Endoscopic resection of residual rectal neoplasia after definitive chemoradiotherapy for rectal cancer.

The conventional approach to treating locally advanced rectal cancer, commonly defined as cT3 or cT4 primary tumors or with nodal metastases, involves chemoradiation (CRT) followed by surgical resection. There is a growing recognition of the potential for nonsurgical management following CRT or total neoadjuvant therapy (TNT), which allows for organ preservation. "Watch and wait" strategy may be considered if complete clinical response is achieved. In cases when adenoma or superficial cancer is present, a novel approach known as "salvage endoscopic resection of the residual disease" is emerging as a viable nonsurgical option for carefully selected patients. This review discusses available evidence and future potential for endoscopic management of residual neoplasia after oncological treatment of rectal cancer.

Western outcomes of circumferential endoscopic submucosal dissection for early esophageal squamous cell carcinoma.

BACKGROUND AND AIMS: Circumferential endoscopic submucosal dissection (cESD) in the esophagus has been reported to be feasible in small Eastern case series. We assessed the outcomes of cESD in the treatment of early esophageal squamous cell carcinoma (ESCC) in Western countries. METHODS: We conducted an international study at 25 referral centers in Europe and Australia using prospective databases. We included all patients with ESCC treated with cESD before November 2022. Our main outcomes were curative resection according to European guidelines and adverse events. RESULTS: A total of 171 cESDs were performed on 165 patients. En bloc and R0 resections rates were 98.2% (95% confidence interval [CI], 95.0-99.4) and 69.6% (95% CI, 62.3-76.0), respectively. Curative resection was achieved in 49.1% (95% CI, 41.7-56.6) of the lesions. The most common reason for noncurative resection was deep submucosal invasion (21.6%). The risk of stricture requiring 6 or more dilations or additional techniques (incisional therapy/stent) was high (71%), despite the use of prophylactic measures in 93% of the procedures. The rates of intraprocedural perforation, delayed bleeding, and adverse cardiorespiratory events were 4.1%, 0.6%, and 4.7%, respectively. Two patients died (1.2%) of a cESD-related adverse event. Overall and disease-free survival rates at 2 years were 91% and 79%. CONCLUSIONS: In Western referral centers, cESD for ESCC is curative in approximately half of the lesions. It can be considered a feasible treatment in selected patients. Our results suggest the need to improve patient selection and to develop more effective therapies to prevent esophageal strictures.

To push or to pull? A clinical audit on the efficacy and safety of the pull and push percutaneous endoscopic gastrostomy techniques in oncological patients.

BACKGROUND: The peroral "pull" technique and the direct "push" procedure are the two main methods for percutaneous endoscopic gastrostomy (PEG) placement. Although pull-PEG is generally recommended as the first-line modality, many oncological patients require a push-PEG approach to prevent tumor seeding or overcome tumor-related obstruction. OBJECTIVE: We aimed to compare the efficacy and safety of both PEG procedures in cancer patients. METHODS: We retrospectively analyzed all consecutive PEG procedures within a tertiary oncological center. Patients were followed up with the hospital databases and National Cancer Registry to assess the technical success rate for PEG placement, the rate of minor and major adverse events (AEs), and 30-day mortality rates. We compared those outcomes between the two PEG techniques. Finally, risk factors for PEG-related adverse events were analyzed using a multivariable Cox proportional-hazard regression model adjusted for patients' sex, age, performance status (ECOG), Body Mass Index (BMI), diabetes, chemoradiotherapy (CRT) status (pre-/current-/post-treatment), and type of PEG. RESULTS: We included 1055 PEG procedures (58.7% push-PEG/41.4% pull-PEG) performed in 994 patients between 2014 and 2021 (mean age 62.0 [±10.7] yrs.; 70.2% males; indication: head-and-neck cancer 75.9%/other cancer 24.1%). The overall technical success for PEG placement was 96.5%. Although the "push" technique had a higher rate of all AEs (21.4% vs. 7.1%, Hazard Ratio [HR]  = 2.9; 95% CI = 1.9-4.3, p < 0.001), most of these constituted minor AEs (71.9%), such as tube dislodgement. The methods had no significant difference regarding major AEs and 30-day mortality rates. Previous CRT was associated with an increased risk of major AEs (hazard ratio = 2.7, 95% CI = 1.0-7.2, p = 0.042). CONCLUSION: The risk of major AEs was comparable between the push- and pull-PEG techniques in cancer patients. Due to frequent tube dislodgement in push-PEG, the pull technique may be more suitable for long-term feeding. Previous CRT increases the risk of major AEs, favoring early ("prophylactic") PEG placement when such treatment is expected.

HPV testing in Polish population-based cervical cancer screening programme (HIPPO project)-study protocol of a randomised healthcare policy trial.

BACKGROUND: An Organised Cervical Cancer Screening Programme (OCCSP) was started in Poland in 2006/2007. Each woman aged 25 to 59 is eligible for a free Pap test every 3 years in OCCSP. Despite implementation of the OCCSP, the age-standardised cervical cancer (CC) incidence and mortality rates in 2019 were 7.3/100 000 and 3.9/100 000 respectively and were still higher than those in Western European countries with well-organised screening programmes. Apart from low coverage of the OCCSP, suboptimal performance of the screening test (conventional cytology) may be partially responsible for this situation. Several countries have already incorporated high risk Human Papillomavirus (hrHPV) testing in CC screening as a more sensitive tool reducing the risk of missing precancerous lesions and allowing for extension of screening intervals. The European Guidelines for Quality Assurance in Cervical Cancer Screening recommend pilot evaluation of a new screening test in country-specific conditions before its implementation. METHODS: The HIPPO project (HPV testing In Polish POpulation-based cervical cancer screening program) is a randomised health services study nested in the OCCSP in Poland. The project will randomise 33 000 women aged 30-59 years to cytology or hrHPV testing (ratio: 1:1) with age stratification. In the cytology arm women with repeated Atypical Squamous Cells of Undetermined Significance (ASC-US) or ≥ Low-Grade Squamous Intraepithelial Lesions (LSIL) are referred for colposcopy. In the other arm, hrHPV ( +) women with ≥ ASC-US reflex Liquid-Based Cytology (LBC) are referred for colposcopy. Primary endpoints include detection rates of histologically confirmed high grade intraepithelial lesions or worse (CIN2 +) in each arm. DISCUSSION: This pilot randomised healthcare study nested in the OCCSP in Poland will assess and compare the performance of hrHPV testing to current standard-cytology in order to make decisions on implementation of HPV-based screening in the country. TRIAL REGISTRATION: This randomised healthcare service study was prospectively registered at https://clinicaltrials.gov/ (identifier: NCT04111835, protocol ID 28/2019) on 19th of September 2019.

Estimated Lifetime Gained With Cancer Screening Tests: A Meta-Analysis of Randomized Clinical Trials.

Importance: Cancer screening tests are promoted to save life by increasing longevity, but it is unknown whether people will live longer with commonly used cancer screening tests. Objective: To estimate lifetime gained with cancer screening. Data Sources: A systematic review and meta-analysis was conducted of randomized clinical trials with more than 9 years of follow-up reporting all-cause mortality and estimated lifetime gained for 6 commonly used cancer screening tests, comparing screening with no screening. The analysis included the general population. MEDLINE and the Cochrane library databases were searched, and the last search was performed October 12, 2022. Study Selection: Mammography screening for breast cancer; colonoscopy, sigmoidoscopy, or fecal occult blood testing (FOBT) for colorectal cancer; computed tomography screening for lung cancer in smokers and former smokers; or prostate-specific antigen testing for prostate cancer. Data Extraction and Synthesis: Searches and selection criteria followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guideline. Data were independently extracted by a single observer, and pooled analysis of clinical trials was used for analyses. Main Outcomes and Measures: Life-years gained by screening was calculated as the difference in observed lifetime in the screening vs the no screening groups and computed absolute lifetime gained in days with 95% CIs for each screening test from meta-analyses or single randomized clinical trials. Results: In total, 2 111 958 individuals enrolled in randomized clinical trials comparing screening with no screening using 6 different tests were eligible. Median follow-up was 10 years for computed tomography, prostate-specific antigen testing, and colonoscopy; 13 years for mammography; and 15 years for sigmoidoscopy and FOBT. The only screening test with a significant lifetime gain was sigmoidoscopy (110 days; 95% CI, 0-274 days). There was no significant difference following mammography (0 days: 95% CI, -190 to 237 days), prostate cancer screening (37 days; 95% CI, -37 to 73 days), colonoscopy (37 days; 95% CI, -146 to 146 days), FOBT screening every year or every other year (0 days; 95% CI, -70.7 to 70.7 days), and lung cancer screening (107 days; 95% CI, -286 days to 430 days). Conclusions and Relevance: The findings of this meta-analysis suggest that current evidence does not substantiate the claim that common cancer screening tests save lives by extending lifetime, except possibly for colorectal cancer screening with sigmoidoscopy.

Predictors of long-term outcomes of endoscopic submucosal dissection of early gastric neoplasia in the West: a multicenter study.

BACKGROUND: This study aimed to determine long-term outcomes of gastric endoscopic submucosal dissection (ESD) in Western settings based on the latest Japanese indication criteria, and to examine predictors of outcomes and complications. METHODS: Data were collected from consecutive patients undergoing gastric ESD at four participating centers from 2009 to 2021. Retrospective analysis using logistic regression and survival analysis was performed. RESULTS: 415 patients were included (mean age 71.7 years; 56.4 % male). Absolute indication criteria (2018 guideline) were met in 75.3 % of patients. Median follow-up was 52 months. Post-resection histology was adenocarcinoma, high grade dysplasia, and low grade dysplasia in 49.9 %, 22.7 %, and 17.1 %, respectively. Perforation, early and delayed bleeding occurred in 2.4 %, 4.3 %, and 3.4 %, respectively. Rates of en bloc and R0 resection, and recurrence on first endoscopic follow-up were 94.7 %, 83.4 %, and 2.7 %, respectively. Relative indication (2018 guideline) for ESD was associated with R1 outcome (P = 0.02). Distal location (P = 0.002) and increased procedure time (P = 0.04) were associated with bleeding, and scarring (P = 0.009) and increased procedure duration (P = 0.003) were associated with perforation. Recurrence-free survival at 2 and 5 years was 94 % and 83 %, respectively. CONCLUSION: This is the largest Western multicenter cohort and suggests that gastric ESD is safe and effective in the Western setting. A quarter of patients fell outside the new absolute indications for ESD, suggesting that Western practice involves more advanced lesions. We identified the predictors of complications, which should help to inform future Western practice and research.

Personalized endoscopic surveillance and intervention protocols for patients with familial adenomatous polyposis: the European FAP Consortium strategy.

Background and study aims Patients with familial adenomatous polyposis (FAP) undergo colectomy and lifelong endoscopic surveillance to prevent colorectal, duodenal and gastric cancer. Endoscopy has advanced significantly in recent years, including both detection technology as well as treatment options. For the lower gastrointestinal tract, current guidelines do not provide clear recommendations for surveillance intervals. Furthermore, the Spigelman staging system for duodenal polyposis has its limitations. We present a newly developed personalized endoscopic surveillance strategy for the lower and upper gastrointestinal tract, aiming to improve the care for patients with FAP. We aim to inform centers caring for FAP patients and encourage the discussion on optimizing endoscopic surveillance and treatment in this high-risk population. Methods The European FAP Consortium, consisting of endoscopists with expertise in FAP, collaboratively developed new surveillance protocols. The proposed strategy was consensus-based and a result of several consortium meetings, discussing current evidence and limitations of existing systems. This strategy provides clear indications for endoscopic polypectomy in the rectum, pouch, duodenum and stomach and defines new criteria for surveillance intervals. This strategy will be evaluated in a 5-year prospective study in nine FAP expert centers in Europe. Results We present a newly developed personalized endoscopic surveillance and endoscopic treatment strategy for patients with FAP aiming to prevent cancer, optimize endoscopic resources and limit the number of surgical interventions. Following this new strategy, prospectively collected data in a large cohort of patients will inform us on the efficacy and safety of the proposed approaches.

Gastrointestinal endoscopy devices and the European Union Medical Device Regulation: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

Gastrointestinal endoscopy is largely dependent on medical devices. The European Union (EU) has recently introduced stricter rules and regulations for the approval of medical devices. This has consequences both for endoscopists and for patients. The new regulations increase the need for clinical trials and observational studies for new and current devices used in endoscopy to ensure clinical benefit and reduce patient harm. European endoscopy environments should facilitate industry-sponsored clinical trials and registry studies to meet the demand for robust data on endoscopic devices as required in the new legislation. The European Society of Gastrointestinal Endoscopy (ESGE) will play an active role in the establishment of the new system.The EU is establishing independent expert panels for device regulation in gastroenterology and hepatology, including endoscopy, that are charged with assessing the requirements for device testing. The ESGE encourages endoscopists with expertise in the technical and clinical performance of endoscopy devices to apply for expert panel membership. The ESGE has provided information for interested endoscopists on the ESGE website. Private European companies called "notified bodies" are entitled to conduct device approval for the EU. The ESGE will actively engage with these notified bodies for topics related to the new endoscopy device approval process to ensure continued access to high quality endoscopy devices for endoscopists in Europe.

Narrow-band imaging vs Lugol chromoendoscopy in screening for esophageal squamous cell neoplasia: a randomized trial.

INTRODUCTION: To date, there is no established optimal method for endoscopic detection of esophageal squamous cell neoplasia in high­risk individuals. OBJECTIVES: We aimed to compare the performance of narrow­band imaging (NBI) and Lugol chromoendoscopy in screening for esophageal neoplasia among patients with a history of treatment for head and neck squamous cell cancer (HNSCC). PATIENTS AND METHODS: We randomly assigned 300 patients who had completed curative treatment for HNSCC at least 1 year prior to the inclusion to undergo either NBI or Lugol endoscopy (2:1 ratio). Following white­light examination of the esophagus, the assigned imaging study was performed, and biopsies were taken from any suspicious lesions identified using NBI or Lugol chromoendoscopy. The primary end point was positive predictive value (PPV) of the biopsied lesion for a diagnosis of esophageal neoplasia (high­grade intraepithelial neoplasia [HG­IEN] or invasive esophageal squamous cell carcinoma [ESCC]). The secondary end points included the number of biopsied lesions, duration of esophagus examination, and endoscopy tolerance. RESULTS: In 294 patients included in the final analysis (NBI, n = 204; Lugol chromoendoscopy, n = 90), we diagnosed 3 ESCCs (1.02%) and 2 HG­IENs (0.68%). The PPV of NBI and Lugol chromoendoscopy in per­lesion analysis was 7.69% (95% CI, 0.94%-25.1%) and 8.11% (95% CI, 1.7%-21.9%), respectively (P >0.99). NBI outperformed Lugol chromoendoscopy in terms of the rate of patients requiring biopsy (12.75% vs 41.11%; P = 0.003), duration of esophagus examination (3.5 min vs 5.15 min; P <0.001), and endoscopy tolerance assessed on the visual analog scale (25 mm vs 36.5 mm; P = 0.002). CONCLUSIONS: With a PPV comparable to that of Lugol chromoendoscopy, but a lower number of biopsies required, shorter examination time, and better patient tolerance, NBI could be considered the primary screening method for ESCC in patients with HNSCC.

Endoscopic management of patients with high-risk colorectal colitis-associated neoplasia: a Delphi study.

BACKGROUND AND AIMS: Current guidelines recommend endoscopic resection of visible and endoscopically resectable colorectal colitis-associated neoplasia (CAN) in patients with inflammatory bowel disease (IBD). However, patients with high-risk CAN (HR-CAN) are often not amenable to conventional resection techniques, and a consensus approach for the endoscopic management of these lesions is presently lacking. This Delphi study aims to reach consensus among experts on the endoscopic management of these lesions. METHODS: A 3-round modified Delphi process was conducted to reach consensus among worldwide IBD and/or endoscopy experts (n = 18) from 3 continents. Consensus was considered if ≥75% agreed or disagreed. Quality of evidence was assessed by the criteria of the Cochrane Collaboration group. RESULTS: Consensus was reached on all statements (n = 14). Experts agreed on a definition for CAN and HR-CAN. Consensus was reached on the examination of the colon with enhanced endoscopic imaging before resection, the endoscopic resectability of an HR-CAN lesion, and endoscopic assessment and standard report of CAN lesions. In addition, experts agreed on type of resections of HR-CAN (< 20 mm, >20 mm, with or without good lifting), endoscopic success (technical success and outcomes), histologic assessment, and follow-up in HR-CAN. CONCLUSIONS: This is the first step in developing international consensus-based recommendations for endoscopic management of CAN and HR-CAN. Although the quality of available evidence was considered low, consensus was reached on several aspects of the management of CAN and HR-CAN. The present work and proposed standardization might benefit future studies.

Comparison of Quality Measures for Detection of Neoplasia at Screening Colonoscopy.

BACKGROUND & AIMS: The proportion of colonoscopies with at least one adenoma (adenoma detection rate [ADR]) is inversely associated with colorectal cancer (CRC) risk and death. The aim of this study was to examine whether such associations exist for colonoscopy quality measures other than ADR. METHODS: We used data from the Polish Colorectal Cancer Screening Program collected in 2000-2011. For all endoscopists who performed ≥100 colonoscopies we calculated detection rates of adenomas (ADR), polyps (PDR), and advanced adenomas (≥10 mm/villous component/high-grade dysplasia [AADR]); and number of adenomas per colonoscopy (APC) and per colonoscopy with ≥1 adenoma (APPC). We followed patients until CRC diagnosed before recommended surveillance, death, or December 31, 2019. We estimated hazard ratios (HRs) and 95% confidence intervals (CIs) using Cox proportional-hazard models. We used Harrell's C statistic to compare the predictive power of the quality measures. RESULTS: Data on 173,287 patients (median age, 56 years; 37.8% male) and 262 endoscopists were used. During a median follow-up of 10 years and 1,490,683 person-years, we identified 395 CRCs. All quality measures were significantly associated with CRC risk and death. The relative reductions in CRC risk were as follows: for ADR ≥24.9% (reference <12.1%; HR, 0.41; 95% CI, 0.25-0.66), PDR ≥42.7% (reference <19.9%; HR, 0.35; 95% CI, 0.24-0.51), AADR ≥9.1% (reference <4.1%; HR, 0.69; 95% CI, 0.49-0.96), APC ≥0.37 (reference <0.15; HR, 0.35; 95% CI, 0.21-0.58), and APPC ≥1.54 (reference <1.19; HR, 0.54; 95% CI, 0.35-0.83). AADR was the only quality measure with significantly lower predictive power than ADR (Harrell's C, 59.7 vs 63.4; P = .001). Similar relative reductions were observed for CRC death. CONCLUSIONS: This large observational study confirmed the inverse association between ADR and CRC risk and death. The PDR and APC quality measures appear to be comparable with ADR.

Effect of Colonoscopy Screening on Risks of Colorectal Cancer and Related Death.

BACKGROUND: Although colonoscopy is widely used as a screening test to detect colorectal cancer, its effect on the risks of colorectal cancer and related death is unclear. METHODS: We performed a pragmatic, randomized trial involving presumptively healthy men and women 55 to 64 years of age drawn from population registries in Poland, Norway, Sweden, and the Netherlands between 2009 and 2014. The participants were randomly assigned in a 1:2 ratio either to receive an invitation to undergo a single screening colonoscopy (the invited group) or to receive no invitation or screening (the usual-care group). The primary end points were the risks of colorectal cancer and related death, and the secondary end point was death from any cause. RESULTS: Follow-up data were available for 84,585 participants in Poland, Norway, and Sweden - 28,220 in the invited group, 11,843 of whom (42.0%) underwent screening, and 56,365 in the usual-care group. A total of 15 participants had major bleeding after polyp removal. No perforations or screening-related deaths occurred within 30 days after colonoscopy. During a median follow-up of 10 years, 259 cases of colorectal cancer were diagnosed in the invited group as compared with 622 cases in the usual-care group. In intention-to-screen analyses, the risk of colorectal cancer at 10 years was 0.98% in the invited group and 1.20% in the usual-care group, a risk reduction of 18% (risk ratio, 0.82; 95% confidence interval [CI], 0.70 to 0.93). The risk of death from colorectal cancer was 0.28% in the invited group and 0.31% in the usual-care group (risk ratio, 0.90; 95% CI, 0.64 to 1.16). The number needed to invite to undergo screening to prevent one case of colorectal cancer was 455 (95% CI, 270 to 1429). The risk of death from any cause was 11.03% in the invited group and 11.04% in the usual-care group (risk ratio, 0.99; 95% CI, 0.96 to 1.04). CONCLUSIONS: In this randomized trial, the risk of colorectal cancer at 10 years was lower among participants who were invited to undergo screening colonoscopy than among those who were assigned to no screening. (Funded by the Research Council of Norway and others; NordICC ClinicalTrials.gov number, NCT00883792.).

Expected value of artificial intelligence in gastrointestinal endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

This ESGE Position Statement defines the expected value of artificial intelligence (AI) for the diagnosis and management of gastrointestinal neoplasia within the framework of the performance measures already defined by ESGE. This is based on the clinical relevance of the expected task and the preliminary evidence regarding artificial intelligence in artificial or clinical settings. MAIN RECOMMENDATIONS:: (1) For acceptance of AI in assessment of completeness of upper GI endoscopy, the adequate level of mucosal inspection with AI should be comparable to that assessed by experienced endoscopists. (2) For acceptance of AI in assessment of completeness of upper GI endoscopy, automated recognition and photodocumentation of relevant anatomical landmarks should be obtained in ≥90% of the procedures. (3) For acceptance of AI in the detection of Barrett's high grade intraepithelial neoplasia or cancer, the AI-assisted detection rate for suspicious lesions for targeted biopsies should be comparable to that of experienced endoscopists with or without advanced imaging techniques. (4) For acceptance of AI in the management of Barrett's neoplasia, AI-assisted selection of lesions amenable to endoscopic resection should be comparable to that of experienced endoscopists. (5) For acceptance of AI in the diagnosis of gastric precancerous conditions, AI-assisted diagnosis of atrophy and intestinal metaplasia should be comparable to that provided by the established biopsy protocol, including the estimation of extent, and consequent allocation to the correct endoscopic surveillance interval. (6) For acceptance of artificial intelligence for automated lesion detection in small-bowel capsule endoscopy (SBCE), the performance of AI-assisted reading should be comparable to that of experienced endoscopists for lesion detection, without increasing but possibly reducing the reading time of the operator. (7) For acceptance of AI in the detection of colorectal polyps, the AI-assisted adenoma detection rate should be comparable to that of experienced endoscopists. (8) For acceptance of AI optical diagnosis (computer-aided diagnosis [CADx]) of diminutive polyps (≤5 mm), AI-assisted characterization should match performance standards for implementing resect-and-discard and diagnose-and-leave strategies. (9) For acceptance of AI in the management of polyps ≥ 6 mm, AI-assisted characterization should be comparable to that of experienced endoscopists in selecting lesions amenable to endoscopic resection.

Performance measures for colonoscopy in inflammatory bowel disease patients: European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative.

The European Society of Gastrointestinal Endoscopy (ESGE) presents a short list of performance measures for colonoscopy in inflammatory bowel disease (IBD) patients. Current performance measures for colonoscopy mainly focus on detecting (pre)malignant lesions. However, these performance measures are not relevant for all colonoscopy indications in IBD patients. Therefore, our aim was to provide endoscopy services across Europe and other interested countries with a tool for quality monitoring and improvement in IBD colonoscopy. Eight key performance measures and one minor performance measure were recommended for measurement and evaluation in daily endoscopy practice.