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Resumen Objetivo Evaluar la eficacia y seguridad de la terapia de vacio endoscopica (TVE) en perforaciones y dehiscencias del tracto digestivo superior. Pacientes y metodos Estudio retrospectivo observacional donde se incluyeron todos los pacientes que presentaron algun defecto del tracto gastrointestinal superior y que fueron sometidos a TVE en el periodo comprendido entre abril de 2017 y febrero de 2019 en 3 centros espanoles. Para ello se utilizo el unico sistema de terapia de vacio aprobado para uso endoscopico hasta la fecha (Eso-SPONGEr; B. Braun Melsungen AG, Melsungen, Alemania). Resultados Un total de 11 pacientes fueron sometidos a TVE como tratamiento de una dehiscencia de sutura anastomotica tras esofaguectomia (n = 7), gastrectomia (n = 2), como tratamiento de una perforacion esofagica tras septomiotomia endoscopica de Zenker (n = 1) y tras una perforacion esofagica espontanea o sindrome de Boerhaave (n = 1). La mediana del tamano de la cavidad fue de 8 × 3 cm. De mediana, la TVE se inicio a los 7 dias de la cirugia inicial. La mediana de duracion de la TVE fue de 28 dias. La mediana de esponjas colocadas fue de 7 y el intervalo de recambio de las esponjas, de 3,7 dias. En 10 casos (91%) se consiguio el cierre del defecto y en 9 casos (82%) la resolucion clinica del cuadro infeccioso asociado. Cinco pacientes presentaron algun evento adverso: 3 estenosis anastomoticas, un episodio de dolor retrofaringeo y un caso de neumonia de nueva aparicion. La mediana de estancia hospitalaria desde el inicio de la TVE fue de 45 dias. Un paciente fallecio debido a complicaciones septicas secundarias a la dehiscencia de sutura. Conclusion La TVE tiene una eficacia superior al 90% en las perforaciones y fugas anastomoticas del tracto digestivo superior. Adicionalmente es una terapia segura, siendo los eventos adversos leves.

INTRODUCTION: Delayed bleeding (DB) is the most common major complication of endoscopic mucosal resection (EMR). Two randomized clinical trials recently demonstrated that clip closure after EMR of large nonpedunculated colorectal polyps (LNPCPs) reduces the risk of DB. We analyzed the cost-effectiveness of this prophylactic measure. METHODS: EMRs of LNCPCPs were consecutively registered in the ongoing prospective multicenter database of the Spanish EMR Group from May 2013 until July 2017. Patients were classified according to the Spanish Endoscopy Society EMR group (GSEED-RE2) DB risk score. Cost-effectiveness analysis was performed for both Spanish and US economic contexts. The average incremental cost-effectiveness ratio (ICER) thresholds were set at 54,000 euro or $100,000 per quality-adjusted life year, respectively. RESULTS: We registered 2,263 EMRs in 2,130 patients. Applying their respective DB relative risk reductions after clip closure (51% and 59%), the DB rate decreased from 4.5% to 2.2% in the total cohort and from 13.7% to 5.7% in the high risk of the DB GSEED-RE2 subgroup. The ICERs for the universal clipping strategy in Spain and the United States, 469,706 euro and $1,258,641, respectively, were not cost effective. By contrast, selective clipping in the high-risk of DB GSEED-RE2 subgroup was cost saving, with a negative ICER of -2,194 euro in the Spanish context and cost effective with an ICER of $87,796 in the United States. DISCUSSION: Clip closure after EMR of large colorectal lesions is cost effective in patients with a high risk of bleeding. The GSEED-RE2 DB risk score may be a useful tool to identify that high-risk population.

[Background and Aims]: The Endoscopic Resection Group of the Spanish Society of Endoscopy (GSEED-RE) model and the Australian Colonic Endoscopic Resection (ACER) model were proposed to predict delayed bleeding (DB) after EMR of large superficial colorectal lesions, but neither has been validated. We validated and updated these models., [Methods]: A multicenter cohort study was performed in patients with nonpedunculated lesions ≥20 mm removed by EMR. We assessed the discrimination and calibration of the GSEED-RE and ACER models. Difficulty performing EMR was subjectively categorized as low, medium, or high. We created a new model, including factors associated with DB in 3 cohort studies., [Results]: DB occurred in 45 of 1034 EMRs (4.5%); it was associated with proximal location (odds ratio [OR], 2.84; 95% confidence interval [CI], 1.31-6.16), antiplatelet agents (OR, 2.51; 95% CI, .99-6.34) or anticoagulants (OR, 4.54; 95% CI, 2.14-9.63), difficulty of EMR (OR, 3.23; 95% CI, 1.41-7.40), and comorbidity (OR, 2.11; 95% CI, .99-4.47). The GSEED-RE and ACER models did not accurately predict DB. Re-estimation and recalibration yielded acceptable results (GSEED-RE area under the curve [AUC], .64 [95% CI, .54-.74]; ACER AUC, .65 [95% CI, .57-.73]). We used lesion size, proximal location, comorbidity, and antiplatelet or anticoagulant therapy to generate a new model, the GSEED-RE2, which achieved higher AUC values (.69-.73; 95% CI, .59-.80) and exhibited lower susceptibility to changes among datasets., [Conclusions]: The updated GSEED-RE and ACER models achieved acceptable prediction levels of DB. The GSEED-RE2 model may achieve better prediction results and could be used to guide the management of patients after validation by other external groups. (Clinical trial registration number: NCT 03050333.), Research support for this study was received from “La Caixa/Caja Navarra” Foundation (ID 100010434;project PR15/11100006).

[Background & Aims]: It is not clear whether closure of mucosal defects with clips after colonic endoscopic mucosal resection (EMR) prevents delayed bleeding, although it seems to have no protective effects when risk is low. We performed a randomized trial to evaluate the efficacy of complete clip closure of large (≥2 cm) nonpedunculated colorectal lesions after EMR in patients with an estimated average or high risk of delayed bleeding., [Methods]: We performed a single-blind trial at 11 hospitals in Spain from May 2016 through June 2018, including 235 consecutive patients who underwent EMR for large nonpedunculated colorectal lesions with an average or high risk of delayed bleeding (based on Spanish Endoscopy Society Endoscopic Resection Group score). Participants were randomly assigned to groups that received closure of the scar with 11-mm through-the-scope clips (treated, n = 119) or no clip (control, n = 116). The primary outcome was proportion of patients in each group with delayed bleeding, defined as evident hematochezia that required medical intervention within 15 days after colonoscopy., [Results]: In the clip group, complete closure was achieved in 68 (57%) cases, with partial closure in 33 (28%) cases and failure to close in 18 (15%) cases. Delayed bleeding occurred in 14 (12.1%) patients in the control group and in 6 (5%) patients in the clip group (absolute risk difference, reduction of 7% in the clip group; 95% confidence interval, –14.7% to 0.3%). After completion of the clip closure, there was only 1 (1.5%) case of delayed bleeding (absolute risk difference, reduction of 10.6%; 95% confidence interval, –4.3% to 17.9%)., [Conclusions]: In a randomized trial of patients with large nonpedunculated colorectal lesions undergoing EMR, we found that clip closure of mucosal defects in patients with a risk of bleeding can be a challenge, but also reduces delayed bleeding. Prevention of delayed bleeding required complete clip closure. ClinicalTrials.gov ID: NCT02765022., This work was supported by a grant from the Spanish Society of Digestive Endoscopy. Micro-Tech Endoscopy (Nanjing, China) contributed the clips needed for the study. The authors declare no conflicts of interest with this company or any other that relates to the topic addressed in this study. The first author received a grant from “La Caixa/Caja Navarra” Foundation (ID 100010434; Project PR15/11100006).

Pose SM is an endolumenal weight-loss intervention in which suture anchors are placed endoscopically in the gastric fundus/distal gastric body. Observational studies of pose have shown safe, effective weight loss. Twelve-month results of a randomized controlled trial comparing weight loss and satiety after pose vs. conventional medical therapy are reported. Subjects with classes I–II obesity were randomized in a 3:1 ratio to pose or diet/exercise guidance only (control). Pose subjects received gastric fundus and distal body suture-anchor plications with diet/exercise counseling. Total body (%TBWL) and excess weight loss (%EWL) were assessed at 6 and 12 months. Analysis of covariance (ANCOVA) was used to analyze 12-month %TBWL. Satiety changes were assessed at 6 and 12 months. From November 2013 to July 2014, 44 subjects were randomized (34, 77.3 % female; mean age, 38.3 ± 10.7 years; body mass index, 36.5 ± 3.4 kg/m2) to pose (n = 34) or control (n = 10) groups in three centers. Mean pose procedure time was 51.8 ± 14.5 min; pose subjects received a mean 8.8 ± 1.3 fundal and 4.2 ± 0.7 distal body plications. Twelve-month TBWL: pose, 13.0 % (EWL, 45.0 %), n = 30 vs. control group, 5.3 % (18.1 %), n = 9; significant mean difference, 7.7 % (95 % CI 2.2, 13.2; p

BACKGROUND: Primary Obesity Surgery Endolumenal (POSE) is a novel bariatric endoscopic procedure that has been shown to reduce weight safely through 12 months. The study investigated potential mechanisms of weight loss following POSE. METHODS: Patients with class I-II obesity received transmural plications in the gastric fundus and distal gastric body. Patients were evaluated at baseline and at 2- and 6-month follow-up with gastric-emptying (GE) scintigraphy, a validated test of intake capacity (kcal) and plasma glucose homeostasis hormones/gastrointestinal peptides. Weight was recorded through 15 months. Mean data and 95 % CIs are reported. Regression modeling assessed variables that influenced total weight loss (%TWL) and excess weight loss (%EWL). RESULTS: POSE was performed on 18 patients (14 F/4 M); mean age 39 years (34-44), body mass index (BMI, kg/m(2)) 36 (95 % CI, 35; 37). At 15 months (n = 15), mean TWL was 19.1 ± 6.6 % (15.5; 22.8) and EWL was 63.7 ± 25.1 % (49.8; 77.6). At 2 and 6 months (n = 18), intake capacity decreased significantly from 901 (685; 1117) to 473 (345; 600) and 574 kcal (418; 730), respectively (p

Resumen Introduccion y objetivo La adecuacion de las indicaciones de la colonoscopia a las recomendaciones vigentes es importante para optimizar los recursos disponibles. El objetivo fue valorar el grado de adecuacion de las indicaciones de colonoscopia en una unidad de endoscopia de acceso abierto utilizando los criterios EPAGE II. Metodos Se incluyeron de forma retrospectiva las colonoscopias realizadas entre el 1 de octubre y el 30 de noviembre de 2011. La adecuacion de la colonoscopia se establecio de acuerdo con los criterios EPAGE II. Se registraron datos demograficos, medicos solicitantes, indicaciones y hallazgos relevantes de estas exploraciones. Resultados Se incluyeron 440 colonoscopias (54% mujeres; edad, 60,8 ± 16,3 anos). La indicacion fue apropiada en 75,4% (IC: 71-79,3%), incierta en 13,1% (IC: 10,2-16,6%) e inapropiada en 11,4% (IC: 8,7-14,8%). En el analisis univariante la presencia de hallazgos relevantes se asocio a la edad, el sexo, la indicacion y EPAGE II. En el analisis de regresion logistica la edad ≥ 50 anos (OR: 1,84), el sexo masculino (OR: 2,7) y 2 indicaciones, control EII y vigilancia pospolipectomia (p Conclusiones El grado de inadecuacion de la colonoscopia es elevado, sobre todo en pacientes jovenes (

Two recent genome-wide association studies in Asians have reported the association between the PSCA (prostate stem cell antigen) rs2294008C>T gene polymorphism and two Helicobacter pylori infection-related diseases such as gastric cancer (GC) and duodenal ulcer (DU). Since rs2294008 allele frequencies differ notably among ethnicities, we aimed to assess the role of rs2294008 on the susceptibility to GC and DU in a Caucasian population in Spain. Moreover, the relevance of rs2294008 on GC prognosis was evaluated. Genomic DNA from 603 Spanish patients with primary GC, 139 with DU and 675 healthy controls was typed for the PSCA rs2294008C>T polymorphism by PCR-TaqMan assays. H. pylori infection [odds ratio (OR): 8.27; 95% confidence interval (CI): 3.45-15.33] and nonsteroidal anti-inflammatory drugs (OR: 6.54; 95% CI: 3.19-12.43) were identified as independent risk factors for DU whereas the rs2294008T allele was associated with reduced risk of developing the disease (OR: 0.52; 95% CI: 0.33-0.82). Infection with CagA strains (OR: 2.10; 95% CI: 1.63-2.34), smoking (OR: 1.93; 95% CI: 1.54-2.61), family history of GC (OR: 2.83; 95% CI: 2.01-3.83), and the rs2294008T allele (OR: 1.46; 95% CI: 1.07-1.99) were associated with increased risk of GC. Interestingly, the association with the rs2294008T allele was restricted to noncardia GC (OR: 1.43; 95% CI: 1.12-1.82), particularly of the diffuse histotype (OR: 1.59; 95% CI: 1.16-1.92). Finally, Cox regression analysis identified the rs2294008T variant as a prognosis factor associated with worse overall survival in patients with diffuse-type GC (hazard ratio: 1.85; 95% CI: 1.12-3.06). From these results we conclude that the PSCA rs2294008 polymorphism is involved in the susceptibility to GC and DU, as well as in the prognosis of the diffuse-type of GC in Caucasians.