Efficacy of Nasogastric Tube Application in Postoperative Care of Esophagectomy

Efficacy of Nasogastric Tube Application in Postoperative Care of Esophagectomy: a Randomized Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Esophageal Cancer
• Intervention / Treatment: Procedure: Discharge the NG tube during the surgery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complication	the occurrence of major pulmonary complications and anastomotic leaks.	an expected average of 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the need for placing/ replacing the NG tube	the need for placing/ replacing the NG tube	an expected average of 2 weeks
Length of postoperative stay	Length of postoperative stay	an expected average of 2 weeks

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Jiaqing Xiang, MD, Professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center

Study record dates

Study Major Dates

• Study Start (Anticipated): September 15, 2017
• Primary Completion (Anticipated): January 15, 2018
• Study Completion (Anticipated): April 15, 2018

Study Registration Dates

• First Submitted: September 4, 2017
• First Submitted That Met QC Criteria: September 4, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2017
• Last Update Submitted That Met QC Criteria: September 4, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Esophageal Cancer; Nasogastric Tube
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: ESO-NGT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No