Back to Authors

Fleischer, David

Mayo Clinic

Hospital Británico

Citations 10

Position statement of the World Endoscopy Organization: Role of endoscopy in screening, diagnosis, and treatment of esophageal superficial squamous neoplasiaia
Hassan, Cesare , Goda, Kenichi, Iyer, Prasad G. , Awadhi, Sameer Al , Lehibi, Abed Al , Arantes, Vitor , Burgos, Herbert, Cerisoli, Cecilio L., Dawsey, Sanford, Fleischer, David, Fluxá, Fernando, Inoue, Haruhiro , John, Sneha , Khashab, Mouen A., Kothari, Shivangi , Lee, Yeong Yeh, Ngamruengphong, Saowanee , Sharara, Ala I. , Shimamura, Yuto , Varocha, Mahachai, Villa‐Gomez, Guido, Wang, Kenneth K. , Yip, Hon Chi , Sharma, Prateek , Lee, Yeong Yeh , Chiu, Philip Wai Yan , Emura, Fabian , G Iyer, Prasad, Kim, Gwang Ha , Shimamura, Yuto , Yip, Hon-Chi , Hassan, Cesare , Lee, Yeong Yeh , Antonelli, Giulio , Burgos, Herbert, Dawsey, Sanford, Draganov, Peter V. , González, Nicolás , Kashin, Sergey V. , Khashab, Mouen A. , Lee, Yeong Yeh, Remes Troche, José M , Varocha, Mahachai, Wang, Wen‐Lun

Digestive Endoscopy | December 26, 2024 | Volume: 37 | Issue: 5 | Pages: 470-489

10.1111/den.14967 Get It

Esophageal squamous cell carcinoma (ESCC) remains a significant global health challenge, being the sixth leading cause of cancer mortality with pronounced geographic variability. The incidence rates range from 125 per 100,000 in northern China to 1–1.5 per 100,000 in the United States, driven by environmental and lifestyle factors such as tobacco and alcohol use, dietary habits, and pollution. Major modifiable risk factors include tobacco and alcohol consumption, with a synergistic risk increase when combined. Nonmodifiable risk factors include previous diagnoses of head and neck squamous cell carcinoma (H&N SCC), achalasia, and prior radiotherapy. Prevention strategies must be tailored to specific regional burdens to efficiently allocate medical and financial resources. Gastrointestinal endoscopy is crucial in reducing ESCC burden through early detection and characterization of neoplastic changes, such as high‐grade dysplasia. Early diagnosis significantly improves survival rates, while endoscopic resection of noninvasive dysplasia can prevent ESCC onset, reducing treatment burden for advanced disease. Postresection surveillance can detect high‐risk metachronous lesions. Despite these benefits, endoscopic prevention faces challenges, including the lack of high‐level evidence supporting its efficacy, opportunity costs, the need for specialized training and techniques, and the requirement for advanced technology investments. This Position Statement from the World Endoscopy Organization (WEO) aims to address these challenges, supplying recommendations for the exploitation of endoscopic resources regarding the possible role of screening, quality, and training for the detection, characterization, resection, and surveillance of ESCC.
Predictors of adverse events and early mortality after esophageal stent placement in a low resource setting: a series of 3823 patients in Kenya
Parker, Robert K. , Lando, Justus , Simel, Ian , Chol, Nyail, Ranketi, Sinkeet, Chepkwony, Robert, Pyego, Linus, Chepkirui, Caren, Chepkemoi, Winnie, Fleischer, David E., Topazian, Mark , Burgert, Steve, White, Russell E., Fleischer, David, Mwachiro, Michael , Dawsey, Sanford M. , Burgert, Stephen L.

Endoscopy International Open | April 14, 2022 | Volume: 10 | Issue: 04 | Pages: E479-E487

10.1055/a-1783-9829 Get It

Abstract Background and study aims Dysphagia from esophageal cancer may be palliated with self-expanding metallic stents (SEMS). Controversy exists about the use of dilation before SEMS deployment. Patients and methods We performed a retrospective cohort study of patients who had SEMS placement without fluoroscopy for palliation at Tenwek Hospital in Bomet, Kenya between January 1999 and April 2019. The primary outcome was any serious adverse event (AE) (chest pain, stent migration, perforation, bleeding, or all-cause mortality) within 30 days of the procedure. Various demographic and clinical characteristics, and procedural details, were examined as risk factors. Technical success, defined as correct SEMS placement, and clinical success, defined as dysphagia score improvement without 30-day mortality, were examined. Results A total of 3823 patients underwent SEMS placement, with 2844 (74.4 %) placed in the second decade of the study. Technical and clinical success were achieved in 97.2 % and 95.5 %, respectively, with mean dysphagia scores improving from 3.4 (SD 0.6) to 0.9 (SD 1.3) post-stent placement. AEs occurred in 169 patients (4.4 %). AEs, specifically perforations, were associated with dilation to greater than 36F in the first decade. Perforation rates decreased from the first (4.1 %) to the second decade (0.2 %). Only 30% had complete 30-day follow-up data. Conclusions SEMS placement is a safe, effective method of palliating malignant dysphagia, with low rates of AEs and 30-day mortality and high rates of clinical and technical success. Dilation can facilitate placement of SEMS without fluoroscopy but should not be performed above 36F due to the risk of perforation.
Gastrointestinal endoscopy capacity in Eastern Africa
Mulima, Gift , Ogutu, Elly O., Erkie, Mengistu, Lenga, Gome, Mutie, Thomas M., Mukhwana, Eva, Desalegn, Hailemichael, Berhe, Rezene, Meshesha, Berhane Redae, Kaimila, Bongani , Kelly, Paul , Fleischer, David E., Topazian, Mark , Fleischer, David, Mwachiro, Michael , Topazian, Hillary M. , Kayamba, Violet J. , Berhe, Rezene, Dawsey, Sanford M.

Endoscopy International Open | November 12, 2021 | Volume: 09 | Issue: 11 | Pages: E1827-E1836

10.1055/a-1551-3343 Get It

Abstract Background and study aims Limited evidence suggests that endoscopy capacity in sub-Saharan Africa is insufficient to meet the levels of gastrointestinal disease. We aimed to quantify the human and material resources for endoscopy services in eastern African countries, and to identify barriers to expanding endoscopy capacity. Patients and methods In partnership with national professional societies, digestive healthcare professionals in participating countries were invited to complete an online survey between August 2018 and August 2020. Results Of 344 digestive healthcare professionals in Ethiopia, Kenya, Malawi, and Zambia, 87 (25.3 %) completed the survey, reporting data for 91 healthcare facilities and identifying 20 additional facilities. Most respondents (73.6 %) perform endoscopy and 59.8 % perform at least one therapeutic modality. Facilities have a median of two functioning gastroscopes and one functioning colonoscope each. Overall endoscopy capacity, adjusted for non-response and additional facilities, includes 0.12 endoscopists, 0.12 gastroscopes, and 0.09 colonoscopes per 100,000 population in the participating countries. Adjusted maximum upper gastrointestinal and lower gastrointestinal endoscopic capacity were 106 and 45 procedures per 100,000 persons per year, respectively. These values are 1 % to 10 % of those reported from resource-rich countries. Most respondents identified a lack of endoscopic equipment, lack of trained endoscopists and costs as barriers to provision of endoscopy services. Conclusions Endoscopy capacity is severely limited in eastern sub-Saharan Africa, despite a high burden of gastrointestinal disease. Expanding capacity requires investment in additional human and material resources, and technological innovations that improve the cost and sustainability of endoscopic services.
Expert assessment on volumetric laser endomicroscopy full scans in Barrett’s esophagus patients with or without high grade dysplasia or early cancer
Struyvenberg, Maarten R., Fleischer, David E., Swager, Anne-Fré, Bouma, Brett E. , Ganguly, Eric K. , Konda, Vani J. , Lightdale, Charles J. , Pleskow, Douglas K. , Sethi, Amrita , Smith, Michael S. , Wallace, Michael B. , Wang, Kenneth T. , Wolfsen, Herbert C. , Tearney, Guillermo J. , Curvers, Wouter L., Leggett, Cadman L. , Bergman, Jacques , Kahn, Allon , Fleischer, David, Wallace, Michael B , Pleskow, Douglas , Leggett, Cadman L , Trindade, Arvind J.

Endoscopy | June 25, 2020 | Volume: 53 | Issue: 03 | Pages: 218-225

10.1055/a-1194-0397 Get It

Abstract Background Volumetric laser endomicroscopy (VLE) allows for near-microscopic imaging of the superficial esophageal wall and may improve detection of early neoplasia in Barrett’s esophagus (BE). Interpretation of a 6-cm long, circumferential VLE “full scan” may however be challenging for endoscopists. We aimed to evaluate the accuracy of VLE experts in correctly diagnosing VLE full scans of early neoplasia and non-dysplastic BE (NDBE). Methods 29 VLE full scan videos (15 neoplastic and 14 NDBE) were randomly evaluated by 12 VLE experts using a web-based module. Experts were blinded to the endoscopic BE images and histology. The 15 neoplastic cases contained a subtle endoscopically visible lesion, which on endoscopic resection showed high grade dysplasia or cancer. NDBE cases had no visible lesions and an absence of dysplasia in all biopsies. VLE videos were first scored as “neoplastic” or “NDBE.” If neoplastic, assessors located the area most suspicious for neoplasia. Primary outcome was the performance of VLE experts in differentiating between non-dysplastic and neoplastic full scan videos, calculated by accuracy, sensitivity, and specificity. Secondary outcomes included correct location of neoplasia, interobserver agreement, and level of confidence. Results VLE experts correctly labelled 73 % (95 % confidence interval [CI] 67 % – 79 %) of neoplastic VLE videos. In 54 % (range 27 % – 66 %) both neoplastic diagnosis and lesion location were correct. NDBE videos were consistent with endoscopic biopsies in 52 % (95 %CI 46 % – 57 %). Interobserver agreement was fair (kappa 0.28). High level of confidence was associated with a higher rate of correct neoplastic diagnosis (81 %) and lesion location (73 %). Conclusions Identification of subtle neoplastic lesions in VLE full scans by experts was disappointing. Future studies should focus on improving methodologies for reviewing full scans, development of refined VLE criteria for neoplasia, and computer-aided diagnosis of VLE scans.
Timeline and location of recurrence following successful ablation in Barrett’s oesophagus: an international multicentre study
Sami, Sarmed S. , Ravindran, Adharsh, Snyder, Diana L. , Santiago, José , Ortiz‐Fernández‐Sordo, Jacobo , Tan, Wei Keith , Dierkhising, Ross , Johnson, Michele L., Lansing, Ramona, Ragunath, Krish , Pietro, Massimiliano di , Wolfsen, Herbert C. , Ramirez, Francisco C. , Fleischer, David E., Wang, Kenneth K, Leggett, Cadman L. , Katzka, David A. , Iyer, Prasad G. , Kahn, Allon , Snyder, Diana, Dierkhising, Ross A, Crook, Julia E. , Wolfsen, Herbert, Ramirez, Francisco, Fleischer, David, Katzka, D A , Iyer, P G , Leggett, Cadman L , Santiago, Jose, Heckman, Michael G.

Gut | January 11, 2019 | Volume: 68 | Issue: 8 | Pages: 1379-1385

10.1136/gutjnl-2018-317513 Get It

Objective Surveillance interval protocols after complete remission of intestinal metaplasia (CRIM) post radiofrequency ablation (RFA) in Barrett’s oesophagus (BE) are currently empiric and not based on substantial evidence. We aimed to assess the timeline, location and patterns of recurrence following CRIM to inform these guidelines. Design Data on patients undergoing RFA for BE were obtained from prospectively maintained databases of five (three USA and two UK) tertiary referral centres. RFA was performed until CRIM was confirmed on two consecutive endoscopies. Results 594 patients achieved CRIM as of 1 May 2017. 151 subjects developed recurrent BE over a median (IQR) follow-up of 2.8 (1.4–4.4) years. There was 19% cumulative recurrence risk of any BE within 2 years and an additional 49% risk over the next 8.6 years. There was no evidence of a clinically meaningful change in the recurrence hazard rate of any BE, dysplastic BE or high-grade dysplasia/cancer over the duration of follow-up, with an estimated 2% (95% CI −7% to 12%) change in recurrence rate of any BE in a doubling of follow-up time. 74% of BE recurrences developed at the gastro-oesophageal junction (GOJ) (24.1% were dysplastic) and 26% in the tubular oesophagus. The yield of random biopsies from the tubular oesophagus, in the absence of visible lesions, was 1% (BE) and 0.2% (dysplasia). Conclusions BE recurrence risk following CRIM remained constant over time, suggesting that lengthening of follow-up intervals, at least in the first 5 years after CRIM, may not be advisable. Sampling the GOJ is critical to detecting recurrence. The requirement for random biopsies of the neosquamous epithelium in the absence of visible lesions may need to be re-evaluated.
The Republic of Malta and endoscopic eradication therapy for Barrett’s esophagus
Fleischer, David, Fleischer, David E.

Endoscopy | September 27, 2018 | Volume: 50 | Issue: 10 | Pages: 943-945

10.1055/a-0662-5584 Get It

Barrett Esophagus Length, Nodularity, and Low-grade Dysplasia are Predictive of Progression to Esophageal Adenocarcinoma
Solanky, Dipesh , Krishnamoorthi, Rajesh , Crews, Nicholas R. , Johnson, Michele L., Wolfsen, Herbert C. , Fleischer, David E., Ramirez, Francisco C. , Katzka, David A. , Buttar, Navtej , Iyer, Prasad G. , Crews, Nicholas, Johnson, Michele, Wolfsen, Herbert, Fleischer, David, Katzka, David, Wang, Kenneth

Journal of Clinical Gastroenterology | April 2, 2018 | Volume: 53 | Issue: 5 | Pages: 361-365

10.1097/mcg.0000000000001027 Get It

Goals: To investigate factors predictive of progression from nondysplastic Barrett esophagus (NDBE) or low-grade dysplasia (LGD) to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) using a large, prospective cohort of patients, wherein all esophageal biopsies undergo expert gastrointestinal pathologist review. Background: Efficacy and cost-effectiveness of endoscopic surveillance to detect incident EAC in the setting of Barrett esophagus (BE), particularly in NDBE patients, is questioned. Previous studies have reported factors predictive of progression to EAC to guide surveillance intervals, but their strength is limited by small sample size and absence of expert gastrointestinal pathologist involvement in esophageal biopsy review. Study: NDBE and LGD subjects were identified from a prospective registry in a tertiary care center. “Progressors” were BE subjects who developed HGD/EAC>12 months after the initial NDBE or LGD diagnosis. Cox proportional hazards model were used to identify predictors of progression. Results: In total, 318 with NDBE and 301 with BE-LGD (mean age, 62.6 y, 85% male) were included. The mean follow-up was 5.3 years. The 7 NDBE and 21 LGD subjects progressed to HGD/EAC. BE length [hazards ratio (HR), 1.16; 95% confidence interval (CI), 1.03-1.29], presence of nodularity (HR, 4.98; 95% CI, 1.80-11.7), and baseline LGD (HR, 2.57; 95% CI, 1.13-6.57) were significant predictors of progression on multivariate analysis. Conclusions: In this well-defined cohort of NDBE and BE-LGD subjects, BE length, presence of LGD, and nodularity were independent predictors of progression to HGD/EAC. These factors may aid in identifying high-risk patients who may benefit from closer endoscopic surveillance/therapy.
Value metrics of a nurse navigator patient support program within a multidisciplinary esophageal cancer clinic.
Ross, Helen J. , Freese, Joy, Ciafone, Denise, Ashman, Jonathan B. , Rule, William G., Jaroszewski, Dawn E. , Harold, Kristi L., Paripati, Harshita, Pannala, Rahul , Faigel, Douglas O. , Bright, Robert K. , Fleischer, David, Crowell, Michael D. , Ramirez, Francisco Eduardo

Journal of Clinical Oncology | February 24, 2017 | Volume: 30 | Issue: 34_suppl | Pages: 158-158

10.1200/jco.2012.30.34_suppl.158 Get It

158 Background: Esophageal cancer patients (pts) require multidisciplinary management involving thoracic and general surgeons, medical and radiation oncologists, gastroenterologists and psychiatrists. Pts navigate complex medical discussions and endure challenges to nutrition, body image, swallowing mechanics, energy level and weight, mood, and performance status. Coordination of care is complicated by multiple sites of pt entry, complex scheduling requirements, and incomplete information at multidisciplinary consultation. A nurse navigator to coordinate the patient experience may optimize treatment and improve outcomes, quality of life and patient satisfaction. Methods: The nurse navigator evaluates all pt records prior to initial appointment and coordinates scheduling, records acquisition, testing and specialty appointments. The nurse navigator serves as a liaison with pts throughout the course of care and provides a patient navigation book (PNB) as a central source for patient-directed information and record keeping. Benchmarks compared before and after creation of the nurse navigator position include: (1) time from appointment request to multidisciplinary evaluation and start of treatment; (2) completeness of medical records and data (scans, pathology slides); (3) patient awareness of support services for themselves and caregivers; (4) utilization of the PNB; (5) number and frequency of interim hospitalizations and emergency room visits; (6) patient, caregiver, and physician satisfaction. Results: From January to July 2012, 27 gastroesophageal cancer pts have been followed by the nurse navigator. Most of these patients remain on active treatment, hence benchmark analysis is ongoing. Metrics thus far suggest improvement in time to treatment start and awareness of patient resources, use of the PNB and patient satisfaction. Conclusions: Esophageal cancer pts undergo complex and toxic multimodality therapy with curative intent. A dedicated nurse navigator may improve the patient experience, optimize adherence to guideline based therapy and appropriate timeframes and provide continuity to pts undergoing multidisciplinary treatment.
Endoscopic radiofrequency ablation for early esophageal squamous cell neoplasia: report of safety and effectiveness from a large prospective trial
He, Shun , Bergman, Jacques , Zhang, Yueming , Weusten, Bas L. , Xue, Liyan , Qin, Xiumin, Dou, Lizhou, Liu, Yong , Fleischer, David E., Lü, Ning , Wang, Gui-Qi, Fleischer, David, Dawsey, Sanford M.

Endoscopy | February 10, 2015 | Volume: 47 | Issue: 05 | Pages: 398-408

10.1055/s-0034-1391285 Get It

Abstract CN06-03: Randomized double-blinded phase II trial of esomeprazole versus esomeprazole + two doses of aspirin in Barrett's esophagus patients
Sontag, Steven, Cruz-Correa, Marica, Weinberg, David S. , Chak, Amitabh , Fleischer, David, Smyrk, Thomas C. , Butar, Navtej, Foster, Nathan R. , Romero, Yvonne , Corley, Douglas A. , DeVault, Kenneth R. , Marcon, Norman E. , Schnell, Thomas , Falk, Gary W. , Hur, Chin

Cancer Prevention Research | June 27, 2012 | Volume: 4 | Issue: 10_Supplement | Pages: CN06-03-CN06-03

10.1158/1940-6207.prev-11-cn06-03 Get It

Abstract Background and Aims: In patients with Barrett's esophagus (BE), reflux-induced injury promotes esophageal adenocarcinoma, presumably through cyclooxygenase 2 (COX-2) related pathways. Proton pump inhibitors (PPIs) and nonsteroidal anti-inflammatory drugs (NSAIDs) may interrupt reflux-associated carcinogenesis by reducing acid exposure and subsequent inflammation. However, clinical trial data regarding the chemopreventive efficacy of a PPI + NSAID combination are limited. The aim of this multi-center, randomized, phase II trial was to assess the effects of a 28-day intervention with esomeprazole 40 mg bid and aspirin 81 mg qd, 325 mg qd, or placebo qd on tissue prostaglandin E2 (PGE2) concentrations in BE patients. Methods: Using the infrastructure of the Cancer Prevention Network, participants (> 18 years) with histologically confirmed non dysplastic BE were randomly assigned to receive one of three interventions for 28 days: (arm A) esomeprazole 40 mg bid+ aspirin 81 mg placebo qd + aspirin 325 mg placebo qd (n=42); (arm B) esomeprazole 40 mg bid+ aspirin 81 mg qd + aspirin placebo 325 qd (n=63); (arm C) esomeprazole 40 mg bid + aspirin 81 mg qd placebo + aspirin 325 mg qd (n=63). Esophageal biopsies were obtained pre- and post-intervention to assess change in PGE2 concentration as the primary endpoint. Results: In total, 122 participants were randomized, 121 (99%) completed the trial per protocol, and 115 (94%) were evaluated for the primary endpoint. Baseline characteristics were similar across intervention arms. The absolute change (mean + SD) in tissue PGE2 concentration was −67.6 (229.68) in Arm A, −120.9 (281.28) in Arm B (p = 0.10 vs Arm A) and −174.9 (263.62) in Arm C (p = 0.02 vs Arm A). Conclusions: In combination with esomeprazole 40 mg twice per day, aspirin 325 mg per day significantly reduced tissue PGE2 concentration in BE patients after a 28-day intervention, as compared to aspirin placebo. Given the relevance of PGE2 pathways in BE-associated carcinogenesis, further evaluation of this chemoprevention strategy in larger, more definitive phase III trials is warranted. Citation Information: Cancer Prev Res 2011;4(10 Suppl):CN06-03.