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A prosperctive randomized control trial comparing video-assisted thoracoscopy surgery and radical Resection in treatment of stage I and II esophageal carcinoma

A prosperctive randomized control trial comparing video-assisted thoracoscopy surgery and radical Resection in treatment of stage I and II esophageal carcinoma

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000132
Enrollment
Unknown
Registered
2008-07-24
Start date
2008-08-01
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

Esophageal carcinoma (Stage I and II)

Interventions

Group A:video-assisted thoracoscopy surgey
Group B:Routine radical resection

Sponsors

Zhongshan Hospital of Fudan University, Evidence-based medicine center of Fudan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed pathologically as carcinoma by endoscope biopsy or Cytological examination. Pathological type was squamous carcinoma or adenocarcinoma. UGI barium meal showed length of tumor =12 months; 3. Patients diagnosed pathologically as carcinoma by endoscope biopsy or Cytological examination. Pathological type was squamous carcinoma or adenocarcinoma. UGI barium meal showed length of tumor 4.0*10^9/L, N% 50-70%, platelet >100*10^9/L, Hb>95g/L. Liver function indices: serum bilirubin is lower than 1.5 times of normal maximum level. ALT and AST are lower than 1.5 times of normal maximum level; Lung function: FEV1 >=1.2L, FEV1% >=50% and DLCO >=50%; 4. Patients can understand the trial and voluntarely sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Esophageal carcinoma stage is not stage I (T1N0M0), IIa (T2N0M0?T3N0M0) or IIb(T1-2N1M0); 2. patients have received been receiving Chemotherapy/Radiotherapy/targeted therapy; 3. Patients had other type of tumour (Except cured carcinoma in situ of uterine cervix and basal cell carcinoma); 4. Patients have uncontrolled Diabetes; 5. Patients have abnormal function of heart, Lung, liver and kidney; 6. Patients have sever complications that can not receive operation; 7. Patients have uncontrolled psychiatric disease; 8. Researchers do not think the patients are not suitable to the trial.

Design outcomes

Primary

MeasureTime frame
progression-free survival;Overall survival time;

Secondary

MeasureTime frame
Quality of life;

Countries

China

Contacts

Public ContactLijie Tan
tan.lijie@zs-zshospital.sh.cn+86 0 13681972151

Outcome results

None listed

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