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

NCT ID: NCT04224363

Last Updated: 2020-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2020-02-29

Brief Summary

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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

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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.

Conditions

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Esophageal Squamous Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Downward Staining

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

Group Type EXPERIMENTAL

staining from cervical esophagus to esophagogastric junction

Intervention Type PROCEDURE

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

Upward Staining

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

Group Type EXPERIMENTAL

staining from esophagogastric junction to cervical esophagus

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Xiuli Zuo

director of Qilu Hospital gastroenterology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiuli Zuo, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Central Contacts

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Xiuli Zuo, MD,PhD

Role: CONTACT

15588818685

Other Identifiers

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2020SDU-QILU-G001

Identifier Type: -

Identifier Source: org_study_id

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