Clinical trial NCT05443841: Value of Pleural Lavage Cytology in Resectable Esophageal Carcinoma Eastern Cooperative Thoracic Oncology Projects 2005, ECTOP-2005)
Official title: A Prospective Study for Pleural Lavage Cytology in Patients With Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Cancer
Keywords: Squamous cell carcinoma
Esophagectomy
Pleural Lavage
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 385
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with esophageal cancer

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.

Eligibility criteria: 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

Primary outcomes:
measure: number of patients who had positive pleural lavage cytology
timeFrame: July 2022 to July 2023
Secondary outcomes:
measure: Time period from date of surgery to the date of death
timeFrame: July 2022 to July 2026
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC
state: Anhui
city: Shijia Zhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Nantong
country: China
facility: Nantong Tumor Hospital
state: Jiangsu
city: Nantong
country: China
facility: The Second Affiliated Hospital of Nantong University
state: Jiangsu
city: Taixing
country: China
facility: Taixing People's Hospital
state: Jiangsu
city: Taizhou
country: China
facility: Taizhou People's Hospital
state: Jiangsu
city: Xi'an
country: China
facility: Shaanxi Provincial cancer Hospital
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shannxi
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute
state: Tianjin
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Haiquan Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: