Clinical trial NCT02309619: Lifting of Gastric Tube Through Trans-substernal Versus Trans-esophageal Bed Path in MIE
Official title: Lifting of Gastric Tube Through Trans-substernal Versus Trans-esophageal Bed Path in Minimally Invasive Esophagectomy: a Single-Center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Neoplasms
Esophagectomy
Keywords: esophageal cancer
esophagectomy
quality of life
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2014-12-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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: 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.

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.

Primary outcomes:
measure: Composite intra-operative features.
timeFrame: During the operation (an expected average of 5 hours).
measure: Composite post-operative features.
timeFrame: From the day of operation to hospital discharge (an expected average of 2 weeks).
measure: Mortality and complications.
timeFrame: From the day of operation to hospital discharge (an expected average of 2 weeks).
Secondary outcomes:
measure: Composite nutrition status.
timeFrame: Every 3 months until the 1st year after operation (follow-up for a year after surgery).
measure: Quality of life.
timeFrame: Every 3 months until the 1st year after operation (follow-up for a year after surgery).
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
state: Chongqing
Study officials:
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Kun Li, MD
role: STUDY_CHAIR
References: