Lifting of Gastric Tube Through Trans-substernal Versus Trans-esophageal Bed Path in MIE

NCT ID: NCT02309619

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

2008-01-31

Study Completion Date

2015-12-31

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 can be lifted to the neck for anastomosis through two different paths - Trans-substernal and trans-esophageal bed routes. However, the differences of operative outcomes between the two paths have not been systematically described. In this study, clinical outcomes including intra- and post-operative status, morbidity and complications, nutrition status, as well as quality of life after surgery will be evaluated, and differences between the trans-substernal and trans-esophageal bed groups will be compared. The study might help to individualization treatment for EC.

Detailed Description

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1. Patients with esophageal cancer (EC) will be histologically proved by endoscopic biopsy, and staged by thoracicoabdominal computed tomography (CT), endoluminal ultrasonography and positron emission tomography (PET) before surgery. The other crucial test including barium meal, pulmonary function tests, arterial blood gas analysis, cardiac ultrasonography, electrocardiogram and treadmill test, as well as blood biochemistry examinations will also be accomplished preoperatively.
2. Patients who meet clinical criteria will be asked to sign a consent form, and divided randomly into two groups - trans-substernal group and trans-esophageal bed group. Patients in both groups will undergo a minimally invasive esophagectomy which consist of 4 steps: (1) thoracoscopic esophageal mobilization followed by mediastinal lymphadenectomy; (2) laparoscopic gastric mobilization followed by abdominal lymphadenectomy and gastric tube construction; (3) cervical esophageal mobilization and transection; (4) lifting of the gastric tube to the neck for gastro-esophageal anastomosis through trans-substernal or trans-esophageal bed path. The operative procedure of the two groups is similar except step 4.
3. Patients in both groups will be followed-up regularly. Intra- and post-operative status, morbidity and complications, nutrition status, as well as quality of life after surgery will be evaluated, and differences between the trans-substernal and trans-esophageal bed groups will be compared.

Conditions

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Esophageal Neoplasms Esophagectomy

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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trans-substernal group

Patients who undergo esophagectomy with the gastric tube lifting to the neck through trans-substernal path.

Group Type EXPERIMENTAL

lifting of the gastric tube to the neck for gastro-esophageal anastomosis through trans-substernal or trans-esophageal bed path.

Intervention Type PROCEDURE

Patients with esophageal cancer (EC) will undergo minimally invasive esophagectomy and be classified into two groups according to the last step of the procedure. The gastric tube will be lifted to the neck for gastro-esophageal anastomosis through trans-substernal path in the trans-substernal group, and through trans-esophageal bed path in the trans-esophageal bed group.

trans-esophageal bed group

Patients who undergo esophagectomy with the gastric tube lifting to the neck through trans-esophageal bed path.

Group Type EXPERIMENTAL

lifting of the gastric tube to the neck for gastro-esophageal anastomosis through trans-substernal or trans-esophageal bed path.

Intervention Type PROCEDURE

Patients with esophageal cancer (EC) will undergo minimally invasive esophagectomy and be classified into two groups according to the last step of the procedure. The gastric tube will be lifted to the neck for gastro-esophageal anastomosis through trans-substernal path in the trans-substernal group, and through trans-esophageal bed path in the trans-esophageal bed group.

Interventions

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lifting of the gastric tube to the neck for gastro-esophageal anastomosis through trans-substernal or trans-esophageal bed path.

Patients with esophageal cancer (EC) will undergo minimally invasive esophagectomy and be classified into two groups according to the last step of the procedure. The gastric tube will be lifted to the neck for gastro-esophageal anastomosis through trans-substernal path in the trans-substernal group, and through trans-esophageal bed path in the trans-esophageal bed group.

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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Kli

Identifier Type: -

Identifier Source: org_study_id

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