NCT01555801

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 29, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

6.8 years

First QC Date

February 29, 2012

Last Update Submit

January 23, 2017

Conditions

Esophageal Cancer

Keywords

esophageal cancerearly cancerultrasonography (EUS)stage

Outcome Measures

Primary Outcomes (3)

  • Sensitivity

    The stages judged from submucosal injection plus EUS or ordinary EUS will be compared with the pathological results after endoscopic or surgical resection.So the sensitivity,specificity,positive predictive value,negative predictive value and diagnostic accuracy of either submucosal injection plus EUS or ordinary EUS for early esophageal cancer will be measured respectivly.

    Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days

  • Specificity

    As well as sensitivity described above.

    Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days

  • Diagnostic accuracy

    As well as sensitivity described above.

    Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days

Study Arms (2)

Submucosal injection combining with EUS

EXPERIMENTAL

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.

Device: submucosal injection needle ; EUS

ordinary endosonography(EUS)

PLACEBO COMPARATOR

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.

Device: ordinary endosonography(EUS)

Interventions

submucosal injection needle ; EUSDEVICE

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

Also known as: submucosal injection needle:Olympus,NM-20K-0423;, EUS:Olympus,UM2000
Submucosal injection combining with EUS
ordinary endosonography(EUS)DEVICE

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

Also known as: EUS:Olympus,UM2000
ordinary endosonography(EUS)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

cancer center, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31615934DERIVED

MeSH Terms

Conditions

Esophageal NeoplasmsNeoplasms

Interventions

Endosonography

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Jian-jun Li, M.D.

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

86-2087343381lijj@sysucc.org.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 29, 2012

First Posted

March 15, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 25, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

Locations

CN(1)