Radical Resection of Single-hole Inflatable Mediastinal Mirror Synchronization With Laparoscopic Esophageal Carcinoma

Esophagus Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03657914
• Other study ID #: ZDWY.XXW.001
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2017
• Est. completion date: March 2019

Study information

• Verified date: September 2018
• Source: Fifth Affiliated Hospital, Sun Yat-Sen University
• Contact: Cao Qingdong, bachelor
• Phone: +86 13680356988
• Email: 13680356988[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 carcinoma as a new minimally invasive operation for esophageal carcinoma.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophagus Cancer

Intervention

Procedure:
• Single-hole inflatable mediastinal mirror
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.

Locations

Country	Name	City	State
China	Anyang Cancer Hospital	Anyang	Henan
China	Beijing Chao-yang Hospital	Beijing	Beijing
China	The First People's Hospital of Changzhou	Changzhou	Jiangsu
China	Affiliated Daping Hospital	Chongqing	Chongqing
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Hainan Medical University	Haikou	Hainan
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Jining No.1 People's Hospital	Jining	Shandong
China	The First People's Hospital of Yunnan Province	Kunming	Yunnan
China	Jiansu Cancer Hospital	Nanjing	Jiangsu
China	Ningbo No.2 Hospital	Ningbo	Zhejiang
China	Shanghai Changzheng Hospital	Shanghai	Shanghai
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Shantou Central Hospital	Shantou	Guangdong
China	Affiliated Tumor Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Xiangyang No.1 People's Hospital	Xiangyang	Hubei
China	General Hospital of Ningxia Medical University	Yinchuan	The Ningxia Hui Autonomous Region
China	Affiliated Hospital of Zunyi Medical College	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Qingdong Cao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Local recurrence rate of tumor within 3 years	The rate of tumor recurrence or metastasis	3 years
Primary	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
Primary	Number of lymph nodes dissected	number of lymph nodes dissected during operation	During the operation
Secondary	Intraoperative bleeding volume	Calculation of intraoperative bleeding with ml/kg	During the operation
Secondary	Operative time	Calculate the operating time in minutes	During the operation
Secondary	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
Secondary	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
Secondary	Postoperative hospital stay	The days of postoperative hospitalization	Up to 2 weeks after the operation
Secondary	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
Secondary	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
Secondary	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
Secondary	Postoperative drainage	Total postoperative thoracic or mediastinal drainage (ml/kg)	0-12 days after the operation
Secondary	Postoperative drainage tube indwelling time	The retention time of different types of drainage tube	0-12 days after the operation