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

NCT03180970 — Phase 4, Unknown, 50 participants, Shandong University

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

Registry	NCT03180970
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: double, diagnostic
Enrollment	50 (Estimated)
Sponsor	Shandong University (Other)
Conditions	Image Quality of Early Esophageal Squamous Neoplasia, Endoscopists'Subjective Assessments
Interventions	1.2% Lugol's solution, 1.0% Lugol's solution, 0.8% Lugol's solution, 0.6% Lugol's solution, 0.4% Lugol's solution (Drug)
Dates	start 2017-06-01 (estimated), primary completion 2017-12-01 (estimated), completion 2017-12-01 (estimated), first posted 2017-06-08, last updated 2017-06-08
Locations	1 site in China

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
group 1	Experimental	Drug: 1.2% Lugol's solution	This group patients were given dosages of 1.2% Lugol's solution for chromoendoscopy.
group 2	Experimental	Drug: 1.0% Lugol's solution	This group patients were given dosages of 1.0% Lugol's solution for chromoendoscopy.
group 3	Experimental	Drug: 0.8% Lugol's solution	This group patients were given dosages of 0.8% Lugol's solution for chromoendoscopy.
group 4	Experimental	Drug: 0.6% Lugol's solution	This group patients were given dosages of 0.6% Lugol's solution for chromoendoscopy.
group 5	Experimental	Drug: 0.4% Lugol's solution	This group patients were given dosages of 0.4% Lugol's solution for chromoendoscopy.

1.2% Lugol's solution (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).
1.0% Lugol's solution (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).
0.8% Lugol's solution (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).
0.6% Lugol's solution (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).
0.4% Lugol's solution (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).

+Outcome measures

Primary outcomes

Image Quality of Esophageal Lesions [seven months]: Evaluated by Image J software (National Institutes of Health)

Secondary outcomes

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]
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.
The amount of Lugol's solution [intraoperative]
Severe adverse events (allergic reactions, esophageal burns, spasms and even perforation) [1 month]

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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.

+Locations (1)

Facility	City	Country	Status
Qilu Hospital, Shandong University	Jinan, Shandong	China

+Investigators

Xiuli Zuo, PhD, Principal investigator, Qilu Hospital of Shandong University

My Notes

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