Sessile Serrated AdenomaNCT06173297
Assessing the Agreement Between Endoscopic and Histopathological Diagnosis of Colorectal Sessile Serrated Lesions.
An observational study of Sessile Serrated Adenoma and Colorectal Polyp, run by Hospital Sirio-Libanes at 1 site in Brazil.
Trial summary
The goal of this observational study was to assess the degree of agreement between the endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions in adult patients undergoing colonoscopy in Hospital Sírio-Libanes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sessile Serrated Adenoma, Colorectal Polyp, Adenoma Colon
- How many people
- 772 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2020to 1 Sep 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged over 18 undergoing colonoscopy at Hospital Sírio-Libanês in the Bela-Vista unit, São Paulo, Brazil, between June and August of 2020.
Who may be able to join
- Patients undergoing elective colonoscopy at Hospital Sírio-Libanês between February 2020 and August 2020.
- Age over 18 years.
Who cannot join
- Patients with inflammatory bowel disease (IBD)
- Patients diagnosed with hereditary polyposis or non-polyposis syndromes.
- Patients with a history of colorectal surgery.
- Patients previously diagnosed with colorectal cancer (CRC).
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study was to assess the degree of agreement between the endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions in adult patients undergoing colonoscopy in Hospital Sírio-Libanes.
The main questions it aimed to answer were:
Read more
- The degree of agreement between endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions by calculating the Kappa Value of agreement.
- To establish the detection rate of sessile serrated lesions and adenomas in the Endoscopy Department at Hospital Sírio-Libanês.
- To evaluate the degree of agreement between endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions based on the resection method.
- To assess the accuracy, positive predictive value, and negative predictive value of endoscopic diagnosis of serrated lesions compared to anatomopathological diagnosis.
The data were prospectively collected through a form specifically designed for this project, that was completed immediately after the examination by the performing colonoscopist. All patients enrolled in this study agreed to participate in it and signed an informed consent form prior to the colonoscopy.
Read the detailed description
The study population was:
Patients aged over 18 undergoing colonoscopy at Hospital Sírio-Libanês in the Bela-Vista unit, São Paulo, Brazil, between June and August 2020.
The sample:
For the present study, an odds ratio of 1.5 in the adenoma detection rate of colorectal lesions was considered concerning the vascular pattern classification of the lesion (NICE), with an expected discordance rate of 30% regarding the histopathological pattern. To achieve this, an estimated sample size of 758 patients was calculated, considering an 80% statistical power and a risk α≤5% for a Type I error, using the McNemar's test for proportions.
Inclusion criteria:
- Patients undergoing elective colonoscopy at Hospital Sírio-Libanês between February 2020 and August 2020.
- Age over 18 years.
Exclusion criteria:
- Patients with inflammatory bowel disease (IBD)
- Patients diagnosed with hereditary polyposis or non-polyposis syndromes.
- Patients with a history of colorectal surgery.
- Patients previously diagnosed with colorectal cancer (CRC).
Study variables analyzed:
- Age (years)
- Gender
- Colon preparation (Boston Scale)
- Presence of colorectal lesions
- Lesion resection technique
- Lesion size
- Lesion location
- Morphological classification of the lesion (Paris)
- Vascular pattern classification of the lesion (NICE)
- Number of lesions found per examination/patient.
Methods:
All colonoscopies in this study were conducted in the endoscopy department of Hospital Sírio-Libanês, and the equipment used was the Olympus™ EVIS Exera III - CV190.
All lesions identified in the study were sent to the pathology service of Hospital Sírio-Libanês for specialized and standardized anatomopathological analysis. The pathologists were blinded to the endoscopic diagnosis of the lesions. The lesions were classified according to the 2019 WHO Classification and subsequently categorized for this study into: hyperplastic polyps, adenomas, sessile serrated lesions, adenocarcinoma, or "others".
Statistical analysis:
Data obtained was assessed using the Gaussian curve and determined as parametric or non-parametric using the Kolmogorov-Smirnov test and the Shapiro-Wilk test. Parametric data were represented by mean and standard deviation, while non-parametric data were represented by median and interquartile range (25th and 75th percentiles). Categorical data were represented by absolute frequency (n) and relative frequency (%) and presented through contingency tables.
Sensitivity, specificity, positive predictive values, and negative predictive values (with corresponding 95% confidence intervals) of colonoscopy for diagnosing sessile serrated lesions using the anatomopathological examination as the gold standard were calculated.
To evaluate agreement between colonoscopy diagnosis and anatomopathological diagnosis, both overall and according to the resection method employed, Cohen's Kappa coefficients and their respective 95% confidence intervals were calculated. These coefficients were then categorized based on Landis \& Koch's criteria (1977).
Ethical considerations:
The research project for this study was thoroughly detailed and submitted for analysis to the Research Ethics Committee (CEP) of Hospital Sírio-Libanês, receiving approval under CAAE 27604919.2.0000.5461. Patients participating in the study agreed to take part and signed the Informed Consent Form. The involved colonoscopists committed to maintaining the confidentiality of the data.
- Conditions
- Sessile Serrated Adenoma, Colorectal Polyp, Adenoma Colon, Colorectal Cancer, Colonoscopy, Adenoma Detection Rate
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the degree of agreement between the endoscopic and the anatomopathological diagnosis of sessile serrated colorectal lesions
To evaluate concordance between colonoscopy diagnosis and anatomopathological diagnosis, both overall and according to the resection method employed, Cohen's Kappa coefficients and their respective 95% confidence intervals were calculated. These coefficients were then categorized based on Landis \& Koch's criteria (1977).
Measured: 2 years
Secondary outcomes (3)
To establish the detection rate of sessile serrated lesions and adenomas in the Endoscopy Department at Hospital Sírio-Libanês.
The Detection Rate in colonoscopy is calculated by dividing the number of procedures where at least one of the interested lesion is detected by the total number of procedures performed by the colonoscopist, and then multiplying by 100 to get a percentage.
Measured: 2 years
Evaluate the degree of agreement between endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions based on the resection method.
To evaluate concordance between colonoscopy diagnosis and anatomopathological diagnosis, both overall and according to the resection method employed, Cohen's Kappa coefficients and their respective 95% confidence intervals were calculated. These coefficients were then categorized based on Landis \& Koch's criteria (1977).
Measured: 2 years
Assess the accuracy, positive predictive value, and negative predictive value of endoscopic diagnosis of serrated lesions compared to anatomopathological diagnosis.
Sensitivity, specificity, positive predictive values, and negative predictive values (with corresponding 95% confidence intervals) of colonoscopy for diagnosing sessile serrated lesions using the anatomopathological examination as the gold standard were calculated.
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 posted15 Dec 2023
- Study start1 Feb 2020
- Primary completion1 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Sessile Serrated AdenomaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 772 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniela S Oliveira, Master, Principal investigator, Hospital Sirio-Libanes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173297
- Sponsor's protocol ID
- AVAP-NG 1415
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Pan J, Xin L, Ma YF, Hu LH, Li ZS. Colonoscopy Reduces Colorectal Cancer Incidence and Mortality in Patients With Non-Malignant Findings: A Meta-Analysis. Am J Gastroenterol. 2016 Mar;111(3):355-65. doi: 10.1038/ajg.2015.418. Epub 2016 Jan 12.
PubMed 26753884Kaminski MF, Robertson DJ, Senore C, Rex DK. Optimizing the Quality of Colorectal Cancer Screening Worldwide. Gastroenterology. 2020 Jan;158(2):404-417. doi: 10.1053/j.gastro.2019.11.026. Epub 2019 Nov 20.
PubMed 31759062Wolf AMD, Fontham ETH, Church TR, Flowers CR, Guerra CE, LaMonte SJ, Etzioni R, McKenna MT, Oeffinger KC, Shih YT, Walter LC, Andrews KS, Brawley OW, Brooks D, Fedewa SA, Manassaram-Baptiste D, Siegel RL, Wender RC, Smith RA. Colorectal cancer screening for average-risk adults: 2018 guideline update from the American Cancer Society. CA Cancer J Clin. 2018 Jul;68(4):250-281. doi: 10.3322/caac.21457. Epub 2018 May 30.
PubMed 29846947Brenner H, Hoffmeister M, Arndt V, Stegmaier C, Altenhofen L, Haug U. Protection from right- and left-sided colorectal neoplasms after colonoscopy: population-based study. J Natl Cancer Inst. 2010 Jan 20;102(2):89-95. doi: 10.1093/jnci/djp436. Epub 2009 Dec 30.
PubMed 20042716Hassan C, Antonelli G, Dumonceau JM, Regula J, Bretthauer M, Chaussade S, Dekker E, Ferlitsch M, Gimeno-Garcia A, Jover R, Kalager M, Pellise M, Pox C, Ricciardiello L, Rutter M, Helsingen LM, Bleijenberg A, Senore C, van Hooft JE, Dinis-Ribeiro M, Quintero E. Post-polypectomy colonoscopy surveillance: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2020. Endoscopy. 2020 Aug;52(8):687-700. doi: 10.1055/a-1185-3109. Epub 2020 Jun 22.
PubMed 32572858O'Brien MJ, Winawer SJ, Zauber AG, Gottlieb LS, Sternberg SS, Diaz B, Dickersin GR, Ewing S, Geller S, Kasimian D, et al. The National Polyp Study. Patient and polyp characteristics associated with high-grade dysplasia in colorectal adenomas. Gastroenterology. 1990 Feb;98(2):371-9.
PubMed 2403953Mareth K, Gurm H, Madhoun MF. Endoscopic Recognition and Classification of Colorectal Polyps. Gastrointest Endosc Clin N Am. 2022 Apr;32(2):227-240. doi: 10.1016/j.giec.2021.12.003. Epub 2022 Feb 22.
PubMed 35361333Kim JH, Kang GH. Evolving pathologic concepts of serrated lesions of the colorectum. J Pathol Transl Med. 2020 Jul;54(4):276-289. doi: 10.4132/jptm.2020.04.15. Epub 2020 Jun 26.
PubMed 32580537Vennelaganti S, Cuatrecasas M, Vennalaganti P, Kennedy KF, Srinivasan S, Patil DT, Plesec T, Lanas A, Horndler C, Andraws N, Cherian R, Mathur S, Hassan C, Repici A, Klotz D, Musulen E, Risio M, Castells A, Gupta N, Sharma P. Interobserver Agreement Among Pathologists in the Differentiation of Sessile Serrated From Hyperplastic Polyps. Gastroenterology. 2021 Jan;160(1):452-454.e1. doi: 10.1053/j.gastro.2020.09.015. Epub 2020 Sep 18. No abstract available.
PubMed 32950521Ahmad A, Moorghen M, Wilson A, Saunders BP. NBI International Colorectal Endoscopic-derived high-confidence optical diagnosis of small polyps compared with histology: understanding errors to improve diagnostic accuracy. Gastrointest Endosc. 2023 Jan;97(1):78-88. doi: 10.1016/j.gie.2022.08.032. Epub 2022 Aug 24.
PubMed 36029884
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Agreement Between Endoscopic and Histopathological Diagnosis of Colorectal Sessile Serrated Lesions.
- ClinicalTrials.gov ID
- NCT06173297
- Acronym / sponsor ID
- AVAP-NG 1415
- Conditions
- Sessile Serrated Adenoma, Colorectal Polyp, Adenoma Colon, Colorectal Cancer, Colonoscopy, Adenoma Detection Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 772 participants (actual)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 15 Dec 2023 (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 goal of this observational study was to assess the degree of agreement between the endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions in adult patients undergoing colonoscopy in Hospital Sírio-Libanes.
The main questions it aimed to answer were:
- The degree of agreement between endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions by calculating the Kappa Value of agreement.
- To establish the detection rate of sessile serrated lesions and adenomas in the Endoscopy Department at Hospital Sírio-Libanês.
- To evaluate the degree of agreement between endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions based on the resection method.
- To assess the accuracy, positive predictive value, and negative predictive value of endoscopic diagnosis of serrated lesions compared to anatomopathological diagnosis.
The data were prospectively collected through a form specifically designed for this project, that was completed immediately after the examination by the performing colonoscopist. All patients enrolled in this study agreed to participate in it and signed an informed consent form prior to the colonoscopy.
Detailed description
The study population was:
Patients aged over 18 undergoing colonoscopy at Hospital Sírio-Libanês in the Bela-Vista unit, São Paulo, Brazil, between June and August 2020.
The sample:
For the present study, an odds ratio of 1.5 in the adenoma detection rate of colorectal lesions was considered concerning the vascular pattern classification of the lesion (NICE), with an expected discordance rate of 30% regarding the histopathological pattern. To achieve this, an estimated sample size of 758 patients was calculated, considering an 80% statistical power and a risk α≤5% for a Type I error, using the McNemar's test for proportions.
Inclusion criteria:
- Patients undergoing elective colonoscopy at Hospital Sírio-Libanês between February 2020 and August 2020.
- Age over 18 years.
Exclusion criteria:
- Patients with inflammatory bowel disease (IBD)
- Patients diagnosed with hereditary polyposis or non-polyposis syndromes.
- Patients with a history of colorectal surgery.
- Patients previously diagnosed with colorectal cancer (CRC).
Study variables analyzed:
- Age (years)
- Gender
- Colon preparation (Boston Scale)
- Presence of colorectal lesions
- Lesion resection technique
- Lesion size
- Lesion location
- Morphological classification of the lesion (Paris)
- Vascular pattern classification of the lesion (NICE)
- Number of lesions found per examination/patient.
Methods:
All colonoscopies in this study were conducted in the endoscopy department of Hospital Sírio-Libanês, and the equipment used was the Olympus™ EVIS Exera III - CV190.
All lesions identified in the study were sent to the pathology service of Hospital Sírio-Libanês for specialized and standardized anatomopathological analysis. The pathologists were blinded to the endoscopic diagnosis of the lesions. The lesions were classified according to the 2019 WHO Classification and subsequently categorized for this study into: hyperplastic polyps, adenomas, sessile serrated lesions, adenocarcinoma, or "others".
Statistical analysis:
Data obtained was assessed using the Gaussian curve and determined as parametric or non-parametric using the Kolmogorov-Smirnov test and the Shapiro-Wilk test. Parametric data were represented by mean and standard deviation, while non-parametric data were represented by median and interquartile range (25th and 75th percentiles). Categorical data were represented by absolute frequency (n) and relative frequency (%) and presented through contingency tables.
Sensitivity, specificity, positive predictive values, and negative predictive values (with corresponding 95% confidence intervals) of colonoscopy for diagnosing sessile serrated lesions using the anatomopathological examination as the gold standard were calculated.
To evaluate agreement between colonoscopy diagnosis and anatomopathological diagnosis, both overall and according to the resection method employed, Cohen's Kappa coefficients and their respective 95% confidence intervals were calculated. These coefficients were then categorized based on Landis \& Koch's criteria (1977).
Ethical considerations:
The research project for this study was thoroughly detailed and submitted for analysis to the Research Ethics Committee (CEP) of Hospital Sírio-Libanês, receiving approval under CAAE 27604919.2.0000.5461. Patients participating in the study agreed to take part and signed the Informed Consent Form. The involved colonoscopists committed to maintaining the confidentiality of the data.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged over 18 undergoing colonoscopy at Hospital Sírio-Libanês in the Bela-Vista unit, São Paulo, Brazil, between June and August of 2020.
Key inclusion criteria (2 listed)
- Patients undergoing elective colonoscopy at Hospital Sírio-Libanês between February 2020 and August 2020.
- Age over 18 years.
Key exclusion criteria (4 listed)
- Patients with inflammatory bowel disease (IBD)
- Patients diagnosed with hereditary polyposis or non-polyposis syndromes.
- Patients with a history of colorectal surgery.
- Patients previously diagnosed with colorectal cancer (CRC).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the degree of agreement between the endoscopic and the anatomopathological diagnosis of sessile serrated colorectal lesions
Time frame: 2 years
To evaluate concordance between colonoscopy diagnosis and anatomopathological diagnosis, both overall and according to the resection method employed, Cohen's Kappa coefficients and their respective 95% confidence intervals were calculated. These coefficients were then categorized based on Landis \& Koch's criteria (1977).
3 secondary outcomes
To establish the detection rate of sessile serrated lesions and adenomas in the Endoscopy Department at Hospital Sírio-Libanês.
Time frame: 2 years
Evaluate the degree of agreement between endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions based on the resection method.
Time frame: 2 years
Assess the accuracy, positive predictive value, and negative predictive value of endoscopic diagnosis of serrated lesions compared to anatomopathological diagnosis.
Time frame: 2 years
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 15 Dec 2023.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Background: PubMed 26753884Pan J, Xin L, Ma YF, Hu LH, Li ZS. Colonoscopy Reduces Colorectal Cancer Incidence and Mortality in Patients With Non-Malignant Findings: A Meta-Analysis. Am J Gastroenterol. 2016 Mar;111(3):355-65. doi: 10.1038/ajg.2015.418. Epub 2016 Jan 12.
- Background: PubMed 31759062Kaminski MF, Robertson DJ, Senore C, Rex DK. Optimizing the Quality of Colorectal Cancer Screening Worldwide. Gastroenterology. 2020 Jan;158(2):404-417. doi: 10.1053/j.gastro.2019.11.026. Epub 2019 Nov 20.
- Background: PubMed 29846947Wolf AMD, Fontham ETH, Church TR, Flowers CR, Guerra CE, LaMonte SJ, Etzioni R, McKenna MT, Oeffinger KC, Shih YT, Walter LC, Andrews KS, Brawley OW, Brooks D, Fedewa SA, Manassaram-Baptiste D, Siegel RL, Wender RC, Smith RA. Colorectal cancer screening for average-risk adults: 2018 guideline update from the American Cancer Society. CA Cancer J Clin. 2018 Jul;68(4):250-281. doi: 10.3322/caac.21457. Epub 2018 May 30.
- Background: PubMed 20042716Brenner H, Hoffmeister M, Arndt V, Stegmaier C, Altenhofen L, Haug U. Protection from right- and left-sided colorectal neoplasms after colonoscopy: population-based study. J Natl Cancer Inst. 2010 Jan 20;102(2):89-95. doi: 10.1093/jnci/djp436. Epub 2009 Dec 30.
- Background: PubMed 32572858Hassan C, Antonelli G, Dumonceau JM, Regula J, Bretthauer M, Chaussade S, Dekker E, Ferlitsch M, Gimeno-Garcia A, Jover R, Kalager M, Pellise M, Pox C, Ricciardiello L, Rutter M, Helsingen LM, Bleijenberg A, Senore C, van Hooft JE, Dinis-Ribeiro M, Quintero E. Post-polypectomy colonoscopy surveillance: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2020. Endoscopy. 2020 Aug;52(8):687-700. doi: 10.1055/a-1185-3109. Epub 2020 Jun 22.
- Background: PubMed 2403953O'Brien MJ, Winawer SJ, Zauber AG, Gottlieb LS, Sternberg SS, Diaz B, Dickersin GR, Ewing S, Geller S, Kasimian D, et al. The National Polyp Study. Patient and polyp characteristics associated with high-grade dysplasia in colorectal adenomas. Gastroenterology. 1990 Feb;98(2):371-9.
- Background: PubMed 35361333Mareth K, Gurm H, Madhoun MF. Endoscopic Recognition and Classification of Colorectal Polyps. Gastrointest Endosc Clin N Am. 2022 Apr;32(2):227-240. doi: 10.1016/j.giec.2021.12.003. Epub 2022 Feb 22.
- Background: PubMed 32580537Kim JH, Kang GH. Evolving pathologic concepts of serrated lesions of the colorectum. J Pathol Transl Med. 2020 Jul;54(4):276-289. doi: 10.4132/jptm.2020.04.15. Epub 2020 Jun 26.
- Background: PubMed 32950521Vennelaganti S, Cuatrecasas M, Vennalaganti P, Kennedy KF, Srinivasan S, Patil DT, Plesec T, Lanas A, Horndler C, Andraws N, Cherian R, Mathur S, Hassan C, Repici A, Klotz D, Musulen E, Risio M, Castells A, Gupta N, Sharma P. Interobserver Agreement Among Pathologists in the Differentiation of Sessile Serrated From Hyperplastic Polyps. Gastroenterology. 2021 Jan;160(1):452-454.e1. doi: 10.1053/j.gastro.2020.09.015. Epub 2020 Sep 18. No abstract available.
- Results publication: PubMed 36029884Ahmad A, Moorghen M, Wilson A, Saunders BP. NBI International Colorectal Endoscopic-derived high-confidence optical diagnosis of small polyps compared with histology: understanding errors to improve diagnostic accuracy. Gastrointest Endosc. 2023 Jan;97(1):78-88. doi: 10.1016/j.gie.2022.08.032. Epub 2022 Aug 24.
- 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.
Daniela S Oliveira, Master principal investigator
Hospital Sirio-Libanes
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 Sessile Serrated Adenoma and Colorectal Polyp, run by Hospital Sirio-Libanes at 1 site in Brazil.
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 4 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 15 Dec 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 Brazil. 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?
To assess the degree of agreement between the endoscopic and the anatomopathological diagnosis of sessile serrated colorectal lesions (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 NCT06173297, which also lists 11 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 15 Dec 2023.