Gastrointestinal Imaging With pCLENCT02725398
Effect of Buscopan on Gastrointestinal Imaging Quality With Probe-based Confocal Laser Endomicroscopy
A study testing Buscopan, Scopolamine and physiological saline in people with Gastrointestinal Imaging With pCLE, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Imaging With pCLE
- What is being tested?
- Buscopan, Scopolamine and physiological saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Lu Niu contact
China1 site, 1 recruiting
- Recruiting
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
Shuhui Liang, M.D., 86-13572885507, liangsh@fmmu.edu.cn
Lu Niu, 710257073@qq.com
About this study
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.
Read the 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).
- Conditions
- Gastrointestinal Imaging With pCLE
- Being tested
- Buscopan, Scopolamine, physiological saline
- Keywords
- Buscopan, probe-based confocal laser endomicroscopy, Imaging Quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuscopanDrug
Also called Butylscopolammonium Bromide
Buscopan is administered by endoscopic nurse in the Buscopan group,and then recording the outcome measures.
ScopolamineDrug
Also called 654-2, in China
Scopolamine is administered by endoscopic nurse in the Scopolamine group,and then recording the outcome measures.
physiological salineDrug
Also called Sodium Chloride Physiological Solution; NS, normal saline
Physiological saline is administered by endoscopic nurse in the physiological saline group,and then recording the outcome measures.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: physiological saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
high quality image ratio
Measured: up to 3 years
Secondary outcomes (3)
spasm score
the rate which spasm score decline was significant (spasm score decline two points before and after the drug)
Measured: 3 years
diagnosis accuracy rate
the rate of participants among which the pCLE diagnosis agree with the pathologic diagnosis
Measured: 3 years
scale value of patient' comfort degree assessed by using visual analogue scale (VAS)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startDec 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Imaging With pCLEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuhui Liang, Xijing Hospital of Digestive Diseases
- Investigators
- Kaichun Wu, M.D., Prof., Study director, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725398
- Sponsor's protocol ID
- pCLE-BSP
- Status last verified
- Mar 2016
- First submitted
- 21 Mar 2016
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Buscopan on Gastrointestinal Imaging Quality With Probe-based Confocal Laser Endomicroscopy
- ClinicalTrials.gov ID
- NCT02725398
- Acronym / sponsor ID
- pCLE-BSP
- Conditions
- Gastrointestinal Imaging With pCLE
- Keywords
- Buscopan, probe-based confocal laser endomicroscopy, Imaging Quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Buscopan group | Experimental | Drug: BuscopanFirst 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. |
| Scopolamine group | Active comparator | Drug: ScopolamineFirst to use standard white light to observe, to record spasm score, to observe the lesion.Scopolamine is administered by endoscopic nurse, recorded blindly. |
| physiological saline group | Placebo comparator | Drug: physiological salineFirst to use standard white light to observe, to record spasm score, to observe the lesion. Physiological saline is administered by endoscopic nurse, recorded blindly. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BuscopanAlso: Butylscopolammonium BromideBuscopan is administered by endoscopic nurse in the Buscopan group,and then recording the outcome measures. | Drug | Buscopan group |
| ScopolamineAlso: 654-2, in ChinaScopolamine is administered by endoscopic nurse in the Scopolamine group,and then recording the outcome measures. | Drug | Scopolamine group |
| physiological salineAlso: Sodium Chloride Physiological Solution; NS, normal salinePhysiological saline is administered by endoscopic nurse in the physiological saline group,and then recording the outcome measures. | Drug | physiological saline group |
Primary outcome
high quality image ratio
Time frame: up to 3 years
3 secondary outcomes
spasm score
Time frame: 3 years
diagnosis accuracy rate
Time frame: 3 years
scale value of patient' comfort degree assessed by using visual analogue scale (VAS)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lu Niu contact
Kaichun Wu, M.D., Prof. study director
Xijing Hospital of Digestive Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buscopan, Scopolamine and physiological saline in people with Gastrointestinal Imaging With pCLE, run by Xijing Hospital of Digestive Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuhui Liang, M.D. (86-13572885507, liangsh@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
high quality image ratio (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2016; AzTrials last refreshed its copy on 6 Nov 2026.