Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Neoplasms

Esophageal Squamous Cell Carcinoma

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Coagulants

All Drugs and Chemicals

Lugol's solution

* GI endoscopy examination and additional the entire length of esophagus is evaluate with NBI endoscopy
* Biopsy at the visually abnormal lesions
* Pathologic examination of all biopsy tissue specimens
* Advises of endoscopic/surgical or oncological treatment will be given to participants who will be diagnosed with ESCC or high grade dysplasia of the esophagus.

* GI endoscopy examination and additional the entire length of esophagus is evaluate with Lugol chromoendoscopy
* Biopsy at the unstained lesions \>= 5 mm diameter
* Pathologic examination of all biopsy tissue specimens
* Advises of endoscopic/surgical or oncological treatment will be given to participants who will be diagnosed with ESCC or high grade dysplasia of the esophagus.

GI endoscopy examination and additional the entire length of esophagus is evaluate with NBI endoscopy Biopsy at the visually abnormal lesions

NBI endoscopy

GI endoscopy examination and additional the entire length of esophagus is evaluate with Lugol chromoendoscopy Biopsy at the unstained lesions \>= 5 mm diameter Pathologic examination of all biopsy tissue specimens

Lugol chromoendoscopy

Jaroslaw Regula, PhD

Anna Chaber-Ciopinska, MD

This study evaluates the role of narrow band imaging (NBI) endoscopy compared with Lugol chromoendoscopy in the early detection of esophageal cancer in patients with prior head and neck cancers.

Patients with head and neck cancers have an increased risk for developing an esophageal squamous cell carcinoma (ESCC). Small, superficial, curable lesions are difficult to diagnose using only white light endoscopy. To improve detection chromoendoscopy is recommended. In this project patients are divided into two groups based on received chromoendoscopy (NBI versus Lugol). The results of two methods will be compare regarding positive predictive value to establish usage of chromoendoscopy in early detection of ESCC.

The Role of Chromoendoscopy in the Early Detection of Esophageal Cancer in Patients With Prior Head and Neck Cancers

The Role of Narrow Band Imaging (NBI) Endoscopy Compared With Lugol Chromoendoscopy in the Early Detection of Esophageal Cancer in Patients With Prior Head and Neck Cancers: a Prospective Randomized Study

The results of two methods are compare regarding positive predictive value.

Centre of Postgraduate Medical Education

Maria Sklodowska-Curie National Research Institute of Oncology

probe-based confocal laser endomicroscopy narrow band imaging with magnification

Olympus

probe-based confocal laser endomicroscopy

Cellvizio

Rapat Pittayanon, M.D.

This descriptive cross sectional study aims to directly compare the diagnostic capability of the probed-based confocal laser endomicroscopy (pCLE) and the magnifying narrow band imaging (M-NBI) in the Lugol's voiding lesions.

A Diagnostic Study of the Advanced Endoscopy to Detect Early Esophageal Cancer

Diagnostic Values of Probe-based Confocal Laser Endomicroscopy (pCLE) and Magnifying Narrow Band Imaging (M-NBI) for Early Neoplasms Detection in Esophageal Lugol'S-voiding Lesions.

Diagnostic performance of the pCLE and M-NBI in Lugol's voiding lesions size larger than 5 millimeters.

Chulalongkorn University

King Chulalongkorn Memorial Hospital

Gastroenterologist

Probe-based confocal laser endomicroscopy and narrow band imaging with magnification in esophageal Lugol's voiding lesions.

Study Arm

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Thailand

Region of Enrollment

This was a pilot study and the sample size was small. We did not randomly assign the order of dNBI and pCLE. The unwashed Lugol's stain significantly influenced the observation of IPCL structure on dNBI study.

Dr. Piyapan Prueksapanich

pCLE

dNBI

Twenty-one Lugol's voiding lesions larger than 5mm were detected in 12 patients.

Accuracy

Overall Study

Pharmaceutical Solutions

Micronutrients

Anti-Infective Agents

Iodine

Cadexomer iodine

Anti-Infective Agents, Local

Trace Elements

Hemostatics

Esophageal chromoendoscopy will be performed with a 15 ml volume of 1% Lugol iodine solution.

Esophageal chromoendoscopy will be performed with a 3 ml volume of 5% iodine stock solution.

1% Lugol iodine solution was sprayed from the esophagogastric junction towards a location approximately 20 cm away from the upper incisors in the cervical esophagus.

1% Lugol's iodine solution

Before chromoendoscopy, a 20 ml syringe was employed to draw 3 ml of 5% iodine stock solution and 17 ml air. When staining, the iodine was quickly expelled through the endoscope's working channel at 20 cm of the esophagus from the incisor. An iodine mist was created because of the rapid spurt of the iodine solution and air, which prompts even distribution of the iodine solution on the esophageal wall. The lower segments of the esophageal wall were stained with the remaining iodine solution in the working channel by repeatedly spraying the air/iodine mixture using the syringe, resulting in consistent and uniform staining for the whole esophagus.

5% Lugol's iodine solution

Zhiguo Liu, M.D.

Kai Liu, M.D.

Yaze Tan, M.D.

Jun Wang, M.D.

Shasha Wang, M.D.

Hua Tang, M.D.

Shuxin Tian, M.D.

This clinical trial aims to test the participants' tolerance for different concentration iodine solutions during esophageal chromoendoscopy. The main question it aims to answer is:

Under the same iodine dosage, do the participants have the same tolerance for 1% and 5% iodine solutions? Participants will be asked to score based on pain and discomfort and describe symptoms and corresponding location at 5 minutes (only for unanesthetized participants) and 30 minutes after chromoendoscopy.

Lugol's iodine chromoendoscopy is the commonly used method for detecting and diagnosing esophageal squamous cell carcinoma. However, iodine can induce mucosal irritation and has been commonly associated with adverse retrosternal symptoms, including retrosternal pain and/or heartburn. The existing research shows that spraying iodine solution neutralizers (Sodium thiosulfate solution, N-acetylcysteine, and vitamin C solution) after esophageal iodine chromoendoscopy can alleviate patient discomfort. However, a recent study has shown that excessive iodine concentration or excessive dosage of iodine can still increase patient discomfort even under spraying an iodine solution neutralizer. It is currently unclear whether the factors affecting patient tolerance are the iodine solution concentration or the total dosage of iodine used. Therefore, the multicenter randomized controlled trial will compare the patient's tolerance for the 1% and 5% iodine solutions under the same iodine dosage conditions. The trial will help determine the specific reasons influencing patient tolerance. Participants will be asked to score based on pain and discomfort and describe symptoms and corresponding location at 5 minutes (only for unanesthetized participants) and 30 minutes after chromoendoscopy.

High-concentration Small-volume Versus Low-concentration Large-volume Iodine Solution for Esophageal Chromoendoscopy

High-concentration Small-volume Versus Low-concentration Large-volume Iodine Solution for Esophageal Chromoendoscopy: a Multicenter, Randomized Equivalence Trial

According to the visual analogue scale, participants will be asked to score based on pain or discomfort 30 minutes after chromoendoscopy.

After spraying Lugol's iodine, the esophageal mucosa displaying a homogeneous dark brown staining was classified as normal, while faded or unstained lesions larger than 0.5 cm were deemed potential high-grade intraepithelial neoplasia or mucosal cancer. The Lugol's unstained lesions were further evaluated for the presence of the pink-color sign and photographed 2-3 minutes after Lugol's iodine staining. The images were also taken at 30 cm distal to the incisors at 2-3 minutes after Lugol's iodine staining if no lesion was found. The images were retrospectively analyzed and scored for an objective evaluation based on the L\* a\* b\* (L\* = light/dark; a\* = red/green; b\* = yellow/blue) color values in the CIELAB color space system.

The endoscopist will be asked to complete a questionnaire survey immediately after chromoendoscopy. The questionnaire asked the endoscopist to rate the staining effect as good (The color concentration is sufficient and the color retention time is adequate) or poor (The color concentration is insufficient and/or the color retention time is inadequate).

The percentage of heart rate change 5 min (only for unanesthetized participants) or 30 min compared to that before endoscopy.

When the endoscopist believes that insufficient esophageal iodine staining affects the detection or diagnosis of lesions, they can spray additional iodine solution. The incidence rate of the need for additional iodine solution spraying of the two groups will be compared.

When the endoscopist believes that insufficient esophageal iodine staining affects the detection or diagnosis of lesions, they can spray additional iodine solution. The dosage of additional iodine spraying of the two groups will be compared.

According to the visual analogue scale, participants without sedation or general anesthesia will be asked to score based on pain or discomfort 5 minutes after chromoendoscopy.

The incidence rate of esophageal spasms of the two groups will be compared.

The incidence rate of adverse incidents of the two groups will be compared.

Participants will be asked to describe retrosternal discomfort symptoms and corresponding location at 5 minutes (only for unanesthetized participants)) and 30 minutes after chromoendoscopy. The incidence rate of upper abdominal discomfort or pain will be compared between the two groups.

Visual analogue scale scores may be influenced by other factors. Univariable analysis will first be used to identify potential factors that influenced visual analogue scale scores. All possible factors will then be included in multivariable analysis.

Ankang Central Hospital

The First Affiliated Hospital of ShiheziI University

Xi'an International Medical Center Hospital

Air Force 986 Hospital

Xianyang Central Hospital (the second people's Hospital of Xianyang City)

Xijing Hospital of Digestive Diseases

Associate professor

Respiratory System Agents

Acetylcysteine

N-monoacetylcystine

Sodium thiosulfate

Antiviral Agents

Expectorants

Antioxidants

Protective Agents

Antidotes

Antitubercular Agents

Anti-Bacterial Agents

Chelating Agents

20ml of 5% sodium thiosulfate solution were prepared with 1g sodium thiosulfate crystal dissolved in normal saline in a 20 ml syringe

20ml of 3% N-acetylcysteine solution were prepared with one piece of N-acetylcysteine effervescent tablet （ net weight 0.6g ）dissolved in normal saline in a 20 ml syringe

use N-acetylcysteine solution to alleviate esophageal irritation caused by Lugol's chromoendoscopy

N-acetylcysteine solution

use sodium thiosulfate solution to alleviate esophageal irritation caused by Lugol's chromoendoscopy

sodium thiosulfate solution

Shaohua Zhu

Lugol chromoendoscopy is essential in detecting and characterizing squamous cell carcinoma of esophagus. Esophageal irritating symptom has been reported as an common adverse event, which could be alleviated by sodium thiosulfate solutions. However, sodium thiosulfate was not widely available. N-acetylcysteine has been previously used as a mucolytic reagent, we propose that it may also be used to alleviate irritating symptoms caused by Lugo's chromoendoscopy. A prospective, non-inferior, randomized double-blind clinical trial was designed to study the efficacy of N-acetylcysteine solutions in relieving esophageal discomfort .

The Efficacy of N-acetylcysteine on Alleviating Symptom Caused by Lugol Chromoendoscopy

The Efficacy of N-acetylcysteine on Alleviating Symptom Caused by Lugol Chromoendoscopy: a Prospective, Non-inferiority, Randomized Controlled Trial

Visual analogue scale change for esophageal irritation after Lugol chromoendoscopy

The percentage of patients with symptom after Lugol chromoendoscopy for certain time

Neutralizing effect for residual iodine in esophagus and stomach

the percentage of heart rate change 5 min or 30 min compared to that Before endoscopy

the percentage of patient with Visual analogue scale over 4

the time of endoscopy from the beginning of spraying diluted Lugol's solution to end of endoscopy minus time required for biopsy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Role of Chromoendoscopy in the Early Detection of Esophageal Cancer in Patients With Prior Head and Neck Cancers	NCT02435602	Esophageal Squa... Squamous Cell C...	NBI endoscopy Lugol chromoend...	18 Years -	Maria Sklodowska-Curie National Research Institute of Oncology
A Diagnostic Study of the Advanced Endoscopy to Detect Early Esophageal Cancer	NCT02182804	Esophageal Neop...	Olympus Cellvizio	20 Years -	King Chulalongkorn Memorial Hospital
A Diagnostic Study of the Advanced Endoscopy to Detect Early Esophageal Cancer	NCT02182804	Esophageal Neop...	Olympus Cellvizio	20 Years -	King Chulalongkorn Memorial Hospital
A Diagnostic Study of the Advanced Endoscopy to Detect Early Esophageal Cancer	NCT02182804	Esophageal Neop...	Olympus Cellvizio	20 Years -	King Chulalongkorn Memorial Hospital
A Diagnostic Study of the Advanced Endoscopy to Detect Early Esophageal Cancer	NCT02182804	Esophageal Neop...	Olympus Cellvizio	20 Years -	King Chulalongkorn Memorial Hospital
High-concentration Small-volume Versus Low-concentration Large-volume Iodine Solution for Esophageal Chromoendoscopy	NCT06063941	Esophageal Squa...	1% Lugol's iodi... 5% Lugol's iodi...	18 Years -	Xijing Hospital of Digestive Diseases
The Efficacy of N-acetylcysteine on Alleviating Symptom Caused by Lugol Chromoendoscopy	NCT04764643	Esophageal Squa...	N-acetylcystein... sodium thiosulf...	18 Years - 80 Years	Xijing Hospital of Digestive Diseases
High-concentration Small-volume Versus Low-concentration Large-volume Iodine Solution for Esophageal Chromoendoscopy	NCT06063941	Esophageal Squa...	1% Lugol's iodi... 5% Lugol's iodi...	18 Years -	Xijing Hospital of Digestive Diseases
The Efficacy of N-acetylcysteine on Alleviating Symptom Caused by Lugol Chromoendoscopy	NCT04764643	Esophageal Squa...	N-acetylcystein... sodium thiosulf...	18 Years - 80 Years	Xijing Hospital of Digestive Diseases

Spots Global Cancer Trial Database for lugol chromoendoscopy