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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Esophageal Cancer
• Intervention / Treatment: Procedure: Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery; Procedure: Thoracoscopy Combined With Laparoscopic Surgery

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 1164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cao Qingdong, bachelor; Phone Number: +86 13680356988; Email: 13680356988@163.com
• Study Contact Backup: Name: Wang Xiaojin, master; Phone Number: +86 13798967219; Email: wxjhny@163.com

Study Locations

• China
  • Guangdong
    • Zhuhai, Guangdong, China
      • The Fifth Affiliated Hospital of Sun Yat-sen University
      • Contact: Wu xiangwen; Phone Number: 13346652266
      • Contact: Wang xiaojing; Phone Number: 13798967219

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single port inflatable mediastinoscope and synchronized laparoscopic radical resection; 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; 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.
Active Comparator: Thoracoscopy combined with laparoscopic radical resection; Patients will receive a standardized thoracoscopy and laparoscopy combined radical esophageal cancer surgery	Procedure: Thoracoscopy Combined With Laparoscopic Surgery; Patients will receive a standardized thoracoscopy and laparoscopy combined radical esophageal cancer surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative blood loss	Calculation of intraoperative bleeding with ml/kg	During the operation, an average of 2 hours
Operation time	Calculate the operating time in minutes	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	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	During the operation, an average of 2 hours
Postoperative hospital stay	The days of postoperative hospitalization	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	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	An average of 3 days after the operation
Postoperative drainage	Total postoperative thoracic or mediastinal drainage (ml/kg)	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	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	Pathology report time, an average of 4 days

Collaborators and Investigators

• Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
• Collaborators: The First Affiliated Hospital of Nanchang University; West China Hospital; Hubei Cancer Hospital; Peking University Cancer Hospital & Institute; Nanfang Hospital of Southern Medical University; Beijing Chao Yang Hospital; Shanghai Chest Hospital; Jiangsu Cancer Institute & Hospital; General Hospital of Ningxia Medical University; Harbin Medical University; Changzhi Medical College; Shandong Jining No.1 People's Hospital; Zhangzhou Affiliated Hospital of Fujian Medical University
• Investigators: Study Chair: Liu Shaoxuan, Office of clinical research center

Publications and helpful links

General Publications

• 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.
• 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 oncology group (E2202) study. Ann Surg. 2015 Apr;261(4):702-7. doi: 10.1097/SLA.0000000000000993.
• 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 Gastrointest Surg. 2019 Aug;23(8):1533-1540. doi: 10.1007/s11605-018-04069-w. Epub 2019 Jan 11.
• 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.
• 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 infracarinal lymph node dissection. Dis Esophagus. 2016 Feb-Mar;29(2):131-8. doi: 10.1111/dote.12303. Epub 2014 Dec 9.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 11, 2021
• Primary Completion (Anticipated): December 28, 2027
• Study Completion (Anticipated): December 28, 2028

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Minimally invasive surgery
• Other Study ID Numbers: ZDWY.XXW.005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No