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A Prospective, Multicentral, Open-label, Randomized, Controlled, Non-inferiority Trial to Compare Thoracoscopy Combined with Total Laparoscopy to Thoracoscopy Combined with Laparoscopy-assisted Mckeown Esophagectomy to Treat Advanced Esophageal Cancer (ToMIE trial)

A Prospective, Multicentral, Open-label, Randomized, Controlled, Non-inferiority Trial to Compare Thoracoscopy Combined with Total Laparoscopy to Thoracoscopy Combined with Laparoscopy-assisted Mckeown Esophagectomy to Treat Advanced Esophageal Cancer (ToMIE trial)

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099952
Enrollment
Unknown
Registered
2025-04-01
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Esophageal cancer

Interventions

Experimental group:Thoracoscopy Combined with Total Laparoscopy
Control group:Thoracoscopic combined with laparoscopic-assisted esophagectomy with a small abdominal incision

Sponsors

Shanghai Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 80 years old; 2. Pathological diagnosis of primary squamous cell carcinoma or adenocarcinoma by endoscopic biopsy; 3. Preoperatively, it is expected that radical resection of McKeown esophageal cancer can be achieved through radical resection of McKeown esophageal cancer; 4. ECOG score of 0 or 1; 5. ASA score of I, II or III; 6BMI <= 28; 7. Signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating females; 2. Suffering from severe mental disorder; 3. History of thoracic or upper abdominal surgery (except laparoscopic cholecystectomy); 4. Other malignant tumor diseases within the past five years; 5. History of unstable angina pectoris or myocardial infarction in the past six months; 6. History of cerebrovascular accident in the past six months; 7. Continuous and systematic use of corticosteroids within one month; 8. Surgery is required to treat other diseases at the same time; 9. Emergency surgery is required due to complications of esophageal cancer (bleeding, perforation); 10. FEV1 is less than 50% of the predicted value.

Design outcomes

Primary

MeasureTime frame
Intraoperative or early postoperative complications (within 30 days);

Secondary

MeasureTime frame
Overall intraoperative and postoperative complications within 30 days;Postoperative pain scores;Disease-free survival;Overall survival;Postoperative recovery parameters;

Countries

China

Contacts

Public ContactLi Zhigang Yifeng Sun

Shanghai Chest Hospital

sunyifeng@shchest.org+86 180 1732 1353

Outcome results

None listed

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