Effect of Buscopan on Gastrointestinal Imaging Quality With Probe-based Confocal Laser Endomicroscopy

NCT02725398 | Unknown DMC

• 1 other identifier: pCLE-BSP
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Gastrointestinal cancer has developed into a serious health problem in China. 80%-90% patients were detected at middle and later stage. The five-year survival rate for advanced cancer patients is less than 10%. The main reason of the bad clinical diagnosis and treatment is that the present technical method is difficult to achieve early diagnosis. Endoscopy with biopsy is still the main method for confirming gastrointestinal cancer. But it is limited to identify early tumors and it leads to the low diagnostic rate of early tumors and the poor overall therapeutic effect. Confocal laser endoscopy (CLE) can obtain pathologic information of lesion in real time and improve the diagnostic rate of early tumors. Probe-based confocal laser endomicroscopy(pCLE) is a new technology recently. Since its laser probe is applicable to all conventional endoscopes, pCLE greatly increased its clinical application. However, gastrointestinal motility has greatly influence on pCLE imaging quality and inspection effect owing to the poor stability of the small probe manipulation. Scopolamine (654-2, in China) is clinically used to inhibit bowel peristalsis, but its effect is still not ideal and its side effects are common.

Conditions

Gastrointestinal Imaging With pCLE

Keywords

Buscopan; probe-based confocal laser endomicroscopy; Imaging Quality

Outcome Measures

Primary Outcomes (1)

• high quality image ratio

  up to 3 years

Secondary Outcomes (3)

• spasm score

  3 years

• diagnosis accuracy rate

  3 years

• scale value of patient' comfort degree assessed by using visual analogue scale (VAS)

  3 years

Study Arms (3)

Buscopan group

EXPERIMENTAL

First to use standard white light to observe, to record spasm score, to observe the lesion.Buscopan (BSP, 20mg) is administered by endoscopic nurse, recorded blindly.

Drug: Buscopan

Scopolamine group

ACTIVE COMPARATOR

First to use standard white light to observe, to record spasm score, to observe the lesion.Scopolamine is administered by endoscopic nurse, recorded blindly.

Drug: Scopolamine

physiological saline group

PLACEBO COMPARATOR

First to use standard white light to observe, to record spasm score, to observe the lesion. Physiological saline is administered by endoscopic nurse, recorded blindly.

Drug: physiological saline

Interventions

Buscopan DRUG

Buscopan is administered by endoscopic nurse in the Buscopan group,and then recording the outcome measures.

Also known as: Butylscopolammonium Bromide

Buscopan group

Scopolamine DRUG

Scopolamine is administered by endoscopic nurse in the Scopolamine group,and then recording the outcome measures.

Also known as: 654-2, in China

Scopolamine group

physiological saline DRUG

Physiological saline is administered by endoscopic nurse in the physiological saline group,and then recording the outcome measures.

Also known as: Sodium Chloride Physiological Solution; NS, normal saline

physiological saline group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: over 18 years
• Sex unlimited
• Patients who were suspected or previous gastrointestinal disease
• Screening outpatients
• Other patients who are willing to accept the case of CLE

You may not qualify if:

• Patients with severe heart or pulmonary disease which is not suitable for endoscopic examination
• Pregnant or lactating female
• Patients who were allergic to contrast medium or clinical drug
• Higher blood risk of esophageal varices
• Patients who were known or suspected gastrointestinal stenosis or obstruction
• Patients who had prostatic hypertrophy, or glaucoma and so on
• Without patient's consent
• Others who can not cooperate with endoscopic examination

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Interventions

Butylscopolammonium Bromide; Scopolamine; Saline Solution

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Belladonna Alkaloids; Solanaceous Alkaloids; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Kaichun Wu, M.D., Prof.

  Xijing Hospital of Digestive Diseases

  STUDY DIRECTOR

Central Study Contacts

Shuhui Liang, M.D.

CONTACT

86-13572885507; liangsh@fmmu.edu.cn

Lu Niu

CONTACT

710257073@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: April 1, 2016
• Study Start: December 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 1, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)