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Value of Pleural Lavage Cytology in Resectable Esophageal Carcinoma

Sponsor
Fudan University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05443841
Collaborator
(none)
385
Enrollment
10
Locations
48
Anticipated Duration (Months)
38.5
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
385 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Study for Pleural Lavage Cytology in Patients With Esophageal Cancer
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2026

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of USTC Hefei Anhui China
2 The Fourth Hospital of Hebei Medical University Shijia Zhuang Hebei China
3 Henan Provincial People's Hospital Zhengzhou Henan China
4 Nantong Tumor Hospital Nantong Jiangsu China
5 The Second Affiliated Hospital of Nantong University Nantong Jiangsu China
6 Taixing People's Hospital Taixing Jiangsu China
7 Taizhou People's Hospital Taizhou Jiangsu China
8 Shaanxi Provincial cancer Hospital Xi'an Shaanxi China
9 The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shannxi China
10 Tianjin Medical University Cancer Institute Tianjin Tianjin China

Sponsors and Collaborators

  • Fudan University

Investigators

  • Principal Investigator: Haiquan Chen, MD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haiquan Chen, Fudan University Shanghai Cancer Center, Fudan University
ClinicalTrials.gov Identifier:
NCT05443841
Other Study ID Numbers:
  • EC-PLC
First Posted:
Jul 5, 2022
Last Update Posted:
Jul 5, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Haiquan Chen, Fudan University Shanghai Cancer Center, Fudan University
Squamous cell carcinoma
Esophagectomy
Pleural Lavage
Additional relevant MeSH terms:
Esophageal Neoplasms

Study Results

No Results Posted as of Jul 5, 2022