Different Lugol's Solution Concentration for Image Quality of Esophageal Lesions in 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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-30

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Image Quality of Early Esophageal Squamous Neoplasia Endoscopists'Subjective Assessments

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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group 1

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

Group Type EXPERIMENTAL

1.2% Lugol's solution

Intervention Type DRUG

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 2

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

Group Type EXPERIMENTAL

1.0% Lugol's solution

Intervention Type DRUG

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).

group 3

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

Group Type EXPERIMENTAL

0.8% Lugol's solution

Intervention Type DRUG

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).

group 4

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

Group Type EXPERIMENTAL

0.6% Lugol's solution

Intervention Type DRUG

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).

group 5

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

Group Type EXPERIMENTAL

0.4% Lugol's solution

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type 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).

Intervention Type 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).

Intervention Type 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).

Intervention Type 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).

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No