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

March 31, 2016 updated by: Shuhui Liang, Xijing Hospital of Digestive Diseases

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Buscopan can more effectively relieve gastrointestinal spasm, and its side effects is fewer. It has been reported that Buscopan can more effectively relieve gastrointestinal spasm, facilitate scope insertion and improve patients' comfort during endoscopy.Buscopan may make the endoscopic physicians to observe easily and effectively improve the diagnostic rate. Buscopan may effectively inhibit duodenum motility and facilitate the ERCP operation.It has not been reported in the literature whether Buscopan can be used on pCLE examination to improve imaging quality and the detection accuracy of the lesion.

Hence, the investigators plan to develop a prospective, double-blind, randomized, controlled study, the effect of Buscopan on gastrointestinal imaging quality and diagnosis accuracy with probe-based confocal laser endomicroscopy, in order to confirm the practical application value of Buscopan in pCLE examination.

Patient selection, grouping, and operating process:

Subjects were selected based on the inclusion and exclusion criterion from the volunteers eligible for this trial who are inpatient or outpatient applying for pCLE examination in the endoscopy center of Xijing Digestive Disease Hospital. Patients were divided into three groups: Buscopan (BSP), Scopolamine (654-2) and physiological saline (NS) control group, according to the ratio of 1:1:1. Operators were blind to random grouping,and patients were unclear to accept Buscopan, 654-2 or NS drugs before operation. All endoscopy operation should be completed by clinical experienced endoscopists (WKC or LSH) by using gastroscopy、 colonoscopy and enteroscopy, respectively GIF-H260、CF-H260、SIF-260 (Olympus Medical Systems, Tokyo, Japan).

Operating process: Preoperative preparation are basically the same to conventional endoscopy.Patients ingested mucosal surface anesthesia and defoaming agent 30 minutes before endoscopy,and accepted the fluorescein sodium allergy test intravenously (2%, 1 ml) 20 minutes before endoscopy, established venous pathway. Negative patients could accept pCLE examination. First to use standard white light to observe, to record spasm score,to observe the lesion. It is administered by endoscopic nurse which is respectively Buscopan (BSP, 20mg), Scopolamine (654-2,10mg), physiological saline (NS), recorded blindly. Then to inject 10% fluorescein sodium 5ml (Guangzhou Baiyun Shan Ming Xing Pharmaceutical Co., Ltd.) intravenously,to start button to scan by pCLE. To scan in the order of the back of endoscopy,to indicate each observation position by pCLE, to do targeted biopsy by pCLE if met lesion. During the examination,spasm scores (2 minutes,20 minutes after administering drug) and operation time were recorded. Visual analogue scale (visual field stability and patient comfort) level was given after the examination. To record whether related complications happen and positively process. To evaluate the quality of each imaging according to Kiesslich pCLE image quality analysis method and diagnostic accuracy combining with the pathologic diagnosis(through the target biopsy, pathological examination, comparative calculation).

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing Hospital of Digestive Diseases
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shuhui Liang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Buscopan group
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
Buscopan is administered by endoscopic nurse in the Buscopan group,and then recording the outcome measures.
Other Names:
  • Butylscopolammonium Bromide
Active Comparator: Scopolamine group
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
Scopolamine is administered by endoscopic nurse in the Scopolamine group,and then recording the outcome measures.
Other Names:
  • 654-2, in China
Placebo Comparator: physiological saline group
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
Physiological saline is administered by endoscopic nurse in the physiological saline group,and then recording the outcome measures.
Other Names:
  • Sodium Chloride Physiological Solution; NS, normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
high quality image ratio
Time Frame: up to 3 years
up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
spasm score
Time Frame: 3 years
the rate which spasm score decline was significant (spasm score decline two points before and after the drug)
3 years
diagnosis accuracy rate
Time Frame: 3 years
the rate of participants among which the pCLE diagnosis agree with the pathologic diagnosis
3 years
scale value of patient' comfort degree assessed by using visual analogue scale (VAS)
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital of Digestive Diseases

Investigators

  • Study Director: Kaichun Wu, M.D., Prof., Xijing Hospital of Digestive Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

March 21, 2016

First Submitted That Met QC Criteria

March 31, 2016

First Posted (Estimate)

April 1, 2016

Study Record Updates

Last Update Posted (Estimate)

April 1, 2016

Last Update Submitted That Met QC Criteria

March 31, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pCLE-BSP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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