Assessing Endoscopic Ultrasound-Guided Radiofrequency Ablation in Unresectable Pancreatic Ductal Adenocarcinoma: A Single-Center Historic Cohort Study.

BACKGROUND: /aims: Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) has emerged as an alternative for the local treatment of unresectable pancreatic ductal adenocarcinoma (PDAC). We aim to assess the feasibility and safety of EUS-RFA in patients with unresectable PDAC. METHODS: The following was a historic cohort compounded by locally advanced (LA) and metastatic (m) PDAC naïve patients, who underwent EUS-RFA between October 2019 to March 2022. EUS-RFA was performed with a 19-g needle electrode with a 10 mm active tip for energy delivery. Study primary endpoints were feasibility, safety, and clinical follow-up; secondary endpoints were performance status (PS), local control (LC) and overall survival (OS). RESULTS: Twenty-six patients were selected: 15/26 LA-PDAC and 11/26 mPDAC. Technical success was achieved in all patients with no major adverse events. Six months after EUS-RFA, OS was 11/26 (42.3%), with significant PS improvement (P=.03). LC was achieved, with tumor reduction from 39.5 to 26 mm (P=.04). Post-treatment hypodense necrotic area was observed at six-month follow-up in 11/11 alive cases. Metastatic disease was a significant factor for OS worsening (HR 5.021; IC 95% 1.589 - 15.87; P=.004) CONCLUSIONS: EUS-RFA of pancreatic adenocarcinoma is a minimally invasive and safe technique that may have an important role as targeted therapy for local treatment of unresectable cases, as well as an alternative for poor surgical candidates. Also, RFA may play a role in downstaging cancer with potential OS increase in non-metastatic cases. Large prospective cohorts are required to evaluate this technique in clinical practice.

Spanish translation and validation of a hybrid, health-related quality of life questionnaire for chronic esophageal conditions: NEQOL-S.

BACKGROUND: Chronic esophageal conditions (CEC) are associated with significant disease-related burden, disability, and costs. Health-related quality of life (HRQOL) constructs are intended to capture the physical, mental, social, and emotional aspects of a patient's life and how health status impacts these domains. The Northwestern Esophageal Quality of Life (NEQOL) can be used among esophageal diseases while maintaining sensitivity to specific conditions. We aimed to translate, cross-cultural adapt, and validate the NEQOL into Spanish. METHODS: After language and cross-cultural adaptation, the NEQOL was applied to an outpatient clinic-based population in a single tertiary center. We analyzed the internal consistency, construct, criterion validity, and test-retest reliability of the questionnaire. The criterion validity was tested against the SF-12 questionnaire. KEY RESULTS: After completing the translation process, no item was considered problematic. A total of 385 patients were included in the validation study. The internal consistency (Cronbach's alpha) for the total NEQOL-S score was 0.89. The NEQOL-S questionnaire showed moderate test-retest reliability (ICC = 0.828; 95% CI 0.755-0.881; p < 0.001). Criterion validity showed good coherence when correlated with the SF-12 survey (R2  = 0.538; 95% CI 0.491-0.585, p < 0.001). CONCLUSIONS AND INFERENCES: The translated and cross-culturally adapted NEQOL-S showed good psychometric properties that allow its use in Spanish-speaking patients suffering from CEC.

Newly proposed quantitative criteria can assess chronic atrophic gastritis via probe-based confocal laser endomicroscopy (pCLE): a pilot study.

Background and study aims Probe-based confocal laser endomicroscopy (pCLE) can provide high magnification to evaluate chronic atrophic gastritis (CAG), but the current pCLE criteria are qualitative and prone to variability. We aimed to propose a quantitative CAG criterion based on pCLE to distinguish non-atrophic gastritis (NAG) from CAG. Patients and methods This observational, exploratory pilot study included patients with NAG and CAG evaluated via esophagogastroduodenoscopy, pCLE, and histology. We measured the gastric glands density, gastric gland area, and inter-glandular distance during pCLE. Results Thirty-nine patients (30/39 with CAG) were included. In total, 194 glands were measured by pCLE, and 18301 were measured by histology, with a median of five glands per NAG patient and 4.5 per CAG patient; pCLE moderately correlate with histology (rho = 0.307; P  = 0.087). A gland area of 1890-9105 µm 2 and an inter-glandular distance of 12 to 72 µm based on the values observed in the NAG patients were considered normal. The proposed pCLE-based CAG criteria were as follows: a) glands density < 5; b) gland area < 1/16 the pCLE field area (< 1890 µm 2 ) or > 1/4 the pCLE field area (> 9105 µm 2 ); or c) inter-glandular distance < 12 or > 72 µm; CAG was diagnosed by the presence of at least one criterion. The proposed criteria discriminated CAG with a ranged sensitivity of 76.9 % to 92.3 %, a negative predictive value of 66.6 % to 80.0 %, and 69.6 % to 73.9% accuracy. Conclusions The proposed pCLE criteria offer an accurate quantitative measurement of CAG with high sensitivity and excellent interobserver agreement. Larger studies are needed to validate the proposed criteria.

Confocal laser endomicroscopy detects colonic inflammation in patients with irritable bowel syndrome: a prospective study.

Background and aims Irritable bowel syndrome (IBS) is considered to be a functional disease, but recent data indicate measurable organic alterations. We aimed to determine the presence of colorectal mucosa microinflammation in vivo via probe-confocal laser endomicroscopy (pCLE) and histological evaluation in IBS patients. Methods This was a prospective, controlled, nonrandomized single-blind diagnostic trial performed in a tertiary institution. pCLE images and targeted biopsy of each colon segment obtained during colonoscopies of IBS patients and controls were analyzed for inflammatory changes. Biopsies were classified using the Geboes scale, and the odds ratio and overall diagnostic accuracy were calculated. Results During the 15-month study period, 37 patients were allocated to each group. The mean age was 53.1 ±â€Š14.3 years; 64.9 % were female. Signs of colonic mucosa inflammation were evident on 65.8 % of pCLE images from IBS patients compared to 23.4 % of images from controls (OR 6.28; 4.14-9.52; P  < 0.001). In total, 20/37 patients had microinflammation via pCLE in ≥ 3 colon segments in the IBS group, compared to 1/37 in the control group. A Geboes score > 0 was attributed to 60.8 % of biopsies from patients in the IBS group compared to 27.5 % of biopsies from the control group. The sensitivity, specificity, positive and negative predictive values, observed and interrater agreement of pCLE-detected inflammatory changes in IBS using histology as gold standard were 76 %, 91 %, 76 %, 91 %, 86.5 %, and 66.8 %, respectively. Conclusions Patients with IBS have a six-fold higher prevalence of colorectal mucosa microinflammation than healthy controls. pCLE might be a reliable method to detect colorectal mucosa microinflammation in IBS patients.

High-definition optical magnification with digital chromoendoscopy detects gastric mucosal changes in dyspeptic-patients.

BACKGROUND: Accurate detection of gastric infection by Helicobacter pylori (H. pylori) and premalignant lesions are important for effective provision of treatment, preventing the development of gastric neoplasia. Optical enhancement systems with optical magnification improved the identification of mucosal superficial and vascular patterns in patients with dyspepsia. AIM: To evaluate an optical enhancement system with high-definition magnification, for diagnosis of normal gastric mucosa, H. pylori-associated gastritis, and gastric atrophy. METHODS: A cross-sectional, nonrandomized study from November 2015 to April 2016 performed in a single-tertiary academic center from Ecuador. Seventy-two consecutive patients with functional dyspepsia according to the Rome III criteria, were tested for H. pylori using a stool antigen test and were assigned to an Hp + group or an Hp - control group. Esophagogastroduodenoscopy with high-definition optical magnification and digital chromoendoscopy was performed, and patients were classified into 4 groups, in accordance to the microvascular-architecture pattern of the mucosa. Interobserver and intraobserver agreement among operators were calculated. RESULTS: Of the 72 participants, 35 were Hp + and 37 were Hp -. Among 10 patients with normal mucosal histology in biopsy samples, 90% had a Type I pattern of microvascular architecture by endoscopy. Among participants with type IIa and type IIb patterns, significantly more were Hp+ than Hp- (32 vs 8), and most (31 out of 40) had histological diagnoses of chronic active gastritis. Two of the three participants with a histological diagnosis of atrophy had a type III microvascular pattern. The type I pattern predicted normal mucosa, type IIa-IIb predicted H. pylori infection, and type III predicted atrophy with sensitivities of 90.0%, 91.4%, and 66.7%, respectively. The intraobserver and interobserver agreements had kappa values of 0.91 and 0.89, respectively. CONCLUSION: High-definition optical magnification with digital chromoendoscopy is useful for diagnosis of normal gastric mucosa and H. pylori-associated gastritis with high accuracy, but further studies are needed to determine whether endoscopic diagnosis of gastric atrophy is feasible.

Detection of minimal mucosal esophageal lesions in non-erosive gastroesophageal reflux disease using optical enhancement plus optical magnification.

Background and study aims The aim of this study was to evaluate the diagnostic yield of endoscopy using optical enhancement (OE system) with optical magnification to predict reflux in non-erosive reflux disease (NERD) patients. Patients and methods A prospective, non-randomized, single-blind study was performed from September 2015 to January 2016. Participants suffered from gastroesophageal reflux disease (GERD) symptoms and were assigned to the NERD group or the non-reflux disease control group based on endoscopic findings and a 24-hour pH-impedance-monitoring test. Endoscopy using the OE system with optical magnification was performed in all patients to detect minimal mucosal esophageal lesions (MMEL), specifically abnormalities in the numbers, dilation, and tortuosity of intrapapillary capillary loops (IPCLs). Biopsies were obtained from each esophageal segment, and diagnoses from images were compared to diagnoses of reflux and inflammation using 24-hour pH-impedance monitoring and histology, respectively. Results Fifty-seven patients were included (36 in the NERD group, 21 in the control group). IPCLs were observed in 94.4 % of cases in the NERD group and 38 % of cases in the control group ( P  < 0.05). There were significant differences in IPCL abnormalities between groups that were associated with histologically identified inflammation. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 94.4 %, 61.9 %, 80.9 %, 86.6 %, and 82.4 %, respectively. The 24-hour pH-impedance-monitoring test was used as the gold standard. The Kappa interobserver and intraobserver values were 0.85 and 0.90, respectively. Conclusion The OE system with optical magnification can detect MMEL and predict NERD with high sensitivity, accuracy, and interobserver and intraobserver agreement. Presence of IPCLs highly correlates with histologically identified inflammation.

TREATING SIMPLE BENIGN ESOPHAGEAL STRICTURES WITH SAVARY-GILLIARD DILATORS: IS THE RULE OF THREE STILL NECESSARY?

BACKGROUND: Bougies dilation is considered an effective technique for the treatment of simple benign esophageal strictures. The "rule of three" has been advocated to prevent reported adverse events such as bleeding and perforation. However, adherence to this rule has increased the cost and duration of treatment. OBJECTIVE: To demonstrate the safety and long-term benefits of progressive bougie dilations until reaching 15 mm (45Fr) in one single session endoscopy with non-adherence to the rule of three. METHODS: A retrospective analysis of a prospectively collected data of patients with simple benign esophageal strictures treated with multiple progressive bougie dilators until reaching 15 mm (45Fr) in one single session. RESULTS: The median age was 58 years (range 28-89), and 83.3% of patients were female. The main presenting symptom was dysphagia for solids in 11/12 cases (91.6%). The cause of their simple benign esophageal stricture was distributed as follows: 7/12 esophageal webs, 2/12 peptic stenosis, 2/12 Schatzki rings and one caustic injury. 75% required only one session for clinical success. No serious adverse events were described. No recurrence of symptoms was noted in a median follow-up of 20 months. CONCLUSION: The rule of three in patients with simple benign esophageal strictures secondary to esophageal webs, Schatzki rings and peptic strictures treated with Savary-Gilliard dilators is not necessary, showing good clinical results. Prospective studies with more patients are necessary.

Tratamento das estenoses esofágicas benignas simples com dilatadores de Savary-Gilliard: ainda é necessária a regra de três? / Treating simple benign esophageal strictures with savary-gilliard dilators: is the rule of three still necessary?

ABSTRACT BACKGROUND: Bougies dilation is considered an effective technique for the treatment of simple benign esophageal strictures. The "rule of three" has been advocated to prevent reported adverse events such as bleeding and perforation. However, adherence to this rule has increased the cost and duration of treatment. OBJECTIVE: To demonstrate the safety and long-term benefits of progressive bougie dilations until reaching 15 mm (45Fr) in one single session endoscopy with non-adherence to the rule of three. METHODS: A retrospective analysis of a prospectively collected data of patients with simple benign esophageal strictures treated with multiple progressive bougie dilators until reaching 15 mm (45Fr) in one single session. RESULTS: The median age was 58 years (range 28-89), and 83.3% of patients were female. The main presenting symptom was dysphagia for solids in 11/12 cases (91.6%). The cause of their simple benign esophageal stricture was distributed as follows: 7/12 esophageal webs, 2/12 peptic stenosis, 2/12 Schatzki rings and one caustic injury. 75% required only one session for clinical success. No serious adverse events were described. No recurrence of symptoms was noted in a median follow-up of 20 months. CONCLUSION: The rule of three in patients with simple benign esophageal strictures secondary to esophageal webs, Schatzki rings and peptic strictures treated with Savary-Gilliard dilators is not necessary, showing good clinical results. Prospective studies with more patients are necessary.

RESUMO CONTEXTO: A dilatação por velas é considerada uma técnica eficaz para o tratamento de estenoses esofágicas benignas simples. A "regra de três" tem sido defendida para prevenir eventos adversos relatados, como sangramento e perfuração. No entanto, a adesão a esta regra aumentou o custo e a duração do tratamento. OBJETIVO: Demonstrar a segurança e os benefícios de longo prazo das dilatações progressivas por velas até chegar a 15 mm (45Fr) em uma única sessão de endoscopia com não adesão à regra de três. MÉTODOS: Uma análise retrospectiva de dados coletados prospectivamente de pacientes com estenoses esofágicas benignas simples tratadas com múltiplos dilatadores de velas progressivas até atingir 15 mm (45Fr) em uma única sessão. RESULTADOS: A mediana de idade foi de 58 anos (variação de 28-89) e 83,3% dos pacientes eram do sexo feminino. O principal sintoma de apresentação foi a disfagia para sólidos em 11/12 casos (91,6%). A causa da estenose esofágica benigna simples foi distribuída como segue: 7/12 membranas esofágicas, 2/12 estenose péptica, 2/12 anéis de Schatzki e um ferimento cáustico. 75% necessitaram apenas de uma sessão para o sucesso clínico. Não foram descritos eventos adversos graves. Nenhum retorno dos sintomas foi anotado em uma continuação mediana de 20 meses. CONCLUSÃO: A regra de três em pacientes com as estenoses esofágicas benignas simples secundárias às membranas esofágicas, os anéis de Schatzki e as estenoses péptica tratadas com os dilatadores de Savary-Gilliard não é necessária, mostrando bons resultados clínicos. Estudos prospectivos com mais pacientes são necessários.

Reliability and accuracy of a novel classification system using peroral cholangioscopy for the diagnosis of bile duct lesions.

BACKGROUND: The aim of this study was to propose a novel, comprehensive, macroscopic classification for bile duct lesions. METHODS: A two-stage protocol was designed. In Stage I, a retrospective study (September 2013 to September 2015) of patients with bile duct lesions detected by peroral cholangioscopy (POCS) was performed. A total of 315 images with at least 6 months of follow-up were recorded, analyzed, and correlated to histology, and were classified as non-neoplastic (one of three types, 1 - 3) or neoplastic (one of four types, 1 - 4) based on morphological and vascular patterns. In Stage II, a prospective, nonrandomized, double-blind study was performed from December 2015 to December 2016 to validate the proposed classification. Sensitivity, specificity, positive and negative predictive values (PPV and NPV, respectively), and positive and negative likelihood ratios (LR + and LR - , respectively) were calculated (gold standard: 6-month follow-up). Inter- and intraobserver agreement (kappa value, κ) among experts and non-experts were calculated. RESULTS: 171 patients were included (65 retrospective; 106 prospective). In Stage I, 28/65 cases were neoplastic and 37 /65 were non-neoplastic, according to the final diagnosis. In Stage II, 56/106 were neoplastic with a sensitivity, specificity, PPV, NPV, LR + , and LR - for neoplastic diagnosis of 96.3 %, 92.3 %, 92.9 %, 96 %, 12.52, and 0.04, respectively. The proposed classification presented high reproducibility among observers, for both neoplastic and subtypes categories. However, it was better for experts (κ > 80 %) than non-experts (κ 64.7 % - 81.9 %). CONCLUSION: The novel classification system could help physicians to distinguish non-neoplastic from neoplastic bile duct lesions.