Clinical trial NCT06022978: Submucosal Saline Injection Followed by Endoscopic Ultrasound
Official title: Submucosal Saline Injection Followed by Endoscopic Ultrasound Versus Endoscopic Ultrasound Only for Distinguishing Between T1a and T1b Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Keywords: Submucosal Saline Injection
Endoscopic Ultrasound
Early Esophageal Cancer
Staging
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Zhejiang Cancer Hospital
name: Sichuan Cancer Hospital and Research Institute
name: Shandong Cancer Hospital and Institute
name: Xinqiao Hospital of Chongqing
name: Sir Run Run Shaw Hospital
name: The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
First posted: 2023-09-05
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Endoscopic ultrasound (EUS) is unsatisfactory in distinguishing between T1a and T1b stage esophageal squamous cell carcinoma (ESCC). Consequently, the National Comprehensive Cancer Network guidelines recommend endoscopic resection (ER) as a diagnostic tool for substaging T1 stage ESCC. However, as an invasive approach, diagnostic ER is not an optimal approach especially for T1b cases as most of them might not be fully cured by ER. It is necessary to develop reliable and less invasive methods to distinguish between T1a and T1b stage ESCC. In our previous unicentral trial, we found that submucosal saline injection (SSI) significantly improved the diagnostic accuracy of EUS in differentiating between T1a and T1b stage ESCC. It can be used as an alternative to diagnostic ER for preoperative substaging T1 stage ESCC cases in remote regions where few endoscopists are able to perform diagnostic ER. The use of EUS and SSI would help T1b stage patients avoid invasive diagnostic ER.

Therefore, we aim to conduct a multi-center clinical trail to examine whether SSI can improve traditional EUS accuracy in distinguishing between T1a and T1b stage ESCC.


Eligibility criteria: Inclusion Criteria:

* Age 18-75 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: Diagnostic accuracy for T1a and T1b staging
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
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: