Clinical trial NCT01555801: Endoscopic Ultrasound Plus Submucosal Injection for Early Esophageal Cancer
Official title: Efficacy Study of Endoscopic Ultrasound Combining With Submucosal Saline Injection for Pretreatment Staging of T1a and T1b in Patients With Early Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Keywords: esophageal cancer
early cancer
ultrasonography (EUS)
stage
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2012-03-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Preoperative accurately staging T1a or T1b in early esophageal cancer is vital for the choices of treatment. At present, the main diagnostic method for early esophageal cancer is endoscopic ultrasound (EUS). However, the accuracy of EUS alone is poor. Thus, it is necessary to improve endoscopic ultrasound examination methods. This project is concerning on the efficacy of EUS combining with submucosal injection of saline for staging T1a and T1b-esophageal cancer. Patients and methods: 80 cases of pathological confirmed early esophageal cancer were randomly divided into two groups: endoscopic ultrasonography group (EUS group) and EUS combining with submucosal injecting saline group (EUS+SIS group). All the cases will be performance by endoscopic or surgical resection; postoperative pathologic diagnosis will be obtained involving echo, depth, margin and other features. The EUS results of two groups of patients will be compared with pathologic results. From comparison, the efficacy and accuracy of EUS+SIS for staging T1a and T1b in esophageal cancer patients will be validated. Through this study, the investigators may develop a routine diagnostic and accurately staging method for early esophageal cancer patients.

Detailed description: Someone whom may concern our IPD are available to the PI, Jian-jun Li M.D. or at lijj@sysucc.org.cn

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years old, no gender limited;
* Patients with esophageal squamous cell carcinoma who be confirmed by ordinary endoscopy and pathologic biopsy;
* Patients who agree to accept endoscopic resection or surgical excision of the lesion in esophagus;
* patients with normal cardio-pulmonary function and normal coagulative function,are predicted to be tolerated anesthesia and surgery;
* patients who understand test purpose, volunteer to join these study and sign the consent inform.

Exclusion Criteria:

* Patients with stages of T2, T3, or T4 displayed by EUS;
* Patients who can't tolerate endoscopy and surgical treatment for various reasons;
* Patients who have distant metastasis, or multiple source of malignant tumors;
* Patients with blood coagulative disorder;
* Patients don't accept the endoscopic examination or surgical treatment;
* Patients with poor compliancy.

Primary outcomes:
measure: Sensitivity
timeFrame: Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days
measure: Specificity
timeFrame: Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days
measure: Diagnostic accuracy
timeFrame: Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou city
country: China
facility: cancer center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Jian-jun Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: He LJ, Xie C, Wang ZX, Li Y, Xiao YT, Gao XY, Shan HB, Luo LN, Chen LM, Luo GY, Yang P, Zeng SC, Xu GL, Li JJ. Submucosal Saline Injection Followed by Endoscopic Ultrasound versus Endoscopic Ultrasound Only for Distinguishing between T1a and T1b Esophageal Cancer. Clin Cancer Res. 2020 Jan 15;26(2):384-390. doi: 10.1158/1078-0432.CCR-19-1722. Epub 2019 Oct 15.