search
Back to results

Effect of Neck Flexion on Esophagogastric Anastomotic Leakage After MIE

Primary Purpose

Esophageal Neoplasms, Esophagectomy, Anastomotic Leak

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
neck flexion
Sponsored by
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Neoplasms focused on measuring esophageal cancer, minimally invasive esophagectomy, anastomotic leak, neck flexion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

neck flexion group

control group

Arm Description

Patients who fixed in neck flexion position after MIE

Patients without posture intervention after MIE

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 12, 2015
Last Updated
April 15, 2015
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT02418052
Brief Title
Effect of Neck Flexion on Esophagogastric Anastomotic Leakage After MIE
Official Title
Effect of Neck Flexion on Post-operative Esophagogastric Anastomotic Leakage After Minimally Invasive Esophagectomy: a Single-center Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms, Esophagectomy, Anastomotic Leak
Keywords
esophageal cancer, minimally invasive esophagectomy, anastomotic leak, neck flexion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
neck flexion group
Arm Type
Experimental
Arm Description
Patients who fixed in neck flexion position after MIE
Arm Title
control group
Arm Type
No Intervention
Arm Description
Patients without posture intervention after MIE
Intervention Type
Procedure
Intervention Name(s)
neck flexion
Intervention 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.
Primary Outcome Measure Information:
Title
Incidence of post-operative cervical esophagogastric anastomotic leakage
Description
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.
Time Frame
From the day of operation to hospital discharge (an expected average of 2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kun Li, MD
Phone
+8615023072303
Ext
023-68757983
Email
soloonline1981@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jinghai Zhou, MD
Phone
+8613983612263
Ext
023-68757982
Email
tmmuzjh@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun Li, MD
Organizational Affiliation
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kun Li, MD
Phone
+8615023072303
Ext
023-68757983
Email
soloonline1981@163.com
First Name & Middle Initial & Last Name & Degree
Jinghai Zhou, MD
Phone
+8613983612263
Ext
023-68757982
Email
tmmuzjh@163.com

12. IPD Sharing Statement

Learn more about this trial

Effect of Neck Flexion on Esophagogastric Anastomotic Leakage After MIE

We'll reach out to this number within 24 hrs