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

Shandong University

Status and phase: Completed; Phase 2

Conditions: Image Quality; Mucosal Irritation

Treatments: Drug: 0.6% Lugol's solution; Drug: 0.8% Lugol's solution; Drug: 1.2% Lugol's solution; Drug: 1.0% Lugol's solution; Drug: 0.4% Lugol's solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03180944

2017SDU-QILU-G001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 patients

Sex: All

Ages: 40 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 included the following:

• 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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 5 patient groups

1.2% Lugol's solution

Experimental group

Description:

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

Treatment:

Drug: 1.2% Lugol's solution

1.0% Lugol's solution

Experimental group

Description:

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

Treatment:

Drug: 1.0% Lugol's solution

0.8% Lugol's solution

Experimental group

Description:

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

Treatment:

Drug: 0.8% Lugol's solution

0.6% Lugol's solution

Experimental group

Description:

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

Treatment:

Drug: 0.6% Lugol's solution

0.4% Lugol's solution

Experimental group

Description:

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

Treatment:

Drug: 0.4% Lugol's solution