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

January 8, 2020 updated by: Xiuli Zuo, Shandong University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • High risk patients of early esophageal squamous neoplasias.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Downward Staining
This group patients were given Lugol's solution staining from cervical esophagus to esophagogastric junction （downward）during chromemdoscopy.
Procedure: staining from cervical esophagus to esophagogastric junction
This group patients were given Lugol's solution staining from cervical esophagus to esophagogastric junction （downward）during chromemdoscopy.
Experimental: Upward Staining
This group patients were given Lugol's solution staining from esophagogastric junction to cervical esophagus（upward）during chromemdoscopy.
Procedure: staining from esophagogastric junction to cervical esophagus
This group patients were given Lugol's solution staining from esophagogastric junction to cervical esophagus（upward）during chromemdoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image Quality
Time Frame: intraoperative
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
Adverse events
Time Frame: 24 hours
Adverse events of the two groups.
24 hours
Dose
Time Frame: intraoperative
Usage of Lugol's solution in each group.
intraoperative
Effectiveness
Time Frame: 1 month
Detection rate of esophageal squamous cell carcinoma of the two groups.
1 month
Tolerance
Time Frame: intraoperative
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

January 8, 2020

First Submitted That Met QC Criteria

January 8, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 8, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020SDU-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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe