Retrospective Cohort Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jan 7, 2020; 26(1): 70-85
Published online Jan 7, 2020. doi: 10.3748/wjg.v26.i1.70
Risk of gastrointestinal cancer in a symptomatic cohort after a complete colonoscopy: Role of faecal immunochemical test
Noel Pin-Vieito, María J Iglesias, David Remedios, Lorena Rodríguez-Alonso, Francisco Rodriguez-Moranta, Victoria Álvarez-Sánchez, Fernando Fernández-Bañares, Jaume Boadas, Eva Martínez-Bauer, Rafael Campo, Luis Bujanda, Ángel Ferrandez, Virginia Piñol, Daniel Rodríguez-Alcalde, Jordi Guardiola, Joaquín Cubiella, on behalf of the COLONPREDICT study investigators
Noel Pin-Vieito, María J Iglesias, David Remedios, Joaquín Cubiella, Gastroenterology Department, Complexo Hospitalario Universitario de Ourense, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Ourense 32005, Spain
Noel Pin-Vieito, María J Iglesias, David Remedios, Instituto de Investigación Biomedica Galicia Sur, Ourense 32005, Spain
Noel Pin-Vieito, Department of Biochemistry, Genetics and Immunology, Faculty of Biology, University of Vigo, Vigo 36200, Spain
Lorena Rodríguez-Alonso, Francisco Rodriguez-Moranta, Jordi Guardiola, Department of Gastroenterology and Hepatology, University Hospital of Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona 08907, Spain. Ciber de Epidemiología y Salud Pública (CIBERESP), Spain
Victoria Álvarez-Sánchez, Gastroenterology Department, Complejo Hospitalario de Pontevedra, Pontevedra 36001, Spain
Fernando Fernández-Bañares, Gastroenterology Department, Hospital Universitari Mútua de Terrassa, CIBERehd, Terrassa 08221, Spain
Jaume Boadas, Gastroenterology Department, Consorci Sanitari de Terrassa, Terrassa 08221, Spain
Eva Martínez-Bauer, Rafael Campo, Gastroenterology Department, Hospital de Sabadell, Corporació Sanitària i Universitària Parc Taulí, Sabadell 08208, Spain
Luis Bujanda, Donostia Hospital, Biodonostia Institute, University of the Basque Country UPV/EHU, CIBERehd, San Sebastian 20010, Spain
Ángel Ferrandez, Servicio de Aparato Digestivo, Hospital Clínico Universitario, IIS Aragón, University of Zaragoza, CIBERehd, Zaragoza 50009, Spain.
Virginia Piñol, Gastroenterology Department, Hospital Dr. Josep Trueta, Girona 17007, Spain
Daniel Rodríguez-Alcalde, Digestive Disease Section, Hospital Universitario de Móstoles, Madrid 28935, Spain
Author contributions: Pin-Vieito N and Cubiella J designed the analysis, Pin-Vieito N, Iglesias M, Remedios D, Álvarez-Sánchez V, Fernández-Bañares F, Rodríguez-Alonso L, Rodríguez-Moranta F, Boadas J, Martínez-Bauer E, Campo R, Bujada L, Ferrández A, Piñol V, Rodríguez-Alcalde D and Guardiola J were involved in acquisition of data; Pin-Vieito N and Cubiella J analysed and prepared manuscript drafts; all authors contributed to writing of the paper. All authors had full access to all the data, tables and statistical reports in the study and take responsibility for integrity of the data and accuracy of the data analysis; Cubiella J and Pin-Vieito N acted as full guarantors of the research.
Supported by Instituto de Salud Carlos III through the project PI17/00837 (Co-funded by European Regional Development Fund/European Social Fund "A way to make Europe"/"Investing in your future").
Institutional review board statement: This is a post hoc cohort analysis performed within two prospective diagnostic test studies. The protocols of both studies conform to the ethical guidelines of the 1975 Declaration of Helsinki. COLONPREDICT study was approved by the Clinical Research Ethics Committee of Galicia (Code 2011/038) under resolution dated 11 April, 2012. The study of Rodríguez-Alonso et al. was approved by Bellvitge Hospital Clinical Research Ethics Committee (Code 21/11) on 1 December, 2011.
Informed consent statement: Patients of both studies provided written informed consent before inclusion.
Conflict-of-interest statement: Dr. Pin-Vieito reports non-financial support from ABBVIE, non-financial support from GILEAD SCIENCES, outside the submitted work; Dr. Cubiella reports grants from Instituto de Investigación Sanitaria Galicia Sur, grants from Fondo de Investigaciones Sanitarias (FIS), during the conduct of the study; personal fees from NORGINE, personal fees from IMC, outside the submitted work; Dr. Rodríguez-Alcalde reports non-financial support from SALVAT, outside the submitted work; all other authors have no conflict of interest related to the manuscript to declare.
Data sharing statement: The original anonymous dataset is available on request from the corresponding author at noel.pin.vieito@sergas.es.
STROBE statement: The authors have read the STROBE Statement checklist of items, and the manuscript was prepared and revised according to the STROBE Statement checklist of items.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Noel Pin-Vieito, MD, Staff Physician, Statistician, Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, C/ Ramón Puga 52-54, Ourense 32005, Spain. noel.pin.vieito@sergas.es
Received: September 20, 2019
Peer-review started: September 20, 2019
First decision: November 22, 2019
Revised: December 11, 2019
Accepted: December 21, 2019
Article in press: December 22, 2019
Published online: January 7, 2020
Processing time: 108 Days and 10.6 Hours
Abstract
BACKGROUND

Faecal immunochemical test (FIT) has been recommended to assess symptomatic patients for colorectal cancer (CRC) detection. Nevertheless, some conditions could theoretically favour blood originating in proximal areas of the gastrointestinal tract passing through the colon unmetabolized. A positive FIT result could be related to other gastrointestinal cancers (GIC).

AIM

To assess the risk of GIC detection and related death in FIT-positive symptomatic patients (threshold 10 μg Hb/g faeces) without CRC.

METHODS

Post hoc cohort analysis performed within two prospective diagnostic test studies evaluating the diagnostic accuracy of different FIT analytical systems for CRC and significant colonic lesion detection. Ambulatory patients with gastrointestinal symptoms referred consecutively for colonoscopy from primary and secondary healthcare, underwent a quantitative FIT before undergoing a complete colonoscopy. Patients without CRC were divided into two groups (positive and negative FIT) using the threshold of 10 μg Hb/g of faeces and data from follow-up were retrieved from electronic medical records of the public hospitals involved in the research. We determined the cumulative risk of GIC, CRC and upper GIC. Hazard rate (HR) was calculated adjusted by age, sex and presence of significant colonic lesion.

RESULTS

We included 2709 patients without CRC and a complete baseline colonoscopy, 730 (26.9%) with FIT ≥ 10 µgr Hb/gr. During a mean time of 45.5 ± 20.0 mo, a GIC was detected in 57 (2.1%) patients: An upper GIC in 35 (1.3%) and a CRC in 14 (0.5%). Thirty-six patients (1.3%) died due to GIC: 22 (0.8%) due to an upper GIC and 9 (0.3%) due to CRC. FIT-positive subjects showed a higher CRC risk (HR 3.8, 95%CI: 1.2-11.9) with no differences in GIC (HR 1.5, 95%CI: 0.8-2.7) or upper GIC risk (HR 1.0, 95%CI: 0.5-2.2). Patients with a positive FIT had only an increased risk of CRC-related death (HR 10.8, 95%CI: 2.1-57.1) and GIC-related death (HR 2.2, 95%CI: 1.1-4.3), with no differences in upper GIC-related death (HR 1.4, 95%CI: 0.6-3.3). An upper GIC was detected in 22 (0.8%) patients during the first year. Two variables were independently associated: anaemia (OR 5.6, 95%CI: 2.2-13.9) and age ≥ 70 years (OR 2.7, 95%CI: 1.1-7.0).

CONCLUSION

Symptomatic patients without CRC have a moderate risk increase in upper GIC, regardless of the FIT result. Patients with a positive FIT have an increased risk of post-colonoscopy CRC.

Keywords: Colonoscopy; Colorectal cancer; Faecal immunochemical test; Gastric cancer; Gastroesophageal cancer; Gastrointestinal cancer; Symptoms

Core tip: Our study, evaluates for the first time whether symptomatic patients with a positive faecal immunochemical test (FIT) result, no colorectal cancer (CRC) and a complete exploration of the colon have increased risk of related gastrointestinal cancer (GIC) detection or death. We found that this cohort of patients only have an increased risk of related CRC and death when compared with the cohort with a negative FIT result. Although the risk of upper GIC is higher than expected, the probability of detecting an upper GIC is unrelated to the FIT result and only associated with anaemia and advanced age.