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The Application of Spasmolytic in PCLE Examination of Superior Gastrointestinal Endoscope

S

Shandong University

Status and phase

Completed
Phase 1

Conditions

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

Treatments

Drug: normal saline
Drug: Scopolamine Hydrobromide

Study type

Interventional

Funder types

Other

Identifiers

NCT02811341
2015SDU-QILU-G01

Details and patient eligibility

About

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

Full 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.

Enrollment

122 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

122 participants in 2 patient groups, including a placebo group

A group
Placebo Comparator group
Description:
Using normal saline before pcle examination
Treatment:
Drug: normal saline
B group
Experimental group
Description:
Using Scopolamine Hydrobromide before pcle examination
Treatment:
Drug: Scopolamine Hydrobromide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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