<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/NCT03039608</url>
  </required_header>
  <id_info>
    <org_study_id>xmdrct</org_study_id>
    <nct_id>NCT03039608</nct_id>
  </id_info>
  <brief_title>Effect of a Combination of Local Steroid Injection With Oral Steroid Administration for the Prevention on Esophageal Stricture After Endoscopic Submucosal Dissection for Early Esophageal Neoplasm</brief_title>
  <official_title>Effect of a Combination of Local Steroid Injection With Oral Steroid Administration for the Prevention on Esophageal Stricture After Endoscopic Submucosal Dissection for Early Esophageal Neoplasm：a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan 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 method of esophageal endoscopic submucosal dissection (ESD) to remove superficial&#xD;
      esophageal neoplasms has gained widespread acceptance as an alternative to surgery recently&#xD;
      these years especially in Asian countries. However, besides of perforation and bleeding,&#xD;
      another complication postoperative esophageal stricture is frequently observed after the&#xD;
      removal of large-sized esophageal neoplasms by ESD. Dysphagia caused by postoperative&#xD;
      stricture substantially decreases the patient's quality of life, requiring further therapy.&#xD;
      Although the exact incidence is unknown, esophageal stricture is supposed to be related to&#xD;
      the extent of the circumference being resected. In previous study by Ono et al，it is reported&#xD;
      that 90% of patients with lesions of circumferential extension of more than three-fourths&#xD;
      experienced postoperative stricture after esophageal ESD. There were some reported studies&#xD;
      exploring new ways to prevent esophageal stricture after ESD, such as oral prednisolone and&#xD;
      local corticosteroid injection. Corticosteroids can inhibit not only collagen synthesis but&#xD;
      also enhance collagen breakdown, thereby inhibiting stricture formation. Some studies reveled&#xD;
      that just oral prednisolone oral is effective option for the prevention of post-ESD&#xD;
      stricture. However, most of the reported studies were non RCTs with small sample. In the&#xD;
      primary study, the investigators search a new method of combination of both oral and local&#xD;
      injection to prevent esophageal stricture，as a result，stricture at 8 weeks after ESD was&#xD;
      found in 19 of 36 patients in the no corticosteroid group but only 4 of 34 in the&#xD;
      corticosteroid group. Unfortunately，the study was also retrospective. So, the investigators&#xD;
      plan to undertake a prospective, randomized controlled trial to evaluate the prophylactic&#xD;
      effects of combination of local steroid injection with oral steroid administration for&#xD;
      esophageal stenoses complicating extensive ESD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2017</start_date>
  <completion_date type="Actual">November 10, 2018</completion_date>
  <primary_completion_date type="Actual">July 10, 2018</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the stricture rate</measure>
    <time_frame>12weeks</time_frame>
    <description>the incidence of esophageal rate after ESD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the time when stricture occurs</measure>
    <time_frame>12weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>the frequency of dilatation sessions required</measure>
    <time_frame>12 months</time_frame>
    <description>the frequency of dilatation sessions required after stricture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the frequency of complications</measure>
    <time_frame>12 months</time_frame>
    <description>complications related with steroid administrations or the process of ESD</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Esophageal Stricture</condition>
  <arm_group>
    <arm_group_label>combination group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone）</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>oral steroid administration（prednisone）</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone）</intervention_name>
    <description>local steroid injection and oral steroid</description>
    <arm_group_label>combination group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oral steroid administration（prednisone）</intervention_name>
    <description>oral steroid</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who has undergone esophageal ESD&#xD;
&#xD;
          2. Histologically confirmed early squamous cell carcinoma or high grade intraepithelial&#xD;
             neoplasia of the esophagus&#xD;
&#xD;
          3. ESD resulted in a mucosal defect involving more than two-thirds of the esophageal&#xD;
             circumference.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe circulatory or respiratory disease，severe renal impairment&#xD;
&#xD;
          2. Women in pregnancy and lactation&#xD;
&#xD;
          3. Patients with steroid contraindications&#xD;
&#xD;
          4. Patients refuse to join in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meidong Xu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Zhongshan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>September 3, 2019</last_update_submitted>
  <last_update_submitted_qc>September 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>esophageal stricture</keyword>
  <keyword>endoscopic submucosal dissection</keyword>
  <keyword>prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
    <mesh_term>Esophageal Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Triamcinolone</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03039608
org study id: xmdrct
nct id: NCT03039608
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The method of esophageal endoscopic submucosal dissection (ESD) to remove superficial
      esophageal neoplasms has gained widespread acceptance as an alternative to surgery recently
      these years especially in Asian countries. However, besides of perforation and bleeding,
      another complication postoperative esophageal stricture is frequently observed after the
      removal of large-sized esophageal neoplasms by ESD. Dysphagia caused by postoperative
      stricture substantially decreases the patient's quality of life, requiring further therapy.
      Although the exact incidence is unknown, esophageal stricture is supposed to be related to
      the extent of the circumference being resected. In previous study by Ono et al，it is reported
      that 90% of patients with lesions of circumferential extension of more than three-fourths
      experienced postoperative stricture after esophageal ESD. There were some reported studies
      exploring new ways to prevent esophageal stricture after ESD, such as oral prednisolone and
      local corticosteroid injection. Corticosteroids can inhibit not only collagen synthesis but
      also enhance collagen breakdown, thereby inhibiting stricture formation. Some studies reveled
      that just oral prednisolone oral is effective option for the prevention of post-ESD
      stricture. However, most of the reported studies were non RCTs with small sample. In the
      primary study, the investigators search a new method of combination of both oral and local
      injection to prevent esophageal stricture，as a result，stricture at 8 weeks after ESD was
      found in 19 of 36 patients in the no corticosteroid group but only 4 of 34 in the
      corticosteroid group. Unfortunately，the study was also retrospective. So, the investigators
      plan to undertake a prospective, randomized controlled trial to evaluate the prophylactic
      effects of combination of local steroid injection with oral steroid administration for
      esophageal stenoses complicating extensive ESD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: the stricture rate
time frame: 12weeks
description: the incidence of esophageal rate after ESD
measure: the time when stricture occurs
time frame: 12weeks
measure: the frequency of dilatation sessions required
time frame: 12 months
description: the frequency of dilatation sessions required after stricture
measure: the frequency of complications
time frame: 12 months
description: complications related with steroid administrations or the process of ESD
arm group label: combination group
arm group type: Experimental
description: combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone）
arm group label: control group
arm group type: Active Comparator
description: oral steroid administration（prednisone）
intervention type: Drug
intervention name: combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone）
description: local steroid injection and oral steroid
arm group label: combination group
intervention type: Drug
intervention name: oral steroid administration（prednisone）
description: oral steroid
arm group label: control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Meidong Xu, PhD
role: Principal Investigator
affiliation: Shanghai Zhongshan Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Esophageal Neoplasms
mesh term: Esophageal Stenosis
mesh term: Constriction, Pathologic
mesh term: Prednisone
mesh term: Triamcinolone