Esophagus CancerNCT03657914
Radical Resection of Single-hole Inflatable Mediastinal Mirror Synchronization With Laparoscopic Esophageal Carcinoma
A study testing Single-hole inflatable mediastinal mirror in people with Esophagus Cancer, run by Qingdong Cao at 21 sites in China.
Trial summary
This study is evaluating the feasibility and safety of radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma, as well as the clinical value of the radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Esophagus Cancer
- What is being tested?
- Single-hole inflatable mediastinal mirror
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 21 sitesChina
- Study dates
- 12 Jul 2017to Mar 2019
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-85 years male and female
- Patients with esophageal squamous cell carcinoma diagnosed by cytological or histological examination, requires surgical treatment
- Patients in tumor stage of T1-2N0-1M0 confirmed by ultrasonic gastroscopy preoperatively;Or patients in T3N1M0 (IIIa) reached PR after neoadjuvant radio(chemo-) therapy, suitable for surgical resection
- The tumor located in the chest or abdomen segment of esophagus
- No surrounding vital organs were invaded and no distant metastasis
- No obvious enlargement was shown in supraclavicular and retroperitoneal lymph nodes, no evidence of distant metastasis (M0)
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- Vital organs function normally: lung functions normally and could stand general anesthesia; NYHA heart function grade 0 ~ 1
- Informed consent was signed as voluntarily before study, and patients and/or the legal representatives have the ability to fully understand test content/result, process and possible adverse reactions, and patients could comply with the requirements of the follow-up scheme
- Reproductive women must show a negative pregnancy test, and it should be confirmed that both the women patient and her spouse are taking contraceptives recognized by researchers, and should keep taking this contraceptive by signing the informed consent until 3 months after the study was finished.
Who cannot join
- Patients with other malignant tumors at the same time
- Patients having surgery history of esophageal or gastric resection
- Patients having a history of mediastinal surgery or vast peritoneal adhesion
- Patients with heart thromboembolism at the same time
- People with psychological, mental or nervous system diseases
- Cachexia, severe malnutrition patients
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- Patients with history of recent recurrence of gastric ulcer, stomach bleeding and other severe basic diseases
- Patients with blood coagulation dysfunction, HIV antibody positive, or surgical contraindications such as clinically poorly controlled serious infection
- The subjects with other associated disease (such as liver and renal dysplasia, etc.) or drug combination, which could influence the study results recognized by the researchers
- Patients participating in another clinical study
- Patients with surgical instruments material allergy, or allergic constitution
- The subjects are not judged by investigator to participate in this Clinical trial.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
China21 sites, 21 recruiting
- Recruiting
Anyang Cancer Hospital
Anyang, Henan
Hou Jianbin, doctor
- Not yet recruiting
Beijing Chao-yang Hospital
Beijing, Beijing Municipality
Li Hui, doctor
- Not yet recruiting
The First People's Hospital of Changzhou
Changzhou, Jiangsu
Wang Zhonglin
- Not yet recruiting
Affiliated Daping Hospital
Chongqing, Chongqing Municipality
Tan Qunyou, doctor
- Not yet recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Chen Ju, doctor
- Not yet recruiting
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan
Wu Huangfu
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Liu Jinshi
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Ma Jianqun, doctor
- Recruiting
Jining No.1 People's Hospital
Jining, Shandong
Zhang Kang
- Not yet recruiting
The First People's Hospital of Yunnan Province
Kunming, Yunnan
Pu Liang, doctor
- Recruiting
Jiansu Cancer Hospital
Nanjing, Jiangsu
Hu Zhendong, doctor
- Not yet recruiting
Ningbo No.2 Hospital
Ningbo, Zhejiang
Zhao Guofang
- Not yet recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality
XU Zhifei, doctor
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Sun Yifeng, doctor
- Not yet recruiting
Shantou Central Hospital
Shantou, Guangdong
Fu Junhui, doctor
- Not yet recruiting
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Sun Wei, doctor
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Fu Junke, doctor
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Yu Xiuyi, doctor
- Recruiting
Xiangyang No.1 People's Hospital
Xiangyang, Hubei
Mei Yunqing, doctor
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, The Ningxia Hui Autonomous Region
He Wei, master
- Recruiting
Affiliated Hospital of Zunyi Medical College
Zunyi, Guizhou
Cai Qingyong, master
About this study
Official title: A Multi-center Clinical Study on the Feasibility and Safety of Radical Resection of Single-hole Inflatable Mediastinal Mirror Synchronization With Laparoscopic Esophageal Carcinoma
This study is evaluating the feasibility and safety of radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma, as well as the clinical value of the radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma as a new minimally invasive operation for esophageal carcinoma.
Read the detailed description
This is a prospective, multicenter, open clinical study in which 155 patients (including 5% shedding rate) who require surgical treatment are scheduled to be included in the study. Prior to any screening process, each subject / legal guardian should sign the informed consent form. Screening tests are used to determine whether each subject is eligible for the study. Eligible subjects who meet the standard will be treated with radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma and followed up until 3 years postoperatively. Primary study outcome are the prioperative complication rate and the number of intraoperative lymph node dissection.
- Conditions
- Esophagus Cancer
- Being tested
- Single-hole inflatable mediastinal mirror
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-hole inflatable mediastinal mirrorProcedure or surgery
The radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma is new minimally invasive operation for esophageal carcinoma. All enrolled subjects will receive this operation for their ESCC.
| Study group | Role | What they receive |
|---|---|---|
| Inflatable mediastinal mirror | Experimental | Patients with especially esophageal squamous cell carcinoma ( ESCC ) who meet the inclusion criteria and do not meet the exclusion criteria will undergo radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma, and will be followed up until 3 years after discharging from the hospital. Receives: Procedure: Single-hole inflatable mediastinal mirror |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative complication rate
Perioperative complications include: pulmonary infection, respiratory failure, managed pleural effusion, heart failure, myocardial infarction, managed arrhythmia, anastomotic fistula or gastric fistula, recurrent laryngeal nerve injury, chylothorax, unscheduled reoperation
Measured: Through operation completion, an average of 12 days
Number of lymph nodes dissected
number of lymph nodes dissected during operation
Measured: During the operation
Secondary outcomes (10)
Intraoperative bleeding volume
Calculation of intraoperative bleeding with ml/kg
Measured: During the operation
Operative time
Calculate the operating time in minutes
Measured: During the operation
Proportion of patients undergoing thoracotomy or laparotomy
The ratio of the number of patients converted to thoracotomy or laparotomy to the total number of patients undergoing surgery
Measured: During the operation
Intraoperative mortality
The ratio of the number of patients who died during the operation to the number of patients who underwent the operation
Measured: During the operation
Postoperative hospital stay
The days of postoperative hospitalization
Measured: Up to 2 weeks after the operation
Postoperative pain score
Daily pain scores were recorded by VAS (Visual Analogue Scale/Score) 1-3 days after operation
Measured: 1-3 days after the operation
Postoperative icu monitoring time
If the patient needs to be transferred to ICU after operation, stay in icu monitoring time should be observed
Measured: 0-12 days after the operation
Incidence of adverse events during and after operation
Special attention is paid to observing whether arrhythmias need to be dealt with during the operation (record the types of arrhythmias, treatment methods, medication, time of occurrence, possible causes)
Measured: 3 years
Postoperative drainage
Total postoperative thoracic or mediastinal drainage (ml/kg)
Measured: 0-12 days after the operation
Postoperative drainage tube indwelling time
The retention time of different types of drainage tube
Measured: 0-12 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start12 Jul 2017
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdong Cao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qingdong Cao, Fifth Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Liu Shaoxuan, master, Study chair, Office of clinical research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657914
- Sponsor's protocol ID
- ZDWY.XXW.001
- Status last verified
- Sep 2018
- First submitted
- 6 Aug 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Clinical Study on the Feasibility and Safety of Radical Resection of Single-hole Inflatable Mediastinal Mirror Synchronization With Laparoscopic Esophageal Carcinoma
- ClinicalTrials.gov ID
- NCT03657914
- Acronym / sponsor ID
- ZDWY.XXW.001
- Conditions
- Esophagus Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Qingdong CaoUniversity, hospital or other
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 5 Sep 2018 (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.
This study is evaluating the feasibility and safety of radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma, as well as the clinical value of the radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma as a new minimally invasive operation for esophageal carcinoma.
Detailed description
This is a prospective, multicenter, open clinical study in which 155 patients (including 5% shedding rate) who require surgical treatment are scheduled to be included in the study. Prior to any screening process, each subject / legal guardian should sign the informed consent form. Screening tests are used to determine whether each subject is eligible for the study. Eligible subjects who meet the standard will be treated with radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma and followed up until 3 years postoperatively. Primary study outcome are the prioperative complication rate and the number of intraoperative lymph node dissection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inflatable mediastinal mirror | Experimental | Procedure: Single-hole inflatable mediastinal mirrorPatients with especially esophageal squamous cell carcinoma ( ESCC ) who meet the inclusion criteria and do not meet the exclusion criteria will undergo radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma, and will be followed up until 3 years after discharging from the hospital. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18-85 years male and female
- Patients with esophageal squamous cell carcinoma diagnosed by cytological or histological examination, requires surgical treatment
- Patients in tumor stage of T1-2N0-1M0 confirmed by ultrasonic gastroscopy preoperatively;Or patients in T3N1M0 (IIIa) reached PR after neoadjuvant radio(chemo-) therapy, suitable for surgical resection
- The tumor located in the chest or abdomen segment of esophagus
- No surrounding vital organs were invaded and no distant metastasis
Key exclusion criteria (12 listed)
- Patients with other malignant tumors at the same time
- Patients having surgery history of esophageal or gastric resection
- Patients having a history of mediastinal surgery or vast peritoneal adhesion
- Patients with heart thromboembolism at the same time
- People with psychological, mental or nervous system diseases
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 |
|---|---|---|
| Single-hole inflatable mediastinal mirrorThe radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma is new minimally invasive operation for esophageal carcinoma. All enrolled subjects will receive this operation for their ESCC. | Procedure or surgery | Inflatable mediastinal mirror |
Primary outcome
Perioperative complication rate
Time frame: Through operation completion, an average of 12 days
Perioperative complications include: pulmonary infection, respiratory failure, managed pleural effusion, heart failure, myocardial infarction, managed arrhythmia, anastomotic fistula or gastric fistula, recurrent laryngeal nerve injury, chylothorax, unscheduled reoperation
Number of lymph nodes dissected
Time frame: During the operation
number of lymph nodes dissected during operation
10 secondary outcomes
Intraoperative bleeding volume
Time frame: During the operation
Operative time
Time frame: During the operation
Proportion of patients undergoing thoracotomy or laparotomy
Time frame: During the operation
Intraoperative mortality
Time frame: During the operation
Postoperative hospital stay
Time frame: Up to 2 weeks after the operation
Postoperative pain score
Time frame: 1-3 days after the operation
Postoperative icu monitoring time
Time frame: 0-12 days after the operation
Incidence of adverse events during and after operation
Time frame: 3 years
Postoperative drainage
Time frame: 0-12 days after the operation
Postoperative drainage tube indwelling time
Time frame: 0-12 days after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
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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.
Liu Shaoxuan, master study chair
Office of clinical research center
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-hole inflatable mediastinal mirror in people with Esophagus Cancer, run by Qingdong Cao at 21 sites 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 9 inclusion and 12 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 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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 Cao Qingdong, bachelor (+86 13680356988, 13680356988@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative complication rate (time frame: Through operation completion, an average of 12 days). The study lists 2 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 5 Sep 2018.