<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/NCT03023865</url>
  </required_header>
  <id_info>
    <org_study_id>XH-16-033</org_study_id>
    <nct_id>NCT03023865</nct_id>
  </id_info>
  <brief_title>Individualized Management for Long Gap Esophageal Atresia</brief_title>
  <official_title>Individualized Diagnosis and Treatment for Long Gap Esophageal Atresia Based on the Principle of Biological Growth Under Stress</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The treatment of long gap esophageal atresia (LGEA) in neonates is one of the most&#xD;
      challenging congenital malformations in neonatal surgery. Usually the proximal and distal&#xD;
      segments of the esophagus are too far apart, which leads to primary anastomosis abandoned.&#xD;
      Thus various techniques have been used including Circular and spiral myotomies、Foker and&#xD;
      Kimura elongation and gastrointestinal replacement. They are being widely used but bring more&#xD;
      complications and less effectiveness. And considering about the absence of definite guideline&#xD;
      for the diagnosis and treatment of LGEA worldwide, We prepare to use a preoperative staged&#xD;
      stress function procedure for elongation of the proximal and distal segments, then to obtain&#xD;
      an exact evaluation of the pouch status to achieve an individualized protocol of diagnosis&#xD;
      and treatment utilizing the native esophagus to establish esophageal continuity for patients&#xD;
      with LGEA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with diagnosis of LGEA(gap distance&gt;3.5cm) will be accepted to the program.&#xD;
&#xD;
      After accepted to our center, the patients will feed by gastrostomy tube to keep nutritional&#xD;
      status remain well controlled. Continuous suction in the upper pouch will be applied to avoid&#xD;
      aspiration pneumonia.&#xD;
&#xD;
      We will design a bouginage with baroreceptor. Then the stress function will be performed as&#xD;
      following steps. The designed bouginage will be inserted into the upper esophagus pouch&#xD;
      through oral cavity with a certain downward longitudinal force to increase esophageal length&#xD;
      by tissue stretch and growth, it will be performed 10-15 minutes each time once/twice a day.&#xD;
      While the elongation of distal pouch will be achieved via the gastrostomy using the same&#xD;
      bouginage to give upward pressure, the program will be operated under X-ray firstly to avoid&#xD;
      injury or false passage formation,it can be performed in the ward thereafter. The gap length&#xD;
      and the diameter of the pouch will be evaluated every 1-2 weeks. During the elongation&#xD;
      period, continuous upper pouch suctioning and nutritional support were maintained.&#xD;
&#xD;
      When the gap distance is short enough，the method of surgery will be decided，including&#xD;
      end-to-end anastomosis、Livadites、flip-flap and choice of thoracoscopy use. The purpose of the&#xD;
      program is to achieve the exact management and treatment for patients with LGEA and help&#xD;
      promoting the use of the new technology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">October 2019</completion_date>
  <primary_completion_date type="Anticipated">October 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with LGEA cured by the elongation method</measure>
    <time_frame>up to 3 years</time_frame>
    <description>Provide the numbers of patients with LGEA cured by the method using elongation technique</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Data collection of patients with LGEA</measure>
    <time_frame>up to 3 years</time_frame>
    <description>Circumstances of diagnosis，gap length in centimetre between esophageal pouches ，operation method，modalities in percent of follow-up clinical management</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Esophageal Atresia</condition>
  <arm_group>
    <arm_group_label>Staged stress function</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A preoperative staged stress function procedure for elongation of the proximal and distal segments to achieve utilizing the native esophagus to establish esophageal continuity</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Staged stress function</intervention_name>
    <description>A preoperative staged stress function procedure for elongation of the proximal and distal segments to achieve utilizing the native esophagus to establish esophageal continuity</description>
    <arm_group_label>Staged stress function</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria：&#xD;
&#xD;
          -  Patients with long gap esophageal atresia（LGEA）which the gap lenth≥3.5cm；&#xD;
&#xD;
          -  with（out）tracheoesophageal fistula（TEF）&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with LGEA which can not accept the staged stress function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wang Jun, MD</last_name>
    <role>Study Director</role>
    <affiliation>Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wang Jun, MD</last_name>
    <phone>+8613651752216</phone>
    <email>jwangjl@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sun Suna, bachelor</last_name>
    <phone>+8618801970307</phone>
    <email>sunsuna1231@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Pediatric Surgery</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Wang Jun, MD</last_name>
      <phone>+8613651752216</phone>
      <email>jwangjl@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>von Allmen D, Wijnen RM. Bridging the Gap in the Repair of Long-Gap Esophageal Atresia: Still Questions on Diagnostics and Treatment. Eur J Pediatr Surg. 2015 Aug;25(4):312-7. doi: 10.1055/s-0035-1562926. Epub 2015 Aug 24.</citation>
    <PMID>26302063</PMID>
  </reference>
  <reference>
    <citation>Spitz L, Kiely EM, Drake DP, Pierro A. Long-gap oesophageal atresia. Pediatr Surg Int. 1996 Aug;11(7):462-5. doi: 10.1007/BF00180083. Epub 2013 Sep 21.</citation>
    <PMID>24057783</PMID>
  </reference>
  <reference>
    <citation>Rothenberg SS, Flake AW. Experience with Thoracoscopic Repair of Long Gap Esophageal Atresia in Neonates. J Laparoendosc Adv Surg Tech A. 2015 Nov;25(11):932-5. doi: 10.1089/lap.2015.0124. Epub 2015 Oct 20.</citation>
    <PMID>26485521</PMID>
  </reference>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 26, 2016</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 13, 2017</last_update_submitted>
  <last_update_submitted_qc>January 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Long gap esophageal atresia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Atresia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Share with the period of stress applied,gap distance between two esophageal segments,stress pressure.etc</ipd_description>
  </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/NCT03023865
org study id: XH-16-033
nct id: NCT03023865
lead sponsor: 
has dmc: No
The treatment of long gap esophageal atresia (LGEA) in neonates is one of the most
      challenging congenital malformations in neonatal surgery. Usually the proximal and distal
      segments of the esophagus are too far apart, which leads to primary anastomosis abandoned.
      Thus various techniques have been used including Circular and spiral myotomies、Foker and
      Kimura elongation and gastrointestinal replacement. They are being widely used but bring more
      complications and less effectiveness. And considering about the absence of definite guideline
      for the diagnosis and treatment of LGEA worldwide, We prepare to use a preoperative staged
      stress function procedure for elongation of the proximal and distal segments, then to obtain
      an exact evaluation of the pouch status to achieve an individualized protocol of diagnosis
      and treatment utilizing the native esophagus to establish esophageal continuity for patients
      with LGEA.
Patients with diagnosis of LGEA(gap distance>3.5cm) will be accepted to the program.

      After accepted to our center, the patients will feed by gastrostomy tube to keep nutritional
      status remain well controlled. Continuous suction in the upper pouch will be applied to avoid
      aspiration pneumonia.

      We will design a bouginage with baroreceptor. Then the stress function will be performed as
      following steps. The designed bouginage will be inserted into the upper esophagus pouch
      through oral cavity with a certain downward longitudinal force to increase esophageal length
      by tissue stretch and growth, it will be performed 10-15 minutes each time once/twice a day.
      While the elongation of distal pouch will be achieved via the gastrostomy using the same
      bouginage to give upward pressure, the program will be operated under X-ray firstly to avoid
      injury or false passage formation,it can be performed in the ward thereafter. The gap length
      and the diameter of the pouch will be evaluated every 1-2 weeks. During the elongation
      period, continuous upper pouch suctioning and nutritional support were maintained.

      When the gap distance is short enough，the method of surgery will be decided，including
      end-to-end anastomosis、Livadites、flip-flap and choice of thoracoscopy use. The purpose of the
      program is to achieve the exact management and treatment for patients with LGEA and help
      promoting the use of the new technology.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with LGEA cured by the elongation method
time frame: up to 3 years
description: Provide the numbers of patients with LGEA cured by the method using elongation technique
measure: Data collection of patients with LGEA
time frame: up to 3 years
description: Circumstances of diagnosis，gap length in centimetre between esophageal pouches ，operation method，modalities in percent of follow-up clinical management
arm group label: Staged stress function
arm group type: Experimental
description: A preoperative staged stress function procedure for elongation of the proximal and distal segments to achieve utilizing the native esophagus to establish esophageal continuity
intervention type: Procedure
intervention name: Staged stress function
description: A preoperative staged stress function procedure for elongation of the proximal and distal segments to achieve utilizing the native esophagus to establish esophageal continuity
arm group label: Staged stress function
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Wang Jun, MD
role: Study Director
affiliation: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
last name: Wang Jun, MD
phone: +8613651752216
email: jwangjl@126.com
last name: Sun Suna, bachelor
phone: +8618801970307
email: sunsuna1231@163.com
facility: 
contact: 
country: China
citation: von Allmen D, Wijnen RM. Bridging the Gap in the Repair of Long-Gap Esophageal Atresia: Still Questions on Diagnostics and Treatment. Eur J Pediatr Surg. 2015 Aug;25(4):312-7. doi: 10.1055/s-0035-1562926. Epub 2015 Aug 24.
PMID: 26302063
citation: Spitz L, Kiely EM, Drake DP, Pierro A. Long-gap oesophageal atresia. Pediatr Surg Int. 1996 Aug;11(7):462-5. doi: 10.1007/BF00180083. Epub 2013 Sep 21.
PMID: 24057783
citation: Rothenberg SS, Flake AW. Experience with Thoracoscopic Repair of Long Gap Esophageal Atresia in Neonates. J Laparoendosc Adv Surg Tech A. 2015 Nov;25(11):932-5. doi: 10.1089/lap.2015.0124. Epub 2015 Oct 20.
PMID: 26485521
responsible party type: Sponsor
mesh term: Esophageal Atresia
sharing ipd: Yes
ipd description: Share with the period of stress applied,gap distance between two esophageal segments,stress pressure.etc