xml: <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/NCT05994521</url>
    </required_header>
    <id_info>
      <org_study_id>MP-37-2024-9711</org_study_id>
      <nct_id>NCT05994521</nct_id>
    </id_info>
    <brief_title>Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers</brief_title>
    <acronym>INTERCEPT</acronym>
    <official_title>Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers: A Multicenter Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Jewish General Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Unity Health Toronto</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</source>
    <oversight_info>
      <has_dmc>Yes</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 goal of this randomized controlled trial is to investigate the effectiveness and safety&#xD;
        of Prophylactic EUS-gastroenterostomy (ProEUS-GE) as a preventative approach for malignant&#xD;
        gastric outlet obstruction (MGOO) in men and women aged 18 years or older diagnosed with&#xD;
        periampullary cancer.&#xD;
  &#xD;
        The main question this study aims to answer is can ProEUS-GE effectively prevent the&#xD;
        occurrence of MGOO in patients with periampullary cancer?&#xD;
  &#xD;
        Patients will be randomly assigned to one of two groups: Group 1 (ERCP alone) or Group 2&#xD;
        (ERCP + ProEUS-GE). The study will compare the outcomes between these groups to determine the&#xD;
        effectiveness of ProEUS-GE in preventing MGOO.&#xD;
  &#xD;
        Researchers will compare Group 1 (ERCP alone) with Group 2 (ERCP + ProEUS-GE) to see if the&#xD;
        addition of ProEUS-GE leads to a reduced occurrence of MGOO in patients with periampullary&#xD;
        cancer.&#xD;
  &#xD;
        The primary endpoint is the rate of malignant gastric outlet obstruction.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Research Question:&#xD;
  &#xD;
        The principal research question is whether ProEUS-GE can prevent the occurrence of MGOO in&#xD;
        patients with pancreatic head cancer. We hypothesize that the addition of ProEUS-GE during&#xD;
        ERCP reduces the rate of development of subsequent MGOO in advanced periampullary solid&#xD;
        cancer without significantly increasing the rate of adverse events when compared to ERCP&#xD;
        alone.&#xD;
  &#xD;
        The Proposed Trial Trial Design: This is a patient- and outcome assessor-blinded multicentre&#xD;
        randomized controlled superiority trial. The endoscopist performing the procedure will not be&#xD;
        blinded to treatment allocation.&#xD;
  &#xD;
        Planned Trial Interventions: 1) ERCP with biliary decompression + prophylactic EUS-guided&#xD;
        gastroenterostomy (ProEUS-GE) and 2) ERCP with biliary decompression alone. All procedures&#xD;
        will be performed by experienced endoscopists with or without trainee involvement. Following&#xD;
        informed consent, sedation will be via conscious sedation or general anesthesia, as per&#xD;
        existing institutional procedural protocols. A medical effectiveness approach will be adopted&#xD;
        where only the initial randomly allocated treatment is dictated by the trial.&#xD;
  &#xD;
        Participant Allocation: After confirmation of fulfillment of all study inclusion/exclusion&#xD;
        criteria and pre-procedural consent, patients will be randomly allocated, intra-procedurally&#xD;
        during the ERCP, to one of the two approaches.&#xD;
  &#xD;
        The primary endpoint is the rate of gastric outlet obstruction.&#xD;
  &#xD;
        Sample Size Calculation:&#xD;
  &#xD;
        Using the currently available data in the literature and local data from the MUHC, we&#xD;
        estimate a MGOO risk of 5% vs. 30% with ERCP + ProEUS-GE vs. ERCP alone, respectively, up to&#xD;
        18 months of follow-up. To achieve a statistical power of 80% with a two-sided type I error&#xD;
        of 5% while considering a loss to follow-up of 5%, a final sample size of 74 patients (37&#xD;
        patients in each arm) is needed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">February 2027</completion_date>
    <primary_completion_date type="Anticipated">February 2027</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>
      <intervention_model_description>Patients will be randomly allocated, intra-procedurally during the ERCP, to one of the two approaches.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
      <masking_description>As with most procedural interventional trials, blinding of the endoscopist is not feasible. To limit detection biases, outcome assessors and patients are blinded to the treatment allocation. Outcome assessors are independent individuals not involved with patient consent or randomization and not present at the index procedure.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of gastric outlet obstruction (GOO)</measure>
      <time_frame>18 months</time_frame>
      <description>Gastric outlet obstruction is defined as GOOSS of &lt; 2 AND radiological and/or endoscopic confirmation of the presence of GOO either from a gastroduodenal stricture, stent obstruction, or stent migration.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of adverse events</measure>
      <time_frame>18 months</time_frame>
      <description>Adverse events are defined and rated according to the ASGE lexicon for endoscopic adverse events.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life of the participant</measure>
      <time_frame>18 months</time_frame>
      <description>Quality of life will be assessed through the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nutritional status</measure>
      <time_frame>18 months</time_frame>
      <description>Nutritional status will be assessed using the patient-generated subjective global assessment short form (PG-SGA). The PG-SGA scoring scales from 0 to &gt;9, with a higher score indicating a need for symptom management or nutritional intervention. We will also assess for sarcopenia by incorporating objective quantification of muscle and adipose tissue compartments. These compartments have been shown to have significant prognostic value in patients with pancreatic cancer, including overall survival.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">74</enrollment>
    <condition>Cancer Gi</condition>
    <arm_group>
      <arm_group_label>ERCP alone</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>ERCP procedure alone and management of MGOO will be on a wait-and-see approach, using endoscopic interventions performed only if obstruction is clinically diagnosed</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ERCP + ProEUS-GE</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>ERCP with prophylactic eus-guided gastroenterostomy</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>ERCP alone</intervention_name>
      <description>ERCP with biliary stenting will be performed alone. ERCP is part of standard of care for biliary drainage. An endoscope is advanced to the small intestines and a metal stent is inserted through the tumor instead of bypassing the tumor to effectively drain the biliary system under x-ray guidance.&#xD;
  Management of MGOO will be on a wait-and-see approach, using endoscopic interventions performed only if obstruction is clinically diagnosed</description>
      <arm_group_label>ERCP alone</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>ERCP +ProEUS-GE</intervention_name>
      <description>ERCP is performed as described above. following the ERCP, the scoped is switched for an echoendoscope which is advanced to the stomach. A stent is then placed between the stomach and the small intestines, creating a connection (ProEUS-GE).</description>
      <arm_group_label>ERCP + ProEUS-GE</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria (all of the following):&#xD;
  &#xD;
            1. Radiological diagnosis of a periampullary cancer that is precluded from upfront&#xD;
               surgical resection of curative intent due to advanced tumor stage. These include&#xD;
               locally advanced or metastatic cancers of the pancreatic head, distal bile duct,&#xD;
               duodenum, or ampulla. cancers.&#xD;
  &#xD;
            2. Elevated liver function tests requiring ERCP without evidence of MGOO of significant&#xD;
               gastroparesis (see exclusion criterion #3 and #4)&#xD;
  &#xD;
            3. ECOG 0 or 1&#xD;
  &#xD;
            4. ASA&lt;4&#xD;
  &#xD;
            5. Provision of informed consent&#xD;
  &#xD;
          Exclusion Criteria (any of the following):&#xD;
  &#xD;
            1. Resectable periampullary cancer&#xD;
  &#xD;
            2. Patient with clinical and radiological evidence of malignant gastric outlet&#xD;
               obstruction defined as Gastric Outlet Obstruction Scoring System (GOOSS) of &lt; 3 with&#xD;
               radiological and/or endoscopic evidence of a mechanical obstruction from a gastric or&#xD;
               duodenal stricture. GOOSS is a validated tool for assessing MGOO and is scored based&#xD;
               on the diet tolerated by the patient: 0 for no oral intake, 1 for liquids only, 2 for&#xD;
               soft diet, and 3 for low residue or full diet.&#xD;
  &#xD;
            3. Gastroparesis with a Gastroparesis Cardinal Symptom Index (GCSI) of &gt;2. Gastroparesis&#xD;
               is defined as having symptoms of MGOO without radiological and/or endoscopic evidence&#xD;
               of mechanical obstruction.&#xD;
  &#xD;
            4. Uncorrectable coagulopathy and/or thrombocytopenia&#xD;
  &#xD;
            5. Age &lt; 18&#xD;
  &#xD;
            6. Ascites &gt; grade I&#xD;
  &#xD;
            7. Liver metastasis &gt; 30% of the liver volume&#xD;
  &#xD;
            8. Portal hypertension with gastroesophageal varices and/or ascites&#xD;
  &#xD;
            9. Surgically altered upper gastrointestinal anatomy&#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_contact>
      <last_name>Yen-I Chen, MD</last_name>
      <phone>514-291-3154</phone>
      <email>yen-i.chen@mgcill.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
      <investigator_full_name>Yen-I Chen</investigator_full_name>
      <investigator_title>assistant professor of medicine</investigator_title>
    </responsible_party>
    <keyword>periampullary cancer</keyword>
    <keyword>ERCP</keyword>
    <keyword>EUS-Guided gastroeterostomy</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05994521
  org study id: MP-37-2024-9711
  nct id: NCT05994521
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized controlled trial is to investigate the effectiveness and safety
        of Prophylactic EUS-gastroenterostomy (ProEUS-GE) as a preventative approach for malignant
        gastric outlet obstruction (MGOO) in men and women aged 18 years or older diagnosed with
        periampullary cancer.
  
        The main question this study aims to answer is can ProEUS-GE effectively prevent the
        occurrence of MGOO in patients with periampullary cancer?
  
        Patients will be randomly assigned to one of two groups: Group 1 (ERCP alone) or Group 2
        (ERCP + ProEUS-GE). The study will compare the outcomes between these groups to determine the
        effectiveness of ProEUS-GE in preventing MGOO.
  
        Researchers will compare Group 1 (ERCP alone) with Group 2 (ERCP + ProEUS-GE) to see if the
        addition of ProEUS-GE leads to a reduced occurrence of MGOO in patients with periampullary
        cancer.
  
        The primary endpoint is the rate of malignant gastric outlet obstruction.
  Research Question:
  
        The principal research question is whether ProEUS-GE can prevent the occurrence of MGOO in
        patients with pancreatic head cancer. We hypothesize that the addition of ProEUS-GE during
        ERCP reduces the rate of development of subsequent MGOO in advanced periampullary solid
        cancer without significantly increasing the rate of adverse events when compared to ERCP
        alone.
  
        The Proposed Trial Trial Design: This is a patient- and outcome assessor-blinded multicentre
        randomized controlled superiority trial. The endoscopist performing the procedure will not be
        blinded to treatment allocation.
  
        Planned Trial Interventions: 1) ERCP with biliary decompression + prophylactic EUS-guided
        gastroenterostomy (ProEUS-GE) and 2) ERCP with biliary decompression alone. All procedures
        will be performed by experienced endoscopists with or without trainee involvement. Following
        informed consent, sedation will be via conscious sedation or general anesthesia, as per
        existing institutional procedural protocols. A medical effectiveness approach will be adopted
        where only the initial randomly allocated treatment is dictated by the trial.
  
        Participant Allocation: After confirmation of fulfillment of all study inclusion/exclusion
        criteria and pre-procedural consent, patients will be randomly allocated, intra-procedurally
        during the ERCP, to one of the two approaches.
  
        The primary endpoint is the rate of gastric outlet obstruction.
  
        Sample Size Calculation:
  
        Using the currently available data in the literature and local data from the MUHC, we
        estimate a MGOO risk of 5% vs. 30% with ERCP + ProEUS-GE vs. ERCP alone, respectively, up to
        18 months of follow-up. To achieve a statistical power of 80% with a two-sided type I error
        of 5% while considering a loss to follow-up of 5%, a final sample size of 74 patients (37
        patients in each arm) is needed.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients will be randomly allocated, intra-procedurally during the ERCP, to one of the two approaches.
  primary purpose: Prevention
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  masking description: As with most procedural interventional trials, blinding of the endoscopist is not feasible. To limit detection biases, outcome assessors and patients are blinded to the treatment allocation. Outcome assessors are independent individuals not involved with patient consent or randomization and not present at the index procedure.
  measure: Rate of gastric outlet obstruction (GOO)
  time frame: 18 months
  description: Gastric outlet obstruction is defined as GOOSS of < 2 AND radiological and/or endoscopic confirmation of the presence of GOO either from a gastroduodenal stricture, stent obstruction, or stent migration.
  measure: Rate of adverse events
  time frame: 18 months
  description: Adverse events are defined and rated according to the ASGE lexicon for endoscopic adverse events.
  measure: Quality of life of the participant
  time frame: 18 months
  description: Quality of life will be assessed through the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients questionnaire
  measure: Nutritional status
  time frame: 18 months
  description: Nutritional status will be assessed using the patient-generated subjective global assessment short form (PG-SGA). The PG-SGA scoring scales from 0 to >9, with a higher score indicating a need for symptom management or nutritional intervention. We will also assess for sarcopenia by incorporating objective quantification of muscle and adipose tissue compartments. These compartments have been shown to have significant prognostic value in patients with pancreatic cancer, including overall survival.
  arm group label: ERCP alone
  arm group type: Active Comparator
  description: ERCP procedure alone and management of MGOO will be on a wait-and-see approach, using endoscopic interventions performed only if obstruction is clinically diagnosed
  arm group label: ERCP + ProEUS-GE
  arm group type: Experimental
  description: ERCP with prophylactic eus-guided gastroenterostomy
  intervention type: Procedure
  intervention name: ERCP alone
  description: ERCP with biliary stenting will be performed alone. ERCP is part of standard of care for biliary drainage. An endoscope is advanced to the small intestines and a metal stent is inserted through the tumor instead of bypassing the tumor to effectively drain the biliary system under x-ray guidance.
  Management of MGOO will be on a wait-and-see approach, using endoscopic interventions performed only if obstruction is clinically diagnosed
  arm group label: ERCP alone
  intervention type: Procedure
  intervention name: ERCP +ProEUS-GE
  description: ERCP is performed as described above. following the ERCP, the scoped is switched for an echoendoscope which is advanced to the stomach. A stent is then placed between the stomach and the small intestines, creating a connection (ProEUS-GE).
  arm group label: ERCP + ProEUS-GE
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yen-I Chen, MD
  phone: 514-291-3154
  email: yen-i.chen@mgcill.com
  responsible party type: Principal Investigator
  investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
  investigator full name: Yen-I Chen
  investigator title: assistant professor of medicine
  sharing ipd: No