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

Phase 4

• Conditions: Image Quality of Early Esophageal Squamous Neoplasia; Endoscopists'Subjective Assessments
• Interventions: Drug: 1.2% Lugol's solution; Drug: 1.0% Lugol's solution; Drug: 0.8% Lugol's solution; Drug: 0.6% Lugol's solution; Drug: 0.4% Lugol's solution

• Registration Number: NCT03180970
• Lead Sponsor: Shandong University

Brief Summary

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.

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 Timeline

• Status Verified: 2017-06
• Study Start: 2017-06
• Study First Submitted: 2017-06-04
• Study First Submitted QC: 2017-06-07
• Last Update Submitted: 2017-06-07
• Study First Posted: 2017-06-08
• Last Update Posted: 2017-06-08
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	1.2% Lugol's solution	This group patients were given dosages of 1.2% Lugol's solution for chromoendoscopy.
group 2	1.0% Lugol's solution	This group patients were given dosages of 1.0% Lugol's solution for chromoendoscopy.
group 3	0.8% Lugol's solution	This group patients were given dosages of 0.8% Lugol's solution for chromoendoscopy.
group 4	0.6% Lugol's solution	This group patients were given dosages of 0.6% Lugol's solution for chromoendoscopy.
group 5	0.4% Lugol's solution	This group patients were given dosages of 0.4% Lugol's solution for chromoendoscopy.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Severe adverse events (allergic reactions, esophageal burns, spasms and even perforation)	1 month
Questionnaire of endoscopists' subjective assessments	intraoperative	The picture will be rated for quality according to color contrast of esophageal lesions after iodine sprayed by the endoscopist performing the examination
Complete resection/R0 resection rate	1 month
The amount of Lugol's solution	intraoperative
Mucosal change of the stomach in white-light endoscopy after Lugol's solution sprayed.	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.

Trial Locations

Locations (1)

Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China