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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-hole inflatable mediastinal mirror | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through operation completion, an average of 12 days |
| Number of lymph nodes dissected | number of lymph nodes dissected during operation | During the operation |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative bleeding volume | Calculation of intraoperative bleeding with ml/kg | During the operation |
| Operative time | Calculate the operating time in minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Local recurrence rate of tumor within 3 years | The rate of tumor recurrence or metastasis | 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cao Qingdong, bachelor | Contact | +86 13680356988 | 13680356988@163.com | |
| Wang Xiaojin, master | Contact | +86 13798967219 | wxjhny@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Liu Shaoxuan, master | Office of clinical research center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-yang Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
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|
| 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 | 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 | During the operation |
| Postoperative hospital stay | The days of postoperative hospitalization | 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 | 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 | 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) | 3 years |
| Postoperative drainage | Total postoperative thoracic or mediastinal drainage (ml/kg) | 0-12 days after the operation |
| Postoperative drainage tube indwelling time | The retention time of different types of drainage tube | 0-12 days after the operation |
| Affiliated Daping Hospital | Not yet recruiting | Chongqing | Chongqing Municipality | China |
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| The First Affiliated Hospital of Xiamen University | Not yet recruiting | Xiamen | Fujian | China |
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| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | China |
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| Shantou Central Hospital | Not yet recruiting | Shantou | Guangdong | China |
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| Affiliated Hospital of Zunyi Medical College | Recruiting | Zunyi | Guizhou | China |
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| The Second Affiliated Hospital of Hainan Medical University | Not yet recruiting | Haikou | Hainan | China |
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| Harbin Medical University Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | China |
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| Anyang Cancer Hospital | Recruiting | Anyang | Henan | China |
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| Xiangyang No.1 People's Hospital | Recruiting | Xiangyang | Hubei | China |
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| The First People's Hospital of Changzhou | Not yet recruiting | Changzhou | Jiangsu | China |
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| Jiansu Cancer Hospital | Recruiting | Nanjing | Jiangsu | China |
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| Jining No.1 People's Hospital | Recruiting | Jining | Shandong | China |
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| Shanghai Changzheng Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi’an | Shanxi | China |
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| General Hospital of Ningxia Medical University | Recruiting | Yinchuan | The Ningxia Hui Autonomous Region | China |
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| Affiliated Tumor Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang | China |
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| The First People's Hospital of Yunnan Province | Not yet recruiting | Kunming | Yunnan | China |
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| Zhejiang Cancer Hospital | Not yet recruiting | Hangzhou | Zhejiang | China |
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| Ningbo No.2 Hospital | Not yet recruiting | Ningbo | Zhejiang | China |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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