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NCT Number: NCT05443841

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of USTC, Hefei, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pleural lavage

Other

pleural lavages before tumor resection and after tumor resecion, respectively

Primary outcomes

  1. number of patients who had positive pleural lavage cytology

    Time frame: July 2022 to July 2023

    Frequency of positive pleural lavage cytology in resectable esophageal squamous cell carcinoma

Secondary outcomes

  1. Time period from date of surgery to the date of death

    Time frame: July 2022 to July 2026

    value of pleural lavage cytology in predict patient survival

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Acronym: ECTOP-2005

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
Jul 5, 2022
Registry last updated
Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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