Multicenter Randomized Controlled Trial of Surveillance Versus Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia: The SURVENT Trial: Study Rationale, Methodology, Innovation, and Implications.
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SUBMITTER: Wani S
PROVIDER: S-EPMC9398991 | biostudies-literature | 2022 Sep
REPOSITORIES: biostudies-literature
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Multicenter Randomized Controlled Trial of Surveillance Versus Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia: The SURVENT Trial: Study Rationale, Methodology, Innovation, and Implications.
Wani Sachin S Souza Rhonda F RF Durkalski Valerie L VL Serrano Jose J Hamilton Frank F Shaheen Nicholas J NJ
Gastroenterology 20220606 3
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Project description:BACKGROUND : Endoscopic surveillance of Barrett's esophagus (BE) with Seattle protocol biopsies is time-consuming and inadequately performed in routine practice. There is no recommended procedural time for BE surveillance. We investigated the duration of surveillance procedures with adequate tissue sampling and effect on dysplasia detection rate (DDR). METHODS : We performed post hoc analysis from the standard arm of a crossover randomized controlled trial recruiting patients with BE (≥C2 and/or ≥M3) and no clearly visible dysplastic lesions. After inspection with white-light imaging, targeted biopsies of subtle lesions and Seattle protocol biopsies were performed. Procedure duration and biopsy number were stratified by BE length. The effect of endoscopy-related variables on DDR was assessed by multivariable logistic regression. RESULTS : Of 142 patients recruited, 15 (10.6 %) had high grade dysplasia/intramucosal cancer and 15 (10.6 %) had low grade dysplasia. The median procedural time was 16.5 minutes (interquartile range 14.0-19.0). Endoscopy duration increased by 0.9 minutes for each additional 1 cm of BE length. Seattle protocol biopsies had higher sensitivity for dysplasia than targeted biopsies (86.7 % vs. 60.0 %; P = 0.045). Longer procedural time was associated with increased likelihood of dysplasia detection on quadrantic biopsies (odds ratio [OR] 1.10, 95 %CI 1.00-1.20, P = 0.04), and for patients with BE > 6 cm also on targeted biopsies (OR 1.21, 95 %CI 1.04-1.40; P = 0.01). CONCLUSIONS : In BE patients with no clearly visible dysplastic lesions, longer procedural time was associated with increased likelihood of dysplasia detection. Adequate time slots are required to perform good-quality surveillance and maximize dysplasia detection.
| S-EPMC10212647 | biostudies-literature
Project description:Background and aimsBarrett's esophagus with low-grade dysplasia (BE-LGD) carries a risk of progression to Barrett's esophagus with high-grade dysplasia (BE-HGD) and esophageal adenocarcinoma (EAC). Radiofrequency ablation (RFA) appears to be a safe and efficacious method to eradicate Barrett's esophagus. However, a confirmed consensus regarding treatment of BE-LGD with RFA vs. endoscopic surveillance is lacking. Therefore, this study aimed to elucidate the efficacy and safety for RFA vs. endoscopic surveillance in decreasing the risk of BE-LGD progression to BE-HGD or EAC.MethodsRelevant studies published before May 1, 2021 were identified by searching relevant medical databases. The primary outcome was the rate of progression BE-LGD to HGD and/or EAC after treatment with RFA and endoscopic surveillance. The secondary outcome was the rate of complete eradication of dysplasia (CE-D) and complete eradication of intestinal metaplasia (CE-IM) after treatment with RFA and endoscopic surveillance. Adverse events were also extracted and evaluated.ResultsThree randomized controlled trials were eligible for analysis. The pooled estimate of rate of neoplastic progression of BE-LGD to HGD or EAC was much lower in the RFA group than the endoscopic surveillance group (RR, 0.25; 95% CI, 0.07-0.93; P = 0.04), with moderate heterogeneity (I2 = 55%). Subgroup analysis based on progression grade was performed. The pooled rate of progression of BE-LGD to HGD was much lower in the RFA group than the endoscopic surveillance group (RR, 0.25; 95% CI, 0.07-0.71; P = 0.01), with low heterogeneity (I2 = 15%). Although the pooled risk of progression of BE-LGD to EAC was slightly lower in the RFA group than the endoscopic surveillance group (RR, 0.56; 95% CI, 0.05-6.76), the result was not statistically significant (P = 0.65). RFA also was associated a higher rate of CE-D and CE-IM both at the end of endoscopic treatment and during follow-up. However, the rate of adverse events was slightly higher after RFA treatment.ConclusionRFA decreases the risk of BE-LGD progression to BE-HGD. However, given the uncertain course of LGD and the potential for esophageal stricture after RFA, treatment options should be fully considered and weighed.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021266128, identifier PROSPERO (CRD42021266128).
| S-EPMC8920305 | biostudies-literature
Project description:The optimal management for low-grade dysplasia (LGD) in Barrett's esophagus is unclear. In this article the importance of LGD is discussed, including the significant risk of progression to esophageal adenocarcinoma. Endoscopic surveillance is a management option but is plagued by sampling error and issues of suboptimal endoscopy. Furthermore endoscopic surveillance has not been demonstrated to be cost-effective or to reduce cancer mortality. The emergence of endoluminal therapy over the past decade has resulted in a paradigm shift in the management of LGD. Ablative therapy, including radiofrequency ablation, has demonstrated promising results in the management of LGD with regards to safety, cost-effectiveness, durability and reduction in cancer risk. It is, however, vital that a shared-decision making process occurs between the physician and the patient as to the preferred management of LGD. As such the management of LGD should be "individualised."
| S-EPMC4025077 | biostudies-literature
Project description:IntroductionEndoscopic eradication therapy with radiofrequency ablation (RFA) and endoscopic mucosal resection is a safe and effective treatment for Barrett's esophagus. Although the outcomes of surveillance endoscopy after successful endoscopic eradication therapy have been described, no previous studies have modeled the natural history or the effect of surveillance endoscopy after successful ablation to prevent progression to invasive esophageal adenocarcinoma.MethodsThe US RFA Registry is a multicenter registry consisting of patients treated with RFA for Barrett's esophagus at 148 institutions (113 community-based and 35 academic-affiliated). The authors fit models to impute the natural history of recurrence and neoplastic progression after any recurrence or retreatment. Natural history estimates of invasive adenocarcinoma after ablation therapy were compared with as-treated estimates at 5 years to derive the preventive risk difference for surveillance.ResultsNatural history estimates for the postablation progression of high-grade dysplasia (HGD) or intramucosal adenocarcinoma to invasive adenocarcinoma after treatment were 6.3% at 5 years compared with 1.3% for low-grade dysplasia (LGD). The natural history model found a much higher preventative risk difference for surveillance for HGD/intramucosal adenocarcinoma (-4.8%), compared with LGD (-1.1%). The numbers needed to surveil at 5 years were 21 and 90 for these groups, respectively, to prevent one case of invasive esophageal adenocarcinoma, making surveillance after successful ablation of baseline HGD more than 4 times as effective at preventing invasive cancer than after successful ablation of baseline LGD.DiscussionEndoscopic surveillance after successful ablation of baseline HGD or intramucosal cancer is much more effective than surveillance after successful treatment of baseline LGD in averting invasive adenocarcinoma. Although the modest benefits of surveillance for treated LGD may be greater than the risks for patients at average risk for adverse effects of endoscopy, clinicians should concentrate on retaining patients with baseline HGD or cancer in endoscopic surveillance programs.
| S-EPMC9246923 | biostudies-literature
Project description:BACKGROUND AND STUDY AIMS: Endoscopic mucosal resection (EMR) plays an important role in the staging of Barrett's esophagus (BE) and the evaluation of high grade dysplasia (HGD). The study aim is to assess the interobserver agreement among gastroenterologists expert in BE endotherapy, gastroenterologists without specified expertise in BE endotherapy, and gastroenterology trainees in recommending EMR vs ablation for BE HGD lesions, and to assess the effect of a one-time educational intervention on the interobserver agreement among non-experts and trainees. PATIENTS AND METHODS: An electronic survey containing 30 still endoscopic images of BE HGD was sent to three groups of respondents: experts, non-experts, and trainees. Respondents were asked to select "Endoscopic Mucosal Resection" or "Ablation" as the most appropriate next step in management. Non-experts and trainees were then invited to repeat the survey following an educational intervention. The main outcome measure was interobserver agreement measured by Fleiss' Kappa statistic and percent agreement. RESULTS: In selecting between EMR and ablation, on the pre-intervention survey there was the highest amount of agreement among experts (kappa = 0.437), followed by agreement among trainees (kappa = 0.281), and non-experts (kappa = 0.107). Experts demonstrated significantly higher agreement compared to either trainees (P < 0.001) or non-experts (P < 0.001). On the post-intervention survey, interobserver agreement remained low among both trainees (kappa = 0.20) and non-experts (kappa = 0.14). Comparing the results of the surveys, there was no evidence that agreement differed for either trainees or non-experts. CONCLUSIONS: Future efforts are needed to enable endoscopist recognition of BE HGD lesions. Consensus guidelines alone are insufficient in directing preferred endoscopic management of BE HGD.
| S-EPMC4423254 | biostudies-other
Project description:BackgroundGuidelines suggest that patients with nondysplastic Barrett's esophagus (BE) undergo endoscopic surveillance every 3 to 5 years, but actual use of surveillance endoscopy and the determinants of variation in surveillance intervals are not known.ObjectiveTo measure use of surveillance endoscopy and its variation in patients with nondysplastic BE.DesignMulticenter, cross-sectional study.SettingThree sites in Arizona, Minnesota, and North Carolina.PatientsThis study involved patients who had prevalent BE without a history of high-grade dysplasia or esophageal adenocarcinoma.InterventionParticipants were given validated measures of quality of life, numeracy, and cancer risk perception, and the total number of prior endoscopic surveillance examinations was measured.Main outcome measurementsOversurveillance was defined as >1 surveillance examination per 3-year period.ResultsAmong 235 patients with nondysplastic BE, 76% were male and 94% were white. The average (± standard deviation [SD]) duration of BE was 6.5 ± 5.9 years. The mean (± SD) number of endoscopies per 3-year period was 2.7 ± 2.6. Oversurveillance was present in 65% of participants, resulting in a mean of 2.3 excess endoscopies per patient. Neither numeracy skills nor patient perception of cancer risk were associated with oversurveillance.LimitationsEndoscopies were measured by patient report, which is subject to error. Results may be generalizable only to patients seen in academic centers.ConclusionMost patients with nondysplastic BE had more surveillance endoscopic examinations than is recommended by published guidelines. Patient factors did not predict oversurveillance, indicating that other factors may influence decisions about the interval and frequency of surveillance examinations.
| S-EPMC3961007 | biostudies-literature
Project description:Background & aimsAlthough patients with Barrett's esophagus commonly undergo endoscopic surveillance, its effectiveness in reducing mortality from esophageal/gastroesophageal junction adenocarcinomas has not been evaluated rigorously.MethodsWe performed a case-control study in a community-based setting. Among 8272 members with Barrett's esophagus, we identified 351 esophageal adenocarcinoma: 70 in persons who had a prior diagnosis of Barrett's esophagus (who were eligible for surveillance); 51 of these patients died, 38 as a result of the cancers (cases). Surveillance histories were contrasted with a sample of 101 living persons with Barrett's esophagus (controls), matched for age, sex, and duration of follow-up evaluation.ResultsSurveillance within 3 years was not associated with a decreased risk of death from esophageal adenocarcinoma (adjusted odds ratio, 0.99; 95% confidence interval, 0.36-2.75). Fatal cases were nearly as likely to have received surveillance (55.3%) as were controls (60.4%). A Barrett's esophagus length longer than 3 cm and prior dysplasia each were associated with subsequent mortality, but adjustment for these did not change the main findings. Although all patients should be included in evaluations of effectiveness, excluding deaths related to cancer treatment and patients who failed to complete treatment, changed the magnitude, but not the significance, of the association (odds ratio, 0.46; 95% confidence interval, 0.13-1.64).ConclusionsEndoscopic surveillance of patients with Barrett's esophagus was not associated with a substantially decreased risk of death from esophageal adenocarcinoma. The results do not exclude a small to moderate benefit. However, if such a benefit exists, our findings indicate that it is substantially smaller than currently estimated. The effectiveness of surveillance was influenced partially by the acceptability of existing treatments and the occurrence of treatment-associated mortality.
| S-EPMC3767470 | biostudies-literature
Project description:Background & aimsBarrett's esophagus (BE) is the greatest risk factor for esophageal adenocarcinoma (EAC), but only a small proportion of patients with BE develop cancer. Biomarkers might be able to identify patients at highest risk of progression. We investigated genomic differences in surveillance biopsies collected from patients whose BE subsequently progressed compared to patients whose disease did not progress.MethodsWe performed a retrospective case-control study of 24 patients with BE that progressed to high-grade dysplasia (HGD, n = 14) or EAC (n = 10). The control group (n = 73, called non-progressors) comprised patients with BE and at least 5 years of total endoscopic biopsy surveillance without progression to HGD or EAC. From each patient, we selected a single tissue sample obtained more than 1 year before progression (cases) or more than 2 years before the end of follow-up (controls). Pathogenic mutations, gene copy numbers, and ploidy were compared between samples from progressors and non-progressors.ResultsTP53 mutations were detected in 46% of samples from progressors and 5% of non-progressors. In this case-control sample set, TP53 mutations in BE tissues increased the adjusted risk of progression 13.8-fold (95% confidence interval, 3.2-61.0) (P < .001). We did not observe significant differences in ploidy or copy-number profile between groups. We identified 147 pathogenic mutations in 57 distinct genes-the average number of pathogenic mutations was higher in samples from progressors (n = 2.5) than non-progressors (n = 1.2) (P < .001). TP53 and other somatic mutations were recurrently detected in samples with limited copy-number changes (aneuploidy).ConclusionsIn genomic analyses of BE tissues from patients with or without later progression to HGD or EAC, we found significantly higher numbers of TP53 mutations in BE from patients with subsequent progression. These mutations were frequently detected before the onset of dysplasia or substantial changes in copy number.
| S-EPMC6035092 | biostudies-literature
Project description:BackgroundThe yield of early repeat endoscopy in patients with Barrett's esophagus (BE) is not well established.AimsTo determine how often early repeat endoscopy detected missed dysplasia or esophageal adenocarcinoma (EAC) in a population-based cohort of patients with BE. Secondary aims were to identify risk factors for missed dysplasia/EAC and compare detection of prevalent versus incident HGD/EAC.MethodsA population-based cohort of BE subjects in Olmsted County, MN, was studied. Patients with initial non-dysplastic BE or low-grade dysplasia (LGD) who underwent repeat endoscopy within 24 months were included. Those with a worse histologic diagnosis on repeat endoscopy were considered to have missed dysplasia/EAC. Baseline characteristics among patients with and without missed dysplasia/EAC were compared. The absolute numbers of asymptomatic prevalent or missed, and incident HGD/EAC in the entire cohort were ascertained.ResultsOf 488 BE cases, 210 were included for the primary aim of this study. Repeat endoscopy revealed four HGD/EAC (1.9 %) and 16 LGD (8.8 %) for a combined miss rate of 9.5 %. Long-segment BE (LSBE) and lack of PPI use were predictors of missed dysplasia/EAC (P = 0.008), but adherence to biopsy protocol was not. Increased prevalent HGD/EAC (n = 30) rather than incident HGD/EAC (n = 22) was identified during a median 4.8 years of follow-up in this cohort.ConclusionsDysplasia/EAC is commonly missed at initial BE diagnosis, particularly in patients with LSBE and no PPI use. Efforts should be made to enhance the sensitivity of detecting dysplasia/neoplasia around the time of initial BE diagnosis.
| S-EPMC4639465 | biostudies-literature
Project description:Background and aimsAngiogenesis is associated with neoplastic progression of Barrett's esophagus (BE). Volumetric optical coherence tomography angiography (OCTA) visualizes subsurface microvasculature without exogenous contrast agents. We investigated the association of OCTA microvascular features with low-grade dysplasia (LGD) and high-grade dysplasia (HGD).MethodsFifty-two patients undergoing BE surveillance or endoscopic eradication therapies for dysplasia were imaged using volumetric OCTA and corresponding histologic diagnoses wre obtained to yield 97 data sets (nondysplastic BE [NDBE], 74; LGD, 10; HGD, 13). After evaluating OCTA image quality, 54 datasets (NDBE, 35; LGD, 8; HGD, 11) from 32 patients were used to develop a training and reading protocol. The association of abnormal vessel branching and heterogeneous vessel size with LGD/HGD and a regular honeycomb vessel pattern with NDBE were investigated.ResultsBlinded OCTA reading of 41 OCTA datasets (NDBE, 27; LGD, 7; HGD, 7) was performed by readers with various levels of OCT/OCTA experience including 3 OCT trainees, 1 gastroenterologist, and 2 gastroenterology fellows. Among the 6 readers, OCTA features of abnormal vessel branching and heterogeneous vessel size had an overall 94% sensitivity (95% CI, 89-99) and 69% specificity (95% CI, 62-76) for differentiating LGD/HGD versus NDBE with a mean reading time of 45 seconds per data set and moderate (kappa = .58) interobserver agreement.ConclusionsVolumetric en face OCTA imaging enables rapid examination of depth resolved microvascular features with near-microscopic resolution. OCTA can visualize microvascular features associated with LGD/HGD with high accuracy, which motivates new technologic advances and future studies investigating the diagnostic performance of OCTA.
| S-EPMC5545067 | biostudies-literature