An interventional study of Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery and Thoracoscopy Combined With Laparoscopic Surgery in Esophageal Cancer, sponsored by Fifth Affiliated Hospital, Sun Yat-Sen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-11-03.
Sponsored by Fifth Affiliated Hospital, Sun Yat-Sen University · Not applicable, Interventional, and Treatment
We previously developed a novel non-trans thoracic esophagectomy, the single-port inflatable mediastinoscopy combined with laparoscopy for the radical esophagectomy of esophageal cancer.This study is evaluating the feasibility and safety of radical resection of single-port inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma, as well as the clinical value of the radical resection of single-port inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma as a new minimally invasive operation for esophageal carcinoma.
To reduce postoperative pulmonary complications, considerable efforts have been made to develop the nontransthoracic esophagectomy for esophageal cancer. For instance, esophageal stripping and transhiatal esophagectomy are the nontransthoracic operations developed for treatment for esophageal cancer. These methods possess several advantages, including non-thoracotomy, less postoperative pain, less postoperative cardiac and pulmonary complications, and safer for elderly patients. However, these two methods are limited with the poor surgical view, poor mediastinal lymph node dissection (especially upper mediastinal lymph nodes), and high risk of bleeding.
In 2015 and 2016, Prof. Fujiwara has developed novel surgical methods on the dissection of upper mediastinal lymph nodes using single-port mediastinoscopy through the cervical incision and the lower mediastinal lymph nodes (including the subcarinal lymph nodes) by laparoscopy, respectively.For the first time, non-transthoracic radical resection of esophageal cancer could be achieved along with the dissection of all the mediastinal lymph nodes. Based on the Fujiwara's method, we further improved this surgical method to the"single-port inflatable mediastinoscopy combined with laparoscopy for the radical treatment of esophageal cancer"and has successfully performed this novel surgical method for the first case in March 2016. We have completed over 200 cases of radical resection of esophageal carcinoma using this novel surgical technique from May 2016 to August 2021.
This is a prospective, multicenter, open clinical study in which 1164 patients (including 10% drop-off 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 5 years postoperatively. Primary study outcome are the prioperative complication rate and the number of intraoperative lymph node dissection.
Fifth Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 57 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Detailed surgical procedures and related instructions have been published in "Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery for Radical Esophagectomy Is an Effective and Safe Treatment for Esophageal Cancer" J Gastrointest Surg. 2019 Aug;23(8):1533-1540. doi: 10.1007/s11605-018-04069-w. Epub 2019 Jan 11.
Procedure: Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery
Patients will receive a standardized thoracoscopy and laparoscopy combined radical esophageal cancer surgery
Procedure: Thoracoscopy Combined With Laparoscopic Surgery
Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery dissects, dissociates and removes the esophagus in the mediastinum through an inflatable endoscopy. Detailed surgical procedures and related instructions have been published in "Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery for Radical Esophagectomy Is an Effective and Safe Treatment for Esophageal Cancer" J Gastrointest Surg. 2019 Aug;23(8):1533-1540. doi: 10.1007/s11605-018-04069-w. Epub 2019 Jan 11.
Patients will receive a standardized thoracoscopy and laparoscopy combined radical esophageal cancer surgery
Perioperative incidence of cardiopulmonary complications
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
Time frame: Through operation completion, an average of 12 days
disease-free survival（DFS）
The period after Operation treatment \[tumor eliminated\] when no disease can be detected
Time frame: After surgery-related treatment until the tumor recurrence，assessed up to 5 years
overall survival（OS）
When the precise cause of Esophageal cancer death is not specified, this is called the overall survival rate or observed survival rate. Doctors use mean overall survival rates to estimate the patient's prognosis. This is often expressed over standard time periods, like one, five, and ten years.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
intraoperative blood loss
Calculation of intraoperative bleeding with ml/kg
Time frame: During the operation, an average of 2 hours
Operation time
Calculate the operating time in minutes
Time frame: During the operation, an average of 2 hours
Proportion of patients who converted to thoracotomy and laparotomy
The ratio of the number of patients converted to thoracotomy or laparotomy to the total number of patients undergoing surgery
Time frame: During the operation, an average of 2 hours
Intraoperative mortality rate
The ratio of the number of patients who died during the operation to the number of patients who underwent the operation
Time frame: During the operation, an average of 2 hours
Postoperative hospital stay
The days of postoperative hospitalization
Time frame: Through postoperative hospital stay, an average of 4 days
Postoperative pain score
Daily pain scores were recorded by VAS (Visual Analogue Scale/Score) 1-3 days after operation
Time frame: An average of 3 days after the operation
Postoperative admission time to ICU
If the patient needs to be transferred to ICU after operation, stay in icu monitoring time should be observed
Time frame: An average of 3 days after the operation
Postoperative drainage
Total postoperative thoracic or mediastinal drainage (ml/kg)
Time frame: An average of 3 days after the operation
Postoperative retention time of various types of drainage tubes
The retention time of different types of drainage tube
Time frame: An average of 3 days after the operation
Number of lymph nodes removed during surgery
The number of dissected lymph nodes reported in the postoperative pathology report
Time frame: Pathology report time, an average of 4 days
Plan to share: No
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Fifth Affiliated Hospital, Sun Yat-Sen University