<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/NCT03273686</url>
  </required_header>
  <id_info>
    <org_study_id>ESO-NGT</org_study_id>
    <nct_id>NCT03273686</nct_id>
  </id_info>
  <brief_title>Efficacy of Nasogastric Tube Application in Postoperative Care of Esophagectomy</brief_title>
  <official_title>Efficacy of Nasogastric Tube Application in Postoperative Care of Esophagectomy: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</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>
      Nasogastric decompression is standard practice after esophageal resection in most centers&#xD;
      because it is expected to reduce the incidence of esophagogastric anastomotic leakage by&#xD;
      preventing overdistension of the gastric conduit. Most esophageal surgeons have been&#xD;
      reluctant to move away from this tradition because of the considerable morbidity of&#xD;
      anastomotic leaks after esophagectomy. However, a contrarian view is that the use of&#xD;
      prolonged NGD may increase the incidence of postoperative pulmonary complications by&#xD;
      promoting aspiration. Considering the numerous complications caused by using the tube and the&#xD;
      uncertainty about its usefulness and the scarcity of studies conducted on the subject,&#xD;
      particularly in patients with esophageal cancer, the necessity of using the tube in these&#xD;
      types of cases is investigated in the present study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods In this clinical trial, patients with esophageal cancer were randomized into groups&#xD;
      with NG tube and without NG tube after surgery. Sequence generation was performed using a&#xD;
      computer-generated sequence of random numbers with permuted blocks. Standard postoperative&#xD;
      management protocols were followed in both groups to avoid potential bias, which including&#xD;
      preoperation nasogastric decompression. Thoracic esophageal mobilization and mediastinal&#xD;
      lymphadenectomy were performed by open thoracotomy surgery. The abdominal part of the surgery&#xD;
      was performed by laparotomy, gastric tube reconstruction was performed using linear staplers,&#xD;
      and the conduit was brought up to the neck through the posterior mediastinal route. A&#xD;
      cervical esophagogastric anastomosis was performed by stapled (linear) techniques. All&#xD;
      patients were mobilized early, began early enteral feeding through jejunostomy tubes.&#xD;
      Randomization was performed during the surgery. The group without NG tube after surgery will&#xD;
      discharge the NG tube during the surgery. While the control group(group with NG tube after&#xD;
      surgery) will discharge the NG tube 6-7days after surgery. The variables recorded for each&#xD;
      patient included pulmonary complications, wound complications, anastomosis leak as well as&#xD;
      the duration of postoperative hospitalization and the need for placing replacing the NG tube.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 15, 2017</start_date>
  <completion_date type="Anticipated">April 15, 2018</completion_date>
  <primary_completion_date type="Anticipated">January 15, 2018</primary_completion_date>
  <phase>Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative complication</measure>
    <time_frame>an expected average of 4 weeks</time_frame>
    <description>the occurrence of major pulmonary complications and anastomotic leaks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the need for placing/ replacing the NG tube</measure>
    <time_frame>an expected average of 2 weeks</time_frame>
    <description>the need for placing/ replacing the NG tube</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of postoperative stay</measure>
    <time_frame>an expected average of 2 weeks</time_frame>
    <description>Length of postoperative stay</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Esophageal Cancer</condition>
  <arm_group>
    <arm_group_label>group without NG tube after surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this goup, patients will undergo preoperative gastrointestinal decompression and investigators will discharge the NG tube during the surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group with NG tube after surgery</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this goup, patients will undergo preoperative gastrointestinal decompression and investigators will discharge the NG tube 6-7 days after the surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Discharge the NG tube during the surgery</intervention_name>
    <description>Discharge the NG tube during the surgery.</description>
    <arm_group_label>group without NG tube after surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients who were fit for esophageal resection and underwent transthoracic or transhiatal&#xD;
        esophagectomy with gastric tube reconstruction.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Stage investigations indicating unresectable advanced disease(T4 or M1a,M1b).&#xD;
&#xD;
          2. Patients with any other serious underlying medical condition that would impair the&#xD;
             ability of the patient to receive or comply with protocol treatment.&#xD;
&#xD;
          3. Patients with unstable situation after surgery (eg, need ventilation and ICU&#xD;
             treatment)&#xD;
&#xD;
          4. Patients medically unfit for surgical resection.&#xD;
&#xD;
          5. Patients with pulmonary reserve inadequate to undergo thoracotomy and extensive&#xD;
             mediastinal lymphadenectomy.&#xD;
&#xD;
          6. Mentally disabled.&#xD;
&#xD;
          7. Expected life duration of less than 3 months.&#xD;
&#xD;
          8. Patients undergoing colonic reconstruction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiaqing Xiang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jiaqing Xiang, MD</last_name>
    <phone>+86 13901992249</phone>
    <email>j.q.xiang@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yiliang Zhang, MD</last_name>
    <phone>+86 18017317284</phone>
    <email>ilya616@126.com</email>
  </overall_contact_backup>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 4, 2017</last_update_submitted>
  <last_update_submitted_qc>September 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Jiaqing Xiang</investigator_full_name>
    <investigator_title>Professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center</investigator_title>
  </responsible_party>
  <keyword>Esophageal Cancer</keyword>
  <keyword>Nasogastric Tube</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Neoplasms</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/NCT03273686
org study id: ESO-NGT
nct id: NCT03273686
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Nasogastric decompression is standard practice after esophageal resection in most centers
      because it is expected to reduce the incidence of esophagogastric anastomotic leakage by
      preventing overdistension of the gastric conduit. Most esophageal surgeons have been
      reluctant to move away from this tradition because of the considerable morbidity of
      anastomotic leaks after esophagectomy. However, a contrarian view is that the use of
      prolonged NGD may increase the incidence of postoperative pulmonary complications by
      promoting aspiration. Considering the numerous complications caused by using the tube and the
      uncertainty about its usefulness and the scarcity of studies conducted on the subject,
      particularly in patients with esophageal cancer, the necessity of using the tube in these
      types of cases is investigated in the present study.
Methods In this clinical trial, patients with esophageal cancer were randomized into groups
      with NG tube and without NG tube after surgery. Sequence generation was performed using a
      computer-generated sequence of random numbers with permuted blocks. Standard postoperative
      management protocols were followed in both groups to avoid potential bias, which including
      preoperation nasogastric decompression. Thoracic esophageal mobilization and mediastinal
      lymphadenectomy were performed by open thoracotomy surgery. The abdominal part of the surgery
      was performed by laparotomy, gastric tube reconstruction was performed using linear staplers,
      and the conduit was brought up to the neck through the posterior mediastinal route. A
      cervical esophagogastric anastomosis was performed by stapled (linear) techniques. All
      patients were mobilized early, began early enteral feeding through jejunostomy tubes.
      Randomization was performed during the surgery. The group without NG tube after surgery will
      discharge the NG tube during the surgery. While the control group(group with NG tube after
      surgery) will discharge the NG tube 6-7days after surgery. The variables recorded for each
      patient included pulmonary complications, wound complications, anastomosis leak as well as
      the duration of postoperative hospitalization and the need for placing replacing the NG tube.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: postoperative complication
time frame: an expected average of 4 weeks
description: the occurrence of major pulmonary complications and anastomotic leaks.
measure: the need for placing/ replacing the NG tube
time frame: an expected average of 2 weeks
description: the need for placing/ replacing the NG tube
measure: Length of postoperative stay
time frame: an expected average of 2 weeks
description: Length of postoperative stay
arm group label: group without NG tube after surgery
arm group type: Experimental
description: In this goup, patients will undergo preoperative gastrointestinal decompression and investigators will discharge the NG tube during the surgery.
arm group label: group with NG tube after surgery
arm group type: No Intervention
description: In this goup, patients will undergo preoperative gastrointestinal decompression and investigators will discharge the NG tube 6-7 days after the surgery.
intervention type: Procedure
intervention name: Discharge the NG tube during the surgery
description: Discharge the NG tube during the surgery.
arm group label: group without NG tube after surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jiaqing Xiang, MD
role: Principal Investigator
affiliation: Professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center
last name: Jiaqing Xiang, MD
phone: +86 13901992249
email: j.q.xiang@hotmail.com
last name: Yiliang Zhang, MD
phone: +86 18017317284
email: ilya616@126.com
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Jiaqing Xiang
investigator title: Professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center
mesh term: Esophageal Neoplasms
sharing ipd: No