Neoplasms

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Symptoms and General Pathology

Rare Diseases

Adenomatous Polyposis Coli

Colorectal Neoplasms

Nasopharyngeal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Polyps

Adenomatous Polyps

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Intestinal Polyposis

Genetic Diseases, Inborn

Familial Adenomatous Polyposis

MYH-associated Polyposis

This study uses one arm. Participants will undergo endoscopic surveillance with intervals between 6 months and 2 years, depending on severity of polyposis and performed endoscopic interventions.

Personalized surveillance and intervention protocol

Evelien Dekker, MD, PhD

Arthur Aelvoet, MD

The purpose of this study is to determine the efficacy and safety of a personalised surveillance and intervention protocol for patients with familial adenomatous polyposis (FAP) that have undergone (procto)colectomy.

Familial adenomatous polyposis (FAP) is characterized by formation of up to hundreds to thousands of polyps throughout the entire colon and rectum. When left untreated, nearly all patients with FAP develop colorectal cancer at a median age of 35-45 years. To prevent colorectal cancer in patients with FAP, prophylactic colorectal surgery is performed. The preferred surgical procedures for FAP are a restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) or a subtotal colectomy with ileorectal anastomosis (IRA) or ileosigmoidal anastomosis (ISA).

After both types of prophylactic colorectal surgery, subtotal colectomy with IRA/ISA or proctocolectomy with IPAA, patients will require life-long surveillance because disease progression and development of new adenomas in retained rectum, pouch or residual rectal cuff will occur.

The 10-years risk of developing one or more adenomas in the rectum after IRA is 100% compared to 33% in the pouch after IPAA. The risk of developing rectal cancer after IRA was found to be 9% and 11% in two large studies with a median follow-up of 12.8 and 15 years, respectively. One study showed that the 10-years risk of developing a carcinoma in the pouch was 1%. As patients are usually operated at a young age, and nowadays have a long life-expectancy, the actual cumulative life-time risk will presumably be higher.

The recently published ESGE (European Society of Gastrointestinal Endoscopy) polyposis guideline recommends a one to two yearly endoscopic surveillance interval after prophylactic colorectal surgery in FAP, both for patients that underwent IRA/ISA and IPAA, with removal of all polyps \>5mm. This recommendation is based on expert-opinion, since no studies have been reported comparing the efficacy and safety of different surveillance intervals. No advices are provided on which patients will benefit from which surveillance interval.

With the proposed study, the investigators aim to provide evidence for personalized endoscopic surveillance for patients with FAP that have undergone (procto)colectomy with construction of an IRA/ISA or IPAA with the goal to prevent development of advanced neoplasia (AN) by endoscopically removing lesions before they progress to AN.

A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis That Have Undergone (Procto)Colectomy

Incidence of advanced neoplasia (advanced adenoma and cancer). An advanced adenoma is defined as size ≥ 10mm and/or high-grade dysplasia. This surveillance and intervention protocol will be considered successful when the incidence of advanced neoplasia is less than 5% after a study period of 5 years.

Incidence and characteristics of polyps detected/removed in patients with IRA/ISA and IPAA

Incidence of lesions not amenable to endoscopic removal

Surveillance burden (number of endoscopies per patient)

Incidence of endoscopy related complications

Leiden University Medical Center

The Netherlands Cancer Institute

St Mark's Hospital Foundation

Hospital Clinic of Barcelona

Hôpital Edouard Herriot

Maria Sklodowska-Curie National Research Institute of Oncology

Hospital General Universitario de Alicante

University Medical Center Mainz

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Prof. dr. Evelien Dekker, MD, PhD

Colonic Neoplasms

Colonic Polyps

Pathological Conditions, Anatomical

Intestinal Polyps

Group 1, surveillance colonoscopy in two years after the last complete colonoscopy in SPS patient.

Group 2, surveillance colonoscopy in three years after the last complete colonoscopy in SPS patient.

Colonoscopy surveillance in SPS patient after 3 years of the last colonoscopy.

Colonoscopy

Jorge López Vicente

The aim of the study is to determine if Serrated Poliposis Syndrome (SPS) patients with SPS criteria 2, with clearing phase achieved and without any advanced lesion or less than 5 relevant lesions at last colonoscopy have the same advanced neoplasia incidence in the surveillance colonoscopy at 2 or 3 years.

Patients selected for the study will be randomised in two groups for the surveillance: group 1, surveillance with colonoscopy in two years; group 2, surveillance with colonoscopy in three years. Randomization will be done at the database program (RedCAP).

All colonoscopies will be performed with high definition (HD) system and it will be the choice of the endoscopist whether to use chromoendoscopy with indigo carmine o virtual chromoendoscopy. Protocol bowel preparation will be recommended by each centre. Sedation will be prescribed and decided by the endoscopist during the examination.

Data from all the resected and visualized lesions during the colonoscopy will be collected on the database. A pathologist familiarized with serrated lesions will be in charge of the sample analysis. Serrated lesions will be classified attending de WHO criteria for serrated lesions. The investigators define "advanced adenoma" as adenomas ≥10 mm with villous histology and/or with high grade of dysplasia (HGD). The investigators define "advanced SL" as any SL ≥10mm and any SL with dysplasia. The investigators also define "advanced neoplasia" as any colorectal cancer (CRC), any advanced adenoma or advanced Serrated Lesions (SL).

Quality of bowel cleansing will be graded by each endoscopist following the Boston Bowel Preparation Scale. This scale evaluates each segment (ascending colon, transverse colon and descending colon) of the following form: 0 = segment of colon whose mucosa cannot be seen due to the existence of solid stools that cannot be eliminated; 1 = mucosa portion of a colonic segment that can be seen, but other areas of the colonic segment are not seen, either due to the presence of dirt, feces or opaque liquid; 2 = existence of small amount of dirt, small fragments of stool and / or opaque liquid, but the mucosa of the colonic segment can be seen well; 3 = all the mucosa of the colonic segment can be seen well without residual dirt, small traces of stool or opaque liquid. Patients with inadequate preparation (when in any segment the score is 0 or 1, or the total score is less than 6) will be excluded from the study.

During colonoscopy all complications as post-polypectomy bleeding, perforation or cardio-respiratory events will be registered. Those complications will be considered if surgery or hospital admission is required.

Colorectal cancer (CRC) is the most frequent neoplasm in developed countries considering both sexes and is the second in terms of cancer mortality. The incidence of the CRC is increasing in all developed countries. Detection of precancerous lesions (colon polyps) or malignant lesions (adenocarcinoma) in early stages in screening programs improves the prognosis and decreases the mortality of these patients. Serrated polyposis syndrome (SPS) is the most common colorectal polyposis syndrome and is characterized by the combination of large and/or numerous serrated lesions (SL) throughout the colorectum. There are three different types of SLs described: hyperplastic polyps (HP), sessile serrated lesions (SSL) and traditional serrated adenomas (TSA).

In 2010 the world health organization (WHO) defined the clinical criteria for the SPS diagnosis: criteria I, any patient with ≥ 5 serrated lesions proximal to the sigma, two of them\> 1 cm in size; criteria II, any first degree relative of a SPS patient with at least one serrated lesion; criteria II, any patient with ≥20 serrated lesions throughout the colon. This criteria were reviewed in 2019 and criteria II was eliminated. The new criteria are: criteria 1, any patient with ≥ 5 SL proximal to the rectum, all ≥5 mm in size, with at least 2 lesions ≥10 mm in size; criteria 2, any patient with \>20 SL of any size distributed throughout the colon, with ≥5 lesions proximal to the rectum.

In recent years, a new pathway in the development of colorectal adenocarcinoma have been described, the "serrated pathway". It is associated with mutations in BRAF and KRAS genes, the existence of hypermethylation in the promoter regions "CpG island" and microsatellite instability phenotype caused by methylation of the MLH-1 gene. This new pathway has a faster progression from the serrated polyp to the CRC in comparison with the classic "adenoma-carcinoma" pathway, hence the importance of detecting and removing these lesions in patients with SPS.

CRC prevalence in patients diagnosed with SPS is 15-35%, according to different studies, and the probability at 5 years of developing a CRC is around 1.3-1.9%. During surveillance, the incidence of advanced neoplasia (advanced adenoma or advanced serrated lesions) at 3 years is 13% for adenomas and 42 for serrated lesions. Risk factors for developing CRC and advanced neoplasia have been described in several studies. One of these factors is the SPS criteria 2, which has been demonstrated as a low risk of CRC and advanced neoplasia during surveillance of SPS patients. Detecting more than two sessile serrated lesions proximal to the spleenic flexure, one sessile serrated lesion with high grade of dysplasia and the detection of advanced neoplasia in previous colonoscopies, are all risk factors of developing advanced neoplasia during surveillance. A recent multicentre prospective study established SPS patient surveillance according to lesions detected at last colonoscopy. Individuals with at least one advanced adenoma, an advanced serrated lesion or more than 5 relevant lesions (sessile serrated lesions, adenomas of any size or hyperplastic polyps more than 5 mm) were followed at one year. Patients with no lesions mentioned before were followed at 2 years with colonoscopy. Advanced neoplasia incidence in 2 years recommendation surveillance was 15.6% compared with 24.4% in the 1 year recommendation surveillance. CRC cumulative 5 years incidence was 1.3%. Regarding SPS type, the 5 years advanced neoplasia incidence was lower for patients with SPS criteria III of 2010 (26%) than for patients diagnosed with criteria I (53%) or criteria I and III (59%). In this study patients starting their surveillance with clearing phase achieved (clear colon of all polyps ≥5mm and all polyps with the optical aspect of adenoma, TSA or SSL) were at low risk of advanced neoplasia than patients without this phase achieve prior to study inclusion (HR: 0.64; p\<0.047).

With all the above described, the investigators can define a SPS patient with low risk of advanced neoplasia during surveillance: those patients with SPS criteria 2, with clearing phase achieved and without any advanced lesion or less than 5 relevant lesions at last colonoscopy.

The Spanish Society of Gastroenterology (AEG) recommends surveillance with colonoscopies in 1-3 years interval for SPS patient, as it does the European Society of Digestive Oncology (ESDO). The European Society of Gastrointestinal Endoscopy (ESGE) recommends surveillance at 1 o 2 years depending on the last colonoscopy findings, annually in case of any advanced adenoma or serrated lesion or ≥5 relevant lesions (adenomas, SSL or HP≥5mm) were removed, and two surveillance in all other cases. The British Society of Gastroenterology (BSG) recommends annually surveillance for SPS patients until all serrated lesions ≥ are removed, and then 2 year-surveillance. All these Guidelines mention the limited evidence to support their recommendations and the need for prospective studies to evaluate them. As well many authors have expressed the possibility of extending the surveillance to 3 or even 5 years in low risk patients.

The aim of the study is to determine if SPS patients with SPS criteria 2, with clearing phase achieved and without any advanced lesion or less than 5 relevant lesions at last colonoscopy have the same advanced neoplasia incidence in the surveillance colonoscopy at 2 or 3 years.

Patients selected for the study will be randomised in two groups for the surveillance: group 1, surveillance with colonoscopy in two years; group 2, surveillance with colonoscopy in three years. Randomization will be done at the database program (RedCAP).

All colonoscopies will be performed with high definition (HD) system and it will be the choice of the endoscopist whether to use chromoendoscopy with indigo carmine o virtual chromoendoscopy. Protocol bowel preparation will be recommended by each centre. Sedation will be prescribed and decided by the endoscopist during the examination.

Data from all the resected and visualized lesions during the colonoscopy will be collected on the database. A pathologist familiarized with serrated lesions will be in charge of the sample analysis. Serrated lesions will be classified attending de WHO criteria for serrated lesions. The investigators define "advanced adenoma" as adenomas ≥10 mm with villous histology and/or with high grade of dysplasia (HGD). The investigators also define "advanced SL" as any SL ≥10mm and any SL with dysplasia. The investigators define "advanced neoplasia" as any CRC, any advanced adenoma or advanced SL.

Quality of bowel cleansing will be graded by each endoscopist following the Boston Bowel Preparation Scale. This scale evaluates each segment (ascending colon, transverse colon and descending colon) of the following form: 0 = segment of colon whose mucosa cannot be seen due to the existence of solid stools that cannot be eliminated; 1 = mucosa portion of a colonic segment that can be seen, but other areas of the colonic segment are not seen, either due to the presence of dirt, feces or opaque liquid; 2 = existence of small amount of dirt, small fragments of stool and / or opaque liquid, but the mucosa of the colonic segment can be seen well; 3 = all the mucosa of the colonic segment can be seen well without residual dirt, small traces of stool or opaque liquid. Patients with inadequate preparation (when in any segment the score is 0 or 1, or the total score is less than 6) will be excluded from the study.

During colonoscopy all complications as post-polypectomy bleeding, perforation or cardio-respiratory events will be registered. Those complications will be considered if surgery or hospital admission is required.

SAMPLE SIZE CALCULATION This is a randomized controlled study for evaluating a non inferiority strategy in the surveillance of SPS type 2 patients, between colonoscopy in 2 years and colonoscopy in 3 years, with the incidence of advanced neoplasia as the principal aim of the study. In the study from the Netherlands, Bleijenberg and col., the incidence of advanced neoplasia in patients at 2 years surveillance was of 15%. The investigators assume an acceptable increase of advanced neoplasia at 3 years surveillance of 25%, so the margin for no inferiority is 10% between the two groups. Accepting the type I error with an unilateral contrast of 0.025, beta risk of 0.2 (power 80% ) and considering a 10% of lost patients, 69 patients in each group (136 in total) are needed to detect significance differences between the two groups.

STUDY VARIABLES:

* Demographic variables: Hospital, identification number (number assigned to each hospital and consecutive number of each patient), date of birth, sex, SPS criteria (according to WHO classification and actualized in2019: 1 or 2), date of the last colonoscopy, number and type of lesions resected at the last colonoscopy, number of previous colonoscopies, number of polyps removed so far (low risk, high risk and serrated lesions), colon surgery (yes/no) and type of surgery (right colectomy, left colectomy, low anterior resection, segmental colectomy or others), smoker (yes/no/prev).
* Variables of the procedure: date of the procedure, bowel preparation according to BBPS scale 14, study arm (Colonoscopy in2 years/Colonoscopy inn3 years), number and description of lesions resected during the procedure describing its size, shape according to Paris classification15, location of the lesions, distance to the anal margin. Inspection time in each exploration (with stopwatch and without counting the therapeutic moments). Complications during the procedure (bleeding, perforation or cardio-respiratory events).

NECESSARY RESOURCES:

The colonoscopy and polypectomy will be done in the usual clinical care practice.

This protocol does not require additional funding. The explorations will be carried out by the researchers who are staff doctors of the Digestive Endoscopy Units. The effort, the minimum marginal expenses that may lead to the prolongation of the exploration and the collection of data will be assumed by the researchers and the Digestive Endoscopy Units.

ETHICAL CONSIDERATIONS:

This protocol follows the ethical principles of non-malfeasance, beneficence, autonomy and justice included in the Declaration of Helsinki (last update, Seoul 2008) 17, as well as in law 41/2002 on patient autonomy18 and research law 14/2007 biomedical19. The personal and clinical data of the patients will be anonymized.

Patients selected for the study will be randomised in two groups for the surveillance: group 1, surveillance with colonoscopy in two years; group 2, surveillance with colonoscopy in three years.

Endoscopic Surveillance in Serrated Polyposis Syndrome and Low-risk of Advanced Neoplasia

Endoscopic Surveillance in Patients With Serrated Polyposis Syndrome and Low-risk of Advanced Neoplasia.

Number of CCR and advanced neoplasia detected in SPS patients with low risk factors of advanced neoplasia during surveillance after a 2 year colonoscopy.

Number of CCR and advanced neoplasia detected in SPS patients with low risk factors of advanced neoplasia during surveillance after a 3 year colonoscopy.

Hospital Universitario de Móstoles

Principal Investigator

Barrett Esophagus

Hyperplasia

Precancerous Conditions

Esophageal Diseases

Anti-Infective Agents

All Drugs and Chemicals

Central Nervous System Depressants

Antineoplastic Agents

Vitamins

Acetic Acid

Propofol

Retinol acetate

Endoscopic surveillance and PPI treatment

HALO device Use of HALO 360° device for the fist procedure and possible use of HALo 90° device for further treatment sessions Treatment zone of 12cm high maximum. Energy delivered 10 J/cm², power 300W

Endoscopic radiofrequency ablation

Upper gastro-intestinal endoscopy every 6 to 12 month under propofol sedation with acetic acid magnification of mucosa and multiple biopsy samples.

Endoscopic surveillance

Frederic PRAT, MD, PhD

Radiofrequency ablation versus endoscopic surveillance in the management of low grade dysplasia in Barrett oesophagus: a multicentric randomised controlled trial.

Background: The occurrence of low grade dysplasia (LGD) in Barrett oesophagus (BE) is known as a pre-cancerous state. Current recommendation in case of LGD is a close endoscopic surveillance every 6 to 12 month and continuous Proton pomp inhibitor (PPI) treatment. Endoscopic radiofrequency ablation (RFA) has been demonstrated as an efficient treatment to eradicate high grade dysplasia (HGD) and most of LGD and BE.

Main aim of this study: To demonstrate that the prevalence of patients with LGD 3 years after a RFA treatment is lower than in a surveillance group.

Patients \& Methods: French multicentric randomized controlled trial for patients with BE with confirmed LGD: RFA vs endoscopic surveillance.

120 patients are planned to be included for at least 40 patients randomized in each group.

Primary endpoint: Prevalence of LGD in each group 3 years after randomization

Secondary endpoints:

* Prevalence of LGD in each group 1 and 5 years after randomization
* Rate of complete eradication of BE at 1, 3 and 5 years after randomization
* Incidence of HGD and adenocarcinoma at 3, 5 years after randomization
* Rate of complications in RFA group after randomization
* Cost - efficacy comparison of the 2 strategies

Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia

Endoscopic Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia: a Randomised Controlled Trial vs Endoscopic Surveillance

Assistance Publique - Hôpitaux de Paris

This study uses one arm. Participants will undergo endoscopic surveillance with intervals between 3-6 months and 5 years, depending on severity of polyposis and performed endoscopic interventions.

The purpose of this study is to determine the efficacy and safety of a personalized surveillance and intervention protocol for duodenal and gastric polyposis in patients with familial adenomatous polyposis (FAP)

Patients with FAP are not only at risk of developing colorectal adenomas but also at high risk of developing duodenal adenomas. In 30% to 92% of FAP patients duodenal adenomas are detected, with a lifetime risk approaching 100%. Of these duodenal adenomas, only a small proportion develops into duodenal cancer, with a prevalence of approximately 5-10% in FAP patients.

Endoscopic surveillance is nowadays the standard of care to prevent FAP patients from developing duodenal cancer. The severity of duodenal polyposis is assessed using the Spigelman classification system. This classification is based on the number, size, histology, and grade of dysplasia of the duodenal adenomas, resulting in a score varying from 0-IV, guiding surveillance intervals and treatment.

Concerns are rising on the accuracy of the Spigelman score as predictor for duodenal cancer, especially for ampullary cancer. Over the past years, multiple studies demonstrated limitations of this staging system including the fact that this classification does not adequately predict duodenal/ampullary cancer and does not guide endoscopic or surgical interventions. A clear endoscopic intervention protocol is needed, not only to prevent the development of cancer but also to prevent the need for duodenal surgery, since these surgical procedures are associated with high complication and mortality rates.

With this study, the investigators aim to evaluate a personalized surveillance and intervention protocol for the duodenum and stomach with the goal to prevent the development of advanced neoplasia (AN) by endoscopically removing lesions before they progress to AN.

A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis

Incidence of advanced neoplasia defined as adenomas ≥15mm, high grade dysplasia (HGD) and/or duodenal/ampullary cancer

Incidence of recurrences after endoscopic interventions after en bloc/piecemeal resection and different techniques such as cold snare polypectomy or endoscopic mucosal resection with or without lifting

The ability of endoscopists to optically diagnose duodenal and gastric lesions. Sensitivity and specificity for optically diagnose high-grade dysplasia in the stomach and duodenum.

Surveillance burden (number of endoscopies for each patient)

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Chrysarobin

Patients will be offered an annual FIT and colonoscopy will be performed if fecal hemoglobin concentration is ≥10µg / g of feces. After performing a colonoscopy the FIT will be sent to the patient:

* After one year if the unscheduled colonoscopy has been incomplete or a lesion requiring endoscopic surveillance has been completely resected.
* After five years if the colonoscopy has evaluated the entire mucosa, it is normal or with lesions that do not require endoscopic surveillance (1-2 non-advanced adenomas).

Annual FIT

First surveillance colonoscopy will be performed in three-year time. If an advanced adenoma or at least three non-advanced adenomas are detected, colonoscopy will be repeated after 3 years. In contrast, if colonoscopy is normal or 1-2 non-advanced adenomas are detected, colonoscopy will be repeated after 5 years.

Endoscopic surveillance.

Joaquín Cubiella, MD PhD

Colorectal cancer (CRC) screening programs have been implemented to reduce the burden of the disease. When an advanced colonic lesions is detected, it is recommended to perform endoscopic surveillance with different intervals between explorations. Although the reduction in CRC incidence, endoscopic surveillance is producing a considerable increase in the number of colonoscopies. However, participation in CRC screening programs based on the fecal immunochemical test (FIT) could be a non inferior alternative to endoscopic surveillance.

Based on this hypothesis, the research group have designed a randomized clinical trial within the population CRC screening programs to compare FIT surveillance to endoscopic surveillance in patients with advanced lesions resected.

Colorectal cancer (CRC) is one of the most common malignancies in western countries. CRC screening programs have been implemented in order to reduce the burden of the disease. Screening programs in Spain are based on the biennial detection of fecal hemoglobin with a fecal immunochemical test (FIT) and a diagnostic colonoscopy if positive. The detection of at least one advanced adenoma or serrated lesion defines a high risk situation for metachronous CRC. This group of patients is recommended to perform endoscopic surveillance with different intervals between explorations. Endoscopic surveillance reduces mortality only 1.7% and increases the number of colonoscopies by 62% with an additional cost of € 68,000 for an increase of 0.9 years of life. Moreover, colonoscopy is a procedure associated with potentially serious side effects.

A recently British study shows that with a cut-off of 10 µg/g, FIT has a higher sensitivity and specificity for CRC with a significant cost reduction compared to colonoscopy surveillance. Additionally, most of the population prefers non-invasive faecal tests rather than colonoscopy.

Based on this evidence, the research group have designed a multicenter, randomized clinical trial to compare the 10 year CRC incidence after resection of advanced colonic lesions detected within CRC screening programs between endoscopic surveillance and participation in CRC screening programs based on FIT.

Apart from this purpose, the investigators will also assess the values and preferences regarding surveillance and risk of CRC. Further, the research group will evaluate the relationship between Mediterranean diet and physical activity with the detection of advanced adenomas and CRC.

Patients will be identified in population CRC secreening programs of Galicia, the Basque Country, the Region of Valencia and Murcia. We will considered individuals aged 50 to 65 years with at least one advanced adenoma (tubulovillous or villous histology, high grade dysplasia or ≥ 10mm), and / or at least three non-advanced adenomas detected and resected completely within the population-based CRC screening program.

Patients will be randomly allocated to perform an annual FIT and colonoscopy if fecal hemoglobin concentration is ≥10µg/g, or to perform endoscopic surveillance. Patients will be also stratified into two groups: ≥5 adenomas or an adenoma ≥20mm and the rest of patients.

Patients will be followed for a period of 10 years.

Polyprev: Study to Compare Fecal Immunochemical Test With Endoscopic Surveillance After Advanced Adenoma Resection in Fecal Immunochemical Test Colorectal Cancer Screening Programs.

Polyprev Study: Randomized, Multicenter, Controlled Trial Comparing Fecal Immunochemical Test With Endoscopic Surveillance After Advanced Adenoma Resection in Fecal Immunochemical Test Colorectal Cancer Screening Programs.

It is the main outcome of the study. Invasive CRC is defined as colonic adenocarcinoma that invades the submucosa. Adenocarcinomas in situ and intramucosal carcinomas will not be considered as invasive CRC.

Interval CRC is defined as the CRC detected between two organized surveillance (FIT or colonoscopy).

The deaths and their cause will be collected: associated with CRC, associated with adverse effects of screening or unrelated.

Advanced colonic lesions will be defined as advanced adenomas (at least 10mm, hairy histology or high grade dysplasia) or advanced serrated lesions (at least 10mm or with dysplasia).

According to the methodology of the information systems of the screening programs, three categories will be defined: non-participation, irregular participation, regular participation.

Adverse effects associated with surveillance are defined as complications that require hospitalization. Those related to the surgical treatment of benign colonic lesions will be included as adverse effects.

Detection of CRC, adenoma and advanced serrated lesion will be collected at 3 years of follow-up.

We will use the International Physical Activity. Questionnaire (IPAQ) to mesure physical activity.

We will use the Mediterranean Lifestyle index (MEDLIFE) to measure overall adherence to the Mediterranean lifestyle.

We will use a survey with vignette questions to evaluate the values and preferences of the subjects regarding surveillance.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis That Have Undergone (Procto)Colectomy	NCT04678011	Familial Adenom...	Personalized su...	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Endoscopic Surveillance in Serrated Polyposis Syndrome and Low-risk of Advanced Neoplasia	NCT04906343	Colonic Polyp Colonic Neoplas... Colonic Cancer Serrated Polypo... Serrated Polyp ...	Colonoscopy	18 Years - 90 Years	Hospital Universitario de Móstoles
Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia	NCT01360541	Barrett Oesopha... Low Grade Dyspl...	Endoscopic radi... Endoscopic surv...	18 Years - 80 Years	Assistance Publique - Hôpitaux de Paris
Endoscopic Surveillance in Serrated Polyposis Syndrome and Low-risk of Advanced Neoplasia	NCT04906343	Colonic Polyp Colonic Neoplas... Colonic Cancer Serrated Polypo... Serrated Polyp ...	Colonoscopy	18 Years - 90 Years	Hospital Universitario de Móstoles
A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis	NCT04677998	Familial Adenom...	Personalized su...	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Polyprev: Study to Compare Fecal Immunochemical Test With Endoscopic Surveillance After Advanced Adenoma Resection in Fecal Immunochemical Test Colorectal Cancer Screening Programs.	NCT04967183	Colorectal Canc...	Annual FIT Endoscopic surv...	50 Years - 65 Years	Fundacin Biomedica Galicia Sur

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