<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/NCT04406428</url>
  </required_header>
  <id_info>
    <org_study_id>NL65652.091.18</org_study_id>
    <nct_id>NCT04406428</nct_id>
  </id_info>
  <brief_title>NKI Therapy Compared to Usual Care of Recurrent Esophagogastric Anastomotic Strictures</brief_title>
  <acronym>SAMURAI</acronym>
  <official_title>Needle-knife inciSion therApy coMpared to Usual caRe of Recurrent Esophagogastric AnastomotIc Strictures: a Multicenter Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Netherlands Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Leiden University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>UMC Utrecht</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Radboud University Medical Center</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>
      Rationale: The study hypothesizes that NKI followed by endoscopic bougie dilation therapy&#xD;
      will result in an increased dysphagia-free period, a reduction of endoscopic procedures and&#xD;
      dysphagia-related quality of life, and lower costs, when compared with the standard&#xD;
      endoscopic bougie dilation (EBD) in recurrent esophagogastric anastomotic strictures.&#xD;
&#xD;
      Objective: To evaluate the efficacy and cost-effectiveness of needle-knife incision (NKI)&#xD;
      followed by EBD compared to standard EBD in patients with recurrent esophagogastric&#xD;
      anastomotic strictures.&#xD;
&#xD;
      Study design: This multicenter study is an randomized controlled trial in which NKI followed&#xD;
      by EBD will be compared with standard EBD.&#xD;
&#xD;
      Study population: Patients with recurrent dysphagia (at least 1 and a maximum of 5 previous&#xD;
      dilations) due to an anastomotic esophagogastric stricture that requires treatment with&#xD;
      repeated endoscopic bougie dilations.&#xD;
&#xD;
      Intervention : The intervention to be investigated is the addition of NKI therapy to EBD to&#xD;
      18 mm esophageal diameter.&#xD;
&#xD;
      Main study parameters/endpoints: The primary outcome of this study will be EBD-free time&#xD;
      during follow-up of 6 months. Secondary outcome parameters will be the number of endoscopic&#xD;
      procedures for treatment of dysphagia, quality of life (QoL), cost-reduction and&#xD;
      cost-effectiveness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 14, 2020</start_date>
  <completion_date type="Anticipated">September 14, 2025</completion_date>
  <primary_completion_date type="Anticipated">September 14, 2025</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 (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dilation free time</measure>
    <time_frame>6 months</time_frame>
    <description>EBD-free time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Endoscopic procedures</measure>
    <time_frame>6 months</time_frame>
    <description>Number of endoscopic procedures for treatment of dysphagia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QoL</measure>
    <time_frame>6 months</time_frame>
    <description>Quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-reduction</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">99</enrollment>
  <condition>Esophageal Stricture</condition>
  <condition>Anastomotic Stenosis</condition>
  <condition>Dilation of Esophagus Due to Disease</condition>
  <arm_group>
    <arm_group_label>NKI followed by EBD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard EBD</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>NKI followed by EBD</intervention_name>
    <description>Needle-knife incision therapy followed by endoscopic bougie dilation</description>
    <arm_group_label>NKI followed by EBD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Recurrent intra- or extrathoracic benign esophagogastric anastomotic stricture after&#xD;
             esophagectomy. The definition of a stricture is based on the Ogilvie Dysphagia score&#xD;
             (severity of dysphagia), i.e. Ogilvie score ≥2 (= ability to swallow semi-solid food&#xD;
             or worse (Appendix table 1)).&#xD;
&#xD;
          -  No patency for a standard endoscope (diameter &lt; 10 mm)&#xD;
&#xD;
          -  The recurrent stricture has been previously treated with at least 1 to a maximum of 5&#xD;
             EBD sessions that reached an esophageal diameter of ≥16 mm.&#xD;
&#xD;
          -  The stricture should be suitable for endoscopic incision (stricture length ≤10 mm).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Benign esophageal stricture other than an esophagogastric anastomotic stricture.&#xD;
&#xD;
          -  Strictures with a morphology unsuitable for NKI, such as long (&gt;1 cm), irregulair or&#xD;
             tortuous strictures.&#xD;
&#xD;
          -  Previous endoscopic treatment of the esophageal stricture with steroid injection,&#xD;
             incision therapy or stent placement within the past 3 months.&#xD;
&#xD;
          -  Previous stent placement post-esophagectomy for anastomotic leakage.&#xD;
&#xD;
          -  (Suspicion of) locally recurrent or metastasized esophageal cancer.&#xD;
&#xD;
          -  Persisting postoperative esophageal fistula.&#xD;
&#xD;
          -  Inability to discontinue anticoagulants or high-dose antiplatelet drugs at time of the&#xD;
             baseline procedure. Low-dose aspirin (max. 100 mg/day) may be continued.&#xD;
&#xD;
          -  Known clotting disorder that cannot pre-procedural be corrected.&#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>Lieke Koggel, Drs.</last_name>
    <phone>+316-25678774</phone>
    <email>lieke.koggel@radboudumc.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Radboudumc</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <zip>6500 HB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lieke Koggel, Drs.</last_name>
      <phone>+316-25678774</phone>
      <email>lieke.koggel@radboudumc.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>January 10, 2023</last_update_submitted>
  <last_update_submitted_qc>January 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <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/NCT04406428
org study id: NL65652.091.18
nct id: NCT04406428
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Rationale: The study hypothesizes that NKI followed by endoscopic bougie dilation therapy
      will result in an increased dysphagia-free period, a reduction of endoscopic procedures and
      dysphagia-related quality of life, and lower costs, when compared with the standard
      endoscopic bougie dilation (EBD) in recurrent esophagogastric anastomotic strictures.

      Objective: To evaluate the efficacy and cost-effectiveness of needle-knife incision (NKI)
      followed by EBD compared to standard EBD in patients with recurrent esophagogastric
      anastomotic strictures.

      Study design: This multicenter study is an randomized controlled trial in which NKI followed
      by EBD will be compared with standard EBD.

      Study population: Patients with recurrent dysphagia (at least 1 and a maximum of 5 previous
      dilations) due to an anastomotic esophagogastric stricture that requires treatment with
      repeated endoscopic bougie dilations.

      Intervention : The intervention to be investigated is the addition of NKI therapy to EBD to
      18 mm esophageal diameter.

      Main study parameters/endpoints: The primary outcome of this study will be EBD-free time
      during follow-up of 6 months. Secondary outcome parameters will be the number of endoscopic
      procedures for treatment of dysphagia, quality of life (QoL), cost-reduction and
      cost-effectiveness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Dilation free time
time frame: 6 months
description: EBD-free time
measure: Endoscopic procedures
time frame: 6 months
description: Number of endoscopic procedures for treatment of dysphagia
measure: QoL
time frame: 6 months
description: Quality of life
measure: Cost-reduction
time frame: 6 months
measure: Cost-effectiveness
time frame: 6 months
arm group label: NKI followed by EBD
arm group type: Experimental
arm group label: Standard EBD
arm group type: No Intervention
intervention type: Procedure
intervention name: NKI followed by EBD
description: Needle-knife incision therapy followed by endoscopic bougie dilation
arm group label: NKI followed by EBD
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lieke Koggel, Drs.
phone: +316-25678774
email: lieke.koggel@radboudumc.nl
facility: 
status: Recruiting
contact: 
country: Netherlands
responsible party type: Sponsor
mesh term: Esophageal Stenosis
mesh term: Constriction, Pathologic
sharing ipd: No