<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/NCT03264027</url>
  </required_header>
  <id_info>
    <org_study_id>kaiserargongjanastomosis</org_study_id>
    <nct_id>NCT03264027</nct_id>
  </id_info>
  <brief_title>Carbon Dioxide Versus Air Insufflation for the Application of Argon Plasma to Reduce the Gastrojejunal Anastomosis</brief_title>
  <official_title>A Multicenter Randomized Clinical Trial of Carbon Dioxide (CO2) Versus Air Insufflation for the Application of Argon Plasma to Reduce the Gastrojejunal Anastomosis in Individuals With Weight Regain After Bypass Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaiser Clinic and Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaiser Clinic and Hospital</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>
      The objective of this randomized clinical trial is to compare pain levels during and after&#xD;
      insufflation with carbon dioxide or in subjects that will undergo endoscopic fulguration with&#xD;
      argon to reduce the diameter of the gastrojejunal anastomosis. The investigators hypothesize&#xD;
      that carbon dioxide will be superior in causing less pain and leading to less discomfort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laparoscopic gastric bypass surgery is one of the strategies oriented towards weight&#xD;
      reduction in obese patients. Although in the short term it has a high degree of success,&#xD;
      weight regain is common in the long term, in part due to the dilatation of the anastomosis&#xD;
      that allows food to pass without barriers and hinders the purpose of bypass surgery.&#xD;
      Fulguration with argon is an endoscopic technique that reduces the diameter of the&#xD;
      anastomosis, offering resistance to food passage and improving patient outcomes.&#xD;
&#xD;
      Although carbon dioxide is the current standard for laparoscopic surgery, its use for&#xD;
      fulguration with argon as compared to ambient air has not been investigated in the setting of&#xD;
      the stenosis of a dilated anastomosis following gastric bypass surgery. stenosis. Therefore,&#xD;
      to investigate pain during and after this procedure, investigators will conduct a randomized&#xD;
      clinical trial comparing carbon dioxide and ambient air.&#xD;
&#xD;
      The secondary aims will be to measure the diameter of the gastrojejunal anastomosis during&#xD;
      three endoscopic sessions and in a final control examination eight weeks after the third&#xD;
      session; to determine whether the patient loses weight or not by the final control objective&#xD;
      after three sessions of endoscopic fulguration with argon; to analyze if the method employed&#xD;
      is able to reduce body weight to the minimum weight achieved after bariatric surgery;and to&#xD;
      investigate whether there is a correlation between the percentage reduction in anastomotic&#xD;
      diameter and the percentage loss of regained weight.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 6, 2017</start_date>
  <completion_date type="Actual">January 12, 2020</completion_date>
  <primary_completion_date type="Actual">January 12, 2020</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>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Both the participant and the outcome assessor will be blinded to the study intervention.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain Visual Analogue Scale</measure>
    <time_frame>Before surgery, and after eight weeks of the first endoscopic session. The outcome will be the substraction of the initial value and the final value of pain.</time_frame>
    <description>A visual scale to assess self-reported pain going from 0 to 10.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in diameter of the gastrojejunal anastomosis</measure>
    <time_frame>Before surgery, and after eight weeks of the first endoscopic session.</time_frame>
    <description>Analysis and measurement in millimeters of the anastomosis will be achieved using Raptor foreign body forceps (Endoscopy Group US, Inc., Mentor - Ohio, USA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight reduction</measure>
    <time_frame>Before surgery, and after eight weeks of the first endoscopic session.</time_frame>
    <description>The final weight measured in kilograms after eight weeks of the initial surgery will be subtracted from the weight at the start of the trial</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Dilatation of Anastomosis</condition>
  <condition>Bypass Complication</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Carbon dioxide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Argon fulguration will be performed using CO2 for insufflation. After using a disposable endoscopic catheter, argon plasma (Argon 2) (MAE, Ribeirão Preto, Brazil) will be applied in a 1-cm band around the entire circumference of the gastrojejunal anastomosis at an intensity of 90 W and a flow rate of 2 L/min.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ambient air</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Argon fulguration will be performed using ambient air for insufflation. After using a disposable endoscopic catheter, argon plasma (Argon 2) (MAE, Ribeirão Preto, Brazil) will be applied in a 1-cm band around the entire circumference of the gastrojejunal anastomosis at an intensity of 90 W and a flow rate of 2 L/min.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carbon dioxide</intervention_name>
    <description>Carbon dioxide will be used as an insufflating gas during argon fulguration of the dilatated anastomosis.</description>
    <arm_group_label>Carbon dioxide</arm_group_label>
    <other_name>Carbon dioxide insufflation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ambient air</intervention_name>
    <description>Ambient air will be used as an insufflating gas during argon fulguration of the dilatated anastomosis.</description>
    <arm_group_label>Ambient air</arm_group_label>
    <other_name>Ambient air insuflattion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Argon fulguration</intervention_name>
    <description>The dilatated anastomosis from the gastric bypass surgery will be reduced in diameter using fulguration with argon. Patient in both groups will be placed in the left lateral decubitus position, with anesthesia being performed exclusively using propofol; adequate cardiopulmonary monitoring will be carried out during the entire procedure. After sedation, endoscopy will be performed with an Olympus CV-180 endoscope (Olympus, Tokyo, Japan) and analysis and measurement of the anastomosis will be achieved using Raptor foreign body forceps (Endoscopy Group US, Inc., Mentor - Ohio, USA). The images will be transferred to an Olympus EvisExera II processor connected to a computer with the ZScan 5 program (Goiânia, GO, Brazil).</description>
    <arm_group_label>Ambient air</arm_group_label>
    <arm_group_label>Carbon dioxide</arm_group_label>
    <other_name>Argon</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Regain of at least 10.0% of the minimum weight reached after the gastric bypass;&#xD;
&#xD;
          -  Ability to understand study procedures;&#xD;
&#xD;
          -  Signed the informed written consent form;&#xD;
&#xD;
          -  Possible to complete all the stages of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of very tight restrictive ring preventing the advancement of the endoscopy&#xD;
             device;&#xD;
&#xD;
          -  Stenosis of the anastomosis preventing the progression of the endoscopy device before&#xD;
             the end of the three endoscopic sessions;&#xD;
&#xD;
          -  History of liver diseases such as cirrhosis or chronic active hepatitis;&#xD;
&#xD;
          -  Patients who required anticoagulant therapy with the exception of antiplatelet agents;&#xD;
&#xD;
          -  Pregnant women or those intending to become pregnant within 12 months after&#xD;
             fulguration with argon;&#xD;
&#xD;
          -  Participant in another ongoing clinical research;&#xD;
&#xD;
          -  Recent history of neoplasia (less than 5 years);&#xD;
&#xD;
          -  Alcoholism or drug use;&#xD;
&#xD;
          -  HIV positive;&#xD;
&#xD;
          -  Unbalanced or uncontrollable psychiatric disorders;&#xD;
&#xD;
          -  Anemia or severe nutritional deficiencies;&#xD;
&#xD;
          -  Allergy to anesthetic compounds;&#xD;
&#xD;
          -  Impossibility to return within defined periods for consultations and endoscopic&#xD;
             sessions of fulguration with argon;&#xD;
&#xD;
          -  Inability to follow nutritional guidelines after each endoscopic session;&#xD;
&#xD;
          -  Inability to understand study procedures;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luiz G Quadros, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaiser Clinic and Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaiser Clinic and Day Hospital</name>
      <address>
        <city>São José do Rio Prêto</city>
        <state>Sao Paolo</state>
        <zip>15015-110</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Baretta GA, Alhinho HC, Matias JE, Marchesini JB, de Lima JH, Empinotti C, Campos JM. Argon plasma coagulation of gastrojejunal anastomosis for weight regain after gastric bypass. Obes Surg. 2015 Jan;25(1):72-9. doi: 10.1007/s11695-014-1363-2.</citation>
    <PMID>25005812</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>August 16, 2022</last_update_submitted>
  <last_update_submitted_qc>August 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kaiser Clinic and Hospital</investigator_affiliation>
    <investigator_full_name>Luiz Gustavo de Quadros, MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dilatation, Pathologic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03264027
org study id: kaiserargongjanastomosis
nct id: NCT03264027
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this randomized clinical trial is to compare pain levels during and after
      insufflation with carbon dioxide or in subjects that will undergo endoscopic fulguration with
      argon to reduce the diameter of the gastrojejunal anastomosis. The investigators hypothesize
      that carbon dioxide will be superior in causing less pain and leading to less discomfort.
Laparoscopic gastric bypass surgery is one of the strategies oriented towards weight
      reduction in obese patients. Although in the short term it has a high degree of success,
      weight regain is common in the long term, in part due to the dilatation of the anastomosis
      that allows food to pass without barriers and hinders the purpose of bypass surgery.
      Fulguration with argon is an endoscopic technique that reduces the diameter of the
      anastomosis, offering resistance to food passage and improving patient outcomes.

      Although carbon dioxide is the current standard for laparoscopic surgery, its use for
      fulguration with argon as compared to ambient air has not been investigated in the setting of
      the stenosis of a dilated anastomosis following gastric bypass surgery. stenosis. Therefore,
      to investigate pain during and after this procedure, investigators will conduct a randomized
      clinical trial comparing carbon dioxide and ambient air.

      The secondary aims will be to measure the diameter of the gastrojejunal anastomosis during
      three endoscopic sessions and in a final control examination eight weeks after the third
      session; to determine whether the patient loses weight or not by the final control objective
      after three sessions of endoscopic fulguration with argon; to analyze if the method employed
      is able to reduce body weight to the minimum weight achieved after bariatric surgery;and to
      investigate whether there is a correlation between the percentage reduction in anastomotic
      diameter and the percentage loss of regained weight.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Both the participant and the outcome assessor will be blinded to the study intervention.
measure: Change in Pain Visual Analogue Scale
time frame: Before surgery, and after eight weeks of the first endoscopic session. The outcome will be the substraction of the initial value and the final value of pain.
description: A visual scale to assess self-reported pain going from 0 to 10.
measure: Change in diameter of the gastrojejunal anastomosis
time frame: Before surgery, and after eight weeks of the first endoscopic session.
description: Analysis and measurement in millimeters of the anastomosis will be achieved using Raptor foreign body forceps (Endoscopy Group US, Inc., Mentor - Ohio, USA).
measure: Weight reduction
time frame: Before surgery, and after eight weeks of the first endoscopic session.
description: The final weight measured in kilograms after eight weeks of the initial surgery will be subtracted from the weight at the start of the trial
arm group label: Carbon dioxide
arm group type: Experimental
description: Argon fulguration will be performed using CO2 for insufflation. After using a disposable endoscopic catheter, argon plasma (Argon 2) (MAE, Ribeirão Preto, Brazil) will be applied in a 1-cm band around the entire circumference of the gastrojejunal anastomosis at an intensity of 90 W and a flow rate of 2 L/min.
arm group label: Ambient air
arm group type: Active Comparator
description: Argon fulguration will be performed using ambient air for insufflation. After using a disposable endoscopic catheter, argon plasma (Argon 2) (MAE, Ribeirão Preto, Brazil) will be applied in a 1-cm band around the entire circumference of the gastrojejunal anastomosis at an intensity of 90 W and a flow rate of 2 L/min.
intervention type: Drug
intervention name: Carbon dioxide
description: Carbon dioxide will be used as an insufflating gas during argon fulguration of the dilatated anastomosis.
arm group label: Carbon dioxide
other name: Carbon dioxide insufflation
intervention type: Drug
intervention name: Ambient air
description: Ambient air will be used as an insufflating gas during argon fulguration of the dilatated anastomosis.
arm group label: Ambient air
other name: Ambient air insuflattion
intervention type: Drug
intervention name: Argon fulguration
description: The dilatated anastomosis from the gastric bypass surgery will be reduced in diameter using fulguration with argon. Patient in both groups will be placed in the left lateral decubitus position, with anesthesia being performed exclusively using propofol; adequate cardiopulmonary monitoring will be carried out during the entire procedure. After sedation, endoscopy will be performed with an Olympus CV-180 endoscope (Olympus, Tokyo, Japan) and analysis and measurement of the anastomosis will be achieved using Raptor foreign body forceps (Endoscopy Group US, Inc., Mentor - Ohio, USA). The images will be transferred to an Olympus EvisExera II processor connected to a computer with the ZScan 5 program (Goiânia, GO, Brazil).
arm group label: Ambient air
arm group label: Carbon dioxide
other name: Argon
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Luiz G Quadros, MD
role: Principal Investigator
affiliation: Kaiser Clinic and Hospital
facility: 
country: Brazil
citation: Baretta GA, Alhinho HC, Matias JE, Marchesini JB, de Lima JH, Empinotti C, Campos JM. Argon plasma coagulation of gastrojejunal anastomosis for weight regain after gastric bypass. Obes Surg. 2015 Jan;25(1):72-9. doi: 10.1007/s11695-014-1363-2.
PMID: 25005812
responsible party type: Principal Investigator
investigator affiliation: Kaiser Clinic and Hospital
investigator full name: Luiz Gustavo de Quadros, MD
investigator title: MD
mesh term: Dilatation, Pathologic
sharing ipd: Undecided