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

Recruiting

• Conditions: Esophageal Cancer

• Registration Number: NCT05443841
• Lead Sponsor: Fudan University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-06-29
• Study First Posted: 2022-07-05
• Study Start: 2022-07-18
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-13
• Primary Completion: 2024-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 385

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

Read More

Exclusion Criteria

• severe major organ dysfunction (American society of anesthesiologisits score >3 )
• patients underwent ESD or EMR
• pleural lavage is unavailable due to adhesions

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of patients who had positive pleural lavage cytology	July 2022 to July 2023	Frequency of positive pleural lavage cytology in resectable esophageal squamous cell carcinoma

Secondary Outcome Measures

Name	Time	Method
Time period from date of surgery to the date of death	July 2022 to July 2026	value of pleural lavage cytology in predict patient survival

Trial Locations

Locations (11)

The Fourth Hospital of Hebei Medical University; 🇨🇳 Shijia Zhuang, Hebei, China

The First Affiliated Hospital of USTC; 🇨🇳 Hefei, Anhui, China

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China

Taixing People's Hospital; 🇨🇳 Taixing, Jiangsu, China

Tianjin Medical University Cancer Institute; 🇨🇳 Tianjin, Tianjin, China

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shannxi, China

Nantong Tumor Hospital; 🇨🇳 Nantong, Jiangsu, China

The Second Affiliated Hospital of Nantong University; 🇨🇳 Nantong, Jiangsu, China

Taizhou People's Hospital; 🇨🇳 Taizhou, Jiangsu, China

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China

Shaanxi Provincial cancer Hospital; 🇨🇳 Xi'an, Shaanxi, China