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.

Bariatric endoscopy, care-curative medicine and legal conflicts. Spanish Bariatric Endoscopy Group (Gettemo-SEED) Positioning.

Bariatric endoscopy treats obesity as a disease, in addition to its multiple associated comorbidities, so it should be considered in the "care-curative" field and not as "satisfying, voluntary or outcoming" medicine. Insufficient weight loss cases, or complications may occur. This, in parallel with the greater diffusion of these techniques, results an increase in the risk of complaints and judicial claims, which will presumably grow during next years. In this sense, we consider that all Bariatric Endoscopic Units working with medical-scientific rigor, must be able to be accredited and have legal support by the Scientific Societies. We propose to create a Medical-Legal Advisory Committee, composed of a medical team and a specialized law firm, which allows advising and guiding the endoscopist when incurring in a conflict.

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.

Endoscopic view of the intrahepatic biliary ducts by direct per-oral cholangioscopy in a patient with a choledochal cyst.

Sixty year old female with hypertension and crampy abdominal pain episodes. Admitted to hospital (September-2020) by obstructive jaundice. MRCP: biliary dilation due to Todani Ic (fusiform) choledocal cyst (CC), distal sludge. ERCP: normal mucosa prominent papilla; biliary dilation compatible with CC; choledocholithiasis; 8-mm CHD filling defect. Sphincterotomy, removal of stones/sludge, brush-cytology of the filling defect (pathology: atypias). US: dilation resolution (CBD: 6.5 mm).

Implementation of endoscopic submucosal dissection in a country with a low incidence of gastric cancer: Results from a prospective national registry.

INTRODUCTION: Endoscopic submucosal dissection (ESD) has become the treatment of choice for early gastric malignancies. In recent years, the ESD technique has been implemented in Western countries with increasing use. OBJECTIVES: To describe the results of gastric ESD in a Western country with a low incidence of gastric cancer. PATIENTS AND METHODS: The prospective national registry was conducted over 4 years in 23 hospitals, including 30 endoscopists. Epithelial and subepithelial lesions (SEL) qualified to complete removal with ESD were assessed. The technique, instruments, and solution for submucosal injection varied at the endoscopist's discretion. ESD was defined as difficult when: en-bloc resection was not achieved, had to be converted to a hybrid resection, lasted more than 2 h or an intraprocedural perforation occurred. Additionally, independent risk factors for difficult ESD were analyzed. RESULTS: Two hundred and thirty gastric ESD in 225 patients were performed from January 2016 to December 2019 (196 epithelial and 34 SEL). Most lesions were located in the lower stomach (111; 48.3%). One hundred and twenty-eight (55.6%) ESD were considered difficult. The median procedure time was 105 min (interquartile range [IQR]: 60-150). The procedure time for SEL was shorter than for epithelial lesions (90 min [45-121] vs. 110 min [62-160]; p = 0.038). En-bloc, R0, and curative resection rates were 91.3%, 75.2%, and 70.9%, respectively. Difficult ESD had lower R0 resection rates than ESD that did not meet the difficulty criteria (64.8% and 87.6%; p = 0.000, respectively). Fibrosis and poor maneuverability were independent factors associated with difficult ESD (OR 3.6, 95%CI 1.1-11.74 and OR 5.07, 95%CI 1.6-16.08; respectively). CONCLUSIONS: Although the number of cases is limited, the results of this analysis show acceptable en-bloc and R0 rates in gastric ESD considering the wide variability in experience among the operators. Fibrosis and poor maneuverability were associated with more difficulty in completing ESD.

Switching from endoscopic submucosal dissection to salvage piecemeal knife-assisted snare resection to remove a lesion: A preoperative risk score from the beginning.

BACKGROUND AND AIMS: endoscopic submucosal dissection (ESD) in the Western setting remains a challenge. Therefore, other simplified techniques such as knife-assisted snare resection (KAR) have been reported to overcome this issue. METHODS: patients who underwent an ESD for the treatment of gastrointestinal neoplasms were included in a retrospective cross-sectional observational study. Factors associated with the end of ESD as a salvage p-KAR were identified and a logistic regression model was developed. RESULTS: a total of 136 lesions in 133 patients were analyzed. Operator experience of under 50 cases and the combination of lesion size > 30 mm and colorectal location were independent predictive factors for switching to a salvage p-KAR according to the multivariate logistic regression analysis. We developed a risk scoring system based on these four variables (experience, size, location and the combination of size and location) with a receiver operating characteristic curve of 0.81 (95% CI: 0.74-0.89). The diagnostic accuracy of the score for a cut-off point ≥ 5 had a sensitivity of 0.79 (95% CI: 0.66-0.93) and a specificity of 0.71 (95% CI: 0.61-0.80). CONCLUSION: a simple predictive score system that includes four preoperative factors accurately predicts ESD to finish as a p-KAR. A careful selection of cases considering these variables could be useful to achieve better outcomes in the Western setting.

Colonic endoscopic full-thickness resection (EFTR) with the over-the-scope device (FTRD): a short case series.

The endoscopic treatment of early gastrointestinal neoplasms usually involves the resection of the superficial layers, mucosa and submucosa, of the wall. However, in some circumstances, a full-thickness resection may be necessary. Endoscopic full-thickness resection (EFTR) may be an adequate approach in challenging lesions such as adenomas or early cancers with severe submucosal fibrosis or small sub-epithelial lesions in the lower GI tract. Furthermore, this novel technique has the potential to spare surgical therapy in a subset of cases. In this paper, we describe our results with the full-thickness resection device (FTRD) in three different situations.

Diagnosis, treatment and long-term outcomes of autoimmune pancreatitis in Spain based on the International Consensus Diagnostic Criteria: A multi-centre study.

OBJECTIVES: Autoimmune pancreatitis (AIP) is a form of chronic pancreatitis that has been reported worldwide for the last two decades. The aim of this study is to analyse the clinical profile of patients from Spain with AIP, as well as treatments, relapses and long-term outcomes. METHODS: Data from 59 patients with suspected AIP that had been diagnosed in 15 institutions are retrospectively analysed. Subjects are classified according to the International Consensus Diagnostic Criteria (ICDC). Patients with type 1 AIP (AIP1) and type 2 AIP (AIP2) are compared. Kaplan-Meier methodology is used to estimate the overall survival without relapses. RESULTS: Fifty-two patients met ICDC, 45 patients were AIP1 (86.5%). Common manifestations included abdominal pain (65.4%) and obstructive jaundice (51.9%). Diffuse enlargement of pancreas was present in 51.0%; other organ involvement was present in 61.5%. Serum IgG4 increased in 76.7% of AIP1 patients vs. 20.0% in AIP2 (p = 0.028). Tissue specimens were obtained in 76.9%. Initial successful treatment with steroids or surgery was achieved in 79.8% and 17.3%, respectively. Maintenance treatment was given in 59.6%. Relapses were present in 40.4% of AIP1, with a median of 483 days. Successful long-term remission was achieved in 86.4%. CONCLUSIONS: AIP1 is the most frequent form of AIP in Spain in our dataset. Regularly, ICDC allows AIP diagnosis without the need for surgery. Steroid and chirurgic treatments were effective and safe in most patients with AIP, although maintenance was required many times because of their tendency to relapse. Long-term serious consequences were uncommon.

Endoscopic submucosal dissection (ESD) of antral subepithelial lesion suspected of malignancy.

Subepithelial gastric tumours comprise a heterogeneous group of lesions. Endoscopic ultrasonography with fine-needle aspiration (EUS-FNA) is a useful approach but cannot always offer a definitive diagnosis to guide future therapeutic decisions. In the case we describe, biopsy samples of an antral subepithelial lesion and cytological analysis obtained with an EUS-FNA suggested the diagnosis of an adenocarcinoma. Endoscopic submucosal dissection (ESD) allowed en bloc resection of the tumour ensuring diagnosis and providing a definitive treatment.

Relapsing upper bleeding in non-Hodgkin's oesophageal lymphoma associated with achalasia.

Achalasia is a disease of unknown origin in which there is a denervation of the myenteric plexus on the smooth muscle of the lower oesophageal sphincter, causing a cardial stenosis and a loss of efficacy of oesophageal peristalsis. The predominant symptoms are dysphagia for solids and liquids and regurgitation of the retained food. Occasionally, there may be oesophageal haemorrhage as a consequence of oesophagitis and stasis ulcers. An important but uncommon complication is the development of oesophageal cancer, which is typically squamous cell carcinoma. We report an exceptional case of a 77-year-old woman with a long-term achalasia and mega-oesophagus who presented four episodes of upper gastrointestinal bleeding in a 2 month period. The patient underwent surgical resection of the 10 cm of distal oesophagus, performing a partial fundoplication, and the pathological study revealed an oesophageal infiltration by a low-grade non-Hodgkin's lymphoma. After an insidious outcome, she died on the 47th day after admission.