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.

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.

Gastroduodenal Burkitt's lymphoma: a rare cause of epigastric pain and diarrhea.

A 54-year-old male with a medical history of diabetes mellitus type 2 and tonsil cancer treated with radiochemotherapy years previously was admitted to hospital due to one-month progressive diarrhea, epigastric pain and 14-kg weight loss. Laboratory tests revealed mild anemia (Hb 10.8 g/dl). Upper endoscopy (UE) showed multiple ulcerated lesions with raised edges and a hard consistency on biopsy, being more evident at the duodenum and with a lower frequency and smaller diameter in the stomach.

Small Bowel Enteroscopy - A Joint Clinical Guideline from the Spanish and Portuguese Small Bowel Study Groups.

The present evidence-based guidelines are focused on the use of device-assisted enteroscopy in the management of small-bowel diseases. A panel of experts selected by the Spanish and Portuguese small bowel study groups reviewed the available evidence focusing on the main indications of this technique, its role in the management algorithm of each indication and on its diagnostic and therapeutic yields. A set of recommendations were issued accordingly.

Estas recomendações baseadas na evidência detalham o uso da enteroscopia assistida por dispositivo no manejo clínico das doenças do intestino delgado. Um conjunto de Gastrenterologistas diferenciados em patologia do intestino delgado foi selecionado pelos grupos de estudos Espanhol e Portugués de intestino delgado para rever a evidência disponível sobre as principais indicações desta técnica, o seu papel nos algoritmos de manejo de cada indicação e sobre o seu rendimento diagnóstico e terapêutico. Foi gerado um conjunto de recomendações pelos autores.

Small bowel enteroscopy - A joint clinical guideline by the Spanish and Portuguese small-bowel study groups

The present evidence-based guidelines are focused on the use of device-assisted enteroscopy in the management of small-bowel diseases. A panel of experts selected by the Spanish and Portuguese small-bowel study groups reviewed the available evidence focusing on the main indications of this technique, its role in the management algorithm of each indication, and its diagnostic and therapeutic yield. A set of recommendations was issued accordingly

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Small bowel enteroscopy - A joint clinical guideline by the Spanish and Portuguese small-bowel study groups.

The present evidence-based guidelines are focused on the use of device-assisted enteroscopy in the management of small-bowel diseases. A panel of experts selected by the Spanish and Portuguese small-bowel study groups reviewed the available evidence focusing on the main indications of this technique, its role in the management algorithm of each indication, and its diagnostic and therapeutic yield. A set of recommendations was issued accordingly.

[Giant hepatic hemangioma, an uncommon presentation of a frequent disease]. / Hemangioma cavernomatoso hepático gigante, presentación infrecuente de una lesión común.

Hepatic hemangiomas, also referred to as cavernous hemangiomas, are the most common benign mesenchymal hepatic tumors. They are often solitary, small lesions that have an excellent safety-prognosis and were commonly incidentally detected. Hepatic hemangiomas are frequently asymptomatic, although symptoms are more likely in those lesions larger than 5 cm also referred to as giant hemangiomas. We present a case of a pauci-asymptomatic 43 year-old woman with an uncommon 16x16x27 cm giant hemangioma and perform a review of the literature.

Hemangioma cavernomatoso hepático gigante, presentación infrecuente de una lesión común / Giant hepatic hemangioma, an uncommon presentation of a frequent disease

Los hemangiomas hepáticos, también denominados hemangiomas cavernomatosos, son los tumores hepáticos más comunes. Se caracterizan por ser lesiones solitarias, pequeñas y benignas que se diagnostican frecuentemente de forma incidental. Suelen ser lesiones asintomáticas, si bien los síntomas se presentan más frecuentemente en aquellas lesiones mayores de 5 cm, también conocidas como hemangiomas gigantes. Presentamos el caso de una mujer de 43 años, pauci-asintomática que presenta un hemangioma gigante de 16x16x27 cm, así como se realiza una revisión sistemática de la literatura.

Hepatic hemangiomas, also referred to as cavernous hemangiomas, are the most common benign mesenchymal hepatic tumors. They are often solitary, small lesions that have an excellent safety-prognosis and were commonly incidentally detected. Hepatic hemangiomas are frequently asymptomatic, although symptoms are more likely in those lesions larger than 5 cm also referred to as giant hemangiomas. We present a case of a pauci-asymptomatic 43 year-old woman with an uncommon 16x16x27 cm giant hemangioma and perform a review of the literature.

Development and validation of a scoring index to predict the presence of lesions in capsule endoscopy in patients with suspected Crohn's disease of the small bowel: a Spanish multicenter study.

BACKGROUND: Capsule endoscopy (CE) is the first-line investigation in cases of suspected Crohn's disease (CD) of the small bowel, but the factors associated with a higher diagnostic yield remain unclear. OBJECTIVE: Our aim is to develop and validate a scoring index to assess the risk of the patients in this setting on the basis of biomarkers. PATIENTS AND METHODS: Data on fecal calprotectin, C-reactive protein, and other biomarkers from a population of 124 patients with suspected CD of the small bowel studied by CE and included in a PhD study were used to build a scoring index. This was first used on this population (internal validation process) and after that on a different set of patients from a multicenter study (external validation process). RESULTS: An index was designed in which every biomarker is assigned a score. Three risk groups have been established (low, intermediate, and high). In the internal validation analysis (124 individuals), patients had a 10, 46.5, and 81% probability of showing inflammatory lesions in CE in the low-risk, intermediate-risk, and high-risk groups, respectively. In the external validation analysis, including 410 patients from 12 Spanish hospitals, this probability was 15.8, 49.7, and 80.6% for the low-risk, intermediate-risk, and high-risk groups, respectively. CONCLUSION: Results from the internal validation process show that the scoring index is coherent, and results from the external validation process confirm its reliability. This index can be a useful tool for selecting patients before CE studies in cases of suspected CD of the small bowel.

Gastroduodenal lesions detected during small bowel capsule endoscopy: incidence, diagnostic and therapeutic impact

Background: Capsule endoscopy was primarily designed for the investigation of the small bowel. However, it may also identify lesions in other segments of the gastrointestinal tract. The aim of the current study was to evaluate the incidence of gastroduodenal abnormalities during small bowel capsule endoscopy and its impact on patient diagnosis and management. Patients and methods: This study is a retrospective analysis of data from 2,217 consecutive capsule endoscopy procedures performed at a single tertiary-care center between January 2008 and February 2016. Patient baseline characteristics, gastroduodenal lesions, diagnosis and management before and after capsule endoscopy were recorded and a descriptive analysis was performed. Results: Two thousands and two hundred seventeen patients were finally included in the analysis. One thousand and seventy patients were male (48.2%) and the mean age was 56.1 ± 19.5 years (range: 12-93). Obscure gastrointestinal bleeding (52.3%) and inflammatory bowel disease (18.3%) were the main procedure indications. Gastroduodenal abnormalities were detected by capsule endoscopy in 696 (31.4%) of 2,217 patients. The most common types of missed gastric and duodenal lesions found were gastric erosions (35.4%), findings suggestive of chronic gastritis (22.9%), duodenal erosions (28.1%) and duodenal erythema (23.5%). This information had a clinical or diagnostic impact of 26.2% and a therapeutic impact of 15.5%. Conclusion: Capsule endoscopy detects not only small bowel lesions but also some gastroduodenal lesions that may be overlooked during an initial gastroscopy. Therefore, all gastroduodenal images should be read during small bowel capsule endoscopy as it may provide relevant information that result in changes in patient management (AU)

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Role of capsule endoscopy in alarm features and non-responsive celiac disease: A European multicenter study.

BACKGROUND AND AIM: The role of capsule endoscopy (CE) in established celiac disease (CD) remains unclear. Our objective was to analyze the usefulness of CE in the suspicion of complicated CD. METHODS: This was a retrospective multicenter study. One hundred and eighty-nine celiac patients (mean age: 46.6 ± 16.6, 30.2% males) who underwent CE for alarm symptoms (n = 86, 45.5%) or non-responsive CD (n = 103, 54.5%) were included. Diagnostic yield (DY), therapeutic impact and safety were analyzed. RESULTS: Capsule endoscopy was completed in 95.2% of patients (small bowel transit time: 270.5 ± 100.2 min). Global DY was 67.2%, detecting atrophic mucosa (n = 92, 48.7%), ulcerative jejunoileitis (n = 21, 11.1%), intestinal lymphoma (n = 7, 3.7%) and other enteropathies (n = 7, 3.7%, six Crohn's disease cases and one neuroendocrine tumor). The DY of CE was significantly higher in patients presenting with non-responsive disease compared to patients with alarm symptoms (73.8% vs 59.3%, P = 0.035). The new findings of the CE modified management in 59.3% of the cases. There were no major complications. CONCLUSION: Capsule endoscopy may be a moderately helpful and safe diagnostic tool in the suspicion of complicated CD, modifying the clinical course of these patients.

Gastroduodenal lesions detected during small bowel capsule endoscopy: incidence, diagnostic and therapeutic impact.

BACKGROUND: Capsule endoscopy was primarily designed for the investigation of the small bowel. However, it may also identify lesions in other segments of the gastrointestinal tract. The aim of the current study was to evaluate the incidence of gastroduodenal abnormalities during small bowel capsule endoscopy and its impact on patient diagnosis and management. PATIENTS AND METHODS: This study is a retrospective analysis of data from 2,217 consecutive capsule endoscopy procedures performed at a single tertiary-care center between January 2008 and February 2016. Patient baseline characteristics, gastroduodenal lesions, diagnosis and management before and after capsule endoscopy were recorded and a descriptive analysis was performed. RESULTS: Two thousands and two hundred seventeen patients were finally included in the analysis. One thousand and seventy patients were male (48.2%) and the mean age was 56.1 ± 19.5 years (range: 12-93). Obscure gastrointestinal bleeding (52.3%) and inflammatory bowel disease (18.3%) were the main procedure indications. Gastroduodenal abnormalities were detected by capsule endoscopy in 696 (31.4%) of 2,217 patients. The most common types of missed gastric and duodenal lesions found were gastric erosions (35.4%), findings suggestive of chronic gastritis (22.9%), duodenal erosions (28.1%) and duodenal erythema (23.5%). This information had a clinical or diagnostic impact of 26.2% and a therapeutic impact of 15.5%. CONCLUSION: Capsule endoscopy detects not only small bowel lesions but also some gastroduodenal lesions that may be overlooked during an initial gastroscopy. Therefore, all gastroduodenal images should be read during small bowel capsule endoscopy as it may provide relevant information that result in changes in patient management.

Linfoma folicular primario gastrointestinal: hallazgos endoscópicos y papel de la enteroscopia con cápsula / Primary follicular lymphoma of the gastrointestinal tract: Endoscopic findings and role of capsule endoscopy

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Anorectal melanoma: An atypical cause of rectorrhagia / Causa atípica de rectorragia: melanoma anorrectal

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Colonic lesions in patients undergoing small bowel capsule endoscopy: incidence, diagnostic and therapeutic impact

Background: Nowadays, capsule endoscopy is the first-line procedure to assess the small bowel. During small bowel procedures, other segments of the gastrointestinal tract may be visualized. The aim of the current study was to evaluate the incidence of colonic abnormalities in patients undergoing small bowel capsule and its impact on patient management. Patients and methods: This study is a retrospective analysis of data from 526 consecutive capsule endoscopy procedures performed at a single tertiary-care centre between 2008 and 2011. Patients with incomplete procedures were excluded from the analysis. Patient baseline characteristics, colonic lesions, diagnosis and management before and after capsule endoscopy were recorded and a descriptive analysis was performed. Results: Four hundred and sixty four patients were finally included in the analysis. Two hundred and ninety three patients were male (57.3%) and the mean age was 61.3 ± 20.03 years (18-86). Obscure gastrointestinal bleeding (59%) and inflammatory bowel disease (19%) were the main indications for the procedure. Colonic abnormalities were detected by capsule endoscopy in 47 (9%) of 464 patients. The most common types of missed lesions were vascular lesions (34%) and colonic ulcers (32%). This information had a clinical or diagnostic impact of 7.55% and a therapeutic impact of 6.03%. Conclusion: All images of the colon should be evaluated during small bowel capsule endoscopy as they may provide relevant information that may result in changes in patient management (AU)

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Colonic lesions in patients undergoing small bowel capsule endoscopy: incidence, diagnostic and therapeutic impact.

BACKGROUND: Nowadays, capsule endoscopy is the first-line procedure to assess the small bowel. During small bowel procedures, other segments of the gastrointestinal tract may be visualized. The aim of the current study was to evaluate the incidence of colonic abnormalities in patients undergoing small bowel capsule and its impact on patient management. PATIENTS AND METHODS: This study is a retrospective analysis of data from 526 consecutive capsule endoscopy procedures performed at a single tertiary-care centre between 2008 and 2011. Patients with incomplete procedures were excluded from the analysis. Patient baseline characteristics, colonic lesions, diagnosis and management before and after capsule endoscopy were recorded and a descriptive analysis was performed. RESULTS: Four hundred and sixty four patients were finally included in the analysis. Two hundred and ninety three patients were male (57.3%) and the mean age was 61.3 ± 20.03 years (18-86). Obscure gastrointestinal bleeding (59%) and inflammatory bowel disease (19%) were the main indications for the procedure. Colonic abnormalities were detected by capsule endoscopy in 47 (9%) of 464 patients. The most common types of missed lesions were vascular lesions (34%) and colonic ulcers (32%). This information had a clinical or diagnostic impact of 7.55% and a therapeutic impact of 6.03%. CONCLUSION: All images of the colon should be evaluated during small bowel capsule endoscopy as they may provide relevant information that may result in changes in patient management.

Meckel´s diverticulum bleeding detected by capsule endoscopy.

A 28-year-old man diagnosed with Charge syndrome and no history of NSAIDs ingestion was referred due to the presentation in the previous 24 h of melenic stools with a negative upper endoscopy. Physical examination was unremarkable, although laboratory tests showed anemia. On the second day, significant painless rectal bleeding and the decrease of hematocrit levels responding to blood transfusion were observed, so colonoscopy was recommended but completely rejected by the patient. Therefore, capsule endoscopy was performed, identifying a saccular image in the terminal ileum suggestive of a Meckel's diverticulum.

Linfoma MALT primario de duodeno / Primary MALT lymphoma of the duodenum

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Hemorragia digestiva por divertículo de Meckel detectado mediante enteroscopia con cápsula endoscópica / Meckel´s diverticulum bleeding detected by capsule endoscopy

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