Clinical Study on the Efficacy of Single-port Inflatable Mediastinoscopy Combined With Laparoscopic-assisted Small Incision Surgery and Thoracoscopy Combined With Laparoscopic Surgery for Radical Esophagectomy

Esophageal Cancer Clinical Trial

Official title:

A Randomized, Controlled, Multi-center Clinical Study on the Efficacy of Single-port Inflatable Mediastinoscopy Combined With Laparoscopic-assisted Small Incision Surgery and Thoracoscopy Combined With Laparoscopic Surgery for Radical Esophagectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05105945
• Other study ID #: ZDWY.XXW.005
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 11, 2021
• Est. completion date: December 28, 2028

Study information

• Verified date: August 2021
• 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

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1164
• Est. completion date: December 28, 2028
• Est. primary completion date: December 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 18 years old = age = 75 years old, no gender limit;

2. Patients who are diagnosed as esophageal malignant tumor by cytology or histology, and agree to undergo surgical treatment;

3. The preoperative clinical tumor staging is T1-2N0-1M0 patients; or T3N1-2M0 patients undergo neoadjuvant treatment (neoadjuvant chemotherapy, neoadjuvant chemoradiation, neoadjuvant radiotherapy, neoadjuvant chemotherapy and immunotherapy, neoadjuvant radiotherapy and immunotherapy After treatment), assess the tumor to achieve partial response (PR) and surgical resection is feasible;

4. The tumor is located in the thoracic esophagus;

5. The tumor has not invaded the surrounding vital organs and has metastasized far away;

6. The function of major organs is basically normal: general anesthesia is acceptable for lung function; NYHA grade of heart function is 0~1;

7. Voluntarily sign an informed consent form before the study. The patient and/or his legal representative have the ability to fully understand the content, process and possible adverse reactions of the experiment, and enable the patient to comply with the visits stipulated in the plan;

Exclusion Criteria:

1. People who suffer from other malignant tumors at the same time;

2. Patients with a history of esophagus or gastrectomy;

3. Patients with a history of mediastinal surgery or extensive abdominal cavity adhesion;

4. Patients with basic diseases such as cardiovascular and cerebrovascular diseases;

5. People suffering from mental, mental or neurological diseases;

6. Patients with cachexia and severe malnutrition who cannot tolerate surgery;

7. Recent recurrence of gastric ulcer, history of gastric bleeding and other serious underlying diseases;

8. Patients with surgical contraindications such as blood coagulation dysfunction, HIV antibody positive, and poorly controlled clinically severe infections;

9. Patients with other comorbid diseases (such as liver and kidney function abnormalities, etc.) or concomitant medications, which may have an impact on the results of this study based on the judgment of the investigator.

10. Patients who have participated in other clinical studies;

11. Others judged by the investigator to be unsuitable to participate in this clinical trial.

Related Conditions & MeSH terms

• Esophageal Cancer

Intervention

Procedure:
• Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision 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.
• Thoracoscopy Combined With Laparoscopic Surgery
Patients will receive a standardized thoracoscopy and laparoscopy combined radical esophageal cancer surgery

Locations

Country	Name	City	State
China	The Fifth Affiliated Hospital of Sun Yat-sen University	Zhuhai	Guangdong

Sponsors (14)

Lead Sponsor

Collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

Beijing Cancer Hospital, Beijing Chao Yang Hospital, Changzhi Medical College, General Hospital of Ningxia Medical University, Harbin Medical University, Hubei Cancer Hospital, Jiangsu Cancer Institute & Hospital, Nanfang Hospital of Southern Medical University, Shandong Jining No.1 People's Hospital, Shanghai Chest Hospital, The First Affiliated Hospital of Nanchang University, West China Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

References & Publications (5)

Choi AR, Chon NR, Youn YH, Paik HC, Kim YH, Park H. Esophageal cancer in esophageal diverticula associated with achalasia. Clin Endosc. 2015 Jan;48(1):70-3. doi: 10.5946/ce.2015.48.1.70. Epub 2015 Jan 31. — View Citation

Fujiwara H, Shiozaki A, Konishi H, Komatsu S, Kubota T, Ichikawa D, Okamoto K, Morimura R, Murayama Y, Kuriu Y, Ikoma H, Nakanishi M, Sakakura C, Otsuji E. Hand-assisted laparoscopic transhiatal esophagectomy with a systematic procedure for en bloc infrac — View Citation

Fujiwara H, Shiozaki A, Konishi H, Kosuga T, Komatsu S, Ichikawa D, Okamoto K, Otsuji E. Single-Port Mediastinoscopic Lymphadenectomy Along the Left Recurrent Laryngeal Nerve. Ann Thorac Surg. 2015 Sep;100(3):1115-7. doi: 10.1016/j.athoracsur.2015.03.122. — View Citation

Luketich JD, Pennathur A, Franchetti Y, Catalano PJ, Swanson S, Sugarbaker DJ, De Hoyos A, Maddaus MA, Nguyen NT, Benson AB, Fernando HC. Minimally invasive esophagectomy: results of a prospective phase II multicenter trial-the eastern cooperative oncolog — View Citation

Wang X, Li X, Cheng H, Zhang B, Zhong H, Wang R, Zhong B, Cao Q. Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery for Radical Esophagectomy Is an Effective and Safe Treatment for Esophageal Cancer. J Gastro — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through operation completion, an average of 12 days
Primary	disease-free survival(DFS)	The period after Operation treatment [tumor eliminated] when no disease can be detected	After surgery-related treatment until the tumor recurrence,assessed up to 5 years
Primary	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.	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
Secondary	intraoperative blood loss	Calculation of intraoperative bleeding with ml/kg	During the operation, an average of 2 hours
Secondary	Operation time	Calculate the operating time in minutes	During the operation, an average of 2 hours
Secondary	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	During the operation, an average of 2 hours
Secondary	Intraoperative mortality rate	The ratio of the number of patients who died during the operation to the number of patients who underwent the operation	During the operation, an average of 2 hours
Secondary	Postoperative hospital stay	The days of postoperative hospitalization	Through postoperative hospital stay, an average of 4 days
Secondary	Postoperative pain score	Daily pain scores were recorded by VAS (Visual Analogue Scale/Score) 1-3 days after operation	An average of 3 days after the operation
Secondary	Postoperative admission time to ICU	If the patient needs to be transferred to ICU after operation, stay in icu monitoring time should be observed	An average of 3 days after the operation
Secondary	Postoperative drainage	Total postoperative thoracic or mediastinal drainage (ml/kg)	An average of 3 days after the operation
Secondary	Postoperative retention time of various types of drainage tubes	The retention time of different types of drainage tube	An average of 3 days after the operation
Secondary	Number of lymph nodes removed during surgery	The number of dissected lymph nodes reported in the postoperative pathology report	Pathology report time, an average of 4 days