Effect of Neck Flexion on Esophagogastric Anastomotic Leakage After MIE
Effect of Neck Flexion on Post-operative Esophagogastric Anastomotic Leakage After Minimally Invasive Esophagectomy: a Single-center Randomized Controlled Trial
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 12, 2015
CompletedFirst Posted
Study publicly available on registry
April 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedApril 16, 2015
April 1, 2015
1.9 years
April 12, 2015
April 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of post-operative cervical esophagogastric anastomotic leakage
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.
From the day of operation to hospital discharge (an expected average of 2 weeks)
Study Arms (2)
neck flexion group
EXPERIMENTALPatients who fixed in neck flexion position after MIE
control group
NO INTERVENTIONPatients without posture intervention after MIE
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, 400042, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kun Li, MD
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Kun Li
Study Record Dates
First Submitted
April 12, 2015
First Posted
April 16, 2015
Study Start
January 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2016
Last Updated
April 16, 2015
Record last verified: 2015-04