Colorectal NeoplasmsPhase 3UPD-3NCT01434199
Does Endoscope Position Detecting Unit Facilitate a Complete Colonoscopy Examination
A Phase 3 study testing UPD guidance in people with Colorectal Neoplasms, run by Chinese University of Hong Kong at 2 sites in China.
Trial summary
As the incidence of colorectal cancer (CRC) has been rapidly rising in Asian countries, more and more screening colonoscopies are now being performed for prevention or early detection of this fatal disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- UPD guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 870 participants
- Where
- 2 sitesChina
- Study dates
- Jul 2011to Jul 2012
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or above
- American Society of Anaesthesiologist (ASA) grading I-III
- Scheduled for elective colonoscopy
Who cannot join
- Previous colonic resection
- Refuse to consent to participate
- History of allergy to propofol or alfentanil
- Has a pacemaker in situ
- Pregnant lady
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Alice Ho Miu Ling Nethersole Hospital
Hong Kong, Hong Kong
Sophie SF Hon, MD, 852-2632 1495, honsf@surgery.cuhk.edu.hk
- Recruiting
Prince of Wales Hospital
Hong Kong, Hong Kong
Sophie SF Hon, MD, 852-2632 1495, honsf@surgery.cuhk.edu.hk
About this study
Official title: Does Endoscope Position Detecting Unit Facilitate Caecal Intubation? A Randomized Controlled Trial
As the incidence of colorectal cancer (CRC) has been rapidly rising in Asian countries, more and more screening colonoscopies are now being performed for prevention or early detection of this fatal disease. Complete colonoscopy as indicated by caecal intubation is essential to make it a reliable screening tool for colorectal cancer or polyps. Cecal intubation rate is highly variable and dependent on individual experience. Colonic looping is the commonest cause of incomplete colonoscopy. Magnetic endoscope imaging (MEI) is a non-radiological imaging technique to provide real time, three-dimensional image and position of the colonoscope during the procedure. It may facilitate straightening of colonic loops and hence cecal intubation.
The investigators aim to evaluate the benefit of MEI in term of cecal intubation rate across endoscopists of all levels of experience by making use of the newly developed Endoscopy Position Detecting Unit (UPD-3)by Olympus Optical Co, Ltd, Japan.
The investigators propose to conduct a prospective randomized controlled trial to compare the caecal intubation rate of colonoscopy being performed with and without UPD-3 guidance. Colonoscopies performed by endoscopists with different level of experience will be randomized to UPD-3 guided group or conventional group (no UPD-3 guidance). Patient controlled sedation (PCS) containing propofol and alfentanil will be given to all patients. The investigators hypothesize that UPD-3 guided colonoscopy is associated with high caecal intubation rate (complete colonoscopy), shorter time to caecum, less patient pain and lower sedative medication requirement. A high caecal intubation rate facilitates a reliable colonoscopy screening. Decreased colonic looping and shorter time to caecum may reduce patient discomfort during the procedure. It may also facilitate learning and acquiring the skill of colonoscopy in trainees.
Read the detailed description
Hypothesis UPD guided colonoscopy improves cecal intubation rate.
Methods
Trial design This is a prospective randomized controlled trial comparing the cecal intubation rate of colonoscopy being performed with and without UPD guidance by endoscopists of different levels of experience. The trial will be conducted in the Endoscopy Unit of a university affiliated hospital.
Patients who will have elective colonoscopy in the Endoscopy Unit during the study period, and meet the following inclusion criteria are recruited. The colonoscopy will be done by 6 dedicated endoscopists with different levels of experience in performing colonoscopy.
Interventions
UPD-3 and the specific colonoscope with an in-built magnetic imaging facility (Olympus Optical Co, Ltd, Japan) will be used in all examinations. A mobile sensor will be attached to the assistant's hand, so that the hand position in relation to the colonoscope could be shown in the imager screen.
Patient controlled sedation (PCS) will be given to all patients. It is delivered by means of Graseby 3300 PCA pump (Graseby Medical Ltd), using a mixture of propofol (200mg in 20ml) and alfentanil (0.5mg in 1ml) in a 25-ml syringe. The drugs will be delivered in response to pressure on a hand-held button controlled by the patient. Each bolus (0.5ml) delivers 4.8mg propofol and 12microgram alfentanil. No loading dose was used and the lock-out time of the PCA machine was set at zero. All patients will be instructed in the use of the hand-held button before colonoscopy. Nasal oxygen (2l/min) will be given to all patients, and oxygen saturation and blood pressure will be continuously monitored throughout the procedure.
The procedure will be randomized to either with the colonoscopist viewing the imager screen or not.
UPD guided group: Both the colonoscopist and assistant will be viewing the imager screen during the whole procedure. Information about colonoscopy looping will interpreted and documented by the colonoscopist. Anterior-position view is the standard reference. When abdominal compression is required, the assistant nurse should have the hand held probe attached, such that abdominal compression is guided by the image.
Conventional group (non- UPD guided): The imager screen will be turned to the other side such that both the colonoscopist and assistant is blind to UPD images. When the colonoscopist encountered looping as defined by paradoxical movement of the tip or disproportionate advancement in endoscopic view to the shaft insertion, the colonoscopist is requested to estimate the type of loop formed. The images will be captured for later interpretation.
The primary outcome is cecal intubation rate. Cecal intubation is defined as visualization of appendix orifice and ileocaecal valve, procedure started by a trainee and taken over by supervisor before caecal intubation is regarded as incomplete.
Sample size
The cecal intubation rate could be increased by at least 11% for trainee in a randomized trial by Shah [14] and 16% for trainee and experienced endoscopist in another trial [15]. Since the overall cecal intubation rate in our Endoscopy unit without UPD guide is at least 90% already, the investigators expect a modest benefit from UPD guidance. Assume a difference of 5% in caecal intubation rate (from 90% in conventional group to 95% in the UPD guided group) with a power of 80% and a type I error of 5%, 2 sided analysis, 435 patients will be needed in each group. Thus a sample size of 870 patients is required.
Randomization
Informed consent will be obtained before colonoscopy in the Endoscopy Unit, if the patient fulfils the inclusion criteria. Block randomization will be done on a 1:1 basis, to ensure equal number of UPD guided or conventional colonoscopies are done by each endoscopist.
A sealed non-opaque envelope (produced according to the computer generated random sequence) will be opened to determine the appropriate limb of entry before scope insertion.
It is not possible to blind the study.
Statistical analysis
The data will be analyzed according to the intention-to-treat principle. The chi-squared test (or Fisher's exact test when appropriate), Student's t-test, and Mann-Whitney U test will be used to compare categorical, parametric, and non-parametric data, respectively. A P value <0.05 is considered statistically significant.
Planned interim analysis will be conducted after recruiting 50% of patients.
Data collection Data will be collected by the in-charged endoscopist and assistant after each procedure in a standardized data sheet.
Accrual rate It is expected that about 20 cases per week will be recruited for randomization. The study could be finished in around 1 year time.
- Conditions
- Colorectal Neoplasms
- Being tested
- UPD guidance
- Keywords
- magnetic endoscope imaging, colonoscopy, caecal intubation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UPD guidanceProcedure or surgery
Also called Magnetic endoscope imaging (MEI)
A real time, three-dimensional image and position of the colonoscope would be provided to the endoscopist during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| UPD guided group | Experimental | Both the colonoscopist and assistant will be viewing the imager screen during the whole procedure. Receives: Procedure: UPD guidance |
| non-UPD guided group | No intervention | Conventional colonoscopy would be done without image guidance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
caecal intubation rate
Caeal intubation is the landmark for complete colonoscopy. Caecal intubation would be documented after each procedure. The caecal intubation rate with or without UPD guidance would be compared. The result would provide information whether the UPD device can faciliate complete colonoscopy.
Measured: 10minutes in average after starting the procedure
Secondary outcomes (1)
Caecal intubation time
Comparison of caecal intubaton time between UPD guided and non-UPD guided group would provide information on whether UPD device faciliate complete colonoscopy.
Measured: 10 minutes in average after starting the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 870 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hon Sok Fei, Chinese University of Hong Kong
- Investigators
- Sophie SF Hon, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434199
- Sponsor's protocol ID
- CRE-2011.125-T
- Acronym
- UPD-3
- Status last verified
- Sep 2011
- First submitted
- 20 Jun 2011
- Last updated
- 14 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shah SG, Brooker JC, Thapar C, Suzuki N, Williams CB, Saunders BP. Effect of magnetic endoscope imaging on patient tolerance and sedation requirements during colonoscopy: a randomized controlled trial. Gastrointest Endosc. 2002 Jun;55(7):832-7. doi: 10.1067/mge.2002.124097.
PubMed 12024136Shah SG, Brooker JC, Williams CB, Thapar C, Saunders BP. Effect of magnetic endoscope imaging on colonoscopy performance: a randomised controlled trial. Lancet. 2000 Nov 18;356(9243):1718-22. doi: 10.1016/S0140-6736(00)03205-0.
PubMed 11095259
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Endoscope Position Detecting Unit Facilitate Caecal Intubation? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01434199
- Acronym / sponsor ID
- UPD-3 / CRE-2011.125-T
- Conditions
- Colorectal Neoplasms
- Keywords
- magnetic endoscope imaging, colonoscopy, caecal intubation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 870 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 14 Sep 2011 (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.
As the incidence of colorectal cancer (CRC) has been rapidly rising in Asian countries, more and more screening colonoscopies are now being performed for prevention or early detection of this fatal disease. Complete colonoscopy as indicated by caecal intubation is essential to make it a reliable screening tool for colorectal cancer or polyps. Cecal intubation rate is highly variable and dependent on individual experience. Colonic looping is the commonest cause of incomplete colonoscopy. Magnetic endoscope imaging (MEI) is a non-radiological imaging technique to provide real time, three-dimensional image and position of the colonoscope during the procedure. It may facilitate straightening of colonic loops and hence cecal intubation.
The investigators aim to evaluate the benefit of MEI in term of cecal intubation rate across endoscopists of all levels of experience by making use of the newly developed Endoscopy Position Detecting Unit (UPD-3)by Olympus Optical Co, Ltd, Japan.
The investigators propose to conduct a prospective randomized controlled trial to compare the caecal intubation rate of colonoscopy being performed with and without UPD-3 guidance. Colonoscopies performed by endoscopists with different level of experience will be randomized to UPD-3 guided group or conventional group (no UPD-3 guidance). Patient controlled sedation (PCS) containing propofol and alfentanil will be given to all patients. The investigators hypothesize that UPD-3 guided colonoscopy is associated with high caecal intubation rate (complete colonoscopy), shorter time to caecum, less patient pain and lower sedative medication requirement. A high caecal intubation rate facilitates a reliable colonoscopy screening. Decreased colonic looping and shorter time to caecum may reduce patient discomfort during the procedure. It may also facilitate learning and acquiring the skill of colonoscopy in trainees.
Detailed description
Hypothesis UPD guided colonoscopy improves cecal intubation rate.
Methods
Trial design This is a prospective randomized controlled trial comparing the cecal intubation rate of colonoscopy being performed with and without UPD guidance by endoscopists of different levels of experience. The trial will be conducted in the Endoscopy Unit of a university affiliated hospital.
Patients who will have elective colonoscopy in the Endoscopy Unit during the study period, and meet the following inclusion criteria are recruited. The colonoscopy will be done by 6 dedicated endoscopists with different levels of experience in performing colonoscopy.
Interventions
UPD-3 and the specific colonoscope with an in-built magnetic imaging facility (Olympus Optical Co, Ltd, Japan) will be used in all examinations. A mobile sensor will be attached to the assistant's hand, so that the hand position in relation to the colonoscope could be shown in the imager screen.
Patient controlled sedation (PCS) will be given to all patients. It is delivered by means of Graseby 3300 PCA pump (Graseby Medical Ltd), using a mixture of propofol (200mg in 20ml) and alfentanil (0.5mg in 1ml) in a 25-ml syringe. The drugs will be delivered in response to pressure on a hand-held button controlled by the patient. Each bolus (0.5ml) delivers 4.8mg propofol and 12microgram alfentanil. No loading dose was used and the lock-out time of the PCA machine was set at zero. All patients will be instructed in the use of the hand-held button before colonoscopy. Nasal oxygen (2l/min) will be given to all patients, and oxygen saturation and blood pressure will be continuously monitored throughout the procedure.
The procedure will be randomized to either with the colonoscopist viewing the imager screen or not.
UPD guided group: Both the colonoscopist and assistant will be viewing the imager screen during the whole procedure. Information about colonoscopy looping will interpreted and documented by the colonoscopist. Anterior-position view is the standard reference. When abdominal compression is required, the assistant nurse should have the hand held probe attached, such that abdominal compression is guided by the image.
Conventional group (non- UPD guided): The imager screen will be turned to the other side such that both the colonoscopist and assistant is blind to UPD images. When the colonoscopist encountered looping as defined by paradoxical movement of the tip or disproportionate advancement in endoscopic view to the shaft insertion, the colonoscopist is requested to estimate the type of loop formed. The images will be captured for later interpretation.
The primary outcome is cecal intubation rate. Cecal intubation is defined as visualization of appendix orifice and ileocaecal valve, procedure started by a trainee and taken over by supervisor before caecal intubation is regarded as incomplete.
Sample size
The cecal intubation rate could be increased by at least 11% for trainee in a randomized trial by Shah [14] and 16% for trainee and experienced endoscopist in another trial [15]. Since the overall cecal intubation rate in our Endoscopy unit without UPD guide is at least 90% already, the investigators expect a modest benefit from UPD guidance. Assume a difference of 5% in caecal intubation rate (from 90% in conventional group to 95% in the UPD guided group) with a power of 80% and a type I error of 5%, 2 sided analysis, 435 patients will be needed in each group. Thus a sample size of 870 patients is required.
Randomization
Informed consent will be obtained before colonoscopy in the Endoscopy Unit, if the patient fulfils the inclusion criteria. Block randomization will be done on a 1:1 basis, to ensure equal number of UPD guided or conventional colonoscopies are done by each endoscopist.
A sealed non-opaque envelope (produced according to the computer generated random sequence) will be opened to determine the appropriate limb of entry before scope insertion.
It is not possible to blind the study.
Statistical analysis
The data will be analyzed according to the intention-to-treat principle. The chi-squared test (or Fisher's exact test when appropriate), Student's t-test, and Mann-Whitney U test will be used to compare categorical, parametric, and non-parametric data, respectively. A P value <0.05 is considered statistically significant.
Planned interim analysis will be conducted after recruiting 50% of patients.
Data collection Data will be collected by the in-charged endoscopist and assistant after each procedure in a standardized data sheet.
Accrual rate It is expected that about 20 cases per week will be recruited for randomization. The study could be finished in around 1 year time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UPD guided group | Experimental | Procedure: UPD guidanceBoth the colonoscopist and assistant will be viewing the imager screen during the whole procedure. |
| non-UPD guided group | No intervention | –Conventional colonoscopy would be done without image guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or above
- American Society of Anaesthesiologist (ASA) grading I-III
- Scheduled for elective colonoscopy
Key exclusion criteria (5 listed)
- Previous colonic resection
- Refuse to consent to participate
- History of allergy to propofol or alfentanil
- Has a pacemaker in situ
- Pregnant lady
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 |
|---|---|---|
| UPD guidanceAlso: Magnetic endoscope imaging (MEI)A real time, three-dimensional image and position of the colonoscope would be provided to the endoscopist during the procedure. | Procedure or surgery | UPD guided group |
Primary outcome
caecal intubation rate
Time frame: 10minutes in average after starting the procedure
Caeal intubation is the landmark for complete colonoscopy. Caecal intubation would be documented after each procedure. The caecal intubation rate with or without UPD guidance would be compared. The result would provide information whether the UPD device can faciliate complete colonoscopy.
1 secondary outcome
Caecal intubation time
Time frame: 10 minutes in average after starting the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2011.
- Background: PubMed 12024136Shah SG, Brooker JC, Thapar C, Suzuki N, Williams CB, Saunders BP. Effect of magnetic endoscope imaging on patient tolerance and sedation requirements during colonoscopy: a randomized controlled trial. Gastrointest Endosc. 2002 Jun;55(7):832-7. doi: 10.1067/mge.2002.124097.
- Background: PubMed 11095259Shah SG, Brooker JC, Williams CB, Thapar C, Saunders BP. Effect of magnetic endoscope imaging on colonoscopy performance: a randomised controlled trial. Lancet. 2000 Nov 18;356(9243):1718-22. doi: 10.1016/S0140-6736(00)03205-0.
Related trials for Colorectal Neoplasms
Recruiting
MRD Monitoring in Colorectal Cancer Using ctDNA
Colorectal Neoplasms, Colorectal Cancer (Diagnosis)
Recruiting
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Ampulla of Vater Carcinoma, Appendix Carcinoma
Not yet recruitingPhase 2/3
Master Protocol for the Study of Rilogrotug for the Treatment of Weight Loss and Anorexia in Patients With Cancer Cachexia and mCRC or mNSCLC
Cachexia; Cancer, Cachexia
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Colon Adenocarcinoma, DNA Repair Disorder
Not yet recruitingPhase 2
Combining DCSZ11 With Radiation and Chemotherapy as Neoadjuvant Treatment for pMMR Locally Advanced Rectal Cancer
Rectal Cancer
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.
Sophie SF Hon, MD principal investigator
Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing UPD guidance in people with Colorectal Neoplasms, run by Chinese University of Hong Kong at 2 sites 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 3 inclusion and 5 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 14 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sophie SF Hon, MD (852-2632 1495, honsf@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
caecal intubation rate (time frame: 10minutes in average after starting the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01434199, which also lists 2 linked publications.
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 14 Sep 2011.