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

June 7, 2017 updated by: Xiuli Zuo, Shandong University

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

The purpose of this study is to assess whether lower Lugol's solution concentration can perceive the same image quality of early esophageal squamous neoplasia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Chromoendoscopy using Lugol's solution is effective for the detection of early esophageal squamous neoplasia. However, this modality may cause severe chest pain and discomfort owing to mucosal irritation.

This study was to test whether a lower concentration of Lugol's solution can provide satisfied image quality of early esophageal squamous neoplasia and has lower mucosal irritation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Xiuli Zuo, PhD
  • Phone Number: 053188369277 15588818685
  • Email: zuoxiuli@sina.com

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital, Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

After esophageal surgery or endoscopic treatment ; Known esophageal radiotherapy or chemotherapy ; Esophageal stenosis; Acute bleeding; A known allergy to iodine; Coagulopathy (prothrombin time <50% of control, partial thromboplastin time >50 seconds); Having food retention; Severe hepatic ,renal, cardiovascular or metabolic dysfunction ; Being pregnant or lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: group 1
This group patients were given dosages of 1.2% Lugol's solution for chromoendoscopy.
Drug: 1.2% Lugol's solution
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).
Experimental: group 2
This group patients were given dosages of 1.0% Lugol's solution for chromoendoscopy.
Drug: 1.0% Lugol's solution
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).
Experimental: group 3
This group patients were given dosages of 0.8% Lugol's solution for chromoendoscopy.
Drug: 0.8% Lugol's solution
0.8% 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).
Experimental: group 4
This group patients were given dosages of 0.6% Lugol's solution for chromoendoscopy.
Drug: 0.6% Lugol's solution
0.6% 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).
Experimental: group 5
This group patients were given dosages of 0.4% Lugol's solution for chromoendoscopy.
Drug: 0.4% Lugol's solution
0.4% 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Image Quality of Esophageal Lesions
Time Frame: seven months
Evaluated by Image J software (National Institutes of Health)
seven months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Questionnaire of endoscopists' subjective assessments
Time Frame: intraoperative
The picture will be rated for quality according to color contrast of esophageal lesions after iodine sprayed by the endoscopist performing the examination
intraoperative
Complete resection/R0 resection rate
Time Frame: 1 month
1 month
Mucosal change of the stomach in white-light endoscopy after Lugol's solution sprayed.
Time Frame: intraoperative
The endoscopic findings of the greater curvature of the gastric body where the agent collected will be evaluated based on the following findings:fold thickening, exudates, ulcers, and hemorrhage.
intraoperative
The amount of Lugol's solution
Time Frame: intraoperative
intraoperative
Severe adverse events (allergic reactions, esophageal burns, spasms and even perforation)
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiuli Zuo, PhD, Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017SDU-QILU-G002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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