Value of Pleural Lavage Cytology in Resectable Esophageal Carcinoma Eastern Cooperative Thoracic Oncology Projects 2005, ECTOP-2005)

Esophageal Cancer Clinical Trial

— ECTOP-2005  

Official title:

A Prospective Study for Pleural Lavage Cytology in Patients With Esophageal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05443841
• Other study ID #: ECTOP-2005
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

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