CClinicalTrials.gg
RecruitingNCT05443841ECTOP-2005Updated Jul 13, 2023

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

An observational study in Esophageal Cancer, sponsored by Fudan University. Recruiting at 11 sites in China. Per ClinicalTrials.gov, last updated 2023-07-13.

Sponsored by Fudan University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started Jul 2022; still recruiting 4 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
385
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Esophageal Cancer

Keywords

  • Squamous cell carcinoma
  • Esophagectomy
  • Pleural Lavage
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's planned enrollment of 385 is above the median of 200 across 341 observational studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients with esophageal cancer

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

Exclusion Criteria:

  • severe major organ dysfunction (American society of anesthesiologisits score >3 )
  • patients underwent ESD or EMR
  • pleural lavage is unavailable due to adhesions
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
385 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Interventions

  • Otherpleural lavage

    pleural lavages before tumor resection and after tumor resecion, respectively

06

What researchers measure

Primary outcomes

  1. number of patients who had positive pleural lavage cytology

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

    Time frame: July 2022 to July 2023

Secondary outcomes

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

    value of pleural lavage cytology in predict patient survival

    Time frame: July 2022 to July 2026

07

Study locations

2 of 11 sites recruiting
  • The First Affiliated Hospital of USTC
    Hefei, Anhui, China
    • Xinyu Mei, MD · Contact
    Not yet recruiting
  • The Fourth Hospital of Hebei Medical University
    Shijia Zhuang, Hebei, China
    • Xinjian Xu, MD · Contact
    Not yet recruiting
  • Henan Provincial People's Hospital
    Zhengzhou, Henan, China
    • Jianjun Wang · Contact
    Not yet recruiting
  • Nantong Tumor Hospital
    Nantong, Jiangsu, China
    • Yihui Fan, MD · Contact
    Not yet recruiting
  • The Second Affiliated Hospital of Nantong University
    Nantong, Jiangsu, China
    • Yiming Xu, MD · Contact
    Not yet recruiting
  • Taixing People's Hospital
    Taixing, Jiangsu, China
    • Xiaoxiang Xi, MD · Contact
    Recruiting
  • Taizhou People's Hospital
    Taizhou, Jiangsu, China
    • Jiangfeng Shen, MD · Contact
    Not yet recruiting
  • Shaanxi Provincial cancer Hospital
    Xi'an, Shaanxi, China
    • Xi Zhang, MD · Contact
    Not yet recruiting
  • The First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shannxi, China
    • Zhuoqi Jia, MD · Contact
    Not yet recruiting
  • Tianjin Medical University Cancer Institute
    Tianjin, Tianjin, China
    • Peng Tang, MD · Contact
    Not yet recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, China
    • Bin Li, MD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — individual participant data could be shared after the recruitment of all 385 patients

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05443841
Lead sponsor
Fudan University
Responsible party
Haiquan Chen (Fudan University Shanghai Cancer Center, Fudan University) — Principal investigator
First posted
Jul 5, 2022
Start date
Jul 18, 2022
Primary completion
Jul 1, 2024 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Jul 13, 2023

Study contacts

Bin Li, MD
Contact
lb0256327@hotmail.com
086-64175590-82500
Haiquan Chen, MD
principal investigator · Fudan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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