Efficacy of Nasogastric Tube Application in Postoperative Care of Esophagectomy

NCT03273686 | Unknown Phase 3

• 1 other identifier: ESO-NGT
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophageal Cancer

Keywords

Esophageal Cancer; Nasogastric Tube

Outcome Measures

Primary Outcomes (1)

• postoperative complication

  the occurrence of major pulmonary complications and anastomotic leaks.

  an expected average of 4 weeks

Secondary Outcomes (2)

• the need for placing/ replacing the NG tube

  an expected average of 2 weeks

• Length of postoperative stay

  an expected average of 2 weeks

Study Arms (2)

group without NG tube after surgery

EXPERIMENTAL

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

group with NG tube after surgery

NO INTERVENTION

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

Interventions

Discharge the NG tube during the surgery PROCEDURE

Discharge the NG tube during the surgery.

group without NG tube after surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Jiaqing Xiang, MD

  Professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaqing Xiang, MD

CONTACT

+86 13901992249; j.q.xiang@hotmail.com

Yiliang Zhang, MD

CONTACT

+86 18017317284; ilya616@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 6, 2017
• Study Start: September 15, 2017
• Primary Completion: January 15, 2018
• Study Completion: April 15, 2018
• Last Updated: September 6, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share