NCT03180970

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 8, 2017

Status Verified

June 1, 2017

Enrollment Period

6 months

First QC Date

June 4, 2017

Last Update Submit

June 7, 2017

Conditions

Image Quality of Early Esophageal Squamous NeoplasiaEndoscopists'Subjective Assessments

Outcome Measures

Primary Outcomes (1)

  • Image Quality of Esophageal Lesions

    Evaluated by Image J software (National Institutes of Health)

    seven months

Secondary Outcomes (5)

  • Questionnaire of endoscopists' subjective assessments

    intraoperative

  • Complete resection/R0 resection rate

    1 month

  • Mucosal change of the stomach in white-light endoscopy after Lugol's solution sprayed.

    intraoperative

  • The amount of Lugol's solution

    intraoperative

  • Severe adverse events (allergic reactions, esophageal burns, spasms and even perforation)

    1 month

Study Arms (5)

group 1

EXPERIMENTAL

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

Drug: 1.2% Lugol's solution

group 2

EXPERIMENTAL

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

Drug: 1.0% Lugol's solution

group 3

EXPERIMENTAL

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

Drug: 0.8% Lugol's solution

group 4

EXPERIMENTAL

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

Drug: 0.6% Lugol's solution

group 5

EXPERIMENTAL

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

Drug: 0.4% Lugol's solution

Interventions

1.2% Lugol's solutionDRUG

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).

group 1
1.0% Lugol's solutionDRUG

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).

group 2
0.8% Lugol's solutionDRUG

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).

group 3
0.6% Lugol's solutionDRUG

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).

group 4
0.4% Lugol's solutionDRUG

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).

group 5

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Interventions

Lugol's solution

Study Officials

  • Xiuli Zuo, PhD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zuo, PhD

CONTACT

15588818685zuoxiuli@sina.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
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

June 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

June 8, 2017

Record last verified: 2017-06

Locations

CN(1)