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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Cancer
• Intervention / Treatment: Other: pleural lavage

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 Type: Observational
• Enrollment (Estimated): 385

Contacts and Locations

• Study Contact: Name: Bin Li, MD; Phone Number: 086-64175590-82500; Email: lb0256327@hotmail.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Fudan University Shanghai Cancer Center
    • Contact: Bin Li, MD
  • Anhui
    • Hefei, Anhui, China
      • Not yet recruiting
      • The First Affiliated hospital of USTC
      • Contact: Xinyu Mei, MD
  • Hebei
    • Shijia Zhuang, Hebei, China
      • Not yet recruiting
      • The Fourth Hospital of Hebei Medical University
      • Contact: Xinjian Xu, MD
  • Henan
    • Zhengzhou, Henan, China
      • Not yet recruiting
      • Henan provincial people's hospital
      • Contact: Jianjun Wang
  • Jiangsu
    • Nantong, Jiangsu, China
      • Not yet recruiting
      • Nantong Tumor Hospital
      • Contact: Yihui Fan, MD
    • Nantong, Jiangsu, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Nantong University
      • Contact: Yiming Xu, MD
    • Taixing, Jiangsu, China
      • Recruiting
      • Taixing People's Hospital
      • Contact: Xiaoxiang Xi, MD
    • Taizhou, Jiangsu, China
      • Not yet recruiting
      • Taizhou People's Hospital
      • Contact: Jiangfeng Shen, MD
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Not yet recruiting
      • Shaanxi Provincial Cancer Hospital
      • Contact: Xi Zhang, MD
  • Shannxi
    • Xi'an, Shannxi, China
      • Not yet recruiting
      • The First Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Zhuoqi Jia, MD
  • Tianjin
    • Tianjin, Tianjin, China
      • Not yet recruiting
      • Tianjin Medical University Cancer Institute
      • Contact: Peng Tang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients with esophageal cancer

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Haiquan Chen, MD, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Squamous cell carcinoma; Esophagectomy; Pleural Lavage
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: ECTOP-2005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: individual participant data could be shared after the recruitment of all 385 patients

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No