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

NCT03180944 | Completed Phase 2 DMC

• 1 other identifier: 2017SDU-QILU-G001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mucosal Irritation; Image Quality

Keywords

Lugol's solution; esophageal squamous cell cancer; mucosal irritation; image quality

Outcome Measures

Primary Outcomes (1)

• Image Quality

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

  intraoperative

Secondary Outcomes (5)

• Gastric Mucosa Injury

  1 months

• Adverse Events

  24 hours

• Severe Adverse Events

  24 hours

• Tolerance

  intraoperative

• Histology analysis

  3-5days

Study Arms (5)

1.2% Lugol's solution

EXPERIMENTAL

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

Drug: 1.2% Lugol's solution

1.0% Lugol's solution

EXPERIMENTAL

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

Drug: 1.0% Lugol's solution

0.8% Lugol's solution

EXPERIMENTAL

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

Drug: 0.8% Lugol's solution

0.6% Lugol's solution

EXPERIMENTAL

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

Drug: 0.6% Lugol's solution

0.4% Lugol's solution

EXPERIMENTAL

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

Drug: 0.4% Lugol's solution

Interventions

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.

1.2% Lugol's solution

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.

1.0% Lugol's solution

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.

0.8% Lugol's solution

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.

0.6% Lugol's solution

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.

0.4% Lugol's solution

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (1)

• 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.

  PMID: 37094943 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Lugol's solution

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Xiuli Zuo, PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of Qilu Hospital

Study Record Dates

• First Submitted: June 4, 2017
• First Posted: June 8, 2017
• Study Start: September 1, 2017
• Primary Completion: November 30, 2018
• Study Completion: December 30, 2018
• Last Updated: January 10, 2020

Record last verified: 2020-01

Locations

CN (1)