Effect of Neck Flexion on Esophagogastric Anastomotic Leakage After MIE

NCT ID: NCT02418052

Last Updated: 2015-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Esophageal Neoplasms Esophagectomy Anastomotic Leak

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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neck flexion group

Patients who fixed in neck flexion position after MIE

Group Type EXPERIMENTAL

neck flexion

Intervention Type PROCEDURE

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.

control group

Patients without posture intervention after MIE

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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neck 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

OTHER

Sponsor Role lead

Responsible Party

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Kun Li, MD

Kun Li

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kun Li, MD

Role: STUDY_CHAIR

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Locations

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Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kun Li, MD

Role: CONTACT

+8615023072303 ext. 023-68757983

Jinghai Zhou, MD

Role: CONTACT

+8613983612263 ext. 023-68757982

Facility Contacts

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Kun Li, MD

Role: primary

+8615023072303 ext. 023-68757983

Jinghai Zhou, MD

Role: backup

+8613983612263 ext. 023-68757982

Other Identifiers

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Kli2

Identifier Type: -

Identifier Source: org_study_id

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