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A clinical study on the feasibility and safety of radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma

A multi-center clinical study on the feasibility and safety of radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-17011044
Enrollment
Unknown
Registered
2017-04-01
Start date
2017-04-05
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Esophagus cancer

Interventions

Not grouped:Radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma

Sponsors

The Fifth Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and above male and female; 2. patients with esophageal squamous cell carcinoma diagnosed by cytological or histological examination, requires surgical treatment; 3. patients in tumor stage of T1-2N0-1M0 confirmed by ultrasonic gastroscopy preoperatively;Or patients in T3N1M0 (IIIa) reached PR after neoadjuvant radio(chemo-) therapy, suitable for surgical resection; 4. the tumor located in the chest or abdomen segment of esophagus; 5. no surrounding vital organs were invaded and no distant metastasis; 6. no obvious enlargement was shown in supraclavicular and retroperitoneal lymph nodes, no evidence of distant metastasis (M0); 7. vital organs function normally: lung functions normally and could stand general anesthesia; NYHA heart function grade 0 ~ 1; 8. informed consent was signed as voluntarily before study, and patients and/or the legal representatives have the ability to fully understand test content/result, process and possible adverse reactions, and patients could comply with the requirements of the follow-up scheme; 9. Reproductive women must show a negative pregnancy test, and it should be confirmed that both the women patient and her spouse are taking contraceptives recognized by researchers, and should keep taking this contraceptive by signing the informed consent until 3 months after the study was finished.

Exclusion criteria

Exclusion criteria: 1. Patients with other malignant tumors at the same time; 2. patients having surgery history of esophageal or gastric resection; 3. patients having a history of mediastinal surgery or vast peritoneal adhesion; 4. patients with heart thromboembolism at the same time; 5. People with psychological, mental or nervous system diseases; 6. Cachexia, severe malnutrition patients; 7. Patients with history of recent recurrence of gastric ulcer, stomach bleeding and other severe basic diseases; 8. Patients with blood coagulation dysfunction, HIV antibody positive, or surgical contraindications such as clinically poorly controlled serious infection; 9. The subjects with other associated disease (such as liver and renal dysplasia, etc.) or drug combination, which could influence the study results recognized by the researchers; 10. Patients participating in another clinical study; 11. Patients with surgical instruments material allergy, or allergic constitution; 12. The subjects are not judged by investigator to participate in this Clinical trial.

Design outcomes

Primary

MeasureTime frame
Perioperative complication rate;The number of intraoperative lymph node dissection;

Countries

China

Contacts

Public ContactCao Qingdong

The Fifth Affiliated Hospital of Sun Yat-sen University

13680356988@163.com+86 13680356988

Outcome results

None listed

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