Esophageal NeoplasmsNCT04125849
Mediastinoscopy-assisted Transhiatal Esophagectomy Versus Thoraco-laparoscopic Esophagectomy for Esophageal Cancer
A study testing Thoraco-laparoscopic esophagectomy and Mediastinoscopy-assisted transhiatal esophagectomy in people with Esophageal Neoplasms, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Esophageal cancer is one of the major diseases that seriously threatens an individual's health and life. To reduce the incidence of postoperative complications and mortality of esophageal cancer, thoraco-laparoscopic oesophagectomy (TLE) has been recommended by many guidelines since the 2000s. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- Thoraco-laparoscopic esophagectomy and Mediastinoscopy-assisted transhiatal esophagectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Apr 2020to Dec 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years≤age≤ 80 years;
- Histologically diagnosed with squamous cell carcinoma by endoscopic biopsy, cT1-3N0M0;
- Primary tumour is located in the thoracic oesophagus
- No clinical evidence of distant organ metastasis
- No severe comorbidity, can tolerate anesthesia;
- ECOG PS scores≤2;
- The patients sign informed consents by themselves.
Who cannot join
- Cervical or abdominal oesophageal carcinoma;
- Previous oesophagectomy, gastrectomy, or mediastinal surgery;
- Current uncontrolled illness such as severe cardiac disease, uncontrollable hypertension or diabetes, or active bacterial infection;
- Unable to tolerate tracheal intubation and general anaesthesia as determined by an anaesthesiologist preoperatively;
- Pregnant or lactating women;
- ECOG PS scores>2;
- Considered unsuitable, such as those who do not agree to participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital of Chinese Academy of Medical Sciences Shenzhen Center
Shenzhen, Guangdong, 518000
Juwei Mu, MD
About this study
Official title: Mediastinoscopy-assisted Transhiatal Esophagectomy (MATHE) Versus Thoraco-laparoscopic Esophagectomy (TLE) for Esophageal Cancer: a Multicenter Randomized Controlled Trial
Esophageal cancer is one of the major diseases that seriously threatens an individual's health and life. To reduce the incidence of postoperative complications and mortality of esophageal cancer, thoraco-laparoscopic oesophagectomy (TLE) has been recommended by many guidelines since the 2000s. Additionally, with developments in endoscopy technology in recent years, mediastinoscopy-assisted transhiatal esophagectomy (MATHE) has been used in clinical practice. In 2015, the first mediastinoscopy combined with laparoscopic radical esophagectomy was reported systematically by Hitoshi Fujiwara. This surgical procedure has been performed in many centres in China. However, there is no multicentre prospective randomized controlled study that explored the safety, feasibility and short-term clinical efficacy between mediastinoscopy-assisted transhiatal esophagectomy and thoraco-laparoscopic esophagectomy. We aim to evaluate the feasibility and safety of MATHE.
Read the detailed description
Esophageal resection remains the mainstay of treatment for esophageal cancer patients. Despite improvements in surgical technique and perioperative management, esophagectomy carries considerable operative risk. To reduce the incidence of postoperative complications and mortality of esophageal cancer, the optional of minimally invasive esophagectomy has been recommended by many guidelines since 2000s. In addition, with the development of endoscopy technology in recent years, mediastinoscopy-assisted transhiatal esophagectomy (MATHE) has been used in clinical practices. In 2015, the first mediastinoscopy combined with laparoscopic radical esophagectomy was reported systematically by Hitoshi Fujiwara. This surgical procedure has been performed in many centers of China since then. Compared with MIE, MATHE allows controlled dissection of upper mediastinum and biopsy of mediastinal lymph nodes. No study directly comparing MATHE versus MIE has been reported to date. In this report, we compare MATHE with MIE in terms of surgical feasibility, safety, and survival.We intend to adopt a randomized controlled study method. The study group is mediastinoscopy-assisted transhiatal esophagectomy (MATHE) group, and the control group is thoraco-laparoscopic esophagectomy (TLE) group. This study is expected to provide high-level evidence for the new methods and to provide better treatment options for patients with esophageal cancer.
- Conditions
- Esophageal Neoplasms
- Being tested
- Thoraco-laparoscopic esophagectomy, Mediastinoscopy-assisted transhiatal esophagectomy
- Keywords
- Mediastinoscopy-assisted transhiatal esophagectomy (MATHE), Thoraco-laparoscopic esophagectomy (TLE)
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoraco-laparoscopic esophagectomyProcedure or surgery
Thoraco-laparoscopic esophagectomy surgery
Mediastinoscopy-assisted transhiatal esophagectomyProcedure or surgery
Mediastinoscopy-assisted transhiatal esophagectomy surgery
| Study group | Role | What they receive |
|---|---|---|
| Thoraco-laparoscopic esophagectomy | Active comparator | Treated by thoraco-laparoscopic esophagectomy in the centers with enough experience in esophageal resection and the volume ≧80 cases each year. Receives: Procedure: Thoraco-laparoscopic esophagectomy |
| Mediastinoscopy-assisted transhiatal esophagectomy | Active comparator | Treated by mediastinoscopy-assisted transhiatal esophagectomy in the centers with enough experience in esophageal resection and the volume ≧80 cases each year. Receives: Procedure: Mediastinoscopy-assisted transhiatal esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative respiratory complications
These respiratory complications involve respiratory distress or failure after the operation with continuation of mechanical ventilation, pulmonary atelectasis requiring sputum suction by bronchoscopy, pneumonia requiring specific antibiotics confirmed by thoracic X-ray or CT scan of the thorax and a positive sputum culture, and acute respiratory distress syndrome.
Measured: 30 days after surgery
Secondary outcomes (14)
pulmonary function indicators
pulmonary function indicators
Measured: 30 days after surgery
anastomotic fistula
anastomotic fistula
Measured: 30 days after surgery
recurrent laryngeal nerve palsy
recurrent laryngeal nerve palsy
Measured: recurrent laryngeal nerve palsy
DFS
Disease-free survival,DFS
Measured: 3 years
duration of surgery
Total operation time
Measured: Intraoperation
Blood loss
blood loss during the surgery
Measured: Intraoperation
Conversion rate
conversion to thoracotomy during surgery
Measured: Intraoperation
postoperative hospital stay
postoperative hospital stay
Measured: postoperation
postoperative pain score
postoperative pain score
Measured: postoperation
drainage time
drainage time
Measured: postoperation
R0 resection rate
R0 resection rate
Measured: Intraoperation
Lymph node dissection
During the surgery, lymph node dissection were performed. The number of removed lymph-nodes were recorded according to the postoperative pathological diagnosis, and the stations of the lymph node were recorded.
Measured: Intraoperation
Local recurrence
three-year local tumour recurrence or distant metastasis rate after surgery
Measured: 3 years
30-day mortality after surgery
30-day mortality after surgery
Measured: postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study startApr 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (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.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- 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
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, Peking University Cancer Hospital & Institute, Hubei Cancer Hospital, The First Affiliated Hospital of Anhui Medical University, Quanzhou First Hospital, The People's Hospital of Gaozhou, The Second People's Hospital of Huai'an
- Responsible party
- Principal investigator, Mu Juwei, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Juwei Mu, MD, Principal investigator, National Cancer Center of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125849
- Sponsor's protocol ID
- NCC201819B69
- Status last verified
- Apr 2020
- First submitted
- 11 Oct 2019
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediastinoscopy-assisted Transhiatal Esophagectomy (MATHE) Versus Thoraco-laparoscopic Esophagectomy (TLE) for Esophageal Cancer: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04125849
- Acronym / sponsor ID
- NCC201819B69
- Conditions
- Esophageal Neoplasms
- Keywords
- Mediastinoscopy-assisted transhiatal esophagectomy (MATHE), Thoraco-laparoscopic esophagectomy (TLE)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, Peking University Cancer Hospital & Institute, Hubei Cancer Hospital, The First Affiliated Hospital of Anhui Medical University, Quanzhou First Hospital, The People's Hospital of Gaozhou, The Second People's Hospital of Huai'an
- Study start
- Apr 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 14 Oct 2019 (actual)
- 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 is one of the major diseases that seriously threatens an individual's health and life. To reduce the incidence of postoperative complications and mortality of esophageal cancer, thoraco-laparoscopic oesophagectomy (TLE) has been recommended by many guidelines since the 2000s. Additionally, with developments in endoscopy technology in recent years, mediastinoscopy-assisted transhiatal esophagectomy (MATHE) has been used in clinical practice. In 2015, the first mediastinoscopy combined with laparoscopic radical esophagectomy was reported systematically by Hitoshi Fujiwara. This surgical procedure has been performed in many centres in China. However, there is no multicentre prospective randomized controlled study that explored the safety, feasibility and short-term clinical efficacy between mediastinoscopy-assisted transhiatal esophagectomy and thoraco-laparoscopic esophagectomy. We aim to evaluate the feasibility and safety of MATHE.
Detailed description
Esophageal resection remains the mainstay of treatment for esophageal cancer patients. Despite improvements in surgical technique and perioperative management, esophagectomy carries considerable operative risk. To reduce the incidence of postoperative complications and mortality of esophageal cancer, the optional of minimally invasive esophagectomy has been recommended by many guidelines since 2000s. In addition, with the development of endoscopy technology in recent years, mediastinoscopy-assisted transhiatal esophagectomy (MATHE) has been used in clinical practices. In 2015, the first mediastinoscopy combined with laparoscopic radical esophagectomy was reported systematically by Hitoshi Fujiwara. This surgical procedure has been performed in many centers of China since then. Compared with MIE, MATHE allows controlled dissection of upper mediastinum and biopsy of mediastinal lymph nodes. No study directly comparing MATHE versus MIE has been reported to date. In this report, we compare MATHE with MIE in terms of surgical feasibility, safety, and survival.We intend to adopt a randomized controlled study method. The study group is mediastinoscopy-assisted transhiatal esophagectomy (MATHE) group, and the control group is thoraco-laparoscopic esophagectomy (TLE) group. This study is expected to provide high-level evidence for the new methods and to provide better treatment options for patients with esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoraco-laparoscopic esophagectomy | Active comparator | Procedure: Thoraco-laparoscopic esophagectomyTreated by thoraco-laparoscopic esophagectomy in the centers with enough experience in esophageal resection and the volume ≧80 cases each year. |
| Mediastinoscopy-assisted transhiatal esophagectomy | Active comparator | Procedure: Mediastinoscopy-assisted transhiatal esophagectomyTreated by mediastinoscopy-assisted transhiatal esophagectomy in the centers with enough experience in esophageal resection and the volume ≧80 cases each year. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years≤age≤ 80 years;
- Histologically diagnosed with squamous cell carcinoma by endoscopic biopsy, cT1-3N0M0;
- Primary tumour is located in the thoracic oesophagus
- No clinical evidence of distant organ metastasis
- No severe comorbidity, can tolerate anesthesia;
Key exclusion criteria (7 listed)
- Cervical or abdominal oesophageal carcinoma;
- Previous oesophagectomy, gastrectomy, or mediastinal surgery;
- Current uncontrolled illness such as severe cardiac disease, uncontrollable hypertension or diabetes, or active bacterial infection;
- Unable to tolerate tracheal intubation and general anaesthesia as determined by an anaesthesiologist preoperatively;
- Pregnant or lactating women;
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 |
|---|---|---|
| Thoraco-laparoscopic esophagectomyThoraco-laparoscopic esophagectomy surgery | Procedure or surgery | Thoraco-laparoscopic esophagectomy |
| Mediastinoscopy-assisted transhiatal esophagectomyMediastinoscopy-assisted transhiatal esophagectomy surgery | Procedure or surgery | Mediastinoscopy-assisted transhiatal esophagectomy |
Primary outcome
Postoperative respiratory complications
Time frame: 30 days after surgery
These respiratory complications involve respiratory distress or failure after the operation with continuation of mechanical ventilation, pulmonary atelectasis requiring sputum suction by bronchoscopy, pneumonia requiring specific antibiotics confirmed by thoracic X-ray or CT scan of the thorax and a positive sputum culture, and acute respiratory distress syndrome.
14 secondary outcomes
pulmonary function indicators
Time frame: 30 days after surgery
anastomotic fistula
Time frame: 30 days after surgery
recurrent laryngeal nerve palsy
Time frame: recurrent laryngeal nerve palsy
DFS
Time frame: 3 years
duration of surgery
Time frame: Intraoperation
Blood loss
Time frame: Intraoperation
Conversion rate
Time frame: Intraoperation
postoperative hospital stay
Time frame: postoperation
postoperative pain score
Time frame: postoperation
drainage time
Time frame: postoperation
R0 resection rate
Time frame: Intraoperation
Lymph node dissection
Time frame: Intraoperation
Local recurrence
Time frame: 3 years
30-day mortality after surgery
Time frame: postoperation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Juwei Mu, MD principal investigator
National Cancer Center of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoraco-laparoscopic esophagectomy and Mediastinoscopy-assisted transhiatal esophagectomy in people with Esophageal Neoplasms, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 7 inclusion and 7 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 15 Apr 2020. 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 Juwei Mu, MD (8610-87788495 ext. 7140, mujuwei@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative respiratory complications (time frame: 30 days after surgery). 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 15 Apr 2020.