Effect of Neck Flexion on Esophagogastric Anastomotic Leakage After MIE

Not Applicable

• Conditions: Esophagectomy; Anastomotic Leak; Esophageal Neoplasms
• Interventions: Procedure: neck flexion

• Registration Number: NCT02418052
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Brief Summary

Esophageal cancer (EC) is the eighth most common cancer and the sixth leading cause of cancer deaths worldwide. Minimally invasive esophagectomy (MIE) is regarded as a safe and effective management for resectable EC. Gastric tube is considered to be an ideal substitute for the resected esophagus, and used for cervical esophagogastric anastomoses for digestive tract reconstruction in MIE. However, the tension at the anastomosed area can not be ignored and may cause cervical anastomotic leakage (CAL) in some cases. Continuous neck flexion is a standard post-operative posture after tracheal resection and reconstruction, and aimed to relieve the anastomotic tension. In this study, the investigators attempt to adopt the maneuver in MIE, and observe its effect on relieving the anastomotic tension and decreasing the incidence of CAL.

Detailed Description

After the cervical esophagogastric anastomoses is completed and the skin incision is closed, the patient's occiput will be lifted, and then the neck will be maintained in flexing position by an assistant. The underside of the chin will be fixed to the anterior chest wall with two stout nylon sutures by the surgeon. The neck will be fixed in the neutral flexing position for 7 to 10 days after surgery.

Study Timeline

• Study Start: 2014-01
• Status Verified: 2015-04
• Study First Submitted: 2015-04-12
• Study First Submitted QC: 2015-04-15
• Last Update Submitted: 2015-04-15
• Study First Posted: 2015-04-16
• Last Update Posted: 2015-04-16
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus.
• Surgical resectable (T1-4a, N0-3, M0).
• Age≥18 and ≤75 years.
• European Clinical Oncology Group (ECOG) performance status 0,1 or 2.
• Written informed consent obtain.

Exclusion Criteria

• Carcinoma of the cervical esophagus.
• Carcinoma of the gastro-esophageal junction (GEJ).
• Prior thoracic surgery or trauma on the right hemithorax, or previous diseases which may lead to right pleural adhesion (these patients will undergo open surgery instead of minimally invasive esophagectomy). -Dysfunction of cardiorespiratory system or other surgical contraindications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
neck flexion group	neck flexion	Patients who fixed in neck flexion position after MIE

Primary Outcome Measures

Name	Time	Method
Incidence of post-operative cervical esophagogastric anastomotic leakage	From the day of operation to hospital discharge (an expected average of 2 weeks)	The post-operative cervical esophagogastric anastomotic leakage is defined as a radiological defect at the anastomotic site, or leakage of swallowed fluid (saliva, gastric juice or food residue) out of the drain site or cervical wound.

Trial Locations

Locations (1)

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China