_name>
    <description>usual care + High-flow nasal oxygenation (HFNO) therapy during GI endoscopy under sedation (with a flow at 70L/min and FiO2 50%) through a dedicated system, the THRIVETM (Fisher&amp;Paykel, New-Zealand)</description>
    <arm_group_label>High-flow nasal cannula oxygenation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than or equal to 18 years&#xD;
&#xD;
          -  Having GI endoscopy expected under sedation&#xD;
&#xD;
          -  At risk of hypoxia defined by (one of the item): an underlying cardiac disease ; an&#xD;
             underlying respiratory disease ; age greater than or equal to 60 years ; ASA II, III&#xD;
             or ASA IV ; with an body mass index greater or equal to 30 (kg/m²); with sleep apnea&#xD;
             syndrome diagnosed or suspected with a STOP-BANG score ≥ 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age below 18&#xD;
&#xD;
          -  Emergency GI endoscopy&#xD;
&#xD;
          -  Need of intubation for the procedure&#xD;
&#xD;
          -  Patient with chronic oxygen treatment&#xD;
&#xD;
          -  Patients with tracheostomy&#xD;
&#xD;
          -  Pregnancy, breastfeeding&#xD;
&#xD;
          -  Not affiliated to French social security&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mai-Anh NAY, Dr</last_name>
    <role>Study Director</role>
    <affiliation>CHR Orléans</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Willy-Serge MFAM, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHR Orléans</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Olivier BAERT, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pôle Santé Oréliance</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Adrien AUVET, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH de Dax</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francis REMERAND, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Tours - hôpital Trousseau</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Center of DAX</name>
      <address>
        <city>DAX</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pole santé ORELIANCE</name>
      <address>
        <city>Orléans</city>
        <zip>45000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orleans Hospital Center</name>
      <address>
        <city>Orléans</city>
        <zip>45067</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Qadeer MA, Lopez AR, Dumot JA, Vargo JJ. Hypoxemia during moderate sedation for gastrointestinal endoscopy: causes and associations. Digestion. 2011;84(1):37-45. doi: 10.1159/000321621. Epub 2011 Feb 8.</citation>
    <PMID>21304242</PMID>
  </results_reference>
  <results_reference>
    <citation>Qadeer MA, Rocio Lopez A, Dumot JA, Vargo JJ. Risk factors for hypoxemia during ambulatory gastrointestinal endoscopy in ASA I-II patients. Dig Dis Sci. 2009 May;54(5):1035-40. doi: 10.1007/s10620-008-0452-2. Epub 2008 Nov 12.</citation>
    <PMID>19003534</PMID>
  </results_reference>
  <results_reference>
    <citation>Cohen LB, Wecsler JS, Gaetano JN, Benson AA, Miller KM, Durkalski V, Aisenberg J. Endoscopic sedation in the United States: results from a nationwide survey. Am J Gastroenterol. 2006 May;101(5):967-74. doi: 10.1111/j.1572-0241.2006.00500.x.</citation>
    <PMID>16573781</PMID>
  </results_reference>
  <results_reference>
    <citation>Griffin SM, Chung SC, Leung JW, Li AK. Effect of intranasal oxygen on hypoxia and tachycardia during endoscopic cholangiopancreatography. BMJ. 1990 Jan 13;300(6717):83-4. doi: 10.1136/bmj.300.6717.83. No abstract available.</citation>
    <PMID>2105779</PMID>
  </results_reference>
  <results_reference>
    <citation>Woods A, Sanowski RA, Wadas DD, Manne RK, Friess SW. Eradication of diminutive polyps: a prospective evaluation of bipolar coagulation versus conventional biopsy removal. Gastrointest Endosc. 1989 Nov-Dec;35(6):536-40. doi: 10.1016/s0016-5107(89)72906-0.</citation>
    <PMID>2689263</PMID>
  </results_reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>February 4, 2020</last_update_submitted>
  <last_update_submitted_qc>February 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>High-flow nasal cannula oxygenation</keyword>
  <keyword>gastrointestinal endoscopy</keyword>
  <keyword>upper gasatrointestinal endoscopy</keyword>
  <keyword>colonoscopy</keyword>
  <keyword>sedation</keyword>
  <keyword>hypoxia</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03829293
org study id: CHRO-2019-01
nct id: NCT03829293
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a randomized controlled trial comparing high-flow nasal oxygen therapy (HFNO)
      versus standard oxygen therapy (nasal prongs, nasopharyngeal catheter or standard face mask)
      during gastrointestinal (GI) endoscopy with sedation to reduce the incidence of hypoxia.
Hypoxemia is the most common complication during a gastrointestinal endoscopy with sedation.
      Oxygenation is usually applied during the procedure to prevent the occurrence of
      desaturation. Conventional oxygen is typically administered by conventional nasal cannula, by
      nasopharyngeal catheter or by a facemask with mild flow of oxygen. The flow of standard
      oxygen is limited to 15L/min.

      High-flow nasal cannula oxygenation is a new method of humidified and heated oxygenation with
      a higher flow rates (up to 70L/min).

      The primary outcome will be the incidence of hypoxia defined by pulsed saturation with oxygen
      (SpO2) ≤92%. The investigator's hypothesis is that high-flow nasal oxygen therapy will
      decrease the frequency of hypoxemia during gastrointestinal endoscopy under sedation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of hypoxia
time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
description: SpO2 ≤ 92%
measure: Incidence of hypoxia in the recovery room
time frame: Length of stay in the recovery room, an expected average of 2 hours
description: SpO2 ≤ 92%
measure: Incidence of apnea during the procedure
time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
description: Breath rate ≤6/min
measure: Incidence of hypoxia with SpO2 ≤ 90%
time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
description: SpO2 ≤ 90%
measure: Incidence of severe hypoxia
time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
description: SpO2 ≤ 85%
measure: Prolonged hypoxia during the procedure
time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
description: SpO2 ≤ 92% for ≥60 s
measure: Severe hypoxia during the procedure
time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
description: SpO2 ≤ 90% and SpO2 ≤85%
measure: Modification of oxygenation during the procedure
time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
description: Increase of oxygen flow in conventional group or FiO2 in the interventional group to maintain an adequate oxygenation
measure: The need of intervention by the anesthesia team
time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
description: Need of airway manipulation, use of noninvasive ventilation or mechanical invasive ventilation
measure: Temporal course of SpO2
time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
description: Absolute changes in SpO2
measure: Temporal course of respiratory rate
time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
description: Absolute changes in respiratory rate, in cycles/minutes
measure: Temporal course of heart rate
time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
description: Absolute changes in heart rate, in bpm
measure: Temporal course of arterial blood pressure
time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
description: Absolute changes arterial blood pressure, in mmHg
measure: Incidence of bradycardia
time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
description: Heart rate < 50 bpm
measure: Incidence of need for mechanical respiratory support
time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
description: noninvasive ventilation, or ventilation through a laryngeal mask, or tracheal intubation
measure: Failure of the endoscopic procedure
time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
description: Number of patients in whom the endoscopic procedure has to be stopped and postponed
measure: Duration of the endoscopic procedure
time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
description: From insertion of the fiberoptic endoscope to its withdrawal, in minutes
measure: Duration of sedation
time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
description: From anaesthesia induction to the awakening of the patient, in minutes
measure: Length of stay in the recovery room
time frame: Length of stay in the recovery room, an expected average of 2 hours
description: From admission at to discharge from the recovery room, in minutes
measure: Need of hospitalisation
time frame: 24 hours
description: percentage of ambulatory patients who needed to be hospitalised after the procedure
measure: Serious adverse event rate
time frame: 24 hours
description: Percentage of patients experiencing at least one serious adverse event
arm group label: High-flow nasal cannula oxygenation group
arm group type: Experimental
description: Participants in the experimental group will receive high-flow nasal oxygen therapy (HFNO) during gastrointestinal endoscopy under sedation (with a flow at 70L/min and oxygen inspired fraction (FiO2) 50%) through a dedicated system, the THRIVETM (Fisher&Paykel, New-Zealand)
arm group label: Standard Oxygenation
arm group type: No Intervention
description: Participants in the current standard of care will receive standard oxygenation by nasal prongs (with a flow at 6L/min) or naropharyngeal catheter (with a flow at 5L/min) or standard face mask (with a flow at 6L/min)
intervention type: Device
intervention name: High-flow nasal cannula oxygenation group
description: usual care + High-flow nasal oxygenation (HFNO) therapy during GI endoscopy under sedation (with a flow at 70L/min and FiO2 50%) through a dedicated system, the THRIVETM (Fisher&Paykel, New-Zealand)
arm group label: High-flow nasal cannula oxygenation group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mai-Anh NAY, Dr
role: Study Director
affiliation: CHR Orléans
last name: Willy-Serge MFAM, Dr
role: Principal Investigator
affiliation: CHR Orléans
last name: Olivier BAERT, Dr
role: Principal Investigator
affiliation: Pôle Santé Oréliance
last name: Adrien AUVET, Dr
role: Principal Investigator
affiliation: CH de Dax
last name: Francis REMERAND, Dr
role: Principal Investigator
affiliation: CHU de Tours - hôpital Trousseau
facility: 
facility: 
facility: 
country: France
citation: Qadeer MA, Lopez AR, Dumot JA, Vargo JJ. Hypoxemia during moderate sedation for gastrointestinal endoscopy: causes and associations. Digestion. 2011;84(1):37-45. doi: 10.1159/000321621. Epub 2011 Feb 8.
PMID: 21304242
citation: Qadeer MA, Rocio Lopez A, Dumot JA, Vargo JJ. Risk factors for hypoxemia during ambulatory gastrointestinal endoscopy in ASA I-II patients. Dig Dis Sci. 2009 May;54(5):1035-40. doi: 10.1007/s10620-008-0452-2. Epub 2008 Nov 12.
PMID: 19003534
citation: Cohen LB, Wecsler JS, Gaetano JN, Benson AA, Miller KM, Durkalski V, Aisenberg J. Endoscopic sedation in the United States: results from a nationwide survey. Am J Gastroenterol. 2006 May;101(5):967-74. doi: 10.1111/j.1572-0241.2006.00500.x.
PMID: 16573781
citation: Griffin SM, Chung SC, Leung JW, Li AK. Effect of intranasal oxygen on hypoxia and tachycardia during endoscopic cholangiopancreatography. BMJ. 1990 Jan 13;300(6717):83-4. doi: 10.1136/bmj.300.6717.83. No abstract available.
PMID: 2105779
citation: Woods A, Sanowski RA, Wadas DD, Manne RK, Friess SW. Eradication of diminutive polyps: a prospective evaluation of bipolar coagulation versus conventional biopsy removal. Gastrointest Endosc. 1989 Nov-Dec;35(6):536-40. doi: 10.1016/s0016-5107(89)72906-0.
PMID: 2689263
responsible party type: Sponsor
sharing ipd: No