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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Singapore1 site
  • Singapore General Hospital

    Singapore, 169608

Other trials in Singapore

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 groups in NCT04512612
Study groupRoleWhat they receive
Dye based ChromoendoscopyActive comparatorThe patients enrolled in this group will undergo pan-colonic chromoendoscopy evaluation.
Receives: Diagnostic Test: Chromoendoscopy
High Definition White Light EndoscopyActive comparatorThe 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.

  1. To evaluate the adenoma detection rate between pan-colonic chromoendoscopy and white light colonoscopy

    Measured: 2 years

Secondary outcomes (4)
  1. Advanced adenoma detection rate white light colonoscopy

    Measured: 2 years

  2. Flat lesion detection rate

    Measured: 2 years

  3. Serrated adenoma detection rate

    Measured: 2 years

  4. 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.

  1. First posted13 Aug 2020
  2. Study start1 Jul 2020
  3. Primary completion1 Aug 2022 (estimated)
  4. Study completion1 Aug 2022 (estimated)

Resources

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)
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 21159889
  • Cubiella 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

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.

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