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Inflatable mediastinoscope-assisted modified-Mckeown esophagectomy: A Single-center, Prospective Study (im-McKeown)

Inflatable mediastinoscope-assisted modified-Mckeown esophagectomy: A Single-center, Prospective Study (im-McKeown)

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083319
Enrollment
Unknown
Registered
2024-04-22
Start date
2024-04-23
Completion date
Unknown
Last updated
2024-05-13

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:Inflatable mediastinoscope-assisted modified-Mckeown esophagectomy

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age: 18-80 years old, gender is not limited; 2) Limited resection of esophageal cancer through the right chest (1) concurrent management of left chest wall or lung disease; 2. Combined treatment of suspicious positive lymph nodes that are difficult to clean into the right chest is required; 3. Right aortic arch; 4. Right side closed chest) 3)ECOG score :0-1; 4) ASA: Level I-III 5) Major organ function is normal, that is, meet the following criteria: (1) Blood routine examination: a.HB=90g/L; b.ANC=1.5×109/L; C. PLT =80×109/L; (2) Biochemical examination: A.LB =30g/L; B.lt and AST=2.5ULN; C.bil =1.5ULN; d. Plasma Cr=1.5ULN or creatinine clearance (CCr)=60ml/min; 6) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) = the lower limit of normal value (50%); 7) Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 6 months after the end of the study period; 8) The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up.

Exclusion criteria

Exclusion criteria: 1) Pregnant or lactating women; 2) Patients who have had other malignancies within 5 years (except basal cell carcinoma of the skin and carcinoma in situ of the cervix that has been cured); 3) Patients who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 4) Patients who have participated in clinical trials of other drugs within four weeks; 5) Severe spinal deformity; 6) Patients with concomitant diseases (such as acute myocardial infarction, cerebral infarction, pulmonary embolism, etc.) that, according to the judgment of the investigator, seriously endanger the safety of the patient or affect the completion of the study; 7) Those deemed unsuitable for inclusion by the researchers.

Design outcomes

Primary

MeasureTime frame
anastomotic leakage;

Secondary

MeasureTime frame
Conversion thoracotomy/laparotomy;operation duration;intraoperatve blood soss;Other perioperative complications;

Countries

China

Contacts

Public ContactLi Xiangnan

The First Affiliated Hospital of Zhengzhou University

lxn-2000@163.com+86 135 9250 2553

Outcome results

None listed

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