BACKGROUND AND AIM:Surgical gastrojejunostomy (GJJ) and endoscopic stenting (ES) are the two most available treatments for palliation of malignant gastric obstruction (MGOO). The aim of this study is to compare these two techniques regarding efficacy, safety, time of hospitalization and survival.METHODS:We performed a literature search from January 2010 to September 2020 to identify available randomized controlled studies and observational studies that compared ES and GJJ for the treatment of MGOO.RESULTS:A total of 17 studies were found. ES and GJJ showed similar technical and clinical success rate. ES was superior to obtain early oral re-feeding, shorter length of hospitalization and a lower incidence of complications than GJJ. Surgical palliation had a lower recurrence rate of obstructive symptoms and longer overall survival than ES.CONCLUSIONS:Both procedures have advantages and disadvantages. Probably we should not find the best palliation but the best approach based on the patient characteristics and tumor type.

Background and study aims Fully-covered self-expandable metal stents (FCSEMS) are frequently used for endoscopic management of gastrointestinal lesions. However, stent migration occurs in up to one-third of patients. Different tools are used to anchor stents to prevent migration. A specifically designed over-the-scope device (Stentfix OTS Clip system) was recently introduced to prevent fully covered SEMS migration in the gastrointestinal tract. The study aimed to evaluate technical success and stent migration rates with the Stentfix device. Patients and methods Data were collected from consecutive patients at four participating centers who were at high risk of FCSEMS migration and in whom the anchoring system was used to prevent migration. Results A total of 31 patients were enrolled. Technically successful clip placement was achieved in all cases. At follow-up, the distal part of the device dislocated from the duodenum into the antrum at 3 days in one patient, accounting for a 3.2 % (95 % CI = 0–9.4) rate of stent migration. The underlying lesion being treated healed in all patients, but 10 patients died before stent removal due to neoplastic progression. Conclusions A dedicated over-the-scope stent fixation device appears to be safe and effective in preventing fully-covered SEMS migration through the gastrointestinal tract.

Pancreatic cancer (PC) carries a poor prognosis with an overall 5-year survival of less than 10%. Early diagnosis, though cumbersome, is essential to allow complete surgical resection. Therefore, primary and secondary prevention are critical to reduce the incidence and to potentially prevent mortality. Given a relatively low lifetime risk of developing PC, identification of high-risk individuals is crucial to allow identification of pre-malignant lesions and small, localized tumors. Although 85-90% of PC cases are sporadic, we could consider risk stratification for the 5-10% of patients with a family history and the 3-5% of cases due to inherited genetic syndromes. These high-risk populations should be considered for screening and surveillance of PC. MRI/MRCP and EUS are the preferred modalities, due to their high sensitivity in lesion detection. Surveillance should be personalized, considering genetics and family history, and assessment of risk factors that may increase cancer risk. Screening programs should be limited to tertiary referral center, with high-volumes and adequate facilities to manage these patients.

Methods 31 consecutive patients (median age: 58 years; males, 80%), with diseases of different etiology and localization (upper or lower GI tract) were enrolled. For each patient, OTSC device was placed to prevent FCSEMS migration. All patients received longitudinal follow-up.

Background and Aims: Piecemeal EMR of colorectal laterally spreading tumors (LSTs) >20 mm is effective. Experience is limited in the use of cap-assisted EMR (EMR-C) for resection of colonic lesions. We compared the efficacy and the safety of EMR-C for the removal of colonic LSTs >= 30 mm with "inject-and-cut" standard EMR (EMR-S). Methods: In this randomized trial from 4 Italian centers, 138 patients were treated with EMR-C and 102 with EMR-S. The rates of residual lesions, percentage of recurrence after 12 months, and adverse events were evaluated. Results: One hundred forty-three lesions were resected with EMR-C and 102 with EMR-S. Argon plasma coagulation (APC) was used as adjunctive treatment in 2.9% of EMR-Cs and in 22.5% of EMR-Ss (P <.001). The median time required was 20 minutes for EMR-C and 30 minutes for EMR-S (P <.001). Adverse events (AEs) occurred in 14 EMR-Cs (10.1%; 2 perforations, 11 bleeding events, and 1 stenosis) and in 22 EMR-Ss (21.6%; 1 perforation and 21 bleeding events) (P = .017). Intraprocedural AEs occurred in 3.6% of EMR-Cs and 16.7% of EMR-Ss (P = .001). Overall, residual lesions within 12 months were found to be significantly higher with EMR-S (32 patients, 31.4%) than with EMR-C (8 patients, 5.8%) (P <.001). Recurrence at follow-up colonoscopy in 12 months occurred in 7 EMR-Cs (5.1%) and 17 EMR-Ss (16.7%; P <.001). Conclusions: The study demonstrated the feasibility and safety of EMR-C for removing large colorectal LSTs, with higher eradication rates, shorter resection time, and less use of APC when compared with EMR-S. (Clinical trial registration number: NCT03498664.)

Main recommendations Malignant disease 1 ESGE recommends placement of partially or fully covered self-expandable metal stents (SEMSs) for palliation of malignant dysphagia over laser therapy, photodynamic therapy, and esophageal bypass. Strong recommendation, high quality evidence. 2 ESGE recommends brachytherapy as a valid alternative, alone or in addition to stenting, in esophageal cancer patients with malignant dysphagia and expected longer life expectancy. Strong recommendation, high quality evidence. 3 ESGE recommends esophageal SEMS placement for sealing malignant tracheoesophageal or bronchoesophageal fistulas. Strong recommendation, low quality evidence. 4 ESGE does not recommend SEMS placement as a bridge to surgery or before preoperative chemoradiotherapy because it is associated with a high incidence of adverse events. Other options such as feeding tube placement are preferable. Strong recommendation, low quality evidence. Benign disease 5 ESGE recommends against the use of SEMSs as first-line therapy for the management of benign esophageal strictures because of the potential for adverse events, the availability of alternative therapies, and their cost. Strong recommendation, low quality evidence. 6 ESGE suggests consideration of temporary placement of self-expandable stents for refractory benign esophageal strictures. Weak recommendation, moderate quality evidence. 7 ESGE suggests that fully covered SEMSs be preferred over partially covered SEMSs for the treatment of refractory benign esophageal strictures because of their very low risk of embedment and ease of removability. Weak recommendation, low quality evidence. 8 ESGE recommends the stent-in-stent technique to remove partially covered SEMSs that are embedded in the esophageal wall. Strong recommendation, low quality evidence. 9 ESGE recommends that temporary stent placement can be considered for the treatment of leaks, fistulas, and perforations. No specific type of stent can be recommended, and the duration of stenting should be individualized. Strong recommendation, low quality of evidence. 10 ESGE recommends considering placement of a fully covered large-diameter SEMS for the treatment of esophageal variceal bleeding refractory to medical, endoscopic, and/or radiological therapy, or as initial therapy for patients with massive bleeding. Strong recommendation, moderate quality evidence.

The management of patients with hypopharyngeal or cervical esophageal refractory benign strictures (RBS) after surgery and radiotherapy ± chemotherapy for laryngeal cancer is challenging. We aimed to assess the long-term efficacy and safety of a new designed fully covered SEMS in these patients. We reviewed the results of a prospectively collected database of 40 consecutive patients with dysphagia due to RBS of the cervical esophagus or hypopharynx after surgery and radiotherapy with or without chemotherapy for laryngeal cancer, unfit for surgery, referred in two tertiary-care endoscopic centers from June 2005 to December 2018. All of them were treated with placement of a Niti-S Conio cervical stent. After placement of the first stent, dysphagia improved in all patients. The total number of adverse events was 35 out of a total of 299 procedures (11.7%): 25 (8.4%) stent migrations, 6 (2%) tumor overgrowth, 3 severe pain and 1 pharyngo-cutaneous fistula. Stents were periodically changed. In only one patient with a cervical esophageal stricture the stent was definitively removed after 7 sessions of stent placement because of stricture resolution. Patients were followed-up for a median of 11.6 months and a significant improvement in dysphagia was reported in all patients (p < 0.001). The use of this conformable, small caliber new designed Niti-S stent, exchanged periodically, appeared safe and permitted durable oral intake in patients with difficult-to-treat hypopharyngeal or cervical esophagus strictures, avoiding the need for periodic dilations.

BACKGROUND:Self-expanding metal stents (SEMS) placement is primarily indicated to palliate dysphagia for patients with expected short-term survival. We aimed to assess the migration rate and other stent-related adverse events (AEs) of a fully covered SEMS with an anti-migration system (FCSEMS-AMS) for palliation of malignant dysphagia.METHODS:This is a prospective study including patients with inoperable esophageal cancer that received a FCSEMS-AMS (Taewoong, Niti-S Beta™), in five tertiary-care endoscopic centers from January 2014 to February 2016.RESULTS:Fifty-three consecutive patients were enrolled. Tumor location was proximal, mid and distal esophagus±esophago-gastric junction (EGJ) in 6, 14, and 33 cases, respectively. Overall, non-severe AEs were reported in 18 patients (34.0%), 13 of them required an additional endoscopic procedure. Migration occurred in 7 patients (13.2%): 3 from the upper and 4 from the lower esophagus and EGJ. Stent retrieval was necessary in one patient due to intolerable pain. Food bolus impaction and tumor overgrowth occurred in 2 patients (3.8%) and 4 (7.5%) patients respectively. Four patients complained of gastroesophageal reflux as late AEs. Median follow-up was 19.3 months. Dysphagia significantly improved until 3 and 6 months from stent insertion (median score before FCSEMS-AMS: 3, vs median score: 1). Median dysphagia-free time was 10 months.CONCLUSIONS:Placement of the Taewoong, Niti-S Beta™ stent appeared to be a safe and effective treatment of malignant dysphagia. The anti-migration system reduced the overall migration rate, although it remained high in strictures located in the upper esophagus and when the stent was placed across the EGJ.

The clinical and endoscopic features of colon ischemia (CI) are non-specific. CI is correctly identified at the time of presentation in only 9% of patients is. The true incidence is likely underestimated because many mild cases resolve spontaneously without medical treatment. Furthermore, since most cases of CI are transient, and no specific cause is detected they are often considered to be "idiopathic". In the setting of severe CI correct diagnosis and prompt recognition and therapy as well as identification of underlying causes are crucial for a favourable outcome. Although less severe, mild cases may present with similar symptoms, the prognosis and management are completely different and managed conservatively rather than with surgery. Unfortunately, data from most studies and current guidelines do not provide recommendations on the long-term management of CI or about the need for endoscopic follow-up to detect the development chronic, recurrent and/or ischemic colonic strictures. In this review, we focus on the definition of CI, its aetiology, and patterns of presentation. We highlight the pharmacological and/or endoscopic management as determined severity of disease that allow for improved outcomes. Prompt recognition and treatment using a multidisciplinary approach are essential for successful management of severe CI because mortality rates are significantly higher when the diagnosis is delayed.

Barrett’s esophagus (BE) and esophagitis share potentially modifiable risk factors such as obesity, smoking, and alcohol. The role of diet on BE and esophagitis is still debated. The objective of this study was to examine the association between some dietary habits and the risk of BE and esophagitis in Italy. A multicenter case–control study involving 1285 individuals was carried out in 12 areas. Patients with a new diagnosis of BE (320) or esophagitis (359) and a group of endoscopic controls (606) were included. Information on personal history and dietary habits was collected using a structured questionnaire. No clear monotonic significant dose–response relationship was found for most of the considered food items. Nevertheless, the most extreme consumption category of red meat, cold cuts, dairy products, and fried foods showed esophagitis risk excesses varying from 19 to 49%. A higher fat rich diet seemed to increase risk by 49% for BE and 94% for esophagitis. A downward tendency in esophagitis (− 27%) and BE risk (− 20%) was found associated with higher frequency of fresh fruit intake. In addition, a statistically significant twofold increased risk for both BE and esophagitis was found for subjects eating late evening snacks more than once every three days in comparison with the lowest intake category (no consumption). BE and esophagitis patients appeared to be more likely than controls to follow a diet rich in fats and poor in fruit and vegetables. Late evening snacks were found to be associated with both disorders.

Background: Fully covered self-expandable metal stents (FCSEMS) have increasingly been used in the endoscopic management of malignant and benign gastrointestinal diseases. The main limitation of FCSEMS is the risk of migration, occurring in at least one-third of patients. Different methods have been employed for anchorage of esophageal stent, as external fixation with endoscopic snare and internal fixation using both through-the-scope (TTS) and over-the scope (OTS) clips to fix the upper flared end of the FCSEMS to the esophageal mucosa. A new designed over-the-scope device called Stentfix OTSC (R) System (AG-Tuebingen- Germany), has been developed to avoid migration. It consists in a Nitinol clip preloaded on the applicator cap used to clip the flared end of FCSEMS to the gastrointestinal mucosal layer Aims: To evaluate the clinical outcomes of patients treated with Stentfix device. Methods: Five consecutive patients (median age: 58 years; males, 80%) were enrolled. All patients had experienced FCSEMS migration. The OTSC device was placed to prevent further stent migration. Results: Technical and clinical success was achieved in all patients. In one patient with a benign rectal anastomotic stricture long-term luminal patency was achieved after stent placement. One patient died of causes unrelated to endoscopic procedures. The other patients are still being followed. Dysphagia improvement of at least 1 point was seen in these patients. Conclusions: The StentfixOTSC (R) System appears to be a useful and safe device in the preventing FCSEMS migration in a variety of clinical scenarios. (C) 2020 Elsevier Inc. All rights reserved.

Despite recent advances aimed to treat transmural inflammation in Crohn’s disease (CD) patients, the progression to a structuring behavior still represents an issue for clinicians. As inflammation becomes chronic and severe, the attempt to repair damaged tissue can result in an excessive production of extracellular matrix components and deposition of connective tissue, thus favoring the formation of strictures. No specific and accurate clinical predictors or diagnostic tools for intestinal fibrosis exist, and to date, no genetic or serological marker is in routine clinical use. Therefore, intestinal fibrosis is usually diagnosed when it becomes clinically evident and strictures have already occurred. Anti-fibrotic agents such as tranilast, peroxisome proliferator-activated receptor gamma agonists, rho kinase inhibitors, and especially mesenchymal stem cell therapy have provided interesting results, but most of the evidence has been derived from studies performed in vitro. Therefore, current therapy of fibrotic strictures relies mainly on endoscopic and surgical procedures. Although its long-term outcomes may be debated, endoscopic balloon dilation appears to be the safest and most effective approach to treat appropriately selected strictures. The use of endoscopic stricturotomy is currently limited by the expertise needed to perform it and by the few data available in the literature. Some good results have been achieved by the positioning of self-expandable metal stents (SEMS). However, there is no concordance regarding the type of stent to use and for how long it should be left in place. The development of new specific SEMS may lead to better outcomes and to an increased use of this alternative in CD-related strictures.

Background and Aims: Self-expandable metal stents (SEMSs) are used to relieve malignant biliary obstructions. We aimed to compare stent patency, the adverse events rate, and overall survival of covered versus uncovered self-conformable metal stents in patients with primary malignant extrahepatic biliary strictures, not eligible for surgery. Methods: This is a multicenter randomized trial analyzing 158 patients with inoperable distal malignant biliary obstruction conducted in 5 Italian referral centers between December 2014 and October 2016. Seventy-eight patients were randomized to receive a fully covered SEMS (FCSEMS), and 80 patients received uncovered SEMSs (USEMSs). Data from 148 (72 FCSEMSs and 76 USEMSs) of 158 patients were analyzed. Results: Median time of stent patency was lower for FCSEMSs (240 days vs 541 days for USEMSs; P=.031). Adverse events occurred with 19 FCSEMSs (26.4%) and 10 USEMSs (13.2%); P=.061. The main causes of FCSEMS dysfunction were migration (7% vs 0% in the USEMS group) and early occlusion mainly because of sludge or overgrowth; late stent occlusion because of tumor ingrowth occurred in 13.2% of patients in the USEMS group. There were no significant differences either in levels of conjugated bilirubin improvement or in overall survival between the FCSEMS and USEMS groups. Median survival was 134 days in the FCSEMS group and 112 days in the USEMS group (P=.23). Conclusion: The number of stent-related adverse events was higher, although not significantly, among patients in the FCSEMS group. FCSEMSs had a significantly higher rate of migration than USEMSs, and stent occlusion occurred earlier. A significant difference in the patency rate was observed in favor of the USEMS group. (Clinical trial registration number: NCT02102984.)

Standard EMR techniques may not allow a complete resection of large lesions located in difficult places like the rectosigmoid junction. The advantages of cap-assisted EMR are better visualization of the operative field and the possibility to resect lesions irrespective of their locations.1Conio M. Competency in endoscopic mucosal resection.Gastrointest Endosc. 2016; 84: 969-970Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar, 2Morgan J. Thomas K. Lee-Robichaud H. et al.Transparent cap colonoscopy versus standard colonoscopy for investigation of gastrointestinal tract conditions.Cochrane Database Syst Rev. 2012; 12: CD008211PubMed Google Scholar We performed cap-assisted EMR of a laterally spreading tumor granular type (Paris classification 0-IIa+Is, Kudo pit pattern IV, 60 mm in size) involving the proximal rectum and the rectosigmoid junction in a 40-year-old woman (Fig. 1) (Video 1, available online at www.VideoGIE.org). The patient underwent colonoscopy because of abdominal pain. The cap-assisted EMR was uneventful, and intraprocedural bleeding was successfully treated by the application of endoclips. The patient was discharged 48 hours later. Histologic assessment showed a villous adenoma with high-grade dysplasia. Endoscopic follow-up at 8 months showed no recurrence. Cap-assisted EMR has been introduced primarily to treat lesions of the upper GI tract. The use of this procedure in the colon is still controversial because of the theoretic risk of entrapping the muscularis propria in the snare, causing perforation. To avoid this adverse event we suggest these measures:•Injection of a large amount of fluid in the submucosa before EMR to prevent thermal damage of the muscularis propria.•Performance of “controlled suction,” avoiding continuous suction, with filling of the cap. Sometimes the simple pressure of the cap against the lesion causes its protrusion into it. In our experience, cap-assisted EMR is effective for the removal of large laterally spreading tumors, avoiding surgical resection in an ever-increasing number of patients; the residual neoplasia rate has been 4%.3Conio M. Blanchi S. Repici A. et al.Cap-assisted endoscopic mucosal resection for colorectal polyps.Dis Colon Rectum. 2010; 42: 677-680Google Scholar However, this procedure should be carried out at referral centers with experienced endoscopists to reduce the risk of adverse events.1Conio M. Competency in endoscopic mucosal resection.Gastrointest Endosc. 2016; 84: 969-970Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar, 4Bhurwal A. Bartel M.J. Heckman M.G. et al.Endoscopic mucosal resection: learning curve for large nonpolypoid colorectal neoplasia.Gastrointest Endosc. 2016; 84: 959-968Abstract Full Text Full Text PDF PubMed Scopus (30) Google Scholar All authors disclosed no financial relationships relevant to this publication. eyJraWQiOiI4ZjUxYWNhY2IzYjhiNjNlNzFlYmIzYWFmYTU5NmZmYyIsImFsZyI6IlJTMjU2In0.eyJzdWIiOiI2NjM3ZjlkNWQxOTMyZmUxN2M4YWMxYjgzMzRiMzk1NCIsImtpZCI6IjhmNTFhY2FjYjNiOGI2M2U3MWViYjNhYWZhNTk2ZmZjIiwiZXhwIjoxNjc4NjA0MjUxfQ.GFDKSX2hf3iSvyadQhqKJy7QuaqveDvDIFtfeNfxeK3ziN59oEn8mkhcf9R2LY8U_QrA_BEBX0s_bC9Ku-TiLTYFfGSfgFZmpVlnSDp5lJ6j5wrJZE5yKnv3LQSyWmcVWy0yxAIPkGJJV4QhplJfIc8LbI6W6nDg-UIdXBaaFuaxP5UPRfOJOxYftN4682nSdo4pUR7Ml4iupXld_RwEIYPYeIgszrtqOZirgTLDNw_H1D9D3EDZ1WPNB6bF1zI99wpJkNWfCnjEwb5C46FGobFRlp8akmsVvPE6eAedpBFyFSlUwJC1M2nuPSzJ-Rep1XnODKyar-WuLScpX7bM7g Download .mp4 (104.07 MB) Help with .mp4 files Video 1Cap-assisted EMR of a large flat colorectal lesion. Download .docx (.02 MB) Help with docx files Video Script

Knowledge about the association between alcohol and Barrett's oesophagus and reflux oesophagitis is conflicting. In this case-control study we evaluated the role of specific alcoholic beverages (red and white wine, beer and liquors) in 339 Barrett's oesophagus and 462 oesophagitis patients compared with 619 endoscopic controls with other disorders, recruited in twelve Italian endoscopic units. Data on alcohol and other individual characteristics were obtained from structured questionnaires. No clear, monotonic significant dose-response relationship was pointed out for red wine. However, a generalised U-shaped trend of Barrett's oesophagus/oesophagitis risk due to red wine consumption particularly among current drinkers was found. Similar results were also found for white wine. Liquor/spirit consumption seemed to bring about a 1·14-2·30 risk excess, although statistically non-significant, for current Barrett's oesophagus/oesophagitis drinkers. Statistically significant decreasing dose-response relationships were found in Barrett's oesophagus for frequency and duration of beer consumption. Similar, but less clear downward tendencies were also found for oesophagitis patients. In conclusion, although often not statistically significant, our data suggested a reduced risk of Barrett's oesophagus and oesophagitis with a low/moderate intake of wine and beer consumption. A non-significant increased risk of Barrett's oesophagus/oesophagitis was observed with a higher intake of any type of heavy alcohol consumption, but no conclusion can be drawn owing to the high number of non-spirit drinkers and to the small number of drinkers at higher alcohol intake levels.

Background/Objectives: Only a few papers have treated of the relationship between Barrett’s esophagus (BE) or erosive esophagitis (E) and coffee or tea intake. We evaluated the role of these beverages in BE and E occurrence. Subjects/Methods: Patients with BE (339), E (462) and controls (619) were recruited. Data on coffee and tea and other individual characteristics were collected using a structured questionnaire. Results: BE risk was higher in former coffee drinkers, irrespective of levels of exposure (cup per day; ⩽1: OR=3.76, 95% CI 1.33–10.6; >1: OR=3.79, 95% CI 1.31–11.0; test for linear trend (TLT) P =0.006) and was higher with duration (>30 years: OR=4.18, 95% CI 1.43–12.3; TLT P =0.004) and for late quitters, respectively (⩽3 years from cessation: OR=5.95, 95% CI 2.19–16.2; TLT P <0.001). The risk of BE was also higher in subjects who started drinking coffee later (age >18 years: OR=6.10, 95% CI 2.15–17.3). No association was found in current drinkers, but for an increased risk of E in light drinkers (<1 cup per day OR =1.85, 95% CI 1.00–3.43). A discernible risk reduction of E (about 20%, not significant) and BE (about 30%, P <0.05) was observed in tea drinkers. Conclusions: Our data were suggestive of a reduced risk of BE and E with tea intake. An adverse effect of coffee was found among BE patients who had stopped drinking coffee. Coffee or tea intakes could be indicative of other lifestyle habits with protective or adverse impact on esophageal mucosa.

BACKGROUND AND AIMS:Colon capsule endoscopy (CCE) has been recognized as an alternative for colorectal cancer (CRC) screening in average-risk people. Our aim was to prospectively assess the accuracy of CCE as a screening tool in first-degree relatives (FDRs) of people with CRC by using optical colonoscopy (OC) with segmental unblinding as the reference standard. METHODS:Consecutive patients admitted with a CRC diagnosis (index cases) were prospectively evaluated and invited to contact their FDRs. Available FDRs were invited to undergo CCE and OC on the following day, with segmental unblinding of CCE results. Sensitivity, specificity, and predictive values/negative predictive values (PPV/NPV) of CCE were assessed for detecting patients with any polyp ≥6 mm and ≥10 mm. RESULTS:A total of 177 FDRs (median age 57.0 years, 54.8% female) identified from 211 index cases were included. Both CCE and OC were completed in all the included FDRs. Overall, CCE identified 51 of 56 FDRs with polyps ≥6 mm (sensitivity 91%; 95% CI, 81-96) and correctly classified as negative 107 of 121 participants without lesions ≥6 mm (specificity 88%; 95% CI, 81-93). Per-patient positive and negative predictive values for ≥6 mm lesions were 78% (95% CI, 67-87) and 95% (95% CI, 90-98), respectively. CCE detected 24 of 27 patients with polyps ≥10 mm and correctly classified as negative 142 of 150 patients, corresponding to 89% sensitivity and 95% specificity. Post-CCE referral rates to colonoscopy were 37% and 18%, respectively. CONCLUSIONS:CCE is an accurate method to screen FDRs of patients with CRC and could be offered as an alternative to those who decline or are unfit for colonoscopy screening. (Clinical trial registration number: NCT01184781.).