The Application of Spasmolytic in PCLE Examination of Superior Gastrointestinal Endoscope

NCT ID: NCT02811341

Last Updated: 2016-06-23

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-06-30

Brief Summary

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Scopolamine butylbromide might be helpful for the outcome of superior gastrointestinal endoscope examination.

Detailed Description

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The peristalsis of gastrointestinal tract has a adverse affection on the process of the PCLE examination .Scopolamine butylbromide is a widely used spasmolytic,which can reduce the peristalsis of gastrointestinal tract effectly.The application of it may benefit the images'quality ,the acurrate of diagnosis and shorten the examination time.

Conditions

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Using Copolamine Butylbromide in Probe-based Confocal Laser Endomicroscopy for Gastroendoscopy Examination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A group

Using normal saline before pcle examination

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

B group

Using Scopolamine Hydrobromide before pcle examination

Group Type EXPERIMENTAL

Scopolamine Hydrobromide

Intervention Type DRUG

Interventions

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Scopolamine Hydrobromide

Intervention Type DRUG

normal saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* outpatients attending endomicroscopy
* able to give written informed consent

Exclusion Criteria

* coagulopathy
* acute upper digestive tract bleeding
* pregnancy or breast feeding
* allergy to fluorescein sodium
* impaired renal function
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice president of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Li, MD.PhD.

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital, Shandong University

Yanqing Li, PhD. MD.

Role: STUDY_DIRECTOR

Department of Gastroenterology, Qilu Hospital, Shandong University

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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2015SDU-QILU-G01

Identifier Type: -

Identifier Source: org_study_id

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