Surgery versus radical endotherapies for early cancer and high-grade dysplasia in Barrett's oesophagus.

BACKGROUND: Barrett's oesophagus is one of the most common pre-malignant lesions in the world. Currently the mainstay of therapy is surgical management of advanced cancer but this has improved the five-year survival very little since the 1980s. As a consequence, improved survival relies on early detection through endoscopic surveillance programmes. Success of this strategy relies on the fact that late-stage pre-malignant lesions or very early cancers can be cured by intervention. Currently there is considerable controversy over which method is best: that is conventional open surgery or endotherapy (techniques involving endoscopy). OBJECTIVES: We used data from randomised controlled trials (RCTs) to examine the effectiveness of endotherapies compared with surgery in people with Barrett's oesophagus, those with early neoplasias (defined as high-grade dysplasia (HGD) and those with early cancer (defined as carcinoma in-situ, superficially invasive, early cancer or superficial cancer T-1m (T1-a) and T-1sm (T1-b)). SEARCH METHODS: We used the Cochrane highly sensitive search strategy to identify RCTs in MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), ISI Web of Science, EBMR, Controlled Trials mRCT and ISRCTN, and LILACS, in July and August 2008. The searches were updated in 2009 and again in April 2012. SELECTION CRITERIA: Types of studies: RCTs comparing endotherapies with surgery in the treatment of high-grade dysplasia or early cancer. All cellular types of cancer were included (i.e. adenocarcinomas, squamous cell carcinomas and more unusual types) but will be discussed separately. TYPES OF PARTICIPANTS: patients of any age and either gender with a histologically confirmed diagnosis of early neoplasia (HGD and early cancer) in Barrett's or squamous lined oesophagus. Types of interventions; endotherapies (the intervention) compared with surgery (the control), all with curative intent. DATA COLLECTION AND ANALYSIS: Reports of studies that meet the inclusion criteria for this review would have been analysed using the methods detailed in Appendix 9. MAIN RESULTS: We did not identify any studies that met the inclusion criteria. In total we excluded 13 studies that were not RCTs but that compared surgery and endotherapies. AUTHORS' CONCLUSIONS: This Cochrane review has indicated that there are no RCTs to compare management options in this vital area, therefore trials should be undertaken as a matter of urgency. The problems with such randomised methods are standardising surgery and endotherapies in all sites, standardising histopathology in all centres, assessing which patients are fit or unfit for surgery and making sure there are relevant outcomes for the study (i.e. long-term survival (over five or more years)) and no progression of HGD.

Development and validation of a training module on the use of acetic acid for the detection of Barrett's neoplasia.

Background and study aims Acetic acid chromoendoscopy (AAC) enhances the ability to correctly identify Barrett's neoplasia, and is increasingly used by both expert and nonexpert endoscopists. Despite its increasing use, there is no validated training strategy to achieve competence. The aims of our study were to develop a validated training tool in AAC-assisted lesion recognition, to assess endoscopists' baseline knowledge of AAC-assisted lesion recognition, and to evaluate the efficacy and impact of this training tool. Methods A validated assessment of 40 images and 20 videos was developed. A total of 13 endoscopists with experience of Barrett's endoscopy but no formal training in AAC were recruited to the study. Participants underwent: baseline assessment 1, online training, assessment 2, interactive seminar, assessment 3. Results Baseline assessment demonstrated a sensitivity of 83 % and a negative predictive value (NPV) of 83 %. The online training intervention significantly improved sensitivity to 95 % and NPV to 94 % (P < 0.01). Further improvement was seen after a 1-day interactive seminar including live cases, with sensitivity increasing to 98 % and NPV to 97 %. Conclusions The data demonstrate the need for training in AAC-assisted lesion recognition as baseline performance, even by Barrett's experts, was poor. The online training and testing tool for AAC for Barrett's neoplasia was successfully developed and validated. The training intervention improved performance of endoscopists to meet ASGE PIVI standards. The training tool increases the endoscopist's degree of confidence in the use of AAC. The training tool also leads to shift in attitudes of endoscopists from Seattle protocol towards AAC-guided biopsy protocol for Barrett's surveillance.

Consensus statements for management of Barrett's dysplasia and early-stage esophageal adenocarcinoma, based on a Delphi process.

BACKGROUND & AIMS: Esophageal adenocarcinoma (EA) is increasingly common among patients with Barrett's esophagus (BE). We aimed to provide consensus recommendations based on the medical literature that clinicians could use to manage patients with BE and low-grade dysplasia, high-grade dysplasia (HGD), or early-stage EA. METHODS: We performed an international, multidisciplinary, systematic, evidence-based review of different management strategies for patients with BE and dysplasia or early-stage EA. We used a Delphi process to develop consensus statements. The results of literature searches were screened using a unique, interactive, Web-based data-sifting platform; we used 11,904 papers to inform the choice of statements selected. An a priori threshold of 80% agreement was used to establish consensus for each statement. RESULTS: Eighty-one of the 91 statements achieved consensus despite generally low quality of evidence, including 8 clinical statements: (1) specimens from endoscopic resection are better than biopsies for staging lesions, (2) it is important to carefully map the size of the dysplastic areas, (3) patients that receive ablative or surgical therapy require endoscopic follow-up, (4) high-resolution endoscopy is necessary for accurate diagnosis, (5) endoscopic therapy for HGD is preferred to surveillance, (6) endoscopic therapy for HGD is preferred to surgery, (7) the combination of endoscopic resection and radiofrequency ablation is the most effective therapy, and (8) after endoscopic removal of lesions from patients with HGD, all areas of BE should be ablated. CONCLUSIONS: We developed a data-sifting platform and used the Delphi process to create evidence-based consensus statements for the management of patients with BE and early-stage EA. This approach identified important clinical features of the diseases and areas for future studies.

JAG consensus statements for training and certification in colonoscopy.

Introduction: In the UK, endoscopy certification is awarded when trainees attain minimum competency standards for independent practice. A national evidence-based review was undertaken to update and develop standards and recommendations for colonoscopy training and certification. Methods: Under the oversight of the Joint Advisory Group (JAG), a modified Delphi process was conducted between 2019 and 2020 with multisociety expert representation. Following literature review and Grading of Recommendations, Assessment, Development and Evaluations appraisal, recommendation statements on colonoscopy training and certification were formulated and subjected to anonymous voting to obtain consensus. Accepted statements were peer reviewed by JAG and relevant stakeholders for incorporation into the updated colonoscopy certification pathway. Results: In total, 45 recommendation statements were generated under the domains of: definition of competence (13), acquisition of competence (20), assessment of competence (8) and postcertification support (4). The consensus process led to revised criteria for colonoscopy certification, comprising: (1) achieving key performance indicators defined within British Society of Gastroenterology standards (ie, unassisted caecal intubation rate >90%, rectal retroversion >90%, polyp detection rate >15%+, polyp retrieval rate >90%, patient comfort <10% with moderate-severe discomfort); (2) minimum procedure count 280+; (3) performing 15+ procedures over the preceding 3 months; (4) attendance of the JAG Basic Skills in Colonoscopy course; (5) terminal ileal intubation rates of 60%+ in inflammatory bowel disease; (6) satisfying requirements for formative direct observation of procedure skills (DOPS) and direct observation of polypectomy skills (Size, Morphology, Site, Access (SMSA) level 2); (7) evidence of reflective practice as documented on the JAG Endoscopy Training System reflection tool; (8) successful performance in summative DOPS. Conclusion: The UK standards for training and certification in colonoscopy have been updated, culminating in a single-stage certification process with emphasis on polypectomy competency (SMSA Level 2+). These standards are intended to support training, improve standards of colonoscopy and polypectomy, and provide support to the newly independent practitioner.

JAG consensus statements for training and certification in flexible sigmoidoscopy.

Introduction: Joint Advisory Group (JAG) certification in endoscopy is awarded when trainees attain minimum competency standards for independent practice. A national evidence-based review was undertaken to update standards for training and certification in flexible sigmoidoscopy (FS). Methods: A modified Delphi process was conducted between 2019 and 2020 with multisociety representation from experts and trainees. Following literature review and Grading of Recommendations, Assessment, Development and Evaluations appraisal, recommendation statements on FS training and certification were formulated and subjected to anonymous voting to obtain consensus. Accepted statements were peer-reviewed by national stakeholders for incorporation into the JAG FS certification pathway. Results: In total, 41 recommendation statements were generated under the domains of: definition of competence (13), acquisition of competence (17), assessment of competence (7) and postcertification support (4). The consensus process led to revised criteria for colonoscopy certification, comprising: (A) achieving key performance indicators defined within British Society of Gastroenterology standards (ie, rectal retroversion >90%, polyp retrieval rate >90%, patient comfort <10% with moderate-severe discomfort); (B) minimum procedure count ≥175; (C) performing 15+ procedures over the preceding 3 months; (D) attendance of the JAG Basic Skills in Lower gastrointestinal Endoscopy course; (E) satisfying requirements for formative direct observation of procedural skill (DOPS) and direct observation of polypectomy skill (SMSA level 1); (F) evidence of reflective practice as documented on the JAG Endoscopy Training System reflection tool and (G) successful performance in summative DOPS. Conclusion: The UK standards for training and certification in FS have been updated to support training, uphold standards in FS and polypectomy, and provide support to the newly independent practitioner.

Surgery versus radical endotherapies for early cancer and high-grade dysplasia in Barrett's oesophagus.

BACKGROUND: Barrett's oesophagus is one of the most common pre-malignant lesions in the world. Currently the mainstay of therapy is surgical management of advanced cancer but this has improved the five-year survival very little since the 1980s. As a consequence, improved survival relies on early detection through endoscopic surveillance programmes. Success of this strategy relies on the fact that late-stage pre-malignant lesions or very early cancers can be cured by intervention. Currently there is considerable controversy over which method is best: that is conventional open surgery or endotherapy (techniques involving endoscopy). OBJECTIVES: We used data from randomised controlled trials (RCTs) to examine the effectiveness of endotherapies compared with surgery in people with Barrett's oesophagus, those with early neoplasias (defined as high-grade dysplasia (HGD) and those with early cancer (defined as carcinoma in-situ, superficially invasive, early cancer or superficial cancer T-1m (T1-a) and T-1sm (T1-b)). SEARCH METHODS: We used the Cochrane highly sensitive search strategy to identify RCTs in MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), ISI Web of Science, EBMR, Controlled Trials mRCT and ISRCTN, and LILACS, in July and August 2008. The searches were updated in 2009 and again in April 2012. SELECTION CRITERIA: Types of studies: RCTs comparing endotherapies with surgery in the treatment of or early cancer. All cellular types of cancer were included (i.e. adenocarcinomas, squamous cell carcinomas and more unusual types) but will be discussed separately. TYPES OF PARTICIPANTS: patients of any age and either gender with a histologically confirmed diagnosis of early neoplasia (HGD and early cancer) in Barrett's or squamous lined oesophagus.Types of interventions; endotherapies (the intervention) compared with surgery (the control), all with curative intent. DATA COLLECTION AND ANALYSIS: Reports of studies that meet the inclusion criteria for this review would have been analysed using the methods detailed in Appendix 9. MAIN RESULTS: We did not identify any studies that met the inclusion criteria. In total we excluded 13 studies that were not RCTs but that compared surgery and endotherapies. AUTHORS' CONCLUSIONS: This Cochrane review has indicated that there are no RCTs to compare management options in this vital area, therefore trials should be undertaken as a matter of urgency. The problems with such randomised methods are standardising surgery and endotherapies in all sites, standardising histopathology in all centres, assessing which patients are fit or unfit for surgery and making sure there are relevant outcomes for the study (i.e. long-term survival (over five or more years)) and no progression of HGD.

Endoscopic full thickness resection in the colo-rectum: outcomes from the UK Registry.

BACKGROUND: Endoscopic full-thickness resection (eFTR) of the colon using the full-thickness resection device (FTRD) is a novel method for removing lesions involving, or tethered to, deeper layers of the colonic wall. The UK FTRD Registry collected data from multiple centres performing this procedure. We describe the technical feasibility, safety and early outcomes of this technique in the UK. METHODS: Data were collected and analysed on 68 patients who underwent eFTR at 11 UK centres from April 2015 to June 2019. Outcome measures were technical success, procedural time, specimen size, R0 resection, endoscopic clearance, and adverse events. Reported technical difficulties were collated. RESULTS: Indications for eFTR included non-lifting polyps (29 cases), T1 tumour resection (13), subepithelial tumour (9), and polyps at the appendix base or diverticulum (17). Target lesion resection was achieved in 60/68 (88.2%). Median specimen size was 21.7 mm (10-35 mm). Histologically confirmed R0 resection was achieved in 43/56 (76.8%) with full-thickness resection in 52/56 (92.9%). Technical difficulties occurred in 17/68 (25%) and complications in 3/68 (5.9%) patients. CONCLUSION: eFTR is a useful technique with a high success rate in treating lesions not previously amenable to endoscopic therapy. Whilst technical difficulties may arise, complication rates are low and outcomes are acceptable, making eFTR a viable alternative to surgery for some specific lesions.

Surgery versus radical endotherapies for early cancer and high grade dysplasia in Barrett's oesophagus.

BACKGROUND: Barrett's oesophagus is one of the most common premalignant lesions in the world. Currently the mainstay of therapy is surgical management of advanced cancer but this has improved the five-year survival very little in the last 30 years. As a consequence, improved survival relies on early detection through endoscopic surveillance programmes. Success of this strategy relies on the fact that late stage premalignant lesions or very early cancers can be cured by intervention. Currently there is considerable controversy over which method is best: i.e. conventional open surgery or endotherapy (techniques involving endoscopy). OBJECTIVES: We used data from randomised controlled trials to examine the effectiveness of endotherapies compared with surgery, in people with Barrett's Oesophagus; those with early neoplasias (defined as high grade dysplasia (HGD), and those with early cancer (defined as carcinoma in-situ, superficially invasive, early cancer or superficial cancer T-1m (T1-a) and T-1sm (T1-b)). SEARCH STRATEGY: We used the Cochrane highly sensitive search strategy to identify randomised trials in MEDLINE, EMBASE, CENTRAL, ISI Web of Science, EBMR, Controlled Trials mRCT and ISRCTN and LILACS, in July and August 2008. SELECTION CRITERIA: Types of studies: randomised controlled trials comparing endotherapies with surgery in the treatment of high grade dysplasia (HGD), or early cancer. All cellular types of cancer were included (i.e. adenocarcinomas, squamous cell carcinomas and more unusual types) but will be discussed separately. TYPES OF PARTICIPANTS: patients of any age and either gender with a histologically confirmed diagnosis of early neoplasia (HGD and early cancer) in Barrett's or squamous lined oesophagus.Types of interventions; endotherapies (the intervention) compared with surgery (the control), all with curative intent. DATA COLLECTION AND ANALYSIS: Reports of studies which meet the inclusion criteria for this review would have been analysed using the methods detailed in Appendix 9. MAIN RESULTS: We did not identify any studies which met the inclusion criteria. AUTHORS' CONCLUSIONS: This Cochrane review has indicated that there are no randomised control trials to compare management options in this vital area, therefore trials should be undertaken as a matter of urgency. The problems with such randomised methods are standardising surgery and endotherapies in all sites; standardising histopathology in all centres; assessing which patients are fit or unfit for surgery; and making sure there are relevant outcomes for the study i.e. long term survival (over five or more years) and no progression of high grade dysplasia.

Curriculum review: serrated lesions of the colorectum.

Colorectal cancer (CRC) is the second leading cause of death from cancer in the UK. Sporadic CRC evolves by the cumulative effect of genetic and epigenetic alterations. Typically, over the course of several years, this leads to the transformation of normal colonic epithelium to benign adenomatous polyp, low-grade to high-grade dysplasia and finally cancer-the adenoma-carcinoma sequence. Over the last decade, the serrated neoplasia pathway which progresses by methylation of tumour suppressing genes has been increasingly recognised as an important alternative pathway accounting for up to 30% of CRC cases. Endoscopists should be aware of the unique features of serrated lesions so that their early detection, appropriate resection and surveillance interval can be optimised.

Impact of a simulation-based induction programme in gastroscopy on trainee outcomes and learning curves.

BACKGROUND: Pre-clinical simulation-based training (SBT) in endoscopy has been shown to augment trainee performance in the short-term, but longer-term data are lacking. AIM: To assess the impact of a two-day gastroscopy induction course combining theory and SBT (Structured PRogramme of INduction and Training - SPRINT) on trainee outcomes over a 16-mo period. METHODS: This prospective case-control study compared outcomes between novice SPRINT attendees and controls matched from a United Kingdom training database. Study outcomes comprised: (1) Unassisted D2 intubation rates; (2) Procedural discomfort scores; (3) Sedation practice; (4) Time to 200 procedures; and (5) Time to certification. RESULTS: Total 15 cases and 24 controls were included, with mean procedure counts of 10 and 3 (P = 0.739) pre-SPRINT. Post-SPRINT, no significant differences between the groups were detected in long-term D2 intubation rates (P = 0.332) or discomfort scores (P = 0.090). However, the cases had a significantly higher rate of unsedated procedures than controls post-SPRINT (58% vs 44%, P = 0.018), which was maintained over the subsequent 200 procedures. Cases tended to perform procedures at a greater frequency than controls in the post-SPRINT period (median: 16.2 vs 13.8 per mo, P = 0.051), resulting in a significantly greater proportion of cases achieving gastroscopy certification by the end of follow up (75% vs 36%, P = 0.017). CONCLUSION: In this pilot study, attendees of the SPRINT cohort tended to perform more procedures and achieved gastroscopy certification earlier than controls. These data support the role for wider evaluation of pre-clinical induction involving SBT.

Surgery versus radical endotherapies for early cancer and high grade dysplasia in Barrett's oesophagus.

BACKGROUND: Barrett's oesophagus is one of the most common premalignant lesions in the world. Currently the mainstay of therapy is surgical management of advanced cancer but this has improved the five-year survival very little in the last 30 years. As a consequence, improved survival relies on early detection through endoscopic surveillance programmes. Success of this strategy relies on the fact that late stage premalignant lesions or very early cancers can be cured by intervention. Currently there is considerable controversy over which method is best: i.e. conventional open surgery or endotherapy (techniques involving endoscopy). OBJECTIVES: We used data from randomised controlled trials to examine the effectiveness of endotherapies compared with surgery, in people with Barrett's Oesophagus; those with early neoplasias (defined as high grade dysplasia (HGD), and those with early cancer (defined as carcinoma in-situ, superficially invasive, early cancer or superficial cancer T-1m (T1-a) and T-1sm (T1-b)). SEARCH STRATEGY: We used the Cochrane highly sensitive search strategy to identify randomized trials in MEDLINE, EMBASE, CENTRAL, ISI Web of Science, EBMR, Controlled Trials mRCT and ISRCTN and LILACS, in July and August 2008. SELECTION CRITERIA: Types of studies: randomised controlled trials comparing endotherapies with surgery in the treatment of high grade dysplasia (HGD), or early cancer. All cellular types of cancer were included (i.e. adenocarcinomas, squamous cell carcinomas and more unusual types) but will be discussed separately. TYPES OF PARTICIPANTS: patients of any age and either gender with a histologically confirmed diagnosis of early neoplasia (HGD and early cancer) in Barrett's or squamous lined oesophagus.Types of interventions; endotherapies (the intervention) compared with surgery (the control), all with curative intent. DATA COLLECTION AND ANALYSIS: Reports of studies which meet the inclusion criteria for this review would have been analysed using the methods detailed in Appendix 9. MAIN RESULTS: We did not identify any studies which met the inclusion criteria. AUTHORS' CONCLUSIONS: This Cochrane review has indicated that there are no randomised control trials to compare management options in this vital area, therefore trials should be undertaken as a matter of urgency. The problems with such randomised methods are standardising surgery and endotherapies in all sites; standardising histopathology in all centres; assessing which patients are fit or unfit for surgery; and making sure there are relevant outcomes for the study i.e. no progression of high grade dysplasia or long term survival i.e. over five years.

Endoscopic therapies for the prevention and treatment of early esophageal neoplasia.

Esophageal cancers have traditionally been diagnosed late and prognosis has been dire. For many years the only real treatment option was esophagectomy with substantial morbidity and mortality. This situation has now changed dramatically. Improvements have been achieved in surgical outcomes and there is an array of new effective treatment options now available, particularly for the increasing proportion diagnosed with early-stage disease. Minimally invasive endoscopic therapies can now prevent, cure or palliate esophageal cancers. This article aims to investigate the role and evidence base for these new therapeutic options.