Efficacy of Nasogastric Tube Application in Postoperative Care of Esophagectomy

• ClinicalTrials.gov Identifier: NCT03273686
• Recruitment Status: Unknown
• First Posted: September 6, 2017
• Last Update Posted: September 6, 2017
• Sponsor: Fudan University
• Information provided by (Responsible Party): Jiaqing Xiang, Fudan University

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.

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

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

More Information

• 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
• Last Update Posted: September 6, 2017
• Last Verified: August 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

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