Polyp ColorectalNCT04576780
An Integrated Management Pathway for Complex Colorectal Polyps
An observational study of Polyp Colorectal, run by Unity Health Toronto.
Trial summary
The purpose of this study is to evaluate the impact of implementing an integrated clinical care pathway for the diagnosis, referral, evaluation and treatment of large complex colorectal polyps on clinical outcomes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyp Colorectal
- What is being tested?
- Integrated Large Complex Polyp Referral Pathway
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Jan 2024
- 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: Adult patients who were identified to have a large, complex polyp on colonoscopy at a community hospital or ambulatory endoscopy center referred for removal to the therapeutic endoscopy group at St. Michaels Hospital.
Who may be able to join
- Adult patient 18 years or older
- Large or complex colorectal polyp found during diagnostic colonoscopy
Who cannot join
- Severe medical comorbidities that contraindicate safe endoscopy procedures
- Inability to provide informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Integrated Strategy for the Expedited Diagnosis, Referral, Assessment and Treatment of Complex Colorectal Polyps
The purpose of this study is to evaluate the impact of implementing an integrated clinical care pathway for the diagnosis, referral, evaluation and treatment of large complex colorectal polyps on clinical outcomes
Read the detailed description
Our project will create a system that links community hospitals and ambulatory endoscopy centers throughout the province of Ontario, directly to the expert endoscopists at our tertiary referral center, to facilitate the timely assessment of polyps based on an electronic referral containing endoscopic video recordings or high-resolution images rather than a paper report through a centralized referral pathway. This polyp adjudication will happen in a timely fashion without involving in-person patient consultation, and will streamline the management of these patients to either referral for surgery or booking for endoscopic polyp removal by therapeutic colonoscopy at our center. Specific endoscopy time slots will be reserved for these patients to ensure they have efficient access to their treatment. This system represents a new care model for managing patients with concerning pre-cancerous lesions diagnosed in disparate local hospitals through a centralized process of referral, diagnostic evaluation and treatment at an expert tertiary referral centre.
The primary aim of our study will be to track the outcomes of the new standard-of-care clinical pathway. Clinical objectives of the project include a reduction in wait times for expert assessment after diagnosis of a large or otherwise concerning polyp combined with reduced wait times for therapeutic removal of these polyps, minimizing unnecessary surgery for benign lesions, and facilitating early recommendation for surgery in those patients who truly require surgical resection. Additional objectives include the achievement of excellent rates of clinical success, complication rates similar to those reported in the literature, and high levels of satisfaction from referring doctors at participating centers. A final, major goal is to assess whether this pilot program could serve as a model to be expanded to other academic, tertiary referral centers throughout the province of Ontario.
Our primary research question seeks to compare the diagnostic accuracy of expert polyp adjudication between the different modes of referral (video clip, color photograph, faxed images) against the real-time endoscopic diagnosis during therapeutic colonoscopy and the final pathologic result. The secondary research question is to follow the clinical outcomes of all patients who undergo endoscopic mucosal resection (EMR) of a large or complex colorectal polyp to evaluate the efficacy and safety of this procedure at our expert tertiary referral center.
- Conditions
- Polyp Colorectal
- Being tested
- Integrated Large Complex Polyp Referral Pathway
- Keywords
- Large Colorectal Polyp, Complex Colorectal Polyp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Large Complex Polyp Referral PathwayOther
The referring doctor will use a standardized template to send the referral along with its associated video or high-resolution photographs.
Referrals will be reviewed in a consensus fashion by at least 2 expert physicians at St. Michael's Hospital (SMH) on a bi-weekly basis. Polyps will be scored using a standardized evaluation form that documents relevant polyp features to assist the determination of whether a lesion is amenable to curative endoscopic resection.
Cases will be triaged as being: (1) a standard polyp suitable for local removal in the community; (2) a complex polyp requiring expert removal at SMH with priority assigned based on the suspected risk of invasive disease; (3) a polyp that is not amenable to endoscopic resection or that is suspicious for cancer will that be recommended for surgical resection.
| Study group | Role | What they receive |
|---|---|---|
| Referred Patients with Large, Complex Colorectal Polyps | Patients referred from outside community care hospitals or ambulatory endoscopy centers to the therapeutic endoscopy group at St. Michaels Hospital via the new integrated management pathway for endoscopic resection of a large or complex colorectal polyp. Receives: Other: Integrated Large Complex Polyp Referral Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of remote polyp diagnosis (based on video clips, electronic color photographs or paper-based images) compared to real-time endoscopic diagnosis during therapeutic colonoscopy
Determination of diagnostic accuracy (reported as sensitivity and specificity) of video-based vs. real-time endoscopic diagnosis of polyps; diagnostic accuracy of electronic color photo-based vs. real-time endoscopic diagnosis of polyps; diagnostic accuracy of paper-based images vs. real-time endoscopic diagnosis of polyps.
Measured: During Procedure
Secondary outcomes (7)
Patient Wait Times
Wait times (measured in days) from index colonoscopy to polyp adjudication, and from index colonoscopy to therapeutic polyp removal. Comparison will be made to historical wait times for polyps > 2 cm referred to SMH for polyp removal.
Measured: During Procedure
Prediction of Polyp Diagnosis
Polyp diagnosis based on initial colonoscopy performed at the referring centre, video- or photo-based assessment during polyp triage, and real-time evaluation during colonoscopy by expert endoscopist at SMH, assessed against final pathology from resected polyp specimen.
Measured: Until availability of histology, generally up to 2 weeks post procedure
Need for adjunctive removal
Rate of complete snare resection of polyps versus need for the use of combined adjunctive techniques (hot/cold avulsion, argon plasma coagulation, etc.) to achieve removal of polyps.
Measured: During Procedure
Prediction of Successful Endoscopic Treatment
Accuracy (reported as likelihood ratios) of the correct prediction of successful endoscopic treatment based on initial video-based, electronic colour photo-based, or paper image-based assessment during polyp triage compared to real-time evaluation during colonoscopy (prior to commencing attempt at polyp removal), assessed against final endoscopic outcome.
Measured: Through study completion, up to 1 year
Procedural complications
Rate of immediate and delayed complications both intra-procedural and post-procedural up to 4 weeks.
Measured: Up to 4 weeks
Residual/Recurrent Polyp
Rate and predictors of residual or recurrent polyp at follow-up surveillance colonoscopy.
Measured: 6 months
Referring Physician Satisfaction
Study specific survey consisting of a 5 point likert scale ranging from 1 ("extremely dissatisfied") to 5 ("extremely satisfied"). Assessed at 1 year from initial referral.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study startJan 2021 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyp ColorectalStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Teshima, MD, Principal investigator, St. Michaels Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576780
- Sponsor's protocol ID
- CTO - 1899
- Status last verified
- Nov 2020
- First submitted
- 15 Sep 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Strategy for the Expedited Diagnosis, Referral, Assessment and Treatment of Complex Colorectal Polyps
- ClinicalTrials.gov ID
- NCT04576780
- Acronym / sponsor ID
- CTO - 1899
- Conditions
- Polyp Colorectal
- Keywords
- Large Colorectal Polyp, Complex Colorectal Polyp
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 6 Oct 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.
The purpose of this study is to evaluate the impact of implementing an integrated clinical care pathway for the diagnosis, referral, evaluation and treatment of large complex colorectal polyps on clinical outcomes
Detailed description
Our project will create a system that links community hospitals and ambulatory endoscopy centers throughout the province of Ontario, directly to the expert endoscopists at our tertiary referral center, to facilitate the timely assessment of polyps based on an electronic referral containing endoscopic video recordings or high-resolution images rather than a paper report through a centralized referral pathway. This polyp adjudication will happen in a timely fashion without involving in-person patient consultation, and will streamline the management of these patients to either referral for surgery or booking for endoscopic polyp removal by therapeutic colonoscopy at our center. Specific endoscopy time slots will be reserved for these patients to ensure they have efficient access to their treatment. This system represents a new care model for managing patients with concerning pre-cancerous lesions diagnosed in disparate local hospitals through a centralized process of referral, diagnostic evaluation and treatment at an expert tertiary referral centre.
The primary aim of our study will be to track the outcomes of the new standard-of-care clinical pathway. Clinical objectives of the project include a reduction in wait times for expert assessment after diagnosis of a large or otherwise concerning polyp combined with reduced wait times for therapeutic removal of these polyps, minimizing unnecessary surgery for benign lesions, and facilitating early recommendation for surgery in those patients who truly require surgical resection. Additional objectives include the achievement of excellent rates of clinical success, complication rates similar to those reported in the literature, and high levels of satisfaction from referring doctors at participating centers. A final, major goal is to assess whether this pilot program could serve as a model to be expanded to other academic, tertiary referral centers throughout the province of Ontario.
Our primary research question seeks to compare the diagnostic accuracy of expert polyp adjudication between the different modes of referral (video clip, color photograph, faxed images) against the real-time endoscopic diagnosis during therapeutic colonoscopy and the final pathologic result. The secondary research question is to follow the clinical outcomes of all patients who undergo endoscopic mucosal resection (EMR) of a large or complex colorectal polyp to evaluate the efficacy and safety of this procedure at our expert tertiary referral center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Referred Patients with Large, Complex Colorectal Polyps | – | Other: Integrated Large Complex Polyp Referral PathwayPatients referred from outside community care hospitals or ambulatory endoscopy centers to the therapeutic endoscopy group at St. Michaels Hospital via the new integrated management pathway for endoscopic resection of a large or complex colorectal polyp. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who were identified to have a large, complex polyp on colonoscopy at a community hospital or ambulatory endoscopy center referred for removal to the therapeutic endoscopy group at St. Michaels Hospital.
Key inclusion criteria (2 listed)
- Adult patient 18 years or older
- Large or complex colorectal polyp found during diagnostic colonoscopy
Key exclusion criteria (2 listed)
- Severe medical comorbidities that contraindicate safe endoscopy procedures
- Inability to provide informed consent
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 |
|---|---|---|
| Integrated Large Complex Polyp Referral PathwayThe referring doctor will use a standardized template to send the referral along with its associated video or high-resolution photographs. Referrals will be reviewed in a consensus fashion by at least 2 expert physicians at St. Michael's Hospital (SMH) on a bi-weekly basis. Polyps will be scored using a standardized evaluation form that documents relevant polyp features to assist the determination of whether a lesion is amenable to curative endoscopic resection. Cases will be triaged as being: (1) a standard polyp suitable for local removal in the community; (2) a complex polyp requiring expert removal at SMH with priority assigned based on the suspected risk of invasive disease; (3) a polyp that is not amenable to endoscopic resection or that is suspicious for cancer will that be recommended for surgical resection. | Other | Referred Patients with Large, Complex Colorectal Polyps |
Primary outcome
Diagnostic accuracy of remote polyp diagnosis (based on video clips, electronic color photographs or paper-based images) compared to real-time endoscopic diagnosis during therapeutic colonoscopy
Time frame: During Procedure
Determination of diagnostic accuracy (reported as sensitivity and specificity) of video-based vs. real-time endoscopic diagnosis of polyps; diagnostic accuracy of electronic color photo-based vs. real-time endoscopic diagnosis of polyps; diagnostic accuracy of paper-based images vs. real-time endoscopic diagnosis of polyps.
7 secondary outcomes
Patient Wait Times
Time frame: During Procedure
Prediction of Polyp Diagnosis
Time frame: Until availability of histology, generally up to 2 weeks post procedure
Need for adjunctive removal
Time frame: During Procedure
Prediction of Successful Endoscopic Treatment
Time frame: Through study completion, up to 1 year
Procedural complications
Time frame: Up to 4 weeks
Residual/Recurrent Polyp
Time frame: 6 months
Referring Physician Satisfaction
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
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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.
Christopher Teshima, MD principal investigator
St. Michaels Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Polyp Colorectal, run by Unity Health Toronto.
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 2 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 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Christopher Teshima, MD ((416) 864-5646, Christopher.Teshima@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of remote polyp diagnosis (based on video clips, electronic color photographs or paper-based images) compared to real-time endoscopic diagnosis during therapeutic colonoscopy (time frame: During Procedure). 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 17 Nov 2020.