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

Sponsor

Xijing Hospital of Digestive Diseases (Other)

Overall Status

Unknown status

CT.gov ID

NCT02725398

Collaborator

(none)

150

Enrollment

Location

Arms

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Imaging With pCLE	Drug: Buscopan Drug: Scopolamine Drug: physiological saline	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Dec 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

high quality image ratio [up to 3 years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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