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

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

staining from cervical esophagus to esophagogastric junction

staining from esophagogastric junction to cervical esophagus

About this trial

This is an interventional diagnostic trial for Esophageal Squamous Cell Carcinoma focused on measuring Lugol's solution, staining sequence, Esophageal Squamous Cell Carcinoma, Effectiveness, Safety

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Downward Staining

Upward Staining

Arm Description

This group patients were given Lugol's solution staining from cervical esophagus to esophagogastric junction （downward）during chromemdoscopy.

This group patients were given Lugol's solution staining from esophagogastric junction to cervical esophagus（upward）during chromemdoscopy.

Outcomes

Primary Outcome Measures

Image Quality

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

Secondary Outcome Measures

Adverse events

Adverse events of the two groups.

Dose

Usage of Lugol's solution in each group.

Effectiveness

Detection rate of esophageal squamous cell carcinoma of the two groups.

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.

Full Information

NCT ID

NCT04224363

First Posted

January 8, 2020

Last Updated

January 8, 2020

Sponsor

Shandong University

1. Study Identification

Unique Protocol Identification Number

NCT04224363

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 2020 (Anticipated)

Primary Completion Date

February 2020 (Anticipated)

Study Completion Date

February 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Squamous Cell Carcinoma

Keywords

Lugol's solution, staining sequence, Esophageal Squamous Cell Carcinoma, Effectiveness, Safety

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Downward Staining

Arm Type

Experimental

Arm Description

This group patients were given Lugol's solution staining from cervical esophagus to esophagogastric junction （downward）during chromemdoscopy.

Arm Title

Upward Staining

Arm Type

Experimental

Arm Description

This group patients were given Lugol's solution staining from esophagogastric junction to cervical esophagus（upward）during chromemdoscopy.

Intervention Type

Procedure

Intervention Name(s)

staining from cervical esophagus to esophagogastric junction

Intervention Description

This group patients were given Lugol's solution staining from cervical esophagus to esophagogastric junction （downward）during chromemdoscopy.

Intervention Type

Procedure

Intervention Name(s)

staining from esophagogastric junction to cervical esophagus

Intervention Description

This group patients were given Lugol's solution staining from esophagogastric junction to cervical esophagus（upward）during chromemdoscopy.

Primary Outcome Measure Information:

Title

Image Quality

Description

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

Time Frame

intraoperative

Secondary Outcome Measure Information:

Title

Adverse events

Description

Adverse events of the two groups.

Time Frame

24 hours

Title

Dose

Description

Usage of Lugol's solution in each group.

Time Frame

intraoperative

Title

Effectiveness

Description

Detection rate of esophageal squamous cell carcinoma of the two groups.

Time Frame

1 month

Title

Tolerance

Description

Time Frame

intraoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiuli Zuo, MD,PhD

Phone

15588818685

zuoxiuli@sdu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiuli Zuo, MD,PhD

Organizational Affiliation

Qilu Hospital of Shandong University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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