A Phase 2 interventional study of 1.2% Lugol's solution and 1.0% Lugol's solution in Mucosal Irritation and Image Quality, sponsored by Shandong University. Completed at 1 site in China. Open to participants aged 40 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-10.
Sponsored by Shandong University · Phase 2, Interventional, and Screening
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.
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.
Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
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This group patients were given concentrations of 1.2% Lugol's solution for chromoendoscopy.
Drug: 1.2% Lugol's solution
This group patients were given concentrations of 1.0% Lugol's solution for chromoendoscopy.
Drug: 1.0% Lugol's solution
This group patients were given concentrations of 0.8% Lugol's solution for chromoendoscopy.
Drug: 0.8% Lugol's solution
This group patients were given concentrations of 0.6% Lugol's solution for chromoendoscopy.
Drug: 0.6% Lugol's solution
This group patients were given concentrations of 0.4% Lugol's solution for chromoendoscopy.
Drug: 0.4% Lugol's solution
This group patients were given concentrations of 1.2% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.
This group patients were given concentrations of 1.0% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.
This group patients were given concentrations of 0.8% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.
This group patients were given concentrations of 0.6% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.
This group patients were given concentrations of 0.4% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.
Image Quality
Image quality is blindly quantified by a 4-point scale from the endoscopists. A higher score representing higher image quality.
Time frame: intraoperative
Gastric Mucosa Injury
The gastric mucosal injury caused by Lugol's solution is defined as post-staining gastritis score minus pre-staining gastritis score in pCLE. The confocal gastritis was graded 0 to 3,according to pit patterns, capillaries, and fluorescein leakage. A higher score representing more serious injury.
Time frame: 1 months
Adverse Events
Both a written and oral form of the Numerical Rating Scale (NRS) was provided to the patients after the endoscopy examination, used for measuring patients' retrosternal pain, retrosternal discomfort, nausea, abdominal discomfort and others. In NRS, 0 is painless, 10 is the most severe pain, less than 4 is mild pain (pain does not affect sleep), 4-6 is moderate pain, and more than 7 is severe pain (pain means unable to sleep or wake up from sleep).
Time frame: 24 hours
Severe Adverse Events
Severe adverse events includes allergic reactions, esophageal burns, spasms and even perforation.
Time frame: 24 hours
Tolerance
The 4-point scale was used to assess the tolerance of endoscopist to the esophageal spasm caused by Lugol's solution which prevent endoscopy from passing. 1-4 means the resistance as intolerable, tolerable, mild, or non-existing.
Time frame: intraoperative
Histology analysis
All specimens were evaluated by two experienced pathologists blind to the groups of the patients. The macroscopic and histologic diagnosis were made based on Paris classification and Vienna classification, respectively.
Time frame: 3-5days
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Shandong University