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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.2% Lugol's solution | Experimental | This group patients were given concentrations of 1.2% Lugol's solution for chromoendoscopy. |
|
| 1.0% Lugol's solution | Experimental | This group patients were given concentrations of 1.0% Lugol's solution for chromoendoscopy. |
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| 0.8% Lugol's solution | Experimental | This group patients were given concentrations of 0.8% Lugol's solution for chromoendoscopy. |
|
| 0.6% Lugol's solution | Experimental | This group patients were given concentrations of 0.6% Lugol's solution for chromoendoscopy. |
|
| 0.4% Lugol's solution | Experimental | This group patients were given concentrations of 0.4% Lugol's solution for chromoendoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1.2% Lugol's solution | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Image Quality | Image quality is blindly quantified by a 4-point scale from the endoscopists. A higher score representing higher image quality. | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 months |
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Inclusion Criteria:
Exclusion criteria included the following:
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| Name | Affiliation | Role |
|---|---|---|
| Xiuli Zuo, PhD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital, Shandong University | Jinan | Shandong | 250012 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37094943 | Derived | Qu JY, Li Y, Liu GQ, Li Z, Zhong N, Zhang MM, Li YY, Yu T, Lu XF, Li LX, Liu H, Qi QQ, Li YQ, Zuo XL. Optimal concentration of Lugol's solution for detecting early esophageal carcinoma: A randomized controlled trial. J Gastroenterol Hepatol. 2023 Jun;38(6):962-969. doi: 10.1111/jgh.16190. Epub 2023 Apr 24. |
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| 1.0% Lugol's solution | Drug | 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. |
|
| 0.8% Lugol's solution | Drug | 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. |
|
| 0.6% Lugol's solution | Drug | 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. |
|
| 0.4% Lugol's solution | Drug | 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. |
|
| 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). |
| 24 hours |
| Severe Adverse Events | Severe adverse events includes allergic reactions, esophageal burns, spasms and even perforation. | 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. | 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. | 3-5days |
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C010389 | Lugol's solution |
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