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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05443841
Other study ID # ECTOP-2005
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 18, 2022
Est. completion date July 1, 2027

Study information

Verified date July 2023
Source Fudan University
Contact Bin Li, MD
Phone 086-64175590-82500
Email lb0256327@hotmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Disease recurrence and metastasis are common after curative treatment for patients with esophageal cancer. Thus, it is important to identify the risk factors to predict disease recurrence and metastasis. Pleural lavage cytology (PLC) is reported to be associated with disease recurrence and patient survival in lung cancer, but the value is unclear in esophageal cancer. The aim of this study is to evaluate the value of PLC in esophageal cancer patient in terms of frequencies, association with patient survival, and efficacy of postoperative treatment.


Description:

Pleural lavage cytology will be performed before esophageal resection, and after resection, respectively. Frequency of positive pleural lavage cytology will be determined, and the value of pleural lavage cytology for patients with resectable esophageal cancer will be studied.


Recruitment information / eligibility

Status Recruiting
Enrollment 385
Est. completion date July 1, 2027
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - esophageal cancer with histological confirmation before treatment. - resectable esophageal cancer with clinical T1-4a/N0-3/M0 staging - potential R0 resection - no history of other malignancies Exclusion Criteria: - severe major organ dysfunction (American society of anesthesiologisits score >3 ) - patients underwent ESD or EMR - pleural lavage is unavailable due to adhesions

Study Design


Related Conditions & MeSH terms


Intervention

Other:
pleural lavage
pleural lavages before tumor resection and after tumor resecion, respectively

Locations

Country Name City State
China The First Affiliated Hospital of USTC Hefei Anhui
China Nantong Tumor Hospital Nantong Jiangsu
China The Second Affiliated Hospital of Nantong University Nantong Jiangsu
China Fudan University Shanghai Cancer Center Shanghai
China The Fourth Hospital of Hebei Medical University Shijia Zhuang Hebei
China Taixing People's Hospital Taixing Jiangsu
China Taizhou People's Hospital Taizhou Jiangsu
China Tianjin Medical University Cancer Institute Tianjin Tianjin
China Shaanxi Provincial cancer Hospital Xi'an Shaanxi
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shannxi
China Henan Provincial People's Hospital Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of patients who had positive pleural lavage cytology Frequency of positive pleural lavage cytology in resectable esophageal squamous cell carcinoma July 2022 to July 2023
Secondary Time period from date of surgery to the date of death value of pleural lavage cytology in predict patient survival July 2022 to July 2026
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