Colon AdenomaPCCNCT04512612
Can Pan-Colonic Chromoendoscopy (PCC) Improve Adenoma Detection Rate in FIT-Positive-Patients: A Randomized Study
A study testing Chromoendoscopy and High definition white light colonoscopy in people with Colon Adenoma, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Colonoscopy is the technique of choice for evaluation of patients with positive fecal occult blood (FIT). Identification of polyps and their removal has been shown to decrease colorectal cancer incidence rates and mortality. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Colon Adenoma
- What is being tested?
- Chromoendoscopy and High definition white light colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jul 2020to 1 Aug 2022
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 50 years
- Positive stool FIT test or FOBT test
Who cannot join
- Known inflammatory bowel disease
- Known polyposis syndromes
- Previous history of colon cancer and surgical resection
- Overt gastrointestinal bleeding
- Stool FIT or FOBT test performed during hospitalization
- Inadequate bowel preparation (Boston Bowel Preparation score <6 or <2 for each colonic segment)
Show all 10Show fewer
- Poor patient tolerance to the procedure
- Pregnancy
- Concurrent intake of anticoagulants and thienopyridines (e.g., Clopidogrel), where these drugs cannot be suspended for the adequate duration before colonoscopy
- Patient with known history of hypersensitivity to Indigo carmine dye
Trial locations and contacts
1 site in 1 country.
About this study
Colonoscopy is the technique of choice for evaluation of patients with positive fecal occult blood (FIT). Identification of polyps and their removal has been shown to decrease colorectal cancer incidence rates and mortality. Many endoscopic imaging technologies and devices have been developed to increase adenoma detection (ADR) during screening colonoscopies. They vary in the way they work, and some of the technologies are costly and not widely available. Studies has shown the simple to use pan-colonic chromoendoscopy can improve ADR compared to standard colonoscopy. However, there is little evidence on the utility of pan-colonic chromoendoscopy in asymptomatic individuals undergoing colonoscopy after a positive FIT test. In this randomized study, the investigators aim to compare the utility of chromoendoscopy and high-definition white-light endoscopy in asymptomatic individuals undergoing colonoscopy after a positive FIT test
Read the detailed description
Eligible subjects with positive screening FIT test referred to the Department of Gastroenterology, Singapore General Hospital will be approached and recruited. The included patients will be randomised to either a) Group A- Chromoendoscopy or b) Group B- high definition white light based evaluation.
Hypothesis:
The investigators hypothesize that application of non-absorbable dye during colonoscopy would enhance the mucosal contrast, delineate the border and surface patterns by accumulating in the innominate grooves and, thereby, enhance the detection of adenoma during colonoscopy
Procedure:
Pan-colonic chromoendoscopy and high-definition white light endoscopy will be performed by five experienced endoscopist, and hospital sedation guidelines will be followed. The colonoscopy will be performed using Olympus (CF-HQ190) or Fujifilm (EC-590) colonoscopies. Indigo carmine dye will be used for pan-colonic chromoendoscopy. Two ampules of Indigo carmine (0.8%, 5ml/ampule) will be dissolved in 250 ml of water and sprayed through the waterjet channel by using the auxiliary foot pump upon reaching the caecum.
The colonoscopy insertion will be performed using high-definition white light, and the scope will be advanced till the caecum. The quality of the bowel preparation will be rated according to the validated Boston bowel preparation score. Participants with inadequate bowel preparation score (Score <6) will be excluded from the study. The fecal residue will be washed, suctioned and cleared during insertion to improve visibility. No special care will be taken to look for lesions during the insertion. Assessment for colonic lesions will only be performed during withdrawal of the endoscope. The minimum withdrawal time was set at 7 minutes. Randomization: Once the caecum is intubated and if the bowel preparation is adequate, the participants will be randomized to pan-colonic chromoendoscopy based withdrawal or high-definition while light based withdrawal. In the pan-colonic chromoendoscopy group, the indigo carmine was sprayed by pressing the auxiliary foot pump, and dye was delivered systematically to coat the entire colonic mucosa. In both, the groups, the lesion size, number, location, morphology will be documented during withdrawal. The investigators characterized the morphology of the lesion according to the established Paris classification. The investigators characterized the lesion as flat neoplasm if the lesion project <2.5mm or polypoid lesion if lesion project >2.5mm into the lumen. The investigators measured the size of the lesions using an open biopsy forceps when needed.
In both the groups, the identified polyps will be removed using the standard techniques, and the tissue will be placed in separate formalin bottles and sent for histology assessment. The histology of the polyps was assessed by dedicated pathologist trained in gastrointestinal pathology. Both the endoscopists and the pathologist will not be blinded to the study technique. The investigators defined advanced adenoma as any adenoma >10 mm in size or with >25% villous histology or high-grade dysplasia. The investigators classified hyperplastic polyps and sessile serrated polyps (SSA) as serrated lesions, The investigators excluded hyperplastic lesions in the rectum from the analysis as such lesions are frequently encountered in the rectum
- Conditions
- Colon Adenoma
- Being tested
- Chromoendoscopy, High definition white light colonoscopy
- Keywords
- FIT- positive, Chromoendoscopy, white light endoscopy, adenoma detection rate, advanced adenoma rate, serrated adenoma rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChromoendoscopyDiagnostic test
Participants randomised to Group A will undergo colonoscopic evaluation using dye-based chromoendoscopy
High definition white light colonoscopyDiagnostic test
Participants randomised to Group B will undergo colonoscopic evaluation using high definition white light endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Dye based Chromoendoscopy | Active comparator | The patients enrolled in this group will undergo pan-colonic chromoendoscopy evaluation. Receives: Diagnostic Test: Chromoendoscopy |
| High Definition White Light Endoscopy | Active comparator | The patients enrolled in this group will undergo high definition white light endoscopy based evaluation Receives: Diagnostic Test: High definition white light colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the adenoma detection rate between pan-colonic chromoendoscopy and white light colonoscopy
Measured: 2 years
Secondary outcomes (4)
Advanced adenoma detection rate white light colonoscopy
Measured: 2 years
Flat lesion detection rate
Measured: 2 years
Serrated adenoma detection rate
Measured: 2 years
Withdrawal time comparison
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Jul 2020
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (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 Colon AdenomaStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants will be randomised to one of the two groups. The first group will undergo colonoscopy evaluation using pan-colonic chromoendoscopy during withdrawal of endoscope. In the second group, colonoscopy evaluation will be performed using high-definition white light endoscopy during withdrawal
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512612
- Sponsor's protocol ID
- PCC2019/2831
- Acronym
- PCC
- Status last verified
- Aug 2020
- First submitted
- 10 Aug 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pohl J, Schneider A, Vogell H, Mayer G, Kaiser G, Ell C. Pancolonic chromoendoscopy with indigo carmine versus standard colonoscopy for detection of neoplastic lesions: a randomised two-centre trial. Gut. 2011 Apr;60(4):485-90. doi: 10.1136/gut.2010.229534. Epub 2010 Dec 15.
PubMed 21159889Cubiella J, Castells A, Andreu M, Bujanda L, Carballo F, Jover R, Lanas A, Morillas JD, Salas D, Quintero E; COLONPREV study investigators. Correlation between adenoma detection rate in colonoscopy- and fecal immunochemical testing-based colorectal cancer screening programs. United European Gastroenterol J. 2017 Mar;5(2):255-260. doi: 10.1177/2050640616660662. Epub 2016 Jul 20.
PubMed 28344793
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Pan-Colonic Chromoendoscopy (PCC) Improve Adenoma Detection Rate in FIT-Positive-Patients: A Randomized Study
- ClinicalTrials.gov ID
- NCT04512612
- Acronym / sponsor ID
- PCC / PCC2019/2831
- Conditions
- Colon Adenoma
- Keywords
- FIT- positive, Chromoendoscopy, white light endoscopy, adenoma detection rate, advanced adenoma rate, serrated adenoma rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 13 Aug 2020 (actual)
- 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.
Colonoscopy is the technique of choice for evaluation of patients with positive fecal occult blood (FIT). Identification of polyps and their removal has been shown to decrease colorectal cancer incidence rates and mortality. Many endoscopic imaging technologies and devices have been developed to increase adenoma detection (ADR) during screening colonoscopies. They vary in the way they work, and some of the technologies are costly and not widely available. Studies has shown the simple to use pan-colonic chromoendoscopy can improve ADR compared to standard colonoscopy. However, there is little evidence on the utility of pan-colonic chromoendoscopy in asymptomatic individuals undergoing colonoscopy after a positive FIT test. In this randomized study, the investigators aim to compare the utility of chromoendoscopy and high-definition white-light endoscopy in asymptomatic individuals undergoing colonoscopy after a positive FIT test
Detailed description
Eligible subjects with positive screening FIT test referred to the Department of Gastroenterology, Singapore General Hospital will be approached and recruited. The included patients will be randomised to either a) Group A- Chromoendoscopy or b) Group B- high definition white light based evaluation.
Hypothesis:
The investigators hypothesize that application of non-absorbable dye during colonoscopy would enhance the mucosal contrast, delineate the border and surface patterns by accumulating in the innominate grooves and, thereby, enhance the detection of adenoma during colonoscopy
Procedure:
Pan-colonic chromoendoscopy and high-definition white light endoscopy will be performed by five experienced endoscopist, and hospital sedation guidelines will be followed. The colonoscopy will be performed using Olympus (CF-HQ190) or Fujifilm (EC-590) colonoscopies. Indigo carmine dye will be used for pan-colonic chromoendoscopy. Two ampules of Indigo carmine (0.8%, 5ml/ampule) will be dissolved in 250 ml of water and sprayed through the waterjet channel by using the auxiliary foot pump upon reaching the caecum.
The colonoscopy insertion will be performed using high-definition white light, and the scope will be advanced till the caecum. The quality of the bowel preparation will be rated according to the validated Boston bowel preparation score. Participants with inadequate bowel preparation score (Score <6) will be excluded from the study. The fecal residue will be washed, suctioned and cleared during insertion to improve visibility. No special care will be taken to look for lesions during the insertion. Assessment for colonic lesions will only be performed during withdrawal of the endoscope. The minimum withdrawal time was set at 7 minutes. Randomization: Once the caecum is intubated and if the bowel preparation is adequate, the participants will be randomized to pan-colonic chromoendoscopy based withdrawal or high-definition while light based withdrawal. In the pan-colonic chromoendoscopy group, the indigo carmine was sprayed by pressing the auxiliary foot pump, and dye was delivered systematically to coat the entire colonic mucosa. In both, the groups, the lesion size, number, location, morphology will be documented during withdrawal. The investigators characterized the morphology of the lesion according to the established Paris classification. The investigators characterized the lesion as flat neoplasm if the lesion project <2.5mm or polypoid lesion if lesion project >2.5mm into the lumen. The investigators measured the size of the lesions using an open biopsy forceps when needed.
In both the groups, the identified polyps will be removed using the standard techniques, and the tissue will be placed in separate formalin bottles and sent for histology assessment. The histology of the polyps was assessed by dedicated pathologist trained in gastrointestinal pathology. Both the endoscopists and the pathologist will not be blinded to the study technique. The investigators defined advanced adenoma as any adenoma >10 mm in size or with >25% villous histology or high-grade dysplasia. The investigators classified hyperplastic polyps and sessile serrated polyps (SSA) as serrated lesions, The investigators excluded hyperplastic lesions in the rectum from the analysis as such lesions are frequently encountered in the rectum
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The participants will be randomised to one of the two groups. The first group will undergo colonoscopy evaluation using pan-colonic chromoendoscopy during withdrawal of endoscope. In the second group, colonoscopy evaluation will be performed using high-definition white light endoscopy during withdrawal
| Arm | Type | Receives |
|---|---|---|
| Dye based Chromoendoscopy | Active comparator | Diagnostic Test: ChromoendoscopyThe patients enrolled in this group will undergo pan-colonic chromoendoscopy evaluation. |
| High Definition White Light Endoscopy | Active comparator | Diagnostic Test: High definition white light colonoscopyThe patients enrolled in this group will undergo high definition white light endoscopy based evaluation |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age older than 50 years
- Positive stool FIT test or FOBT test
Key exclusion criteria (10 listed)
- Known inflammatory bowel disease
- Known polyposis syndromes
- Previous history of colon cancer and surgical resection
- Overt gastrointestinal bleeding
- Stool FIT or FOBT test performed during hospitalization
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 |
|---|---|---|
| ChromoendoscopyParticipants randomised to Group A will undergo colonoscopic evaluation using dye-based chromoendoscopy | Diagnostic test | Dye based Chromoendoscopy |
| High definition white light colonoscopyParticipants randomised to Group B will undergo colonoscopic evaluation using high definition white light endoscopy | Diagnostic test | High Definition White Light Endoscopy |
Primary outcome
To evaluate the adenoma detection rate between pan-colonic chromoendoscopy and white light colonoscopy
Time frame: 2 years
4 secondary outcomes
Advanced adenoma detection rate white light colonoscopy
Time frame: 2 years
Flat lesion detection rate
Time frame: 2 years
Serrated adenoma detection rate
Time frame: 2 years
Withdrawal time comparison
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Results publication: PubMed 21159889Pohl J, Schneider A, Vogell H, Mayer G, Kaiser G, Ell C. Pancolonic chromoendoscopy with indigo carmine versus standard colonoscopy for detection of neoplastic lesions: a randomised two-centre trial. Gut. 2011 Apr;60(4):485-90. doi: 10.1136/gut.2010.229534. Epub 2010 Dec 15.
- Results publication: PubMed 28344793Cubiella J, Castells A, Andreu M, Bujanda L, Carballo F, Jover R, Lanas A, Morillas JD, Salas D, Quintero E; COLONPREV study investigators. Correlation between adenoma detection rate in colonoscopy- and fecal immunochemical testing-based colorectal cancer screening programs. United European Gastroenterol J. 2017 Mar;5(2):255-260. doi: 10.1177/2050640616660662. Epub 2016 Jul 20.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chromoendoscopy and High definition white light colonoscopy in people with Colon Adenoma, run by Singapore General Hospital at 1 site in Singapore.
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 2 inclusion and 10 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 13 Aug 2020. 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 Singapore. 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?
Results are not available in the source record.
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?
To evaluate the adenoma detection rate between pan-colonic chromoendoscopy and white light colonoscopy (time frame: 2 years). 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 NCT04512612, 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 13 Aug 2020.