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Colorectal cancer (CRC) is a leading cause of cancer death and its' incidence is rising in most European countries. Colonoscopy has been shown to reduce CRC incidence, however its effectiveness depends on the sensitivity to detect pre-malignant lesions.
Our aim is to evaluate narrow band imaging (NBI) during colonoscopy and serum miRNAs as novel tools for the early detection of colonic sessile serrated lesions (SSL). The investigators will perform a multicenter-randomized-controlled-trial to study the role of NBI in SSL detection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Narrow band imaging withdrawal | Experimental | colonoscope withdrawal and mucosal inspection performed under narrow band imaging |
|
| white light withdrawal | Placebo Comparator | colonoscope withdrawal and mucosal inspection performed under white light imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| narrow band imaging withdrawal | Device | colonoscope withdrawal and mucosal inspection performed under narrow band imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| average number of serrated lesions ≥10 mm detected per colonoscopy | immediate |
| Measure | Description | Time Frame |
|---|---|---|
| Serrated class lesions detection rate | number of patients with at least 1 lesion/total number of participants | immediate |
| Serrated lesions <10 mm detected per colonoscopy | immediate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandre O Ferreira, MD | Contact | alex.gastrohep@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alexandre O Ferreira, MD | Hospital Beatriz Ângelo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Beatriz Ângelo | Recruiting | Loures | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22710576 | Background | Rex DK, Ahnen DJ, Baron JA, Batts KP, Burke CA, Burt RW, Goldblum JR, Guillem JG, Kahi CJ, Kalady MF, O'Brien MJ, Odze RD, Ogino S, Parry S, Snover DC, Torlakovic EE, Wise PE, Young J, Church J. Serrated lesions of the colorectum: review and recommendations from an expert panel. Am J Gastroenterol. 2012 Sep;107(9):1315-29; quiz 1314, 1330. doi: 10.1038/ajg.2012.161. Epub 2012 Jun 19. |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D011127 | Polyps |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| white light withdrawal | Device | colonoscope withdrawal and mucosal inspection performed under white light imaging |
|
| SSL detection rate | histologically defined according to the WHO criteria | immediate |
| Adenoma detection rate | number of patients with at least 1 adenoma/total number of participants | immediate |
| Adenomas detected per colonoscopy | immediate |
| Advanced (malignant) adenocarcinoma detection rate | immediate |
| Incidence of procedure related adverse events | immediate |
| Centro Hospitalar do Porto | Not yet recruiting | Porto | Portugal |
|
| Instituto Português de Oncologia do Porto | Not yet recruiting | Porto | Portugal |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |