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
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal Cancer, Nasogastric Tube
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.
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
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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Efficacy of Nasogastric Tube Application in Postoperative Care of Esophagectomy
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