Clinical trial NCT03657914: Radical Resection of Single-hole Inflatable Mediastinal Mirror Synchronization With Laparoscopic Esophageal Carcinoma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophagus Cancer
Lead sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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)
* 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.

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Perioperative complication rate
timeFrame: Through operation completion, an average of 12 days
measure: Number of lymph nodes dissected
timeFrame: During the operation
Secondary outcomes:
measure: Intraoperative bleeding volume
timeFrame: During the operation
measure: Operative time
timeFrame: During the operation
measure: Proportion of patients undergoing thoracotomy or laparotomy
timeFrame: During the operation
measure: Intraoperative mortality
timeFrame: During the operation
measure: Postoperative hospital stay
timeFrame: Up to 2 weeks after the operation
measure: Postoperative pain score
timeFrame: 1-3 days after the operation
measure: Postoperative icu monitoring time
timeFrame: 0-12 days after the operation
measure: Incidence of adverse events during and after operation
timeFrame: 3 years
measure: Postoperative drainage
timeFrame: 0-12 days after the operation
measure: Postoperative drainage tube indwelling time
timeFrame: 0-12 days after the operation
Other outcomes:
measure: Local recurrence rate of tumor within 3 years
timeFrame: 3 years
Locations:
city: Beijing
country: China
facility: Beijing Chao-yang Hospital
state: Beijing
city: Chongqing
country: China
facility: Affiliated Daping Hospital
state: Chongqing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Shantou
country: China
facility: Shantou Central Hospital
state: Guangdong
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical College
state: Guizhou
city: Haikou
country: China
facility: The Second Affiliated Hospital of Hainan Medical University
state: Hainan
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Anyang
country: China
facility: Anyang Cancer Hospital
state: Henan
city: Xiangyang
country: China
facility: Xiangyang No.1 People's Hospital
state: Hubei
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
state: Jiangsu
city: Nanjing
country: China
facility: Jiansu Cancer Hospital
state: Jiangsu
city: Jining
country: China
facility: Jining No.1 People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: The Ningxia Hui Autonomous Region
city: Ürümqi
country: China
facility: Affiliated Tumor Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo No.2 Hospital
state: Zhejiang
Study officials:
affiliation: Office of clinical research center
name: Liu Shaoxuan, master
role: STUDY_CHAIR
References: