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BackgroundFor endoscopic resection of early GI neoplasia, endoscopic submucosal dissection (ESD) achieves higher rates of complete resection (R0) than endoscopic mucosal resection (EMR). However, ESD is technically more difficult and evidence from randomised trial is missing.ObjectiveWe compared the efficacy and safety of ESD and EMR in patients with neoplastic Barrett's oesophagus (BO).DesignBO patients with a focal lesion of high-grade intraepithelial neoplasia (HGIN) or early adenocarcinoma (EAC) ≤3 cm were randomised to either ESD or EMR. Primary outcome was R0 resection; secondary outcomes were complete remission from neoplasia, recurrences and adverse events (AEs).ResultsThere were no significant differences in patient and lesion characteristics between the groups randomised to ESD (n=20) or EMR (n=20). Histology of the resected specimen showed HGIN or EAC in all but six cases. Although R0 resection defined as margins free of HGIN/EAC was achieved more frequently with ESD (10/17 vs 2/17, p=0.01), there was no difference in complete remission from neoplasia at 3 months (ESD 15/16 vs EMR 16/17, p=1.0). During a mean follow-up period of 23.1±6.4 months, recurrent EAC was observed in one case in the ESD group. Elective surgery was performed in four and three cases after ESD and EMR, respectively (p=1.0). Two severe AEs were recorded for ESD and none for EMR (p=0.49).ConclusionsIn terms of need for surgery, neoplasia remission and recurrence, ESD and EMR are both highly effective for endoscopic resection of early BO neoplasia. ESD achieves a higher R0 resection rate, but for most BO patients this bears little clinical relevance. ESD is, however, more time consuming and may cause severe AE.Trial registration numberNCT1871636

In this sham-controlled, randomized trial involving patients with dysplastic Barrett's esophagus, patients who were treated with radiofrequency ablation were more likely to have complete eradication of dysplasia and intestinal metaplasia and less likely to progress to more severe dysplasia or cancer. Adverse events included chest pain and esophageal stricture. Patients with dysplastic Barrett's esophagus who were treated with radiofrequency ablation were more likely to have complete eradication of dysplasia and intestinal metaplasia and less likely to progress to more severe dysplasia or cancer. Barrett's esophagus is defined as metaplasia of the esophageal epithelium, with normal squamous epithelium replaced by columnar epithelium containing goblet cells, also known as intestinal metaplasia (Figure 1A). 1 This change is associated with gastroesophageal reflux disease. 2 Approximately 10% of patients with chronic reflux have Barrett's esophagus, 3 , 4 and the prevalence of the condition in a recent population study was 1.6%. 5 The condition is associated with an increased risk of esophageal adenocarcinoma. 6 , 7 The incidence of this once rare cancer has increased by more than 500% since the 1970s. 8 The cancer remains highly lethal, with a 5-year survival rate of less . . .

ObjectiveAfter focal endoscopic resection (ER) of high-grade dysplasia (HGD) or early cancer (EC) in Barrett's oesophagus (BO), eradication of all remaining BO reduces the recurrence risk. The aim of this study was to compare the safety of stepwise radical ER (SRER) versus focal ER followed by radiofrequency ablation (RFA) for complete eradication of BO containing HGD/EC.MethodsA multicentre randomised clinical trial was carried out in three tertiary centres. Patients with BO ≤5 cm containing HGD/EC were randomised to SRER or ER/RFA. Patients in the SRER group underwent piecemeal ER of 50% of BO followed by serial ER. Patients in the ER/RFA group underwent focal ER for visible lesions followed by serial RFA. Follow-up endoscopy with biopsies (four-quadrant/2 cm BO) was performed at 6 and 12 months and then annually. The main outcome measures were: stenosis rate; complications; complete histological response for neoplasia (CR-neoplasia); and complete histological response for intestinal metaplasia (CR-IM).ResultsCR-neoplasia was achieved in 25/25 (100%) SRER and in 21/22 (96%) ER/RFA patients. CR-IM was achieved in 23 (92%) SRER and 21 (96%) ER/RFA patients. The stenosis rate was significantly higher in SRER (88%) versus ER/RFA (14%; p<0.001), resulting in more therapeutic sessions in SRER (6 vs 3; p<0.001) due to dilations. After median 24 months follow-up, one SRER patient had recurrence of EC, requiring ER.ConclusionsIn patients with BO ≤5 cm containing HGD/EC, SRER and ER/RFA achieved comparably high rates of CR-IM and CR-neoplasia. However, SRER was associated with a higher number of complications and therapeutic sessions. For these patients, a combined endoscopic approach of focal ER followed by RFA may thus be preferred over SRER.Clinical trial numberNTR1337.

BackgroundBarrett's oesophagus (BE) is a pre-malignant condition leading to oesophageal adenocarcinoma (OAC). Treatment of neoplasia at an early stage is desirable. Combined endoscopic mucosal resection (EMR) followed by radiofrequency ablation (RFA) is an alternative to surgery for patients with BE-related neoplasia.MethodsWe examined prospective data from the UK registry of patients undergoing RFA/EMR for BE-related neoplasia from 2008 to 2013. Before RFA, visible lesions were removed by EMR. Thereafter, patients had RFA 3-monthly until all BE was ablated or cancer developed (endpoints). End of treatment biopsies were recommended at around 12 months from first RFA treatment or when endpoints were reached. Outcomes for clearance of dysplasia (CR-D) and BE (CR-IM) at end of treatment were assessed over two time periods (2008–2010 and 2011–2013). Durability of successful treatment and progression to OAC were also evaluated.Results508 patients have completed treatment. CR-D and CR-IM improved significantly between the former and later time periods, from 77% and 56% to 92% and 83%, respectively (p<0.0001). EMR for visible lesions prior to RFA increased from 48% to 60% (p=0.013). Rescue EMR after RFA decreased from 13% to 2% (p<0.0001). Progression to OAC at 12 months is not significantly different (3.6% vs 2.1%, p=0.51).ConclusionsClinical outcomes for BE neoplasia have improved significantly over the past 6 years with improved lesion recognition and aggressive resection of visible lesions before RFA. Despite advances in technique, the rate of cancer progression remains 2–4% at 1 year in these high-risk patients.Trial registration numberISRCTN93069556.

BackgroundMultiband mucosectomy (MBM) is the preferred technique for piecemeal resection of early neoplastic lesions in Barrett’s esophagus (BE). The currently most widely used device for MBM is the Duette device. Recently, the Captivator EMR device has come available which might have practical advantages over the Duette device.MethodsPhase I was a randomized pre-esophagectomy trial with a non-inferiority design aiming to compare EMR specimens obtained with the Captivator and the Duette device. Primary outcome: max diameter of the EMR specimens, secondary outcomes: min diameter, max thickness of the EMR specimens and resected submucosal stroma. Phase II were clinical pilot cases aiming to evaluate the feasibility of EMR using the Captivator device. Primary outcome was the successful EMR rate and secondary outcomes included procedure time and adverse events.ResultsPhase I: 24 EMR specimens (12 pairs) were obtained from six patients. The median max diameter of EMR specimens obtained with the Captivator device was 16 mm [IQR 12–21] versus 18 mm [IQR 13–23] for the Duette device. Non-inferiority of the max diameter of the Captivator specimens could not be demonstrated (median difference 1 mm, 95% CI − 3.26 to + 5.26). However, when using paired analysis, no significant difference was found (p 0.573). In addition, no statistically significant differences were found in the min diameter, max thickness of EMR specimens, and max thickness of resected submucosal stroma. Phase II: 5 BE patients with early neoplastic lesions were included. Successful EMR was achieved in 100%. Median procedure time was 33 min (IQR 25–39). One patient developed transient dysphagia, without signs of stenosis on endoscopy.ConclusionsEMR of early Barrett’s neoplasia using the Captivator device is comparable to Duette EMR when looking at size of resected specimens. In the first patients, EMR using the Captivator was feasible, resulting in successful resection without acute adverse events.

Introduction ESD is the treatment of choice for superficial neoplasms of the oesophagus; ESD is oncologically efficient and associated with less morbidity than the surgical alternative. ESD requires a high level of skill, being both technically challenging and time consuming. Therefore, ESD is often reserved for experts. A combination of a tunnel technique with clip-line traction may enable optimisation of oesophageal ESD. Patients and methods From January 2015 to December 2016, we performed a prospective two-centre case study of consecutive “tunnel + clip” oesophageal ESD. Four young operators (each of whom had performed fewer than 50 ESDs and fewer than five oesophageal ESDs) treated patients requiring ESD using the tunnel + clip method. This involves generation of a classic tunnel beneath the lesion, with constant traction being applied by a clip with a line placed at the oral side of the tunnel. Results Sixty-two lesions (25 SCCs and 34 ADK/HGDs complicating Barrett’s oesophagus) were consecutively resected. The en bloc, R0, and curative resection rates were 100% (62/62), 88.7% (55/62), and 74.2% (46/62), respectively. No perforation was noted. The mean ESD velocity was 24.5 mm 2 /min for lesions of mean length 59.6 mm. The tunnel + clip approach greatly aided the procedure. No pathological damage caused by clipping was evident. Conclusion Use of the tunnel + clip strategy to treat oesophageal ESD is effective and safe, even when performed by physicians with little prior experience. It is thus possible to standardise ESD of superficial oesophageal neoplasms and increase the velocity of dissection. Our procedure will encourage the use of oesophageal ESD in Western countries.

BackgroundRadiofrequency ablation (RFA) treatment outcomes vary for unknown reasons. One hypothesis is that variations in Barrett’s epithelial thickness (BET) are associated with reduced RFA efficacy for thicker BET and strictures for thinner BET. Volumetric laser endomicroscopy (VLE) is an imaging modality that acquires high-resolution, depth-resolved images of BE. However, the attenuation of light by tissue and the lack of layering in Barrett’s tissue challenge BET measurements and the study of relationships between thickness and RFA outcomes. We aimed to quantify BET and compared the reliability of standard and contrast-enhanced VLE images.MethodsBaseline VLE scans from BE patients without prior ablative therapy and a Prague (M) length of > 1 cm were obtained from the US VLE Registry. An algorithm was applied to the VLE images to flatten the mucosal surface and enhance the contrast of different esophageal wall layers. Subsequently, BET was measured by two independent VLE readers using both contrast- and non-contrast-enhanced datasets. In order to validate these adjusted images, intra- and interobserver agreements were calculated.ResultsVLE scans from fifty-seven patients were included in this study. BET was measured at eight equidistant locations on the selected cross-sectional images at 0.5 cm intervals from the GEJ to the proximal-most extent of BE. The intra-observer coefficients of the two readers for the contrast-enhanced images were 0.818 (95% CI 0.798–0.836) and 0.890 (95% CI 0.878–0.900). The interobserver agreement for the contrast-enhanced images (0.880; 95% CI 0.867–0.891) was significantly better than for the original images (0.778; 95% CI 0.754–0.799).ConclusionWe developed an algorithm that improves VLE visualization of the mucosal layers of the esophageal wall and enables rapid and reliable measurement of BET. Interobserver variability measurements were significantly reduced when using contrast enhancement. Studies are underway to correlate BET with treatment response.

Strong recruitment and retention into randomised controlled trials involving invasive therapies is a matter of priority to ensure better achievement of trial aims. The BRIDE (Barrett's Randomised Intervention for Dysplasia by Endoscopy) Study investigated the feasibility of undertaking a multicentre randomised controlled trial comparing argon plasma coagulation and radiofrequency ablation, following endoscopic resection, for the management of early Barrett's neoplasia. This paper aims to identify factors influencing patients' participation in the BRIDE Study and determine their views regarding acceptability of a potential future trial comparing surgery with endotherapy. A semistructured telephone interview study was performed, including both patients who accepted and declined to participate in the BRIDE trial. Interview data were analysed using the constant comparison approach to identify recurring themes. Interview participants were recruited from across six UK tertiary centres where the BRIDE trial was conducted. We interviewed 18 participants, including 11 participants in the BRIDE trial and 7 who declined. Four themes were identified centred around interviewees' decision to accept or decline participation in the BRIDE trial and a potential future trial comparing endotherapy with surgery: (1) influence of the recruitment process and participant-recruiter relationship; (2) participants' views of the design and aim of the study; (3) conditional altruism as a determining factor and (4) participants' perceptions of surgical risks versus less invasive treatments. We identified four main influences to optimising recruitment and retention to a randomised controlled trial comparing endotherapies in patients with early Barrett's-related neoplasia. These findings highlight the importance of qualitative research to inform the design of larger randomised controlled trials.

Dysplasia in a Barrett's esophagus (BE) is associated with an increased risk for developing esophageal adenocarcinoma. Ablation using the HALO system has shown promise for the treatment of BE with dysplasia. The objective of this study was to assess the safety and efficacy of a stepwise regimen of circumferential and focal ablation using the HALO system for the treatment of BE with dysplasia. BE patients with low-grade dysplasia (LGD) or high-grade dysplasia (HGD) were enrolled. Primary circumferential ablation was followed every 3 months by further circumferential ablation or focal ablation until complete endoscopic eradication of BE was achieved. At 3- or 6-month intervals, depending on baseline grade, targeted and four quadrant random biopsies were obtained to assess the histological response to ablation. A complete response (CR) is defined as all biopsies negative for intestinal metaplasia (IM) (CR-IM) or dysplasia (CR-D) at last available follow-up. A total of 63 patients were treated (57 men; median age 71 years; median BE length 5 cm), with worst grade of dysplasia being LGD (n=39) and HGD (n=24). Follow-up is available for 62 patients (median 24 months). Overall, CR-IM is 79% and CR-D is 89%. For the LGD cohort, CR-IM is 87% and CR-D is 95%. For the HGD cohort, CR-IM is 67% and CR-D is 79%. Stepwise circumferential and focal ablation of BE containing dysplasia appears to be a safe and effective intervention, achieving a CR for dysplasia in 95% and 79% of LGD and HGD patients, respectively.

Background: Many modalities have been used to ablate Barrett’s oesophagus (BO). However, long term results and comparative effectiveness are unknown. Aims: Our aim was to compare the long term efficacy of achieving complete reversal (endoscopic and histological) between multipolar electrocoagulation (MPEC) and argon plasma coagulation (APC) in BO patients and assess factors influencing successful ablation. Methods: Patients with BO, 2–6 cm long, underwent 24 hour pH testing on proton pump inhibitor (PPI) therapy. Patients were then randomised by BO length to undergo ablation with MPEC or APC every 4–8 weeks until endoscopic reversal or maximal of six treatment sessions. Results: Thirty five BO patients have been followed for at least two years following endoscopic ablation, 16 treated with MPEC and 19 with APC. There was complete reversal of BO in 24 patients (69%); 75% with MPEC and 63% with APC (p = 0.49). There was no difference in the number of sessions required in the two groups. There was no difference in age, pH results, BO length, PPI dose, or hiatal hernia size between patients with and without complete reversal. One patient developed an oesophageal stricture but there were no major complications such as bleeding or perforation. Conclusions: In BO patients treated with MPEC or APC in combination with acid suppression, at long term follow up, complete reversal of BO can be maintained in approximately 70% of patients, irrespective of the technique. There are no predictors associated with achieving complete reversal of BO. Continued surveillance is still indicated in the post ablative setting. As yet, these techniques are not ready for clinical application (other than for high grade dysplasia or early oesophageal adenocarcinoma) and cannot be offered outside the research arena.