Neoplasms

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Carcinoma, Squamous Cell

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Squamous Cell Carcinoma of Head and Neck

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Neoplasms, Glandular and Epithelial

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Neoplasms, Squamous Cell

Head and Neck Neoplasms

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Coagulants

Lugol's solution

A total of 132 patients with HNSCC were enrolled in this study. The patients underwent esophagoscopy and chromoendoscopy. The most frequent primary tumors were oropharyngeal (49/132), tumors of the oral cavity (36/132) and larynx (35/132). The majority of subjects (107/132 patients, 81.1%) had advanced HNSCC carcinomas (stages III and IV). Multiple LVLs were discovered in 24 subjects (18.2%), and no LVLs in 108 (81.8%) subjects. Fifty-five LVL biopsy specimens were obtained and assessed. Squamous cell carcinomas were detected in two patients, peptic esophagitis in 11 patients, gastric heterotopic mucosa in two patients, hyperplasia in two patients, and low- and high-grade dysplasia in three patients.

Esophagoscopy - examination of the interior of the esophagus by means of an esophagoscope.

Chromoendoscopy - a method, which involves the topical application of stains or pigments to improve tissue localization, characterization, or diagnosis during endoscopy.

Esophagoscopy and chromoendoscopy

Pavel Kominek, MD, PhD, MSc

Patients with HNSCC represent a high-risk group for the development of SESCC. Thus, esophagogastrofibroscopy should be performed to detect possible synchronous esophageal carcinomas in these patients.

Although only two patients with synchronous primary carcinomas were found among the patients with newly diagnosed HNSCC in this study, esophagoscopy and better some of advanced endoscopic methods should be recommended after detection of HNSCC to exclude secondary esophageal carcinoma or dysplasia. Staining of the esophagus with Lugol's solution is an easy and inexpensive option and can be done in most of gastroenterology offices.

ABSTRACT Objective: To evaluate the use of flexible esophagoscopy and chromoendoscopy with Lugol's solution in the detection of early esophageal carcinomas (second primary carcinomas) in patients with squamous cell carcinoma of the head and neck (HNSCC).

Methods: All patients with newly diagnosed HNSCC underwent office-based Lugol chromoendoscopy. After flexible esophagoscopy with white light, 3.0% Lugol iodine solution was sprayed over the entire esophageal mucosa. Areas with less-intense staining (LVLs) were evaluated and biopsies taken.

Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma

Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma in Patients With Squamous Cell Carcinomas of the Head and Neck?

To evaluate the use of flexible esophagoscopy and chromoendoscopy with Lugol's solution in the detection of early esophageal carcinomas (second primary carcinomas) in patients with squamous cell carcinoma of the head and neck (HNSCC).

All patients with newly diagnosed HNSCC underwent office-based Lugol chromoendoscopy. After flexible esophagoscopy with white light, 3.0% Lugol iodine solution was sprayed over the entire esophageal mucosa. Areas with less-intense staining (LVLs) were evaluated and biopsies taken.

University Hospital Ostrava

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

Anti-Infective Agents

Antineoplastic Agents

Micronutrients

Vitamins

Acetic Acid

Retinol acetate

Vitamin A

Retinol palmitate

Anti-Bacterial Agents

Adjuvants, Immunologic

Immunologic Factors

Protective Agents

Hemostatics

Retinol

using acetic acid to unmask dysplastic lesions on the cervix uteri

acetic acid test

using Lugol's solution after acetic acid test to unmask dysplastic lesions on the cervix uteri

Lugol's solution test

Ziad Hilal, M.D.

To assess the benefits of using Lugol's solution in addition to acetic acid during colposcopy in women with cervical dysplasia.

Lugol's Solution in Addition to Acetic Acid During Colposcopy

Benefits of Using Lugol's Solution in Addition to Acetic Acid During Colposcopy in Women With Cervical Dysplasia

We count all the cases in which dysplastic lesions on the cervix uteri where identified due to the use

sensitivity of the examination (acetic acid + Lugol´s solution)

Specificity of the examination (acetic acid + Lugol´s solution)

Positive predictive value of the examination (acetic acid + Lugol´s solution)

Negative predictive value of the examination (acetic acid + Lugol´s solution)

Zydolab - Institute of Cytology and Immune Cytochemistry

Esophageal Squamous Cell Carcinoma

Iodine

Cadexomer iodine

This group patients were given concentrations of 1.2% Lugol's solution for chromoendoscopy.

This group patients were given concentrations of 1.0% Lugol's solution for chromoendoscopy.

This group patients were given concentrations of 0.8% Lugol's solution for chromoendoscopy.

This group patients were given concentrations of 0.6% Lugol's solution for chromoendoscopy.

This group patients were given concentrations of 0.4% Lugol's solution for chromoendoscopy.

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.

1.2% Lugol's solution

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.

1.0% Lugol's solution

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.

0.8% Lugol's solution

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.

0.6% Lugol's solution

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.

0.4% Lugol's solution

Xiuli Zuo, PhD

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.

Lower Lugol's Solution Concentration on Reducing the Adverse Symptoms of Chromoendoscopy With Iodine Staining

Image quality is blindly quantified by a 4-point scale from the endoscopists. A higher score representing higher image quality.

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.

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).

Severe adverse events includes allergic reactions, esophageal burns, spasms and even perforation.

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.

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.

Shandong University

director of Qilu Hospital

This group patients were given Lugol's solution staining from cervical esophagus to esophagogastric junction （downward）during chromemdoscopy.

This group patients were given Lugol's solution staining from esophagogastric junction to cervical esophagus（upward）during chromemdoscopy.

staining from cervical esophagus to esophagogastric junction

staining from esophagogastric junction to cervical esophagus

Xiuli Zuo, MD,PhD

The aim of this study is to compare the effectiveness and safety of spraying Lugol's solution from cervical esophagus to esophagogastric junction (downward) and from esophagogastric junction to cervical esophagus （upward）during chromoendoscopy.

Chromoendoscopy using Lugol's solution is effective for the detection of early esophageal squamous neoplasia. However, there is no study to investigate the sequence of Lugol's staining during endoscopic procedure.

The aim of this study is to compare the effectiveness and safety of spraying Lugol's solution from cervical esophagus to esophagogastric junction (downward) and from esophagogastric junction to cervical esophagus （upward）during chromoendoscopy.

Whether it is More Appropriate to Spray Lugol's Solution From Cervical Esophagus to Esophagogastric Junction

Detection rate of esophageal squamous cell carcinoma of the two groups.

director of Qilu Hospital gastroenterology department

Add pronase 20000 U in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate.

No pronase in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate.

use pronase to improve visibility during endoscopical iodine staining

Pronase

No pronase plus Dimethicone and sodium bicarbonate. use without pronase to compare visibility during endoscopical iodiine staining

Control

Kaichun Wu, Ph.D. & M.D.

Lugol's solution staining was regarded as a gold standard to detect early superficial lesion during esophageal cancer screening using endoscopy. However, the sensitivity and specificity were influenced by mucus and food debris of esophagus. Pronase, a kind of protease, was previously shown to improve the visibility of gastrointestinal tract. It's unknown if the pre-treatment with pronase would also improve the quality of iodine staining in esophagus.A randomized double-blind clinical trial was designed to investigate whether or not pronase might improve detection rate of early esophageal lesion, especially high grade dysplasia and early cancer by improving the esophageal visibility.

Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer

Detection Rate=（lesions with confirmed high grade dysplasia/all iodine void lesions）\*100%

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma	NCT01783158	Squamous Cell C...	Esophagoscopy a...	18 Years - 65 Years	University Hospital Ostrava
Lugol's Solution in Addition to Acetic Acid During Colposcopy	NCT04415840	Uterine Cervica...	acetic acid tes... Lugol's solutio...	18 Years - 80 Years	Zydolab - Institute of Cytology and Immune Cytochemistry
Lower Lugol's Solution Concentration on Reducing the Adverse Symptoms of Chromoendoscopy With Iodine Staining	NCT03180944	Mucosal Irritat... Image Quality	1.2% Lugol's so... 1.0% Lugol's so... 0.8% Lugol's so... 0.6% Lugol's so... 0.4% Lugol's so...	40 Years - 74 Years	Shandong University
Whether it is More Appropriate to Spray Lugol's Solution From Cervical Esophagus to Esophagogastric Junction	NCT04224363	Esophageal Squa...	staining from c... staining from e...	18 Years - 80 Years	Shandong University
Lugol's Solution in Addition to Acetic Acid During Colposcopy	NCT04415840	Uterine Cervica...	acetic acid tes... Lugol's solutio...	18 Years - 80 Years	Zydolab - Institute of Cytology and Immune Cytochemistry
Lower Lugol's Solution Concentration on Reducing the Adverse Symptoms of Chromoendoscopy With Iodine Staining	NCT03180944	Mucosal Irritat... Image Quality	1.2% Lugol's so... 1.0% Lugol's so... 0.8% Lugol's so... 0.6% Lugol's so... 0.4% Lugol's so...	40 Years - 74 Years	Shandong University
Lugol's Solution in Addition to Acetic Acid During Colposcopy	NCT04415840	Uterine Cervica...	acetic acid tes... Lugol's solutio...	18 Years - 80 Years	Zydolab - Institute of Cytology and Immune Cytochemistry
Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer	NCT02030769	Esophageal Neop...	Pronase Control	18 Years - 75 Years	Xijing Hospital of Digestive Diseases
Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma	NCT01783158	Squamous Cell C...	Esophagoscopy a...	18 Years - 65 Years	University Hospital Ostrava
Whether it is More Appropriate to Spray Lugol's Solution From Cervical Esophagus to Esophagogastric Junction	NCT04224363	Esophageal Squa...	staining from c... staining from e...	18 Years - 80 Years	Shandong University

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