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

Esophageal Neoplasms Clinical Trial

Official title:

Lifting of Gastric Tube Through Trans-substernal Versus Trans-esophageal Bed Path in Minimally Invasive Esophagectomy: a Single-Center Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02309619
• Other study ID #: Kli
• Status: Recruiting
• Phase: N/A
• First received: November 23, 2014
• Last updated: April 15, 2015
• Start date: January 2008
• Est. completion date: December 2015

Study information

• Verified date: April 2015
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Kun Li, MD
• Phone: +8615023072303
• Email: soloonline1981[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophagectomy

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite intra-operative features.	The composite intra-operative features of patients in trans-substernal and trans-esophageal bed paths will be evaluated and the results will be compared. These intra-operative features will be composed of duration of operation (min), estimated blood loss (ml), mean arterial pressure (mmHg), central venous pressure (cmH2O), heart rate (beat/min), stroke volume variation (%), cardiac output (L/min), cardiac index (L/m2min) and stroke volume index (ml/m2).	During the operation (an expected average of 5 hours).	No
Primary	Composite post-operative features.	The composite post-operative features of patients in trans-substernal and trans-esophageal bed paths will be evaluated and the results will be compared. These post-operative features will be composed of duration of ventilation (hours), duration of chest tube drainage (days), duration of stomach tube drainage (days), duration of duodenal feeding (days), duration of parenteral nutrition (days), duration of fasting (days), duration of systemic inflammatory response syndrome (days), duration of ICU stay (days), duration of postoperative hospital stay (days), gastric fluid drainage (ml), number of transfused patients (%) and expense (thousand yuan).	From the day of operation to hospital discharge (an expected average of 2 weeks).	No
Primary	Mortality and complications.	Mortality and complications of patients with the gastric tube lifted through trans-substernal and trans-esophageal bed paths will be evaluated and the results will be compared. These parameters will be composed of in-hospital/30-day mortality, respiratory failure/adult respiratory distress syndrome (ARDS)/reintubation, chylothorax, pleural infection, hemorrhage requiring reoperation, membranous trachea injury, deep venous thrombosis/pulmonary embolus, diaphragmatic hernia, arrhythmia, pneumonia, cervical anastomotic leak/stricture, vocal cord palsy, cervical anastomotic stricture, delayed gastric emptying and wound infection.	From the day of operation to hospital discharge (an expected average of 2 weeks).	No
Secondary	Composite nutrition status.	Patients with the gastric tube lifted through trans-substernal and trans-esophageal bed paths will be followed-up regularly every 3 months during the first year after surgery. The composite nutrition status of the patients in both groups will be evaluated and the results will be compared. These nutrition status will be composed of weight change (kg), body mass index (kg/m2), body fat (%), red blood cell (10^12/L), hematocrits (%), hemoglobin (g/L), serum albumin (g/L) and serum prealbumin (g/L).	Every 3 months until the 1st year after operation (follow-up for a year after surgery).	No
Secondary	Quality of life.	Patients with the gastric tube lifted through trans-substernal and trans-esophageal bed paths will be followed-up regularly every 3 months during the first year after surgery. Quality of life (QOL) of the patients will be assessed using a composite cancer-specific core questionnaire, the quality of life questionnaire (QLQ)-C30 (version 3.0, in Chinese) and the esophageal module QLQ-Oesophageal(OES)18 (in Chinese) both developed by the European Organization for Research and Treatment of Cancer (EORTC), and the results will be compared.	Every 3 months until the 1st year after operation (follow-up for a year after surgery).	No