Lower Lugol's Solution Concentration on Reducing the Adverse Symptoms of Chromoendoscopy With Iodine Staining

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-12-30

Brief Summary

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This study was to test an optimal concentration of Lugol's solution which can reduce the mucosal irritation and provide high image quality to ensure endoscopy examination by a randomized blinded controlled trial.

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Detailed Description

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It is widely accepted that 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. The conventional concentration of Lugol's solution is in the range of 1.2% to 2.5% . Image quality can be guaranteed with this range of Lugol's solution. However, lead to retrosternal pain and discomfort, and can even induce erosion or ulceration in the esophagus and stomach. This study was to test whether a lower concentration of Lugol's solution, which has minimal mucosal irritation, can provide satisfied image quality by a randomized blinded controlled trial.

Conditions

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Mucosal Irritation Image Quality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1.2% Lugol's solution

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

Group Type EXPERIMENTAL

1.2% Lugol's solution

Intervention Type DRUG

This group patients were given concentrations of 1.2% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.

1.0% Lugol's solution

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

Group Type EXPERIMENTAL

1.0% Lugol's solution

Intervention Type DRUG

This group patients were given concentrations of 1.0% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.

0.8% Lugol's solution

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

Group Type EXPERIMENTAL

0.8% Lugol's solution

Intervention Type DRUG

This group patients were given concentrations of 0.8% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.

0.6% Lugol's solution

This group patients were given concentrations of 0.6% Lugol's solution for chromoendoscopy.

Group Type EXPERIMENTAL

0.6% Lugol's solution

Intervention Type DRUG

This group patients were given concentrations of 0.6% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.

0.4% Lugol's solution

This group patients were given concentrations of 0.4% Lugol's solution for chromoendoscopy.

Group Type EXPERIMENTAL

0.4% Lugol's solution

Intervention Type DRUG

This group patients were given concentrations of 0.4% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.

Interventions

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1.2% Lugol's solution

This group patients were given concentrations of 1.2% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.

Intervention Type DRUG

1.0% Lugol's solution

This group patients were given concentrations of 1.0% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.

Intervention Type DRUG

0.8% Lugol's solution

This group patients were given concentrations of 0.8% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.

Intervention Type DRUG

0.6% Lugol's solution

This group patients were given concentrations of 0.6% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.

Intervention Type DRUG

0.4% Lugol's solution

This group patients were given concentrations of 0.4% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients in the high-risk population of ESCC;
* or general risk population of ESCC between 40 to 74 years old. Definition of high-risk population of ESCC is list in supporting information33.

Exclusion Criteria

* with obvious abnormalities in stomach, confirmed by either white-light endoscopy (WLE) or pCLE, including gastric cancer, acute erosive and hemorrhagic gastritis, chronic atrophic gastritis, H. pylori infection and severe bile reflux gastritis;
* advanced esophageal carcinoma;
* known esophageal surgery or endoscopic treatment;
* known esophageal radiotherapy or chemotherapy;
* esophageal stenosis;
* food retention;
* allergy to iodine or fluorescein sodium;
* hyperthyroid;
* coagulopathy;
* acute bleeding;
* severe organ failure;
* pregnant or breastfeeding women.

Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes