Prevention of delayed bleeding after resection of large colonic polyps.

A significant problem encountered in the resection of large, complex colonic polyps is delayed bleeding. This can occur up to two weeks after the procedure and is a significant source of comorbidity. Untreated it can prove life threatening. It is therefore a priority of modern endoscopy to develop and employ techniques to minimaize this. In this article we will review and discuss the evidence base and controversies in this field, with cold EMR technique, Post-EMR clip closure, and topical haemostatic agents.

National Institute for Health and Care Excellence (NICE) guidance on monitoring and management of Barrett's oesophagus and stage I oesophageal adenocarcinoma.

Barrett's oesophagus is the only known precursor to oesophageal adenocarcinoma, a cancer with very poor prognosis. The main risk factors for Barrett's oesophagus are a history of gastro-oesophageal acid reflux symptoms and obesity. Men, smokers and those with a family history are also at increased risk. Progression from Barrett's oesophagus to cancer occurs via an intermediate stage, known as dysplasia. However, dysplasia and early cancer usually develop without any clinical signs, often in individuals whose symptoms are well controlled by acid suppressant medications; therefore, endoscopic surveillance is recommended to allow for early diagnosis and timely clinical intervention. Individuals with Barrett's oesophagus need to be fully informed about the implications of this diagnosis and the benefits and risks of monitoring strategies. Pharmacological treatments are recommended for control of symptoms, but not for chemoprevention. Dysplasia and stage 1 oesophageal adenocarcinoma have excellent prognoses, since they can be cured with endoscopic or surgical therapies. Endoscopic resection is the most accurate staging technique for early Barrett's-related oesophageal adenocarcinoma. Endoscopic ablation is effective and indicated to eradicate Barrett's oesophagus in patients with dysplasia. Future research should focus on improved accuracy for dysplasia detection via new technologies and providing more robust evidence to support pathways for follow-up and treatment.

Device-assisted enteroscopy performance measures in the United Kingdom: DEEP-UK quality improvement project.

BACKGROUND: Device-assisted enteroscopy (DAE) has become a well-established diagnostic and therapeutic tool for the management of small-bowel pathology. We aimed to evaluate the performance measures for DAE across the UK against the quality benchmarks proposed by the European Society of Gastrointestinal Endoscopy (ESGE). METHODS: We retrospectively collected data on patient demographics and DAE performance measures from electronic endoscopy records of consecutive patients who underwent DAE for diagnostic and therapeutic purposes across 12 enteroscopy centers in the UK between January 2017 and December 2022. RESULTS: A total of 2005 DAE procedures were performed in 1663 patients (median age 60 years; 53% men). Almost all procedures (98.1%) were performed for appropriate indications. Double-balloon enteroscopy was used for most procedures (82.0%), followed by single-balloon enteroscopy (17.2%) and spiral enteroscopy (0.7%). The estimated depth of insertion was documented in 73.4% of procedures. The overall diagnostic yield was 70.0%. Therapeutic interventions were performed in 42.6% of procedures, with a success rate of 96.6%. Overall, 78.0% of detected lesions were marked with a tattoo. Patient comfort was significantly better with the use of deep sedation compared with conscious sedation (99.7% vs. 68.5%; P<0.001). Major adverse events occurred in only 0.6% of procedures. CONCLUSIONS: Performance measures for DAE in the UK meet the ESGE quality benchmarks, with high diagnostic and therapeutic yields, and a low incidence of major adverse events. However, there is room for improvement in optimizing sedation practices, standardizing the depth of insertion documentation, and adopting marking techniques to aid in the follow-up of detected lesions.

Randomized controlled trial of EndoRings assisted colonoscopy versus standard colonoscopy.

OBJECTIVES: The EndoRings device is a distal attachment consisting of two layers of circular flexible rings that evert mucosal folds. The aim of this study was to investigate whether EndoRing assisted colonoscopy (ER) improves polyp and adenoma detection compared to standard colonoscopy (SC). METHODS: Multicenter, parallel group, randomized controlled trial. RESULTS: Total of 556 patients randomized to ER (n = 275) or SC (n = 281). Colonoscopy completed in 532/556 (96%) cases. EndoRings removed in 74/275 (27%) patients. Total number of polyps in ER limb 582 vs. 515 in SC limb, P = 0.04. Total number of adenomas in ER limb 361 vs. 343 for SC limb, P = 0.49. A statistically significant difference in the mean number of polyps per patient in both the intention to treat (1.84 SC vs. 2.10 ER, P = 0.027) and per protocol (PP) (1.84 SC vs. 2.25 ER, P = 0.004). CONCLUSIONS: Our study shows promise for the EndoRings device to improve polyp detection.

Definition of competence standards for optical diagnosis of diminutive colorectal polyps: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

BACKGROUND : The European Society of Gastrointestinal Endoscopy (ESGE) has developed a core curriculum for high quality optical diagnosis training for practice across Europe. The development of easy-to-measure competence standards for optical diagnosis can optimize clinical decision-making in endoscopy. This manuscript represents an official Position Statement of the ESGE aiming to define simple, safe, and easy-to-measure competence standards for endoscopists and artificial intelligence systems performing optical diagnosis of diminutive colorectal polyps (1 - 5 mm). METHODS : A panel of European experts in optical diagnosis participated in a modified Delphi process to reach consensus on Simple Optical Diagnosis Accuracy (SODA) competence standards for implementation of the optical diagnosis strategy for diminutive colorectal polyps. In order to assess the clinical benefits and harms of implementing optical diagnosis with different competence standards, a systematic literature search was performed. This was complemented with the results from a recently performed simulation study that provides guidance for setting alternative competence standards for optical diagnosis. Proposed competence standards were based on literature search and simulation study results. Competence standards were accepted if at least 80 % agreement was reached after a maximum of three voting rounds. RECOMMENDATION 1: In order to implement the leave-in-situ strategy for diminutive colorectal lesions (1-5 mm), it is clinically acceptable if, during real-time colonoscopy, at least 90 % sensitivity and 80 % specificity is achieved for high confidence endoscopic characterization of colorectal neoplasia of 1-5 mm in the rectosigmoid. Histopathology is used as the gold standard.Level of agreement 95 %. RECOMMENDATION 2: In order to implement the resect-and-discard strategy for diminutive colorectal lesions (1-5 mm), it is clinically acceptable if, during real-time colonoscopy, at least 80 % sensitivity and 80 % specificity is achieved for high confidence endoscopic characterization of colorectal neoplasia of 1-5 mm. Histopathology is used as the gold standard.Level of agreement 100 %. CONCLUSION : The developed SODA competence standards define diagnostic performance thresholds in relation to clinical consequences, for training and for use when auditing the optical diagnosis of diminutive colorectal polyps.

Data from a large Western centre exploring the impact of COVID-19 pandemic on endoscopy services and cancer diagnosis.

OBJECTIVE: The global COVID-19 pandemic has changed healthcare across the world. Efforts have concentrated on managing this crisis, with impact on cancer care unclear. We investigated the impact on endoscopy services and gastrointestinal (GI) cancer diagnosis in the UK. DESIGN: Analysis of endoscopy procedures and cancer diagnosis at a UK Major General Hospital. Procedure rates and diagnosis of GI malignancy were examined over 8-week periods in spring, summer and autumn 2019 before the start of the crisis and were compared with rates since onset of national lockdown and restrictions on elective endoscopy. The number of CT scans performed and malignancies diagnosed in the two corresponding periods in 2019 and 2020 were also evaluated. RESULTS: 2 698 2516 and 3074 endoscopic procedures were performed in 2019, diagnosing 64, 73 and 78 cancers, respectively, the majority being in patients with alarm symptoms and fecal immunochemical test+ve bowel cancer screening population. Following initiation of new guidelines for management of endoscopy services 245 procedures were performed in a 6 week duration, diagnosing 18 cancers. This equates to potentially delayed diagnosis of 37 cancers per million population per month. Clinician triage improved, resulting in 13.6 procedures performed to diagnose one cancer. CONCLUSIONS: Our data demonstrate an 88% reduction in procedures during the first 6 weeks of COVID-19 crisis, resulting in 66% fewer GI cancer diagnoses. Triage changes reduced the number of procedures required to diagnose cancer. Our data can help healthcare planning to manage the extra workload on endoscopy departments during the recovery period from COVID-19.

Revising the European Society of Gastrointestinal Endoscopy (ESGE) research priorities: a research progress update.

BACKGROUND: One of the aims of the European Society of Gastrointestinal Endoscopy (ESGE) is to encourage high quality endoscopic research at a European level. In 2016, the ESGE research committee published a set of research priorities. As endoscopic research is flourishing, we aimed to review the literature and determine whether endoscopic research over the last 4 years had managed to address any of our previously published priorities. METHODS: As the previously published priorities were grouped under seven different domains, a working party with at least two European experts was created for each domain to review all the priorities under that domain. A structured review form was developed to standardize the review process. The group conducted an extensive literature search relevant to each of the priorities and then graded the priorities into three categories: (1) no longer a priority (well-designed trial, incorporated in national/international guidelines or adopted in routine clinical practice); (2) remains a priority (i. e. the above criterion was not met); (3) redefine the existing priority (i. e. the priority was too vague with the research question not clearly defined). RESULTS: The previous ESGE research priorities document published in 2016 had 26 research priorities under seven domains. Our review of these priorities has resulted in seven priorities being removed from the list, one priority being partially removed, another seven being redefined to make them more precise, with eleven priorities remaining unchanged. This is a reflection of a rapid surge in endoscopic research, resulting in 27 % of research questions having already been answered and another 27 % requiring redefinition. CONCLUSIONS: Our extensive review process has led to the removal of seven research priorities from the previous (2016) list, leaving 19 research priorities that have been redefined to make them more precise and relevant for researchers and funding bodies to target.

A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection: a randomized controlled trial.

BACKGROUND: Endoscopic submucosal dissection (ESD) is associated with a risk of bleeding. Bleeding is usually treated with diathermy, although this does carry a risk of mucosal thermal injury. Purastat is a topical hemostat that may be effective in controlling bleeding during ESD, thereby reducing the use of heat therapy. The aim of this study was to assess the reduction in heat therapy used in the interventional group (Purastat) compared with the control group. The secondary aims were to compare the procedure length, time for hemostasis, delayed bleeding rate, adverse events, and wound healing between the groups. METHODS: This was a single-center randomized controlled trial of 101 patients undergoing ESD. Participants were randomized to a control group where diathermy was used to control bleeding or an interventional group where Purastat could be used. Follow-up endoscopy was performed at 4 weeks to assess wound healing. RESULTS: There was a significant reduction in the use of heat therapy for intraprocedural hemostasis in the interventional group compared with controls (49.3 % vs. 99.6 %, P < 0.001). There were no significant differences in the procedure length, time for hemostasis, and delayed bleeding rate between the groups. Complete wound healing at 4 weeks was noted in 48.8 % of patients in the interventional group compared with 25.0 % of controls (P = 0.02). CONCLUSIONS: This study has demonstrated that Purastat is an effective hemostat that can reduce the need for heat therapy for bleeding during ESD. It may also have a role in improving post-resection wound healing.

Multicentre randomised controlled trial on virtual chromoendoscopy in the detection of neoplasia during colitis surveillance high-definition colonoscopy (the VIRTUOSO trial).

BACKGROUND: Longstanding colonic IBD increases the risk of developing colorectal cancer. The utility of chromoendoscopy with standard-definition white light technology has been established. However, the use of high-definition virtual chromoendoscopy (HDV) in colitis surveillance remains undefined. OBJECTIVE: To compare the performance of HDV (i-scan OE mode 2) with high-definition white light (HDWL) for detection of neoplasia in patients with IBD undergoing surveillance colonoscopy. Additionally, we assessed the utility of protocol-guided quadrantic non-targeted biopsies. DESIGN: A multioperator randomised controlled trial was carried out in two centres in the UK. Total of 188 patients (101 men, mean age 54) with longstanding ulcerative or Crohn's colitis were randomised, prior to starting the surveillance colonoscopy, to using either HDV (n=94) or HDWL (n=94) on withdrawal. Targeted and quadrantic non-targeted biopsies were taken in both arms per-randomisation protocol. The primary outcome was the difference in neoplasia detection rate (NDR) between HDV and HDWL. RESULTS: There was no significant difference between HDWL and HDV for neoplasia detection. The NDR was not significantly different for HDWL (24.2%) and HDV (14.9%) (p=0.14). All intraepithelial neoplasia (IEN) detected contained low-grade dysplasia only. A total of 6751 non-targeted biopsies detected one IEN only. The withdrawal time was similar in both arms of the study; median of 24 min (HDWL) versus 25.5 min (HDV). CONCLUSION: HDV and HDWL did not differ significantly in the detection of neoplasia. Almost all neoplasia were detected on targeted biopsy or resection. Quadrantic non-targeted biopsies have negligible additional gain. TRIAL REGISTRATION NUMBER: Clinical Trial.gov ID NCT02822352.

A feasibility trial of Acetic acid-targeted Biopsies versus nontargeted quadrantic biopsies during BArrett's surveillance: the ABBA trial.

BACKGROUND: The aims of this study were to compare neoplasia detection rates for nontargeted biopsies (Seattle protocol) versus acetic acid-targeted biopsies (Portsmouth protocol) during Barrett's surveillance and to explore feasibility, patient/clinician experience, acceptance, and barriers/enablers to study participation and implementation of the acetic acid technique. METHODS: This was a mixed-methods feasibility study including a pilot multicenter, randomized, crossover trial with qualitative interviews. Patients under Barrett's surveillance with no history of neoplasia were included. Patients underwent two endoscopies, one with each protocol, 8 weeks apart. Outcomes included recruitment and retention rates, neoplasia yield, and number of biopsies. RESULTS: 200 patients were recruited from 6 centers, and 174 (87.0 %) underwent both procedures. Neoplasia prevalence was 4.7 % (9/192). High grade dysplasia and cancer were detected with both protocols. Five low grade dysplasias were detected (two with acetic acid, four with nontargeted biopsies; one lesion was detected with both techniques). A total of 2139 biopsies were taken in the nontargeted arm and 226 in the acetic acid arm. Both patients and clinicians found the acetic acid technique acceptable. Based on these data, a noninferiority, tandem, crossover trial would require an estimated 2828 patients. CONCLUSIONS: We demonstrated the feasibility of performing a crossover endoscopy trial in Barrett's surveillance. Low neoplasia yield makes this design necessary and qualitative results demonstrated patient and clinician acceptance. The reduced numbers of biopsies suggest that the acetic acid technique could result in cost savings, providing the lack of missed pathology can be proven in a fully powered definitive trial.

Advanced imaging for detection and differentiation of colorectal neoplasia: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2019.

1:  ESGE suggests that high definition endoscopy, and dye or virtual chromoendoscopy, as well as add-on devices, can be used in average risk patients to increase the endoscopist's adenoma detection rate. However, their routine use must be balanced against costs and practical considerations.Weak recommendation, high quality evidence. 2:  ESGE recommends the routine use of high definition systems in individuals with Lynch syndrome.Strong recommendation, high quality evidence. 3:  ESGE recommends the routine use, with targeted biopsies, of dye-based pancolonic chromoendoscopy or virtual chromoendoscopy for neoplasia surveillance in patients with long-standing colitis.Strong recommendation, moderate quality evidence. 4:  ESGE suggests that virtual chromoendoscopy and dye-based chromoendoscopy can be used, under strictly controlled conditions, for real-time optical diagnosis of diminutive (≤ 5 mm) colorectal polyps and can replace histopathological diagnosis. The optical diagnosis has to be reported using validated scales, must be adequately photodocumented, and can be performed only by experienced endoscopists who are adequately trained, as defined in the ESGE curriculum, and audited.Weak recommendation, high quality evidence. 5:  ESGE recommends the use of high definition white-light endoscopy in combination with (virtual) chromoendoscopy to predict the presence and depth of any submucosal invasion in nonpedunculated colorectal polyps prior to any treatment. Strong recommendation, moderate quality evidence. 6:  ESGE recommends the use of virtual or dye-based chromoendoscopy in addition to white-light endoscopy for the detection of residual neoplasia at a piecemeal polypectomy scar site. Strong recommendation, moderate quality evidence. 7:  ESGE suggests the possible incorporation of computer-aided diagnosis (detection and characterization of lesions) to colonoscopy, if acceptable and reproducible accuracy for colorectal neoplasia is demonstrated in high quality multicenter in vivo clinical studies. Possible significant risks with implementation, specifically endoscopist deskilling and over-reliance on artificial intelligence, unrepresentative training datasets, and hacking, need to be considered. Weak recommendation, low quality evidence.

To cap/cuff or ring: do distal attachment devices improve the adenoma detection?

INTRODUCTION: Colonoscopy reduces the risk of colorectal cancer, by interrupting the adenoma-carcinoma sequence enabling the detection and removal of adenomas before they turn into colorectal cancer. Colonoscopy has its limitations as adenoma miss rates as high as 25% have been reported. The reasons for missed pathology are complicated and multi-factorial. The recent drive to improve adenoma detection rates has led to a plethora of new technologies. Areas covered: An increasing number of advanced endoscopes and distal attachment devices have appeared in the market. Advanced endoscopes aim to improve mucosal visualization by widening the field of view. Distal attachment devices aim to increase adenoma detection behind folds by flattening folds on withdrawal. In this review article, we discuss the three following distal attachment devices: the transparent cap, the Endocuff, and the Endoring. Expert commentary: The authors believe that the distal attachment devices will have a greater benefit for endoscopists with low baseline adenoma detection rates.

Haemostasis and prevention of bleeding related to ER: The role of a novel self-assembling peptide.

Background: Endoscopic resection is now commonly used for removal of early gastrointestinal lesions. However, the risk of the procedure may be heightened by intraprocedural or delayed bleeding. A novel, self-assembling peptide (PuraStat®) was recently licensed for use as a haemostat. Objective: The aim of this study was to assess the efficacy and safety of this haemostat when used to control intraprocedural bleeding or to prevent delayed bleeding in endoscopic resection. Methods: PuraStat® was used on 100 patients undergoing endoscopic resection in a tertiary referral centre. The efficacy, safety, feasibility of use and delayed bleeding rates were measured. Results: Forty-eight oesophageal, 31 colorectal, 11 gastric and 10 duodenal procedures were included. The mean lesion size was 3.7 cm and 30% of the patients were on antithrombotic therapy. Intraprocedural bleeding occurred in 64%. PuraStat® was an effective haemostat in 75% of these cases. Only a small amount was required for haemostasis (mean = 1.76 ml) and it took on average 69.5 seconds to stop a bleed. The delayed bleeding rate was 3%. Conclusions: PuraStat® is an effective haemostat for use in controlling bleeds during endoscopic resection. It is safe, easy to use and did not interfere with the procedure.

The role of imaging and biopsy in the management and staging of large non-pedunculated rectal polyps.

INTRODUCTION: Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are often used for benign and Sm1 large non-pedunculated rectal polyps (LNPRPs), although other surgical techniques including transanal endoscopic microsurgery (TEMS) and transanal minimal invasive surgery remain available. This review covers the role of pre-excisional imaging and selective biopsy of LNPRPs. Areas covered: Polyps between 2 and 3 cm with favorable features (Paris 1, Kudo III/IV pit patterns, and non-lateral spreading type [LST]) may have a one-stage EMR without biopsy and imaging, provided adequate expertise is available with other technologies such as magnifying chromoendoscopy. Higher-risk polyps (moderate/severe dysplasia, 0-IIa+c morphology, nongranular LST, Kudo pit pattern V or submucosal carcinoma, or those >3 cm) should have pre-EMR/ESD imaging with magnetic resonance imaging (MRI) and/or endorectal ultrasound (ERUS) ± biopsies and photographs prior to multidisciplinary team discussion. Expert commentary: In some centers, EMR and ESD are considered the primary modality of treatment, with TEMS as a back-up, while elsewhere, TEMS is the main modality for excision of significant polyps and early colorectal cancer lesions. Likewise, the exact roles of ERUS and MRI will depend on availability of local expertise, although it is suggested that the techniques are complementary.

Recent advances in the management of large and complex colonic polyps.

The endoscopic management of large colonic polyps is a rapidly changing field. Rapid evolution in endoscopic techniques and skills has resulted in diminishing the role of surgery in the management of larger and complex polyps. This is resulting in organ preservation for many who otherwise would have undergone surgery. However, it also poses new challenges. This article reviews these new advances and the developments which are overcoming these difficulties.

Acetic acid-guided biopsies in Barrett's surveillance for neoplasia detection versus non-targeted biopsies (Seattle protocol): A feasibility study for a randomized tandem endoscopy trial. The ABBA study.

BACKGROUND AND STUDY AIMS: Barrett's esophagus is a potentially pre-cancerous condition, affecting 375,000 people in the UK. Patients receive a 2-yearly endoscopy to detect cancerous changes, as early detection and treatment results in better outcomes. Current treatment requires random mapping biopsies along the length of Barrett's, in addition to biopsy of visible abnormalities. As only 13 % of pre-cancerous changes appear as visible nodules or abnormalities, areas of dysplasia are often missed. Acetic acid chromoendoscopy (AAC) has been shown to improve detection of pre-cancerous and cancerous tissue in observational studies, but no randomized controlled trials (RCTs) have been performed to date. PATIENTS AND METHODS: A "tandem" endoscopy cross-over design. Participants will be randomized to endoscopy using mapping biopsies or AAC, in which dilute acetic acid is sprayed onto the surface of the esophagus, highlighting tissue through an whitening reaction and enhancing visibility of areas with cellular changes for biopsy. After 4 to 10 weeks, participants will undergo a repeat endoscopy, using the second method. Rates of recruitment and retention will be assessed, in addition to the estimated dysplasia detection rate, effectiveness of the endoscopist training program, and rates of adverse events (AEs). Qualitative interviews will explore participant and endoscopist acceptability of study design and delivery, and the acceptability of switching endoscopic techniques for Barrett's surveillance. RESULTS: Endoscopists' ability to diagnose dysplasia in Barrett's esophagus can be improved. AAC may offer a simple, universally applicable, easily-acquired technique to improve detection, affording patients earlier diagnosis and treatment, reducing endoscopy time and pathology costs. The ABBA study will determine whether a crossover "tandem" endoscopy design is feasible and acceptable to patients and clinicians and gather outcome data to power a definitive trial.

International development and validation of a classification system for the identification of Barrett's neoplasia using acetic acid chromoendoscopy: the Portsmouth acetic acid classification (PREDICT).

BACKGROUND: Barrett's oesophagus is an established risk factor for developing oesophageal adenocarcinoma. However, Barrett's neoplasia can be subtle and difficult to identify. Acetic acid chromoendoscopy (AAC) is a simple technique that has been demonstrated to highlight neoplastic areas but lesion recognition with AAC remains a challenge, thereby hampering its widespread use. OBJECTIVE: To develop and validate a simple classification system to identify Barrett's neoplasia using AAC. DESIGN: The study was conducted in four phases: phase 1-development of component descriptive criteria; phase 2-development of a classification system; phase 3-validation of the classification system by endoscopists; and phase 4-validation of the classification system by non-endoscopists. RESULTS: Phases 1 and 2 led to the development of a simplified AAC classification system based on two criteria: focal loss of acetowhitening and surface patterns of Barrett's mucosa. In phase 3, the application of PREDICT (Portsmouth acetic acid classification) by endoscopists improved the sensitivity and negative predictive value (NPV) from 79.3% and 80.2% to 98.1% and 97.4%, respectively (p<0.001). In phase 4, the application of PREDICT by non-endoscopists improved the sensitivity and NPV from 69.6% and 75.5% to 95.9% and 96.0%, respectively (p<0.001). CONCLUSION: We developed and validated a classification system known as PREDICT for the diagnosis of Barrett's neoplasia using AAC. The improvement seen in the sensitivity and NPV for detection of Barrett's neoplasia in phase 3 demonstrates the clinical value of PREDICT and the similar improvement seen among non-endoscopists demonstrates the potential for generalisation of PREDICT once proven in real time.