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

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.

Study Overview

• Status: Completed
• Conditions: Image Quality; Mucosal Irritation
• Intervention / Treatment: Drug: 1.2% Lugol's solution; Drug: 1.0% Lugol's solution; Drug: 0.8% Lugol's solution; Drug: 0.6% Lugol's solution; Drug: 0.4% Lugol's solution

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital, Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients in the high-risk population of ESCC;
• or general risk population of ESCC between 40 to 74 years old. Definition of high-risk population of ESCC is list in supporting information33.

Exclusion criteria included the following:

• with obvious abnormalities in stomach, confirmed by either white-light endoscopy (WLE) or pCLE, including gastric cancer, acute erosive and hemorrhagic gastritis, chronic atrophic gastritis, H. pylori infection and severe bile reflux gastritis;
• advanced esophageal carcinoma;
• known esophageal surgery or endoscopic treatment;
• known esophageal radiotherapy or chemotherapy;
• esophageal stenosis;
• food retention;
• allergy to iodine or fluorescein sodium;
• hyperthyroid;
• coagulopathy;
• acute bleeding;
• severe organ failure;
• pregnant or breastfeeding women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1.2% Lugol's solution; 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 1.2% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.
Experimental: 1.0% 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 1.0% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.
Experimental: 0.8% 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 0.8% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.
Experimental: 0.6% 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 0.6% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.
Experimental: 0.4% 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 0.4% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Shandong University
• Investigators: Principal Investigator: Xiuli Zuo, PhD, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: June 4, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 8, 2017

Study Record Updates

• Last Update Posted (Actual): January 10, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: image quality; Lugol's solution; esophageal squamous cell cancer; mucosal irritation
• Additional Relevant MeSH Terms: Hemostatics; Coagulants; Pharmaceutical Solutions; Lugol's solution
• Other Study ID Numbers: 2017SDU-QILU-G001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No