Trials Sponsors Conditions Drugs Pricing

Conditions

Endoscopists'Subjective Assessments Image Quality of Early Esophageal Squamous Neoplasia

Outcome Measures

Primary Outcomes (1)

Image Quality of Esophageal Lesions
Evaluated by Image J software (National Institutes of Health)
seven months

Secondary Outcomes (5)

Questionnaire of endoscopists' subjective assessments
intraoperative
Complete resection/R0 resection rate
1 month
Mucosal change of the stomach in white-light endoscopy after Lugol's solution sprayed.
intraoperative
The amount of Lugol's solution
intraoperative
Severe adverse events (allergic reactions, esophageal burns, spasms and even perforation)
1 month

Study Arms (5)

group 1

EXPERIMENTAL

This group patients were given dosages of 1.2% Lugol's solution for chromoendoscopy.

Drug: 1.2% Lugol's solution

group 2

EXPERIMENTAL

This group patients were given dosages of 1.0% Lugol's solution for chromoendoscopy.

Drug: 1.0% Lugol's solution

group 3

EXPERIMENTAL

This group patients were given dosages of 0.8% Lugol's solution for chromoendoscopy.

Drug: 0.8% Lugol's solution

Interventions

1.2% Lugol's solutionDrug

1.2% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD).

group 1

1.0% Lugol's solutionDrug

1.0% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD).

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients with early esophageal squamous neoplasia who underwent endoscopic submucosal dissection.

You may not qualify if:

Sponsors & Collaborators

Shandong University
Otherlead

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Xiuli Zuo, PhDCONTACT15588818685 ext. 053188369277 zuoxiuli@sina.com

Junyan Qu, MDSUB INVESTIGATOR

MeSH Terms

Interventions

Lugol's solution

Study Officials

Xiuli Zuo, PhD
Qilu Hospital of Shandong University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zuo, PhD

CONTACT

15588818685 zuoxiuli@sina.com

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: DIAGNOSTIC
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: director of Qilu Hospital

Study Record Dates

First Submitted

June 4, 2017

First Posted

June 8, 2017

Study Start

June 2017

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

Different Lugol's Solution Concentration for Image Quality of Esophageal Lesions in Chromoendoscopy With Iodine Staining

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (5)

group 1

group 2

group 3

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Central Study Contacts

Study Design

Study Record Dates

group 4

group 5

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (5)

group 1

group 2

group 3

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Central Study Contacts

Study Design

Study Record Dates

group 4

group 5

Source record

Locations