Different Lugol's Solution Concentration for Image Quality of Esophageal Lesions in Chromoendoscopy With Iodine Staining

Different Lugol's Solution Concentration for Image Quality of Early Esophageal Squamous Neoplasia in Chromoendoscopy With Iodine Staining

The purpose of this study is to assess whether lower Lugol's solution concentration can perceive the same image quality of early esophageal squamous neoplasia.

Study Overview

• Status: Unknown
• Conditions: Image Quality of Early Esophageal Squamous Neoplasia; Endoscopists'Subjective Assessments
• 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

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.

This study was to test whether a lower concentration of Lugol's solution can provide satisfied image quality of early esophageal squamous neoplasia and has lower mucosal irritation.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiuli Zuo, PhD; Phone Number: 053188369277 15588818685; Email: zuoxiuli@sina.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital, Shandong University
      • Contact: Xiuli Zuo, PhD; Phone Number: 053188369277 15588818685; Email: zuoxiuli@sina.com
      • Sub-Investigator: Junyan Qu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients with early esophageal squamous neoplasia who underwent endoscopic submucosal dissection.

Exclusion Criteria:

After esophageal surgery or endoscopic treatment ; Known esophageal radiotherapy or chemotherapy ; Esophageal stenosis; Acute bleeding; A known allergy to iodine; Coagulopathy (prothrombin time <50% of control, partial thromboplastin time >50 seconds); Having food retention; Severe hepatic ,renal, cardiovascular or metabolic dysfunction ; Being pregnant or lactating.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1; This group patients were given dosages of 1.2% Lugol's solution for chromoendoscopy.	Drug: 1.2% Lugol's solution; 1.2% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD).
Experimental: group 2; This group patients were given dosages of 1.0% Lugol's solution for chromoendoscopy.	Drug: 1.0% Lugol's solution; 1.0% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD).
Experimental: group 3; This group patients were given dosages of 0.8% Lugol's solution for chromoendoscopy.	Drug: 0.8% Lugol's solution; 0.8% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD).
Experimental: group 4; This group patients were given dosages of 0.6% Lugol's solution for chromoendoscopy.	Drug: 0.6% Lugol's solution; 0.6% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD).
Experimental: group 5; This group patients were given dosages of 0.4% Lugol's solution for chromoendoscopy.	Drug: 0.4% Lugol's solution; 0.4% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image Quality of Esophageal Lesions	Evaluated by Image J software (National Institutes of Health)	seven months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire of endoscopists' subjective assessments	The picture will be rated for quality according to color contrast of esophageal lesions after iodine sprayed by the endoscopist performing the examination	intraoperative
Complete resection/R0 resection rate		1 month
Mucosal change of the stomach in white-light endoscopy after Lugol's solution sprayed.	The endoscopic findings of the greater curvature of the gastric body where the agent collected will be evaluated based on the following findings:fold thickening, exudates, ulcers, and hemorrhage.	intraoperative
The amount of Lugol's solution		intraoperative
Severe adverse events (allergic reactions, esophageal burns, spasms and even perforation)		1 month

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 (Anticipated): June 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: June 4, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (Actual): June 8, 2017

Study Record Updates

• Last Update Posted (Actual): June 8, 2017
• Last Update Submitted That Met QC Criteria: June 7, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Hemostatics; Coagulants; Pharmaceutical Solutions; Lugol's solution
• Other Study ID Numbers: 2017SDU-QILU-G002

Drug and device information, study documents

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