Efficacy of Nasogastric Tube Application in Postoperative Care of Esophagectomy

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03273686
• Other study ID #: ESO-NGT
• Status: Not yet recruiting
• Phase: Phase 3
• First received: September 4, 2017
• Last updated: September 4, 2017
• Start date: September 15, 2017
• Est. completion date: April 15, 2018

Study information

• Verified date: August 2017
• Source: Fudan University
• Contact: Jiaqing Xiang, MD
• Phone: +86 13901992249
• Email: j.q.xiang[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 15, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Procedure:
• Discharge the NG tube during the surgery
Discharge the NG tube during the surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative complication	the occurrence of major pulmonary complications and anastomotic leaks.	an expected average of 4 weeks
Secondary	the need for placing/ replacing the NG tube	the need for placing/ replacing the NG tube	an expected average of 2 weeks
Secondary	Length of postoperative stay	Length of postoperative stay	an expected average of 2 weeks