Lifting of Gastric Tube Through Trans-substernal Versus Trans-esophageal Bed Path in MIE
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 23, 2014
CompletedFirst Posted
Study publicly available on registry
December 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedApril 16, 2015
April 1, 2015
7.9 years
November 23, 2014
April 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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).
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).
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).
Secondary Outcomes (2)
Composite nutrition status.
Every 3 months until the 1st year after operation (follow-up for a year after surgery).
Quality of life.
Every 3 months until the 1st year after operation (follow-up for a year after surgery).
Study Arms (2)
trans-substernal group
EXPERIMENTALPatients who undergo esophagectomy with the gastric tube lifting to the neck through trans-substernal path.
trans-esophageal bed group
EXPERIMENTALPatients who undergo esophagectomy with the gastric tube lifting to the neck through trans-esophageal bed path.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, 400042, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kun Li, MD
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Kun Li
Study Record Dates
First Submitted
November 23, 2014
First Posted
December 5, 2014
Study Start
January 1, 2008
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
April 16, 2015
Record last verified: 2015-04