The Application of Spasmolytic in PCLE Examination of Superior Gastrointestinal Endoscope

Phase 1

Completed

• Conditions: Using Copolamine Butylbromide in Probe-based Confocal Laser Endomicroscopy for Gastroendoscopy Examination
• Interventions: Drug: normal saline; Drug: Scopolamine Hydrobromide

• Registration Number: NCT02811341
• Lead Sponsor: Shandong University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2015-02
• Status Verified: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-21
• Last Update Submitted: 2016-06-21
• Study First Posted: 2016-06-23
• Last Update Posted: 2016-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A group	normal saline	Using normal saline before pcle examination
B group	Scopolamine Hydrobromide	Using Scopolamine Hydrobromide before pcle examination

Primary Outcome Measures

Name	Time	Method
endomicroscopic image quality	7months

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China