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Efficacy of Nasogastric Tube Application in Postoperative Care of Esophagectomy

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ClinicalTrials.gov Identifier: NCT03273686
Recruitment Status : Unknown
Verified August 2017 by Jiaqing Xiang, Fudan University.
Recruitment status was:  Not yet recruiting
First Posted : September 6, 2017
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Jiaqing Xiang, Fudan University

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Procedure: Discharge the NG tube during the surgery Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Nasogastric Tube Application in Postoperative Care of Esophagectomy: a Randomized Clinical Trial
Estimated Study Start Date : September 15, 2017
Estimated Primary Completion Date : January 15, 2018
Estimated Study Completion Date : April 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: group without NG tube after surgery
In this goup, patients will undergo preoperative gastrointestinal decompression and investigators will discharge the NG tube during the surgery.
Procedure: Discharge the NG tube during the surgery
Discharge the NG tube during the surgery.

No Intervention: group with NG tube after surgery
In this goup, patients will undergo preoperative gastrointestinal decompression and investigators will discharge the NG tube 6-7 days after the surgery.



Primary Outcome Measures :
  1. postoperative complication [ Time Frame: an expected average of 4 weeks ]
    the occurrence of major pulmonary complications and anastomotic leaks.


Secondary Outcome Measures :
  1. the need for placing/ replacing the NG tube [ Time Frame: an expected average of 2 weeks ]
    the need for placing/ replacing the NG tube

  2. Length of postoperative stay [ Time Frame: an expected average of 2 weeks ]
    Length of postoperative stay



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273686


Contacts
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Contact: Jiaqing Xiang, MD +86 13901992249 j.q.xiang@hotmail.com
Contact: Yiliang Zhang, MD +86 18017317284 ilya616@126.com

Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Jiaqing Xiang, MD Professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center

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Responsible Party: Jiaqing Xiang, Professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Fudan University
ClinicalTrials.gov Identifier: NCT03273686     History of Changes
Other Study ID Numbers: ESO-NGT
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiaqing Xiang, Fudan University:
Esophageal Cancer
Nasogastric Tube
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases