Colonic PolypsNCT01182623
The Value of Polyp Surface Pattern Recognition in the Identification of Neoplasia: a Prospective Study
An observational study of Colonic Polyps, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
It is current practice to remove any polyps found during colonoscopy. This is because adenomatous polyps have the potential to turn into cancer. However, a proportion of polyps <10mm in size are hyperplastic, which cannot turn into cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Polyps
- What is being tested?
- Observation of surface patterns of polyps
- How many people
- 260 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2009to 30 Sep 2010
- Phase
- Observational
- 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
Study population: Patients undergoing colonoscopy where one or more polyps are found.
Who may be able to join
- Patients found to have polyps up to 10 mm in size
Who cannot join
- Patient preference Clinicians judgement Obvious cancers Ulcerated polyps
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals NHS trust
Portsmouth, Hampshire, PO6 3LY
About this study
Official title: Polyp Surface Pattern Recognition in the Identification of Neoplastic Polyps
It is current practice to remove any polyps found during colonoscopy. This is because adenomatous polyps have the potential to turn into cancer. However, a proportion of polyps <10mm in size are hyperplastic, which cannot turn into cancer. Current practice requires these to be removed, as it is traditionally felt that they cannot be separated clinically from adenomas. This increases the risk of perforation and results in a significant cost in processing the samples. However, it has been suggested that it is possible to differentiate neoplastic from non neoplastic lesions using skills in polyp surface pattern recognition. If this is the case the investigators may be able to reduce the need for polypectomy The investigators believe that it is possible to tell the difference between polyps with cancerous potential and those that are harmless by assessment of surface patterns. This may enable us to improve the investigators clinical decisions when assessing polyps during colonoscopy, and reduce the number of unnecessary polypectomys being performed.
Read the detailed description
Polyps are a common finding during colonoscopy. It is current practice to remove these lesions, as some have the potential to turn into cancer. However, not all polyps are the same. Polyps can be of three different types:
- Hyperplastic, which have negligible potential to turn into cancer and if left would cause no harm. These account for around one third of all small polyps encountered
- Adenomas, which can turn into cancer and should be removed
- Polyp cancers, which should be either biopsied or removed completely
The management pathway for polyps >10mm is very simple as they are either likely to be adenomas which need removal or cancers which need a biopsy and tattoo. There is a rare possibility of these big polyps being hyperplastic / serrated adenomas and given the risk of malignant transformation, they need removal as well.
It has been traditionally felt that hyperplastic polyps cannot be separated clinically from adenomas or polyp cancers by the endoscopist. It is for this reason that all polyps are removed. However, polypectomy increases the risk of perforation and results in a significant cost in processing the samples. Recently it has been suggested that it is possible to differentiate neoplastic from non neoplastic lesions in the colon using skills in polyp surface pattern recognition.
Kudo's pit pattern is an effective way of in-vivo prediction of histology and differentiating neoplastic from non neoplasic polyps. However, it was originally described using vial staining which is cumbersome, time consuming and is not possible to perform outside Japan due to lack of availability and fears of toxicity related to gentian violet. It does however produce excellent results when used for pit pattern recognition. (Hurlstone DP C. S., 2004) It works by irreversibly binding microbial DNA and directly inhibiting cell replication. (Wakelin LPG, 1981).
Gentian violet is not the only way to examine the surface patterns of polyps. Many of the features can be seen with white light endoscopy. (Fu KI, 2004). Furthermore, there is extensive experience with other dies which are commonly used in Western Europe. Indigo carmine dye spray has been performed in studies in Japan, and has proven to be very effective in the assesment of polyp characteristics. It has been used for over 14 years in colonoscopy (Axelrad, 1996). Overall diagnostic accuracy by conventional view, chromoendoscopy and chromoendoscopy with magnification ranged from 68% to 83%, 82% to 92%, and 80% to 96%, respectively. (Axelrad AM, 1996) (Tung SY, 2001) (Eisen GM, 2002) (Su MY, 2004) (Apel D, 2006). It has the advantage over gentian violet that it does not bind to tissues and is therefore very safe. It has been questioned whether widespread applications of the techniques could influence the indications for biopsy sampling during colonoscopy and the indication for mucosectomy (Yasushi Sano, 2005).
When compared to standard colonoscopy, indigo carmine chromoendoscopy, with magnification, has been shown to increase the accuracy for polyp differentiation from 84% to 96% (Fu KI, 2004). High-resolution indigo carmine chromoendoscopy demonstrated a small increase in accuracy over chromoendoscopy without magnification from 81% to 83% . (Hurlstone DP K. M., 2005).
Because of its numerous benefits in lesion detection and assessment of polyps indigo carmine has become a standard part of colonoscopy and is recognised by the British Society of Gastroenterology as an important skill for the practicing endoscopist. It has become standard practice within Portsmouth Hospitals NHS trust when performing colonoscopy. This is a position which is reflected nationally in most large units which participate in the bowel cancer screening programme.
White light endoscopy and chromoendoscopy are not the only methods of examining colonic polyps. Computed virtual colonoscopy, where a video computer processor within the endoscopy equipment enhances the endoscopic picture have become commonly available. There are systems available from all of the main endoscope manufacturers, including narrow band imaging from Olympus and i-scan from Pentax. Fujinon has developed a very effective post processor technology called FICE which helps define the surface pattern of polyps in great detail. This is now a standard feature on all of the endoscopes produced by the company. It has been shown in a limited number of studies to offer a potentially useful alternative to dye spray in predicting in-vivo histology. (J. Pohl, 2008). A prospective randomised multicentre study looked at 764 patients with FICE compared to white light with targeted indigocarmine spray. It found that FICE and indigocarmine were both able to differentiate adenomas from neoplasia. There was a sensitivity in differentiating adenomas from non-neoplastic polyps of 92.7%,with FICE, comparable but not superior to that of indigocarmine (90.4%), with no statistically significant difference between the two techniques observed. (p=0.44.) FICE did not shorten the procedure time. A prospective series looking at FICE in the evaluation of colononic polyps up to 2cm in size by the same team suggested a sensitivity of 89% could be achieved. Unfortunately these studies looked at larger lesions and therefore it is difficult to say whether this could be achieved with polyps <1cm, where accurate assessment is clearly more difficult. However, it is in the smaller lesions where the greatest gain in terms of a change in management exists. (Pohl J N.-T. M., 2008).
It is generally accepted that further research is needed in this field. If it is possible for endoscopists to differentiate neoplastic from non neoplastic polyps the potential benefits both in terms of safety and histopathology costs would be significant. The current policy of polypectomy or biopsy of all polyps detected during colonoscopy is a very expensive option (£ 80-120) and carries a significant risk of perforation.
Within Portsmouth Hospitals NHS trust it has become standard practice to assess all polyps with FICE and dye spray with indigo carmine prior to removal. This is consistent with current guidelines from the British society of Gastroenterologists and is important both in the detection and assessment of polyps. These techniques are established and their importance in colonoscopy is not under investigation. What is unclear is whether endoscopists are able to differentiate neoplastic from non-neoplastic lesions on a basis of surface pattern recognition accurately enough to be able to change clinical practice.
We aim to assess the impact of surface pattern assessment on the potential management of patients, and whether it has the potential to safely replace the policy of biopsy / polypectomy for pateints with polyps <10mm in size.
- Conditions
- Colonic Polyps
- Being tested
- Observation of surface patterns of polyps
- Keywords
- FICE, Chromoendoscopy, Colonic polyps, Adenomas, Hyperplastic polyps
- Medical subject headings
- Colonic Polyps, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of surface patterns of polypsOther
examination of the surface patterns of polyps using FICE and indigo carmine dye spray
| Study group | Role | What they receive |
|---|---|---|
| In vivo diagnosis | Patients undergoing colonoscopy where one or more polyps up to 10mm in size are found. Receives: Other: Observation of surface patterns of polyps |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of predicted in-vivo polyp histology
Measured: 9 months
Secondary outcomes (7)
• Sensitivity of white light endoscopy in predicting histology
Measured: 9 months
specificity of white light endoscopy in predicting histology
Measured: 9 months
Sensitivity of Chromoendoscopy in predicting histology
Measured: 9 months
Specificity of Chromoendoscopy in predicting histology
Measured: 9 months
Sensitivity of fujinon intelligent color enhancement (FICE) in predicting histology
Measured: 9 months
Specificity of fujinon intelligent color enhancement (FICE) in predicting histology
Measured: 9 months
Whether one technique is superior
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startDec 2009
- Primary completion30 Sep 2010
- Study completion30 Sep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pradeep Bhandari, MBBS,MD,MRCP, Principal investigator, Consultant gastroenterologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182623
- Sponsor's protocol ID
- PHT2009/046
- Status last verified
- Apr 2023
- First submitted
- 12 Aug 2010
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyp Surface Pattern Recognition in the Identification of Neoplastic Polyps
- ClinicalTrials.gov ID
- NCT01182623
- Acronym / sponsor ID
- PHT2009/046
- Conditions
- Colonic Polyps
- Keywords
- FICE, Chromoendoscopy, Colonic polyps, Adenomas, Hyperplastic polyps
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- Dec 2009 (actual)
- Primary completion
- 30 Sep 2010 (actual)
- Study completion
- 30 Sep 2010 (actual)
- First posted
- 17 Aug 2010 (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.
It is current practice to remove any polyps found during colonoscopy. This is because adenomatous polyps have the potential to turn into cancer. However, a proportion of polyps <10mm in size are hyperplastic, which cannot turn into cancer. Current practice requires these to be removed, as it is traditionally felt that they cannot be separated clinically from adenomas. This increases the risk of perforation and results in a significant cost in processing the samples. However, it has been suggested that it is possible to differentiate neoplastic from non neoplastic lesions using skills in polyp surface pattern recognition. If this is the case the investigators may be able to reduce the need for polypectomy The investigators believe that it is possible to tell the difference between polyps with cancerous potential and those that are harmless by assessment of surface patterns. This may enable us to improve the investigators clinical decisions when assessing polyps during colonoscopy, and reduce the number of unnecessary polypectomys being performed.
Detailed description
Polyps are a common finding during colonoscopy. It is current practice to remove these lesions, as some have the potential to turn into cancer. However, not all polyps are the same. Polyps can be of three different types:
- Hyperplastic, which have negligible potential to turn into cancer and if left would cause no harm. These account for around one third of all small polyps encountered
- Adenomas, which can turn into cancer and should be removed
- Polyp cancers, which should be either biopsied or removed completely
The management pathway for polyps >10mm is very simple as they are either likely to be adenomas which need removal or cancers which need a biopsy and tattoo. There is a rare possibility of these big polyps being hyperplastic / serrated adenomas and given the risk of malignant transformation, they need removal as well.
It has been traditionally felt that hyperplastic polyps cannot be separated clinically from adenomas or polyp cancers by the endoscopist. It is for this reason that all polyps are removed. However, polypectomy increases the risk of perforation and results in a significant cost in processing the samples. Recently it has been suggested that it is possible to differentiate neoplastic from non neoplastic lesions in the colon using skills in polyp surface pattern recognition.
Kudo's pit pattern is an effective way of in-vivo prediction of histology and differentiating neoplastic from non neoplasic polyps. However, it was originally described using vial staining which is cumbersome, time consuming and is not possible to perform outside Japan due to lack of availability and fears of toxicity related to gentian violet. It does however produce excellent results when used for pit pattern recognition. (Hurlstone DP C. S., 2004) It works by irreversibly binding microbial DNA and directly inhibiting cell replication. (Wakelin LPG, 1981).
Gentian violet is not the only way to examine the surface patterns of polyps. Many of the features can be seen with white light endoscopy. (Fu KI, 2004). Furthermore, there is extensive experience with other dies which are commonly used in Western Europe. Indigo carmine dye spray has been performed in studies in Japan, and has proven to be very effective in the assesment of polyp characteristics. It has been used for over 14 years in colonoscopy (Axelrad, 1996). Overall diagnostic accuracy by conventional view, chromoendoscopy and chromoendoscopy with magnification ranged from 68% to 83%, 82% to 92%, and 80% to 96%, respectively. (Axelrad AM, 1996) (Tung SY, 2001) (Eisen GM, 2002) (Su MY, 2004) (Apel D, 2006). It has the advantage over gentian violet that it does not bind to tissues and is therefore very safe. It has been questioned whether widespread applications of the techniques could influence the indications for biopsy sampling during colonoscopy and the indication for mucosectomy (Yasushi Sano, 2005).
When compared to standard colonoscopy, indigo carmine chromoendoscopy, with magnification, has been shown to increase the accuracy for polyp differentiation from 84% to 96% (Fu KI, 2004). High-resolution indigo carmine chromoendoscopy demonstrated a small increase in accuracy over chromoendoscopy without magnification from 81% to 83% . (Hurlstone DP K. M., 2005).
Because of its numerous benefits in lesion detection and assessment of polyps indigo carmine has become a standard part of colonoscopy and is recognised by the British Society of Gastroenterology as an important skill for the practicing endoscopist. It has become standard practice within Portsmouth Hospitals NHS trust when performing colonoscopy. This is a position which is reflected nationally in most large units which participate in the bowel cancer screening programme.
White light endoscopy and chromoendoscopy are not the only methods of examining colonic polyps. Computed virtual colonoscopy, where a video computer processor within the endoscopy equipment enhances the endoscopic picture have become commonly available. There are systems available from all of the main endoscope manufacturers, including narrow band imaging from Olympus and i-scan from Pentax. Fujinon has developed a very effective post processor technology called FICE which helps define the surface pattern of polyps in great detail. This is now a standard feature on all of the endoscopes produced by the company. It has been shown in a limited number of studies to offer a potentially useful alternative to dye spray in predicting in-vivo histology. (J. Pohl, 2008). A prospective randomised multicentre study looked at 764 patients with FICE compared to white light with targeted indigocarmine spray. It found that FICE and indigocarmine were both able to differentiate adenomas from neoplasia. There was a sensitivity in differentiating adenomas from non-neoplastic polyps of 92.7%,with FICE, comparable but not superior to that of indigocarmine (90.4%), with no statistically significant difference between the two techniques observed. (p=0.44.) FICE did not shorten the procedure time. A prospective series looking at FICE in the evaluation of colononic polyps up to 2cm in size by the same team suggested a sensitivity of 89% could be achieved. Unfortunately these studies looked at larger lesions and therefore it is difficult to say whether this could be achieved with polyps <1cm, where accurate assessment is clearly more difficult. However, it is in the smaller lesions where the greatest gain in terms of a change in management exists. (Pohl J N.-T. M., 2008).
It is generally accepted that further research is needed in this field. If it is possible for endoscopists to differentiate neoplastic from non neoplastic polyps the potential benefits both in terms of safety and histopathology costs would be significant. The current policy of polypectomy or biopsy of all polyps detected during colonoscopy is a very expensive option (£ 80-120) and carries a significant risk of perforation.
Within Portsmouth Hospitals NHS trust it has become standard practice to assess all polyps with FICE and dye spray with indigo carmine prior to removal. This is consistent with current guidelines from the British society of Gastroenterologists and is important both in the detection and assessment of polyps. These techniques are established and their importance in colonoscopy is not under investigation. What is unclear is whether endoscopists are able to differentiate neoplastic from non-neoplastic lesions on a basis of surface pattern recognition accurately enough to be able to change clinical practice.
We aim to assess the impact of surface pattern assessment on the potential management of patients, and whether it has the potential to safely replace the policy of biopsy / polypectomy for pateints with polyps <10mm in size.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In vivo diagnosis | – | Other: Observation of surface patterns of polypsPatients undergoing colonoscopy where one or more polyps up to 10mm in size are found. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing colonoscopy where one or more polyps are found.
Key inclusion criteria (1 listed)
- Patients found to have polyps up to 10 mm in size
Key exclusion criteria (1 listed)
- Patient preference Clinicians judgement Obvious cancers Ulcerated polyps
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 |
|---|---|---|
| Observation of surface patterns of polypsexamination of the surface patterns of polyps using FICE and indigo carmine dye spray | Other | In vivo diagnosis |
Primary outcome
The accuracy of predicted in-vivo polyp histology
Time frame: 9 months
7 secondary outcomes
• Sensitivity of white light endoscopy in predicting histology
Time frame: 9 months
specificity of white light endoscopy in predicting histology
Time frame: 9 months
Sensitivity of Chromoendoscopy in predicting histology
Time frame: 9 months
Specificity of Chromoendoscopy in predicting histology
Time frame: 9 months
Sensitivity of fujinon intelligent color enhancement (FICE) in predicting histology
Time frame: 9 months
Specificity of fujinon intelligent color enhancement (FICE) in predicting histology
Time frame: 9 months
Whether one technique is superior
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
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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.
Pradeep Bhandari, MBBS,MD,MRCP principal investigator
Consultant gastroenterologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Polyps, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Apr 2023. 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 United Kingdom. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of predicted in-vivo polyp histology (time frame: 9 months). 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 10 Apr 2023; AzTrials last refreshed its copy on 29 Oct 2026.