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Efficacy of Nasogastric Tube Application in Postoperative Care of Esophagectomy

Primary Purpose

Esophageal Cancer

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Discharge the NG tube during the surgery
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal Cancer, Nasogastric Tube

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients who were fit for esophageal resection and underwent transthoracic or transhiatal esophagectomy with gastric tube reconstruction.

-

Exclusion Criteria:

  1. Stage investigations indicating unresectable advanced disease(T4 or M1a,M1b).
  2. Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment.
  3. Patients with unstable situation after surgery (eg, need ventilation and ICU treatment)
  4. Patients medically unfit for surgical resection.
  5. Patients with pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy.
  6. Mentally disabled.
  7. Expected life duration of less than 3 months.
  8. Patients undergoing colonic reconstruction.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    group without NG tube after surgery

    group with NG tube after surgery

    Arm Description

    In this goup, patients will undergo preoperative gastrointestinal decompression and investigators will discharge the NG tube during the surgery.

    In this goup, patients will undergo preoperative gastrointestinal decompression and investigators will discharge the NG tube 6-7 days after the surgery.

    Outcomes

    Primary Outcome Measures

    postoperative complication
    the occurrence of major pulmonary complications and anastomotic leaks.

    Secondary Outcome Measures

    the need for placing/ replacing the NG tube
    the need for placing/ replacing the NG tube
    Length of postoperative stay
    Length of postoperative stay

    Full Information

    First Posted
    September 4, 2017
    Last Updated
    September 4, 2017
    Sponsor
    Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03273686
    Brief Title
    Efficacy of Nasogastric Tube Application in Postoperative Care of Esophagectomy
    Official Title
    Efficacy of Nasogastric Tube Application in Postoperative Care of Esophagectomy: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 15, 2017 (Anticipated)
    Primary Completion Date
    January 15, 2018 (Anticipated)
    Study Completion Date
    April 15, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fudan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal Cancer
    Keywords
    Esophageal Cancer, Nasogastric Tube

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group without NG tube after surgery
    Arm Type
    Experimental
    Arm Description
    In this goup, patients will undergo preoperative gastrointestinal decompression and investigators will discharge the NG tube during the surgery.
    Arm Title
    group with NG tube after surgery
    Arm Type
    No Intervention
    Arm 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(s)
    Discharge the NG tube during the surgery
    Intervention Description
    Discharge the NG tube during the surgery.
    Primary Outcome Measure Information:
    Title
    postoperative complication
    Description
    the occurrence of major pulmonary complications and anastomotic leaks.
    Time Frame
    an expected average of 4 weeks
    Secondary Outcome Measure Information:
    Title
    the need for placing/ replacing the NG tube
    Description
    the need for placing/ replacing the NG tube
    Time Frame
    an expected average of 2 weeks
    Title
    Length of postoperative stay
    Description
    Length of postoperative stay
    Time Frame
    an expected average of 2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients who were fit for esophageal resection and underwent transthoracic or transhiatal esophagectomy with gastric tube reconstruction. - Exclusion Criteria: Stage investigations indicating unresectable advanced disease(T4 or M1a,M1b). Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment. Patients with unstable situation after surgery (eg, need ventilation and ICU treatment) Patients medically unfit for surgical resection. Patients with pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy. Mentally disabled. Expected life duration of less than 3 months. Patients undergoing colonic reconstruction.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jiaqing Xiang, MD
    Phone
    +86 13901992249
    Email
    j.q.xiang@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yiliang Zhang, MD
    Phone
    +86 18017317284
    Email
    ilya616@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jiaqing Xiang, MD
    Organizational Affiliation
    Professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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