NCT01930630

Brief Summary

By using a novel technique of extraesophageal saline injection (ESI),the esophagus is to be separate from the adjacent organs.The space between esophagus and adjacent organs can be detected by endoscopic ultrasonography enhanced with ESI.Therefore, ESI plus with EUS is to be differentiate between T3 and T4 stage esophageal squamous cell carcinoma (ESCC). The objective of this Phase Ⅰstudy is to confirm the safety and efficacy of ESI.

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
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2013

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

First Submitted

Initial submission to the registry

August 20, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

August 29, 2013

Status Verified

August 1, 2013

Enrollment Period

11 months

First QC Date

August 20, 2013

Last Update Submit

August 22, 2013

Conditions

Esophageal Cancer

Keywords

extraesophageal saline injection (ESI);esophageal squamous cell carcinoma (ESCC);esophageal cancer;endoscopic ultrasonography (EUS)

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events

    Adverse events included bleeding due to great vessel split, asphyxia, esophageal perforation, acute heart failure or acute mediastinum inflammation during/post ESI.

    10 days

Secondary Outcomes (1)

  • Efficacy of extraesophageal saline separating esophagus from adjacent organs detected by EUS or computerized tomography (CT) just after ESI

    30 minutes

Study Arms (1)

Extraesophageal saline injection (ESI)

EXPERIMENTAL

Extraesophageal saline injection (ESI) guided by EUS in patients with advanced ESCC preoperatively

Device: Extraesophageal saline injection (ESI)

Interventions

Extraesophageal saline injection (ESI)DEVICE

The patients with advanced ESCC are to undergo extraesophageal injection of 15ml saline preoperatively and subsequently detected by EUS to confirm whether saline separates esophagus from adjacent organs.

Also known as: Extraesophageal saline injection;, Mucosal needle;, EUS:Fujinon7000(EG-530UR and EG-530UT)
Extraesophageal saline injection (ESI)

Eligibility Criteria

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

You may qualify if:

  • A)Age ranges 18-65 years old, no gander limited;
  • B)Patients with advanced ESCC (T2-T4) who were confirmed by standard endoscopy and pathologic biopsy;
  • C)Patients who agree to accept esophagectomy;
  • D)Patients with normal cardio-pulmonary and blood coagulation function; patients were predicted to be tolerated anesthesia and surgery;
  • E)Patients who understand the study, are willing to join this study and sign consent inform;

You may not qualify if:

  • Patients with early ESCC of Tis,T1a and T1b stages detected by standard EUS;
  • Patients cannot tolerate endoscopy and esophagectomy with various reasons;
  • Patients who have distant metastatic disease or multiple source of malignant tumor;
  • Patients with blood coagulation disorder;
  • Patients don't accept endoscopic or surgical resection subsequently;
  • Patients with poor compliancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Esophageal NeoplasmsEsophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Study Officials

  • Jian-jun Li, MD & PhD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-jun Li, MD & PhD

CONTACT

+862087343381lijj@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 20, 2013

First Posted

August 29, 2013

Study Start

October 1, 2013

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

August 29, 2013

Record last verified: 2013-08

Locations

CN(1)