Endoscopic Ultrasound Plus Submucosal Injection for Early Esophageal Cancer

NCT ID: NCT01555801

Last Updated: 2017-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2018-12-31

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

Conditions

Esophageal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Submucosal injection combining with EUS

The enrolled patients will be accepted submucosal injection of saline,then ultrasonography will performed(EUS+SIS group).So,stages of EUS in these early esophageal cancer will be recorded and compared with the pathological stages afer endoscopic mucosal resection(EMR) or endoscopic submucosal dissection(ESD) or esophagectomy.

Group Type: EXPERIMENTAL

submucosal injection needle ; EUS

Intervention Type: DEVICE

The patients will accepted submucosal injection of 5ml saline followed by ordinary endosonography(EUS) before surgery or endoscopic dissection.

ordinary endosonography(EUS)

The enrolled patients will accept ordinary ultrasonography .So,stages of EUS in these early esophageal cancer will be recorded and compared with the pathological stages afer endoscopic mucosal resection(EMR) , endoscopic submucosal dissection(ESD) or esophagectomy.

Group Type: PLACEBO_COMPARATOR

ordinary endosonography(EUS)

Intervention Type: DEVICE

These patients will be accepted ordinary EUS followed by surgery or endoscopic dissection.

Interventions

submucosal injection needle ; EUS

The patients will accepted submucosal injection of 5ml saline followed by ordinary endosonography(EUS) before surgery or endoscopic dissection.

Intervention Type: DEVICE

ordinary endosonography(EUS)

These patients will be accepted ordinary EUS followed by surgery or endoscopic dissection.

Intervention Type: DEVICE

Other Intervention Names

submucosal injection needle:Olympus,NM-20K-0423; EUS:Olympus,UM2000; EUS:Olympus,UM2000

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jian-jun Li

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian-jun Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

cancer center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jian-jun Li, M.D. Ph.D.

Role: CONTACT

lijj@sysucc.org.cn

86-2087343381

Facility Contacts

Jian-jun Li, M.D. Ph.D

Role: primary

lijj@sysucc.org.cn

86-2087343381

References

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.

Reference Type: DERIVED

PMID: 31615934 (View on PubMed)

Other Identifiers

1122

Identifier Type: REGISTRY

Identifier Source: secondary_id

112273

Identifier Type: -

Identifier Source: org_study_id