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Clinical Comparative Study of Single-Port Inflatable Mediastinoscopy Synchronous Single-Port Laparoscopy Versus Single-Port Laparoscopy Combined with Conventional Thoracoscopy for Esophageal Cancer Radical Surgery: A Prospective Randomized Controlled Study

Clinical Comparative Study of Single-Port Inflatable Mediastinoscopy Synchronous Single-Port Laparoscopy Versus Single-Port Laparoscopy Combined with Conventional Thoracoscopy for Esophageal Cancer Radical Surgery: A Prospective Randomized Controlled Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098152
Enrollment
Unknown
Registered
2025-03-04
Start date
2025-03-10
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal carcinoma

Interventions

Experimental group:Single-port inflatable mediastinoscopy combined with sing-port laparoscopic
Control group:Single-port laparoscopy combined with conventional thoracoscopic radical resection of esophageal cancer

Sponsors

The First Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed squamous cell carcinoma of the thoracic esophagus: Patients must have a pathological diagnosis of squamous cell carcinoma located in the thoracic esophagus. 2.Age 25-70 years: Patients must be between 25 and 70 years old. 3.Clinical stage of resectable lesions: T1-3, N0-1 (AJCC/UICC 8th edition): According to the 8th edition of the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC), the tumor should be staged as T1-3 (tumor size and depth of invasion) and N0-1 (lymph node metastasis), and the lesion should be resectable. 4.Good general condition, no severe comorbidities, and able to tolerate general anesthesia and surgery: Patients should be in good overall health, without severe comorbidities, and able to withstand general anesthesia and surgical procedures. 5.No invasion of surrounding vital organs and no distant metastasis detected by PET-CT: The tumor should not have invaded surrounding vital organs, and no distant metastasis should be detected by PET-CT imaging. 6.Voluntary consent to participate in the study: Patients must voluntarily sign an informed consent form before enrollment.

Exclusion criteria

Exclusion criteria: 1. History of other malignancies: Patients with a history of other types of cancer are excluded. 2.History of gastric surgery or inability to undergo gastric conduit surgery: Patients who have had previous gastric surgery or are unable to undergo gastric conduit surgery are excluded. 3.Pathologically confirmed or clinically highly suspected distant metastasis, making surgery inappropriate: Patients with confirmed or highly suspected distant metastasis based on pathology or clinical evaluation are excluded. 4.Previous mediastinal surgery or extensive abdominal adhesions: Patients with a history of mediastinal surgery or extensive abdominal adhesions are excluded. 5.Presence of other comorbid diseases (such as significant abnormalities in cardiac, pulmonary, cerebral, hepatic, or renal function) or concurrent medications that may affect the study results, as judged by the investigator: Patients with significant comorbid conditions or those taking medications that may influence the study outcomes are excluded. 6.Refusal to sign the informed consent form: Patients who refuse to sign the informed consent form are excluded.

Design outcomes

Primary

MeasureTime frame
Length of surgery;Intraoperative blood loss;The number of dissected lymph node stations;Local recurrence rate ;

Secondary

MeasureTime frame
Body mass index;Postoperative complications;Length of hospitalization;Intraoperative complications ;Negative margin rate of tumor specimens ;Postoperative pain score ;Survival rate;

Countries

China

Contacts

Public ContactXu Li

The First Affiliated Hospital of Fujian Medical University

lixu1967@hotmail.com+86 137 0501 1308

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026