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Effect of Neck Flexion on Esophagogastric Anastomotic Leakage After MIE

A

Army Medical University of People's Liberation Army

Status

Unknown

Conditions

Esophagectomy
Esophageal Neoplasms
Anastomotic Leak

Treatments

Procedure: neck flexion

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

neck flexion group
Experimental group
Description:
Patients who fixed in neck flexion position after MIE
Treatment:
Procedure: neck flexion
control group
No Intervention group
Description:
Patients without posture intervention after MIE

Trial contacts and locations

1

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Central trial contact

Jinghai Zhou, MD; Kun Li, MD

Data sourced from clinicaltrials.gov

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