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Prospective, randomized, controlled study of the application of enhanced recovery after surgery program in minimally invasive esophagectomy

Prospective, randomized, controlled study of the application of enhanced recovery after surgery program in minimally invasive esophagectomy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017887
Enrollment
Unknown
Registered
2018-08-20
Start date
2018-10-30
Completion date
Unknown
Last updated
2018-08-27

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

Conditions

Esophageal cancer

Interventions

Group 2:Traditional rehabilitation

Sponsors

Shanghai Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) squamous cell carcinoma was diagnosed by biopsy or cytological examination; (2) the primary tumor is located in the thoracic esophagus; (3) According to the above-mentioned examinations, the preoperative clinical stage of esophageal cancer patients with cT3-4aN0-1M0 stage (chest and abdomen enhanced CT, cervical lymph node ultrasound and other means to assess whether the tumor has obvious invasion, mediastinal lymph node has obvious enlargement, there is distant organ metastasis; if suspected tumor primary focus is T4b, mediastinal lymph node multiple metastasis; If long-distance metastasis was found, PET-CT and endoscopic ultrasonography were performed to confirm the clinical stage; (4) Aged 18 to 75 years with ECOG 0-1 (see Annex 1 for details), and life expectancy >12 months; The subjects had no major organ dysfunction and normal blood routine, lung, liver, kidney function and cardiac function. Laboratory tests must meet the following requirements: blood: white blood cell > 4.0 *109/L, absolute neutrophil (ANC) count (>2.0x10^9/L), platelet count > 100x10^9/L, hemoglobin > 90g/L; Lung function: FEV1 > 1.2L, FEV1% > 50% and DLCO > 50%. Explanation: FEV1 measured value of forced vital capacity (litre). FEV1%: forced vital capacity / expected value%. DLCO%: Measured/predicted carbon monoxide breath diffusion function; Liver function: serum bilirubin 1.5 times lower than the maximum normal; ALT and AST 1.5 times lower than the maximum normal. Renal function: serum creatinine (SCr) is less than 120 mol/L, creatinine clearance (CCr) is more than 60ml/min. Understand the research and sign informed consent (informed consent).

Exclusion criteria

Exclusion criteria: 1. Patients with stage T4b unresectable, multiple lymph node enlargement (estimated lymph node metastasis (> 3), multiple lymph node enlargement (estimated number of lymph node metastasis (> 2) or distant metastasis (M1); 2. those who have been or are receiving chemotherapy, radiotherapy or targeted therapy; 3. gastroscopic examination is non squamous cell carcinoma. 4. Previous cases of other tumors (except those with cervical carcinoma in situ or local basal cell carcinoma and cured); Other exclusion criteria: Confirmed history of congestive heart failure; poorly controlled angina; transmural myocardial infarction confirmed by electrocardiogram (ECG); poorly controlled hypertension; clinically significant valvular heart disease; or high-risk uncontrollable arrhythmia; Severe uncontrolled systemic interstitial diseases, such as active infections or poorly controlled diabetes; Abnormal coagulation, bleeding tendency (such as active gastrointestinal ulcer) or receiving thrombolytic or anticoagulant therapy; Women of child-bearing age who have positive serum pregnancy tests or who are breast-feeding and are unwilling to take adequate contraceptive measures during the study period; known immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) active infection or known HIV seropositive; Known to be allergic to any research drug. With history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation). With peripheral nervous system disorders or obvious mental disorders and history of central nervous system disorders. We should use antitumor drugs outside the research program. Participating in other clinical research.

Design outcomes

Primary

MeasureTime frame
Time of hospitalization;complications;

Countries

China

Contacts

Public ContactGUO Xufeng

Shanghai Chest Hospital

shandagxf@126.com+86 18930096739

Outcome results

None listed

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