Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery | Procedure | — | UNRESOLVED |
| Thoracoscopy Combined With Laparoscopic Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Single port inflatable mediastinoscope and synchronized laparoscopic radical resection
- description
- 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.
- interventionNames
- Procedure: Single-Port Inflatable Mediastinoscopy Combined With Laparoscopic-Assisted Small Incision Surgery
- type
- ACTIVE_COMPARATOR
- label
- Thoracoscopy combined with laparoscopic radical resection
- description
- Patients will receive a standardized thoracoscopy and laparoscopy combined radical esophageal cancer surgery
- interventionNames
- Procedure: Thoracoscopy Combined With Laparoscopic Surgery
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (5)
- RESULTChoi 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
- RESULTLuketich 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
- RESULTWang 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
- RESULTFujiwara 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
- RESULTFujiwara 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