Anastomotic Leak, Esophageal Neoplasms, Esophagectomy
Conditions
Keywords
esophageal cancer, minimally invasive esophagectomy, anastomotic leak, neck flexion
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.
Interventions
PROCEDUREneck flexion
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.
Sponsors
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactKun Li, MD
Backup ContactJinghai Zhou, MD
Outcome results
None listed