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

Endoscopists'Subjective Assessments Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03180970
• Other study ID #: 2017SDU-QILU-G002
• Status: Not yet recruiting
• Phase: Phase 4
• First received: June 4, 2017
• Last updated: June 7, 2017
• Start date: June 2017
• Est. completion date: December 2017

Study information

• Verified date: June 2017
• Source: Shandong University
• Contact: Xiuli Zuo, PhD
• Phone: 15588818685
• Email: zuoxiuli[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endoscopists'Subjective Assessments
• Image Quality of Early Esophageal Squamous Neoplasia
• Neoplasms

Intervention

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).
• 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).
• 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).
• 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).
• 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).

Locations

Country	Name	City	State
China	Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Image Quality of Esophageal Lesions	Evaluated by Image J software (National Institutes of Health)	seven months
Secondary	Questionnaire of endoscopists' subjective assessments	The picture will be rated for quality according to color contrast of esophageal lesions after iodine sprayed by the endoscopist performing the examination	intraoperative
Secondary	Complete resection/R0 resection rate		1 month
Secondary	Mucosal change of the stomach in white-light endoscopy after Lugol's solution sprayed.	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
Secondary	The amount of Lugol's solution		intraoperative
Secondary	Severe adverse events (allergic reactions, esophageal burns, spasms and even perforation)		1 month