Esophageal NeoplasmsNCT02309619
Lifting of Gastric Tube Through Trans-substernal Versus Trans-esophageal Bed Path in MIE
A study testing lifting of the gastric tube to the neck for gastro-esophageal anastomosis through trans-substernal or trans-esophageal bed path. in people with Esophageal Neoplasms and Esophagectomy, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Neoplasms, Esophagectomy
- What is being tested?
- lifting of the gastric tube to the neck for gastro-esophageal anastomosis through trans-substernal or trans-esophageal bed path.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Kun Li, MD, +8615023072303 ext. 023-68757983, soloonline1981@163.com
Jinghai Zhou, MD, +8613983612263 ext. 023-68757982, tmmuzjh@163.com
About this study
Official title: Lifting of Gastric Tube Through Trans-substernal Versus Trans-esophageal Bed Path in Minimally Invasive Esophagectomy: a Single-Center Randomized Controlled Trial
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.
Read the detailed description
- 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.
- 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.
- 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
- Esophageal Neoplasms, Esophagectomy
- Being tested
- lifting of the gastric tube to the neck for gastro-esophageal anastomosis through trans-substernal or trans-esophageal bed path.
- Keywords
- esophageal cancer, esophagectomy, quality of life
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifting of the gastric tube to the neck for gastro-esophageal anastomosis through trans-substernal or trans-esophageal bed path.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| trans-substernal group | Experimental | Patients who undergo esophagectomy with the gastric tube lifting to the neck through trans-substernal path. Receives: Procedure: lifting of the gastric tube to the neck for gastro-esophageal anastomosis through trans-substernal or trans-esophageal bed path. |
| trans-esophageal bed group | Experimental | Patients who undergo esophagectomy with the gastric tube lifting to the neck through trans-esophageal bed path. Receives: Procedure: lifting of the gastric tube to the neck for gastro-esophageal anastomosis through trans-substernal or trans-esophageal bed path. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: From the day of operation to hospital discharge (an expected average of 2 weeks).
Secondary outcomes (2)
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).
Measured: Every 3 months until the 1st year after operation (follow-up for a year after surgery).
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.
Measured: Every 3 months until the 1st year after operation (follow-up for a year after surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startJan 2008
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun Li, MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- Kun Li, MD, Study chair, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309619
- Sponsor's protocol ID
- Kli
- Status last verified
- Apr 2015
- First submitted
- 23 Nov 2014
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifting of Gastric Tube Through Trans-substernal Versus Trans-esophageal Bed Path in Minimally Invasive Esophagectomy: a Single-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02309619
- Acronym / sponsor ID
- Kli
- Conditions
- Esophageal Neoplasms, Esophagectomy
- Keywords
- esophageal cancer, esophagectomy, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trans-substernal group | Experimental | Procedure: lifting of the gastric tube to the neck for gastro-esophageal anastomosis through trans-substernal or trans-esophageal bed path.Patients who undergo esophagectomy with the gastric tube lifting to the neck through trans-substernal path. |
| trans-esophageal bed group | Experimental | Procedure: lifting of the gastric tube to the neck for gastro-esophageal anastomosis through trans-substernal or trans-esophageal bed path.Patients who undergo esophagectomy with the gastric tube lifting to the neck through trans-esophageal bed path. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | trans-esophageal bed group, trans-substernal group |
Primary outcome
Composite intra-operative features.
Time frame: During the operation (an expected average of 5 hours).
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).
Composite post-operative features.
Time frame: From the day of operation to hospital discharge (an expected average of 2 weeks).
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).
Mortality and complications.
Time frame: From the day of operation to hospital discharge (an expected average of 2 weeks).
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.
2 secondary outcomes
Composite nutrition status.
Time frame: Every 3 months until the 1st year after operation (follow-up for a year after surgery).
Quality of life.
Time frame: Every 3 months until the 1st year after operation (follow-up for a year after surgery).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
Related trials for Esophageal Neoplasms
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kun Li, MD study chair
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifting of the gastric tube to the neck for gastro-esophageal anastomosis through trans-substernal or trans-esophageal bed path. in people with Esophageal Neoplasms and Esophagectomy, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kun Li, MD (+8615023072303 ext. 023-68757983, soloonline1981@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite intra-operative features. (time frame: During the operation (an expected average of 5 hours).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2015.