Colorectal Polyps Clinical Trial
Official title:
Effectiveness of Cold Biopsy Forceps With Pre-lift for Complete Resection of Colonic Polyps ≤7mm in Size.
There is no consensus method for removal of diminutive (5mm) to small(6-9mm) colorectal
polyps at colonoscopy. Neither the European Society of Gastrointestinal Endoscopy or the
American Society of Gastrointestinal Endoscopy have guidelines for the removal of these
polyps, despite the fact that around 90% of lesions removed by polypectomy at colonoscopy
are diminutive to small.
Multiple techniques are used for polyp removal, especially diminutive lesions. These include
either forceps, both hot and cold, as well as snare with electrocautery or cold snare.
Forceps utilises shearing force to grasp tissue and remove it, with the hot method passing a
current through the grasper to essentially burn tissue. Snare is the use of a small metal
loop placed and tightened at the base of polyps to cut through the tissue either straight
away in a cold method or with electrocautery where a small current is passed through the
loop to assist cutting through tissue. Surveys of Colonoscopists and Gastroenterologists in
Australia and the United States show that the choice of method used for diminutive to small
polyps is highly variable with cold snaring marginally favoured.Studies into polypectomy
techniques are limited and it is clear that additional data and the review of polypectomy
methods needs to be undertaken in order determine the optimal method for the removal of
diminutive and small colorectal polyps.
A technique is used at the Gloucestershire National Health Service (NHS) trust involving a
submucosal pre injection with a standard solution then the use of cold forceps for removal
of polyps ≤7mm. This appears to be both very safe and highly effective method for the
removal of these lesions compared to other techniques. No formal published studies have been
completed to evaluate this method at national and international levels. We propose a study
to evaluate the effectiveness, safety and costs of this method.
Hypothesis A pre injection and cold forceps technique for removal of polyps ≤ 7mm is safe
and results in retrieval rates >98% with complete histological resection >90% of the time.
Objectives
1. Determine the histological complete resection rate (CRR) using a pre injection lift and
cold forceps for polypectomy of polyps ≤7mm.
2. Determine the number of bites required for complete visual resection of these polyps
and the time taken from the beginning of pre injection needle insertion till complete
resection.
3. To determine the polyp retrieval rate of this method.
4. To record any complications from this technique.
5. To compare the CRR, number of biopsies for visual eradication, time taken, polyp
retrieval rate and complication rate of this method to cold forceps alone and cold
snare from previous studies.
Methods
Participants:
Sample size 150 polyps, anticipated to be captured in between 75 and 100 patients based on
an average of 2 polyps per patient. There is no published data on this polypectomy technique
and there is limited data on other diminutive to small polypectomy techniques. Other
comparative published studies looking at polypectomy techniques for diminutive to small
polyps have had polyp numbers between fifty four and one hundred and seventeen.The sample
size of 150 polyps is an approximation based on the fact that it is an achievable figure
within the scope of the project and local clinical service which should yield a relatively
narrow confidence interval.
Colonoscopists 3 experienced Gastroenterologists (JA, TB, PD) working within the
Gloucestershire NHS Trust, each having performed over 3000 colonoscopies. All
Gastroenterologists are certified British Bowel Cancer Screening Program Colonoscopists. As
the technique being studied is already well practiced within the trust the extra time
required for each polyp included in the study is negligible.
Pathologist All Polypectomy specimens and EMR tissue will be examined by an expert
Gastrointestinal Pathologist (NS) who will be blinded to the patient and colonoscopist
details when examining specimens.
The additional work for the pathology department is negligible. It can be routine practice
to take additional material for analysis if incomplete removal of the polyp is suspect. In
the study all polyps will have this review. NS will provide consistency and also time to
support us in this project.
Course of Action:
1. Patients will be consented to participate in the study prior to their procedure.
Information regarding the study will be posted to the patient at least a week prior to
their colonoscopy.
2. If patient agrees to participate details including age, sex and indication for scope
will be recorded. This data will be recorded with a patient study number. The patients
will be otherwise anonymised.
3. Data from each colonoscopy and polypectomy will be recorded, including polyp size,
location, time for resection, bites required for complete visual resection (another
study showed the median number of bites to be at 2 with range 1-5 ), overall withdrawal
time and quality of bowel preparation at the time of the procedure. Any adverse events
at the time of colonoscopy, polypectomy and EMR or at subsequent patient follow up 7
days post procedure will be recorded prospectively on form A (Appendix 1) and also
reported to the Research and Development team within 7 days of the Investigators
becoming aware of the adverse event.
3. All colonoscopies will be performed using Olympus 240 and 260 colonoscopes with magnetic
endoscopic imaging and Narrow band imaging (NBI) available to the Colonoscopist if required.
5. The equipment used for each polypectomy and Endomucosal resection (EMR) of polypectomy
site will include the following.
1. Needle for pre injection
2. Pre injection mix will include 19 ml gelofusine, 1ml 1:10000 adrenaline and 1ml indigo
carmine.
3. Cold forceps with span of 6.8mm and capacity of 7.22mm3
4. Olympus snare master 10mm snare.
6. Any complications relating to the polypectomy will be recorded. 7. Polyps ≤7mm will
be included in the study if deemed appropriate by the colonoscopist. Polyps may be
considered inappropriate if polyp location or appearance is not suitable for the
technique being studied.
8. These polyps will be resected with cold forceps after pre injection into the
submucosa. Data related to this resection will be recorded as noted above.
9. The polypectomy site will then be resected with EMR using conventional snare method
to ascertain if there is any residual polyp tissue. This is the only additional step to
the polypectomy process which would not otherwise take place. The risk from this step
of an adverse event to the patient would be significantly less than the risk of
complication from a therapeutic Colonoscopy which is between 0.05 and 0.07%. A maximum
of 3 polyps per patient will be included for study analysis in order to ensure both
patient and colonoscopist time at procedure does not differ significantly from what it
would normally.
10. Both EMR specimen and resected polyp tissue will be sent for histopathological
evaluation by single expert Gastrointestinal Histopathologist who has kindly agreed to
review the extra EMR tissue in his own time.
11. Recruited patients will be called one-week post colonoscopy to ensure they do not
wish to withdraw from the study and they have had no concerns post their procedure.
Adverse Events As mentioned above the risk of adverse events related to the polypectomy
technique being studied or the EMR of residual tissue is minimal.
All adverse events (or medical occurrence) will be recorded in data collection
spreadsheets. Any events classified as 'serious adverse events' (SAE) will be reported
to the Research and Development Unit (RSDU).
The following criteria will be used to assess the relationship (causality) of the
adverse event to the polypectomy technique and EMR performed
1. None: - The adverse event is definitely not associated with the investigational
technique being used.
2. Possible: - A causal relationship is possible when the adverse event follows a
reasonable temporal sequence from the application of the intervention, but could
have been produced by the patient's clinical state or other modes of treatment
being administered to the patient.
3. Probable: - The causal relationship is probable when the adverse event follows a
reasonable temporal sequence from the application of the investigational
technique. This is likely if the adverse event cannot be explained by the known
characteristics of the patient's clinical state
Adverse events will be assessed by one of the investigators who are qualified
Gastroenterologists and managed accordingly.
The severity of adverse events will be recorded using the following criteria:
1. Mild: - Symptom(s) barely noticeable to the patient or does not make the patient
uncomfortable. The AE does not influence performance or functioning.
Prescription drugs are not ordinarily needed for relief of symptom(s).
2. Moderate: - Symptom(s) of a sufficient severity to make the patient uncomfortable
or require endoscopic intervention or other treatments.
3. Severe: - Symptom(s) of a sufficient severity to cause the patient severe
discomfort requiring subsequent treatment or require major endoscopic
intervention, hospitalisation or surgery.
A serious adverse event (SAE) includes adverse events that result in death, require
either inpatient hospitalization or the prolongation of hospitalization, are life
threatening, result in a persistent or significant disability/incapacity. Other
important medical events, based upon appropriate medical judgement, may be considered
Serious Adverse Events if a trial participant's health is at risk and intervention is
required to prevent an adverse outcome.
Dr Alex di Mambro FRCP (Gloucestershire NHS Trust Gastroenterologist) will evaluate,
report and assist in patient management should there be a SAE. In no other way has she
been involved in study development or will she be involved during the course of the
study.
All reports of serious adverse events (SAE) will be recorded on the SAE form for this
trial and forwarded immediately to the Research & Development Unit (RSDU). A copy of
this form can be seen in the appendix 1. In the event of a SAE persisting greater then
24 hours another form will be submitted to the RSDU. Also, in the case of a persisting
SAE the time of event resolution, patient death or discharge a subsequent form will be
completed and submitted.
Data recording and statistical analysis: All data will be recorded prospectively in a
Microsoft excel spread sheet by the chief investigator (SO) and statistical analysis
completed with SPSS version 16. Based on a target sample size of 150 polyps with 90%
success rate the calculated 95% confidence interval will be 84.5-94.2%.
Data storage: The collected data will be kept secure within the department of
Gastroenterology and not shared with uninvolved persons. The data will be anonymised
and the excel sheet the data is collected on will be password protected and not
available to other individuals not involved with the study. All recorded data will be
destroyed by the end of calendar year 2017 or once the anonymised results have been
presented and published which is expected to be by the end of calendar year 2015.
Results It is anticipated that results of this study will be completed for abstract
submission for United European Gastroenterology Week by May 2015. This meeting will be
held in Europe in October 2015. We will aim to publish this data in an international
Endoscopic journal by late 2015. Results will be made available to our Bowel Cancer
screening nurses who will be able to disseminate these results to various Bowel Cancer
support groups.
Funding
Researchers and Time allocation The chief investigator has time (20hr/week) allocated
into current Gloucestershire NHS Trust contract for education and development.
Development of this study, data recording/entry and generation of an academic paper
will all be undertaken in this time.
Professor Neil Shepherd, Pathologist for this project has agreed to undertake the
additional work of EMR tissue review in his own time.
Additional time for colonoscopists will be for EMR of polypectomy site that is
considered negligible in the course of a standard colonoscopy.
Equipment As explained in the methods section minimal additional pieces of equipment
are needed compared to the standard colonoscopy. Snares for EMR of polypectomy site
will only be additional should a snare not have already been required for the removal
of larger polyps during the course of the colonoscopy.
Olympus will kindly provide the additional snares for the study. All other equipment
such as pre injection solution, pre injection needle and cold forceps would normally be
used in the course of colonoscopy and polypectomy.
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