Evaluating the Safety of the Intragastric Balloon: Spanish Multicenter Experience in 20,680 Cases and with 12 Different Balloon Models.

INTRODUCTION: Intragastric balloon (IGB) is a minimally invasive and reversible option for obesity treatment. There is a worldwide growing number of different IGB models. The efficacy and safety profile for each model must be demonstrated. We aim to evaluate IGB safety profile according to the experience of the Spanish Bariatric Endoscopy Group (GETTEMO). METHODS: A survey of 37 IGBs safety-related questions was sent to all GETTEMO members, to retrospectively collect a multicenter Spanish registry. Incidence, causes, and resolution of both major and minor complications and adverse events (AEs), including legal consequences, differentiated for each balloon model were evaluated. Secondary outcome was weight loss data to confirm efficacy. RESULTS: Twenty-one Spanish hospitals experienced in IGBs responded. The overall data encompassed 20,680 IGBs, including 12 different models. Mean %TBWL of 17.66 ± 2.5% was observed. Early removal rate due to intolerance was 3.62%. Mean major complications rate was 0.70% (> 1% in Spatz2, HB, and Spatz3 models), mainly complicated gastric ulcer. Minor AEs rate was 6.37%, mainly esophagitis. Nine cases (0.04%) required surgery. A single case of mortality (0.0048%) occurred. Seven lawsuits (0.0034%) were received, all with favorable resolution. CONCLUSIONS: In the Spanish experience accumulating 20,680 IGBs and including 12 different balloon models, a low incidence rate of major complications and minor AEs are observed (0.70% and 6.37%, respectively), mostly resolved with medical/endoscopic management. IGB shows good tolerance and efficacy profile. These safety data are within the accepted quality standards.

POEM from A to Z: current perspectives.

The "third space endoscopy" or also called "submucosal endoscopy" is a reality we can transfer to our patients since 2010. Various modifications of the submucosal tunneling technique allow access to the submucosa or deeper layers of the gastrointestinal tract. In addition to peroral endoscopic myotomy for the treatment of achalasia, also called esophageal POEM, other variants have emerged that make it possible to treat different esophageal motility disorders, esophageal diverticula, subepithelial tumors of various locations, gastroparesis, reconnection of complete esophageal strictures or even thanks to exceptional endoscopists, pediatric disorders such as Hirschsprung's disease. Although some technical aspects are yet to be standardized, these procedures are becoming widespread worldwide and will likely become the standard treatment of these pathologies soon.

Spanish Intragastric Balloon Consensus Statement (SIBC): practical guidelines based on experience of over 20 000 cases.

BACKGROUND: intragastric balloons (IGBs) are a minimally invasive, increasingly popular option for obesity treatment. However, there is only one worldwide guideline standardizing the technical aspects of the procedure (BIBC, SOARD 2018). OBJECTIVES: to construct a practical guideline for IGB usage by reproducing and expanding the BIBC survey among the Spanish Bariatric Endoscopy Group (GETTEMO). METHODS: a 140-question survey was submitted to all GETTEMO members. Twenty-one Spanish experienced endoscopists in IGBs answered back. Eight topics on patient selection, indications/contraindications, technique, multidisciplinary follow-up, results, safety, and financial/legal aspects were discussed. Consensus was defined as consensus ≥ 70 %. RESULTS: overall data included 20 680 IGBs including 12 different models. Mean age was 42.0 years-old, 79.9 % were women, and the mean preoperative body mass index (BMI) was 34.05 kg/m². Indication in BMI > 25 kg/m², 10 absolute contraindications, and nutritional and medication measures at follow-up were settled. A mean %TBWL (total body weight loss) of 17.66 % ± 2.5 % was observed. Early removal rate due to intolerance was 3.62 %. Adverse event rate was 0.70 % and 6.37 % for major and minor complications with consensual management. A single case of mortality occurred. IGBs were placed in private health, prior contract, and with full and single payment at the beginning. Seven lawsuits (0.034 %) were received, all ran through civil proceeding, and with favorable final resolution. CONCLUSIONS: this consensus based on more than 20 000 cases represents practical recommendations to perform IGB procedures. This experience shows that the device leads to satisfactory weight loss with a low rate of adverse events. Most results are reproducible compared to those obtained by the BIBC.

Factors associated with pancreatic cancer in Spain. What can we learn from epidemiological studies?

The incidence of pancreatic cancer (PC) in Spain has progressively increased over the past 6 decades. Pancreatic ductal adenocarcinoma represents over 80 % of all pancreatic neoplasms. The study by Enrique Gili-Ortiz on pancreatic cancer-related mortality trends in Spain revealed a significant increase in death rates in our country, which may be partly attributed to population ageing and increased smoking, obesity, and diabetes rates. Other known factors, including chronic pancreatitis, seem to play a less significant role from a quantitative perspective.

Documento español de consenso en endoscopia bariátrica. Parte 2. Tratamientos endoscópicos específicos / Spanish consensus document on bariatric endoscopy. Part 2: specific endoscopic treatments

Durante los últimos años estamos asistiendo a un importante incremento en el número y tipo de técnicas endoscópicas bariátricas: se han propuesto distintos modelos de balones, sistemas de suturas, inyección de sustancias, colocación de prótesis, etc. También se han incorporado técnicas endoscópicas de revisión para aquellos casos de pacientes intervenidos de cirugía bariátrica que presentan recuperación ponderal. Todo ello obliga a la necesidad de protocolizar, posicionar y regularizar todas estas técnicas, mediante un consenso que permita su aplicación clínica con el máximo rigor médico y evidencia científica disponibles. Tras editar una primera parte de Consideraciones Generales, en esta segunda revisaremos las indicaciones, metodología y resultados de cada una las principales técnicas que se realizan en nuestro país, con intención de establecer una base y unos requisitos mínimos que faciliten y favorezcan la correcta práctica diaria de estos procedimientos en las Unidades de Endoscopia Bariátrica

During the last years we have been witnessing a significant increase in the number and type of bariatric endoscopic techniques: we have different types of balloons, suture systems, injection of substances and malabsorptive prosthesis, etc. Also, some endoscopic revisional procedures for patients with weight regain after bariatric surgery have been incorporated. This makes it necessary to protocolize, position and regularize all these techniques, through a consensus that allows their clinical application with the maximum medical rigor and scientific evidence available

Spanish consensus document on bariatric endoscopy. Part 2: specific endoscopic treatments.

During the last years we have been witnessing a significant increase in the number and type of bariatric endoscopic techniques: we have different types of balloons, suture systems, injection of substances and malabsorptive prosthesis, etc. Also, some endoscopic revisional procedures for patients with weight regain after bariatric surgery have been incorporated. This makes it necessary to protocolize, position and regularize all these techniques, through a consensus that allows their clinical application with the maximum medical rigor and scientific evidence available.

Documento Español de Consenso en Endoscopia Bariátrica. Parte 1. Consideraciones generales / Spanish Consensus Document on Bariatric Endoscopy. Part 1. General considerations

La obesidad es una enfermedad crónica multifactorial, incurable, recurrente y progresiva, asociada a importantes complicaciones físicas y psicológicas y con considerable morbimortalidad. Por este motivo, deben individualizarse la evaluación, el tratamiento y el seguimiento del paciente obeso dentro de una unidad multidisciplinar que disponga de unos adecuados recursos humanos y estructurales. Su tratamiento médico mediante medidas higiénicas-dietéticas, aunque imprescindible, puede resultar insuficiente y la opción quirúrgica, reservada a obesidades severas o mórbidas, no está exenta de complicaciones ni es del agrado de muchos pacientes. En este contexto, pueden considerarse tres situaciones en las que el tratamiento endoscópico, como estrategia complementaria y con escasas complicaciones, contribuye al beneficio del paciente obeso: en primer lugar, aquel subgrupo de pacientes con sobrepeso grado II u obesidad no mórbida en el que el tratamiento médico aislado haya fracasado o como complemento al mismo; en segundo lugar, en aquellos pacientes con obesidad mórbida que rechacen la cirugía o a los cuales esta les resulte contraindicada o de riesgo excesivo; y finalmente, en aquellos pacientes afectos de superobesidad que necesitan perder peso previo a la cirugía bariátrica para disminuir la morbimortalidad de la misma. En este sentido, el Grupo Español de Endoscopia Bariátrica (Grupo Español de Trabajo para el Tratamiento Endoscópico del Metabolismo y la Obesidad [GETTEMO]) ha elaborado este Documento de Consenso para que sirva de orientación práctica a todos los profesionales implicados en la endoscopia de la obesidad y permita establecer los requisitos mínimos necesarios para el correcto funcionamiento de una Unidad de Endoscopia Bariátrica

La obesidad es una enfermedad crónica multifactorial, incurable, recurrente y progresiva, asociada a importantes complicaciones físicas y psicológicas y con considerable morbimortalidad. Por este motivo, deben individualizarse la evaluación, el tratamiento y el seguimiento del paciente obeso dentro de una unidad multidisciplinar que disponga de unos adecuados recursos humanos y estructurales. Su tratamiento médico mediante medidas higiénicas-dietéticas, aunque imprescindible, puede resultar insuficiente y la opción quirúrgica, reservada a obesidades severas o mórbidas, no está exenta de complicaciones ni es del agrado de muchos pacientes. En este contexto, pueden considerarse tres situaciones en las que el tratamiento endoscópico, como estrategia complementaria y con escasas complicaciones, contribuye al beneficio del paciente obeso: en primer lugar, aquel subgrupo de pacientes con sobrepeso grado II u obesidad no mórbida en el que el tratamiento médico aislado haya fracasado o como complemento al mismo; en segundo lugar, en aquellos pacientes con obesidad mórbida que rechacen la cirugía o a los cuales esta les resulte contraindicada o de riesgo excesivo; y finalmente, en aquellos pacientes afectos de superobesidad que necesitan perder peso previo a la cirugía bariátrica para disminuir la morbimortalidad de la misma. En este sentido, el Grupo Español de Endoscopia Bariátrica (Grupo Español de Trabajo para el Tratamiento Endoscópico del Metabolismo y la Obesidad [GETTEMO]) ha elaborado este Documento de Consenso para que sirva de orientación práctica a todos los profesionales implicados en la endoscopia de la obesidad y permita establecer los requisitos mínimos necesarios para el correcto funcionamiento de una Unidad de Endoscopia Bariátrica

Spanish Consensus Document on Bariatric Endoscopy. Part 1. General considerations.

Obesity is a chronic multifactorial, incurable, recurrent, and progressive disease associated with significant physical and psychological complications, and considerable morbidity and mortality. For this reason, the assessment, management, and follow-up of obese patients should take place in the setting of a multidisciplinary unit equipped with adequate human and structural resources. Medical treatment using hygienic-dietary measures, while indispensable, may be insufficient, and surgery, which is reserved for severe or morbid obesity, is not exempt from complications neither is to the liking of many patients. In this context three situations may be considered where endoscopic treatment, used as a supplementary strategy with few complications, contributes to benefit obese patients: first, in a subgroup of patients with grade-II overweight or non-morbid obesity where medical therapy alone failed or needs supplementation. Second, in patients with morbid obesity when surgery is rejected, is contraindicated, or entails excessive risk. Finally, in patients with superobesity who need to lose weight before bariatric surgery in order to reduce surgery-related morbidity and mortality. In this regard, the Spanish Task Force on Bariatric Endoscopy (Grupo Español de Trabajo para el Tratamiento Endoscópico del Metabolismo y la Obesidad, GETTEMO) have developed this Consensus Document to serve as practical guidance for all professionals involved in the endoscopic management of obesity, and to facilitate establishing a minimum set of requirements for the proper functioning of a bariatric endoscopy unit.

Prevalence of exocrine pancreatic insufficiency in patients with chronic pancreatitis without follow-up. PANCR-EVOL Study / Prevalencia de insuficiencia pancreática exocrina en pacientes con pancreatitis crónica sin segruimiento. Estudio PANCR-EVOL

Background/objectives. Exocrine pancreatic insufficiency (EPI) is an important complication of chronic pancreatitis (CP). Guidelines recommend to rule out EPI in CP, to detect those patients who would benefit from pancreatic enzyme replacement therapy. The aim of this study was to evaluate the prevalence of EPI in patients with CP without follow-up in the last 2 years and to describe their nutritional status and quality of life (QoL). Methods. This was a cross-sectional, multicenter Spanish study. CP patients without follow-up by a gastroenterologist or surgeon in at least 2 years were included. EPI was defined as fecal elastase test <200mcg/g. For nutritional assessment, laboratory and anthropometric data were obtained. QoL was investigated using the EORTC QLQ-C30 questionnaire. Results. 64 patients (mean age 58.8±10.3 years, 85.9% men) from 10 centers were included. Median time since diagnosis of CP was 58.7 months [37.7-95.4]. Forty-one patients (64.1%) had EPI. Regarding nutritional status, the following differences were observed (EPI vs. Non-EPI): BMI (23.9±3.5kg/m2 vs. 25.7±2.5, p=0.03); glucose (121 [96-189] mg/dL vs. 98 [90-116], p=0.006); HbA1c 6.6% [6.0-8.4] vs. 5.5 [5.3-6.0], p=0.0005); Vitamin A (0.44mg/L [0.35-0.57] vs. 0.53 [0.47-0.63], p=0.048) and Vitamin E (11.2±5.0μg/ml vs. 14.4±4.3, p=0.03). EPI group showed a worse EORTC QLQ-C30 score on physical (93.3 [66.7-100] vs. 100 [93.3-100], p=0.048) and cognitive function (100 [83.3-100] vs. 100 [100-100], p=0.04). Conclusions. Prevalence of EPI is high in patients with CP without follow-up. EPI group had higher levels of glucose, lower levels of vitamins A and E and worse QoL (AU)

Antecedentes/objetivos. la insuficiencia pancreática exocrina (IPE) es una importante complicación de la pancreatitis crónica (PC). Las guías recomiendan el seguimiento de la IPE en PC, para identificar a aquellos pacientes que puedan beneficiarse del tratamiento enzimático sustitutivo. El objetivo de este estudio fue evaluar la prevalencia de IPE en pacientes con PC sin seguimiento en los últimos 2 años y describir su estado nutricional y calidad de vida (QoL). Métodos. estudio trasversal, multicéntrico, español. Se incluyeron pacientes con PC sin seguimiento por un gastroenterólogo/cirujano en los últimos 2años. Se definió IPE como elastasa fecal<200mcg/g. Se recogieron parámetros de laboratorio y datos antropométricos para el análisis nutricional. Para la evaluación de QoL se utilizó el cuestionario EORTC QLQ-C30. Resultados. se incluyeron prospectivamente 64 pacientes (58,8±10,3 años, media 85,9%) de 10 centros. Tiempo medio desde el diagnóstico de PC: 58,7meses [37,7-95,4]. 41 pacientes (64,1%) tenían IPE. Estado nutricional: se observaron las siguientes diferencias (IPE vs No-IPE): IMC (23,9±3,5kg/m2 vs. 25,7±2,5,p=0,03); glucosa 121 [96-189] mg/dL vs. 98 [90-116];p =0,006); HbA1c 6,6% [6,0-8,4] vs. 5,5 [5,3-6,0],p=0,0005); Vitamina-A (0,44mg/L [0,35-0,57] vs. 0,53 [0,47-0,63],p=0,048), Vitamina-E (11,2±5,0μg/ml vs. 14,4±4,3,p=0,03). El grupo de IPE mostró una peor puntuación en el EORTC QLQ-C30 en las funciones física (93,3 [66,7-100] vs. 100 [93,3-100], p=0,048) y cognitiva (100 [83,3-100] vs. 100 [100-100],p=0,04). Conclusiones. la prevalencia de IPE en pacientes con PC sin seguimiento es elevada. En el grupo de IPE se observaron niveles elevados de glucosa, bajos de vitaminas A y E y peor calidad de vida (AU)

Prevalence of exocrine pancreatic insufficiency in patients with chronic pancreatitis without follow-up. PANCR-EVOL Study.

BACKGROUND/OBJECTIVES: Exocrine pancreatic insufficiency (EPI) is an important complication of chronic pancreatitis (CP). Guidelines recommend to rule out EPI in CP, to detect those patients who would benefit from pancreatic enzyme replacement therapy. The aim of this study was to evaluate the prevalence of EPI in patients with CP without follow-up in the last 2 years and to describe their nutritional status and quality of life (QoL). METHODS: This was a cross-sectional, multicenter Spanish study. CP patients without follow-up by a gastroenterologist or surgeon in at least 2 years were included. EPI was defined as fecal elastase test <200mcg/g. For nutritional assessment, laboratory and anthropometric data were obtained. QoL was investigated using the EORTC QLQ-C30 questionnaire. RESULTS: 64 patients (mean age 58.8±10.3 years, 85.9% men) from 10 centers were included. Median time since diagnosis of CP was 58.7 months [37.7-95.4]. Forty-one patients (64.1%) had EPI. Regarding nutritional status, the following differences were observed (EPI vs. Non-EPI): BMI (23.9±3.5kg/m2 vs. 25.7±2.5, p=0.03); glucose (121 [96-189] mg/dL vs. 98 [90-116], p=0.006); HbA1c 6.6% [6.0-8.4] vs. 5.5 [5.3-6.0], p=0.0005); Vitamin A (0.44mg/L [0.35-0.57] vs. 0.53 [0.47-0.63], p=0.048) and Vitamin E (11.2±5.0µg/ml vs. 14.4±4.3, p=0.03). EPI group showed a worse EORTC QLQ-C30 score on physical (93.3 [66.7-100] vs. 100 [93.3-100], p=0.048) and cognitive function (100 [83.3-100] vs. 100 [100-100], p=0.04). CONCLUSIONS: Prevalence of EPI is high in patients with CP without follow-up. EPI group had higher levels of glucose, lower levels of vitamins A and E and worse QoL.

Estudio multicéntrico de seguridad en endoscopia bariátrica / Multicenter study on the safety of bariatric endoscopy

Introducción: la endoscopia bariátrica abarca una serie de técnicas específicas encaminadas al tratamiento del paciente obeso. Como criterios de calidad, además de eficacia debe exigirse seguridad, expresada por una mínima incidencia de complicaciones graves. Métodos: revisión descriptiva y retrospectiva, multicéntrica, incluyendo la experiencia de siete hospitales que forman parte del Grupo Español de Endoscopia Bariátrica (GETTEMO) para documentar la incidencia, causa y resolución (y sus consecuencias médico-legales) de las complicaciones graves detectadas con cada una de las distintas técnicas de endoscopia bariátrica, diferenciadas además en función de la experiencia del endoscopista. Resultados: se recogieron 6.771 procedimientos endoscópicos bariátricos, entre los que se detectaron 57 complicaciones graves (0,84%). Balones: Orbera(R)-Medsil(R): 5/5.589; Spatz2(R) (modelo antiguo): 44/225; Heliosphere(R): 1/70; O’balon(R): 0/107. Suturas: POSE(R): 5/679; gastroplastia en manga con sistema Apollo(R): 0/55. Prótesis: Endobarrier(R): 2/46. Todas ellas se resolvieron con tratamiento médico/ endoscópico, excepto cinco casos (0,07%) que requirieron cirugía. Existió una única demanda judicial (perforación esofágica con balón Spatz2(R)), con resolución judicial favorable. No hubo mortalidad ni aparentemente diferencias en relación con la experiencia de los endoscopistas. Conclusiones: en nuestra experiencia multicéntrica, la endoscopia bariátrica puede considerarse un procedimiento seguro (0,84% total de complicaciones graves). Sin embargo, algunos dispositivos pueden presentar un mayor porcentaje de complicaciones, como en el 19,55% de balones Spatz2(R) (ya sustituido) o en el 4,34% del Endobarrier(R) (en el límite alto de la seguridad aceptada), aunque en este dispositivo nuestra casuística es limitada. Todas las complicaciones se resolvieron con tratamiento médico conservador, requiriendo cirugía solo de forma excepcional (0,07%). No se observó mortalidad relacionada con las técnicas y solo un único caso de demanda judicial. Se requieren más estudios evolutivos de las novedosas técnicas endoscópicas emergentes que corroboren estos resultados (AU)

Introduction: Bariatric endoscopy includes a series of specific techniques focused on the management of obese patients. As a quality criterion, safety as expressed by a minimal incidence of serious complications is required in addition to efficacy. Methods: A descriptive, retrospective, multicenter review of the experience recorded at seven hospitals included in the Grupo Español de Endoscopia Bariátrica (GETTEMO) in order to document the incidence, cause, and resolution (including legal consequences) of serious complications reported for each bariatric technique, and according to endoscopist expertise. Results: In all, 6,771 bariatric endoscopic procedures were collected, wherein 57 serious complications (0.84%) were identified. Balloons: Orbera(R)-Medsil(R), 5/5,589; Spatz2(R) (older model): 44/225; Heliosphere(R): 1/70; Obalon(R): 0/107. Sutures: POSE(R), 5/679; sleeve gastroplasty with Apollo(R) system: 0/55. Prostheses: Endobarrier(R): 2/46. All complications were resolved with medical/endoscopic management except for five cases (0.07%) that required surgery. A single lawsuit occurred (esophageal perforation with Spatz2(R) balloon), which had a favorable outcome. There was no mortality, and apparently no differences were found according to endoscopist expertise level. Conclusions: In our multicenter experience, bariatric endoscopy may be considered as a safe procedure (0.84% of serious complications in all). However, some devices may induce a higher proportion of complications, such as 19.55% for Spatz2(R) balloons (already replaced) or 4.34% for Endobarrier(R) sleeves (at the upper limit of accepted safety), although our experience with the latter is limited. All complications were resolved with conservative medical management, and only exceptionally required surgery (0.07%). No technique-related mortality was seen, and only one lawsuit occurred. Further evolutionary studies are required on the novel endoscopic techniques presently emerging to authenticate our results (AU)

Multicenter study on the safety of bariatric endoscopy.

INTRODUCTION: Bariatric endoscopy includes a series of specific techniques focused on the management of obese patients. As a quality criterion, safety as expressed by a minimal incidence of serious complications is required in addition to efficacy. METHODS: A descriptive, retrospective, multicenter review of the experience recorded at seven hospitals included in the Grupo Español de Endoscopia Bariátrica (GETTEMO) in order to document the incidence, cause, and resolution (including legal consequences) of serious complications reported for each bariatric technique, and according to endoscopist expertise. RESULTS: In all, 6,771 bariatric endoscopic procedures were collected, wherein 57 serious complications (0.84%) were identified. Balloons: Orbera®-Medsil®, 5/5,589; Spatz2® (older model): 44/225; Heliosphere®: 1/70; Obalon®: 0/107. Sutures: POSE®, 5/679; sleeve gastroplasty with Apollo® system: 0/55. Prostheses: Endobarrier®: 2/46. All complications were resolved with medical/endoscopic management except for five cases (0.07%) that required surgery. A single lawsuit occurred (esophageal perforation with Spatz2® balloon), which had a favorable outcome. There was no mortality, and apparently no differences were found according to endoscopist expertise level. CONCLUSIONS: In our multicenter experience, bariatric endoscopy may be considered as a safe procedure (0.84% of serious complications in all). However, some devices may induce a higher proportion of complications, such as 19.55% for Spatz2® balloons (already replaced) or 4.34% for Endobarrier® sleeves (at the upper limit of accepted safety), although our experience with the latter is limited. All complications were resolved with conservative medical management, and only exceptionally required surgery (0.07%). No technique-related mortality was seen, and only one lawsuit occurred. Further evolutionary studies are required on the novel endoscopic techniques presently emerging to authenticate our results.

Enteropatía sprue-like secundaria a olmesartán / Sprue-like enteropathy linked to olmesartan

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Sprue-like enteropathy linked to olmesartan.

Olmesartan is a therapy used for the management of hypertension available since 2002. A sprue like enteropathy associated with olmesartan has been first described in 2012. Endoscopic and histopathological findings are partial or total villous atrophy, mimicking a Celiac Disease. We explain two cases diagnosed in our hospital. Both patients took more than one year of treatment with olmesartan. In both cases, the biopsy showed duodenal villous atrophy, negative serology for celiac disease and they improved after stopping treatment with olmesartan. Olmesartan associate sprue-like enteropathy should be included in the differential diagnosis of seronegative villous atrophy. After the discontinuation of olmesartan, clinical remission usually occurs in every patients.