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

NCT05105945 | Not Yet Recruiting

• 1 other identifier: ZDWY.XXW.005
• Study Type: interventional
• Target: 1,164
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Cancer

Keywords

Minimally invasive surgery

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• intraoperative blood loss

  During the operation, an average of 2 hours

• Operation time

  During the operation, an average of 2 hours

• Proportion of patients who converted to thoracotomy and laparotomy

  During the operation, an average of 2 hours

• Intraoperative mortality rate

  During the operation, an average of 2 hours

• Postoperative hospital stay

  Through postoperative hospital stay, an average of 4 days

Study Arms (2)

Single port inflatable mediastinoscope and synchronized laparoscopic radical resection

EXPERIMENTAL

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

Thoracoscopy combined with laparoscopic radical resection

ACTIVE COMPARATOR

Patients will receive a standardized thoracoscopy and laparoscopy combined radical esophageal cancer surgery

Procedure: Thoracoscopy Combined With Laparoscopic Surgery

Interventions

Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery PROCEDURE

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.

Single port inflatable mediastinoscope and synchronized laparoscopic radical resection

Thoracoscopy Combined With Laparoscopic Surgery PROCEDURE

Patients will receive a standardized thoracoscopy and laparoscopy combined radical esophageal cancer surgery

Thoracoscopy combined with laparoscopic radical resection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old ≤ age ≤ 75 years old, no gender limit;
• Patients who are diagnosed as esophageal malignant tumor by cytology or histology, and agree to undergo surgical treatment;
• 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;
• The tumor is located in the thoracic esophagus;
• The tumor has not invaded the surrounding vital organs and has metastasized far away;
• The function of major organs is basically normal: general anesthesia is acceptable for lung function; NYHA grade of heart function is 0\~1;
• 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;

You may not qualify if:

• People who suffer from other malignant tumors at the same time;
• Patients with a history of esophagus or gastrectomy;
• Patients with a history of mediastinal surgery or extensive abdominal cavity adhesion;
• Patients with basic diseases such as cardiovascular and cerebrovascular diseases;
• People suffering from mental, mental or neurological diseases;
• Patients with cachexia and severe malnutrition who cannot tolerate surgery;
• Recent recurrence of gastric ulcer, history of gastric bleeding and other serious underlying diseases;
• Patients with surgical contraindications such as blood coagulation dysfunction, HIV antibody positive, and poorly controlled clinically severe infections;
• 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.
• Patients who have participated in other clinical studies;
• Others judged by the investigator to be unsuitable to participate in this clinical trial.

Sponsors & Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University: lead
• General Hospital of Ningxia Medical University: collaborator
• Beijing Chao Yang Hospital: collaborator
• West China Hospital: collaborator
• Shanghai Chest Hospital: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Changzhi Medical College: collaborator
• Zhangzhou Affiliated Hospital of Fujian Medical University: collaborator
• Harbin Medical University: collaborator
• Hubei Cancer Hospital: collaborator
• Jining First People's Hospital: collaborator
• Jiangsu Cancer Institute & Hospital: collaborator
• Nanfang Hospital, Southern Medical University: collaborator

Study Sites (1)

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

Location

Related 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.

  PMID: 25674530 RESULT

• 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.

  PMID: 25575253 RESULT

• 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.

  PMID: 30635830 RESULT

• 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.

  PMID: 26354650 RESULT

• 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.

  PMID: 25487303 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Liu Shaoxuan

  Office of clinical research center

  STUDY CHAIR

Central Study Contacts

Cao Qingdong, bachelor

CONTACT

+86 13680356988; 13680356988@163.com

Wang Xiaojin, master

CONTACT

+86 13798967219; wxjhny@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The Logrank method was used to compare the difference in survival time between the two groups of patients. According to previous literature data, it is estimated that the DFS of the control group is 18 months. Assuming that the DFS of the test group can be extended to 21.6 months (corresponding HR=1.20), the test requires 1048 patients (524 in each group) to achieve α=0.05 This difference can be detected with 80% confidence at the (two-sided) significance level. The trial plans to enroll for 48 months, follow up for 60 months, and conduct a final analysis when 944 patients have tumor progression (recurrence or metastasis). It is estimated that the drop-off rate of patients in the experimental group and the control group is 10%, so 1164 (524×2÷0.9=1164) patients need to be enrolled in the final group. Significance Level：0.05

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: November 3, 2021
• Study Start: November 11, 2021
• Primary Completion (Estimated): December 28, 2027
• Study Completion (Estimated): December 28, 2028
• Last Updated: November 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)