Endoscopic removal of lumen-apposing metal stents - risk factors for stent embedment, complex removals, and adverse events: analysis from a multicenter prospective case series.

BACKGROUND: Removing lumen-apposing metal stents (LAMSs) may be difficult and even harmful, but these features have seldom been analyzed. We aimed to generate a comprehensive assessment of the feasibility and safety of LAMS retrieval procedures. METHODS: A prospective multicenter case series including all technically successfully deployed LAMSs between January 2019 and January 2020 that underwent endoscopic stent removal. All retrieval-related data were prospectively recorded using standardized telephone questionnaires as part of centralized follow-up that ended after stent removal had been performed. Multivariable logistic regression models assessed the potential risk factors for complex removal. RESULTS: For the 407 LAMSs included, removal was attempted in 158 (38.8 %) after an indwell time of 46.5 days (interquartile range [IQR] 31-70). The median (IQR) removal time was 2 (1-4) minutes. Removal was labelled as complex in 13 procedures (8.2 %), although advanced endoscopic maneuvers were required in only two (1.3 %). Complex removal risk factors were stent embedment (relative risk [RR] 5.84, 95 %CI 2.14-15.89; P = 0.001), over-the-wire deployment (RR 4.66, 95 %CI 1.60-13.56; P = 0.01), and longer indwell times (RR 1.14, 95 %CI 1.03-1.27; P = 0.01). Partial and complete embedment were observed in 14 (8.9 %) and five cases (3.2 %), respectively. The embedment rate during the first 6 weeks was 3.1 % (2/65), reaching 15.9 % (10/63) during the following 6 weeks (P = 0.02). The adverse event rate was 5.1 %, including seven gastrointestinal bleeds (5 mild, 2 moderate). CONCLUSIONS: LAMS removal is a safe procedure, mostly requiring basic endoscopic techniques attainable in conventional endoscopy rooms. Referral to advanced endoscopy units should be considered for stents with known embedment or long indwell times, which may require more technically demanding procedures.

Success, safety, and usefulness of right colon retroflexion for the detection of additional colonic lesions not visualized with standard frontal view.

BACKGROUND: Missed adenomas are the main concern for endoscopists. Right colon retroflexion (RCR) seems to increase the adenoma detection rate (ADR), but important variation in success and usefulness of this maneuver has been reported in the literature AIMS: Primary objective: to assess additional adenoma detection rate (AADR) detected during the RCR attempt. Secondary objectives: to assess success rates of RCR, variables associated with it, and safety of RCR. METHODS: This is a prospective, unicentric, non-randomized study. Consecutive colonoscopies done by six endoscopists (3 of them with < 3 years of experience and 3 with > 3 years) from March to May 2017 were included. Olympus colonoscopes were used (CF-H190, CF-H180) Demographic, clinical, and endoscopic variables were collected. RESULTS: 463 colonoscopies were included. RCR success rate was 93.1% (431/463 colonoscopies). Forty additional lesions were visualized during RCR in 34/463 colonoscopies (7.3%). Additional adenomas were detected in 31/463 colonoscopies (6.7%; OR 0.07). HISTOLOGY: low-grade dysplasia adenomas in 29/40 (72.5%) lesions; 3/40 (7.5%), adenomas with high-grade dysplasia; and 7/40 (17.5%) sessile serrated lesions. Additional adenoma detection contributed to modify the colonoscopy surveillance interval in 25 patients (5.4% of the cohort). Variables associated with RCR success in multivariate analysis were no previous abdominal surgery, length of colonoscope insertion in cecum < 80 cm, and use of Olympus 190 series colonoscopes. No differences between endoscopists' experience were found. RCR was a safe maneuver, with no adverse events in our study. CONCLUSIONS: RCR is a feasible and safe maneuver that can increase ADR, so its routine inclusion in colonoscopy practice should be considered.

Primary gastric adenocarcinoma in a patient with Peutz-Jeghers syndrome.

We present the case of a 42-year-old female under study due to dyspepsia without response to empirical treatment, with perioral mucocutaneous pigmentation. A gastroscopy revealed a 5 cm gastric tumor in the antrum, as well as multiple sessile gastric and duodenal polyps smaller than 1 cm. Large-capacity forceps biopsies were obtained and a well-differentiated adenocarcinoma with gastric origin was diagnosed, with over expression of the HER2/neu without microsatellite instability in the context of a hamartomatous polyposis. The genomic study confirmed an alteration in the STK11 gene translated to a truncated protein product, compatible with a Peutz-Jeghers syndrome (PJS).

Long-term outcomes and clinical impact of anti-HLA donor-specific antibodies (DSA) after liver transplantation: a prospective study in a pilot cohort.

INTRODUCTION: the presence of donor-specific antibodies (DSA) is thought to affect survival of the allograft and patient after liver transplantation (LT). However, their significance is not well understood. PATIENTS AND METHODS: a prospective study was performed of 32 adult patients who underwent LT in 2011 to analyze the existence of DSA, associated risk factors and medium-term impact. Immunological determinations were performed immediately before LT and at three, six, 12 months and five years after LT. RESULTS: eight patients (24.2 %) presented pre-formed DSA. However, titers were negative in all patients five years after LT and there were no associated events. Eight out of 24 patients (33.3 %) developed de novo DSA. After five years, only two remained positive; both were class II with high mean fluorescence intensity (MFI) values at diagnosis (over 15,000). No association was found between the development of DSA and the risk of rejection, graft loss or death. However, an increase in liver stiffness values was observed in patients with persistent DSA, and focal sinusoidal deposition of C4d and moderate liver fibrosis were reported. CONCLUSION: the incidence of DSA is high after LT. In addition, the persistence of de novo DSA could be associated with silent liver fibrosis with a potential impact on graft outcomes.

Usefulness of fully covered self-expandable biliary metal stents for the treatment of post-sphyncterotomy ERCP bleeding

Background: post-sphyncterotomy endoscopic retrograde cholangiopancreatography (ERCP) bleeding is an adverse event with an estimated incidence rate of 1.34%. There is no established consensus about how to treat this particular type of gastrointestinal bleed. Placement of fully covered self-expandable biliary metal stents (FCSEBMS) has been evaluated as an alternative treatment with positive outcomes and a low complication rate. Aim: to report the results of a cohort of patients with post-sphyncterotomy bleeding treated in a tertiary care referral hospital with FCSEBMS. Methods: a retrospective cases series study was performed including all post-ERCP bleeds treated with FCSEBMS (immediate or delayed) from January 2015 to June 2017. Clinical data, laboratory results and endoscopic reports were collected in order to evaluate the rebleeding rate after endoscopic treatment. Two different scenarios were considered: a) prophylactic stent placement after effective endoscopic treatment; and b) stents placed for the treatment of an active postsphyncterotomy bleed, refractory to standard endoscopic therapy. Results: twenty-two patients (14 male, eight women) diagnosed with postsphyncterotomy bleeding were treated with FCSEBMS placement. The stents were placed prophylactically in 15 patients, while the stents were placed as a treatment for a refractory bleed in seven patients. No differences were found between both groups except for a higher anticoagulation rate in the treatment group. Clinical success was achieved in all but one patient, with no complications in relation to stent placement. Distal migration was described in two of the 22 patients included in the study. Conclusions: temporary placement of FCSEBMS seems to be a technically feasible treatment option for post-ERCP bleeding with a high clinical success rate. The complication rate was low, although randomized studies are needed

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Usefulness of fully covered self-expandable biliary metal stents for the treatment of post-sphyncterotomy ERCP bleeding.

BACKGROUND: post-sphyncterotomy endoscopic retrograde cholangiopancreatography (ERCP) bleeding is an adverse event with an estimated incidence rate of 1.34%. There is no established consensus about how to treat this particular type of gastrointestinal bleed. Placement of fully covered self-expandable biliary metal stents (FCSEBMS) has been evaluated as an alternative treatment with positive outcomes and a low complication rate. AIM: to report the results of a cohort of patients with post-sphyncterotomy bleeding treated in a tertiary care referral hospital with FCSEBMS. METHODS: a retrospective cases series study was performed including all post-ERCP bleeds treated with FCSEBMS (immediate or delayed) from January 2015 to June 2017. Clinical data, laboratory results and endoscopic reports were collected in order to evaluate the rebleeding rate after endoscopic treatment. Two different scenarios were considered: a) prophylactic stent placement after effective endoscopic treatment; and b) stents placed for the treatment of an active postsphyncterotomy bleed, refractory to standard endoscopic therapy. RESULTS: twenty-two patients (14 male, eight women) diagnosed with postsphyncterotomy bleeding were treated with FCSEBMS placement. The stents were placed prophylactically in 15 patients, while the stents were placed as a treatment for a refractory bleed in seven patients. No differences were found between both groups except for a higher anticoagulation rate in the treatment group. Clinical success was achieved in all but one patient, with no complications in relation to stent placement. Distal migration was described in two of the 22 patients included in the study. CONCLUSIONS: temporary placement of FCSEBMS seems to be a technically feasible treatment option for post-ERCP bleeding with a high clinical success rate. The complication rate was low, although randomized studies are needed.

Hemostatic spray powder TC-325 for GI bleeding in a nationwide study: survival and predictors of failure via competing risks analysis.

BACKGROUND AND AIMS: TC-325 (Hemospray, Cook Medical, Winston-Salem, NC) is an inorganic hemostatic powder recently approved by the U.S. Food and Drug Administration. This study aimed to examine the effectiveness, safety, and predictors of TC-325 failure in a large real-life cohort. METHODS: This was a retrospective study conducted at 21 Spanish centers. All patients treated with TC-325 until September 2018 were included. The primary outcome was treatment failure, defined as failed intraprocedural hemostasis or recurrent bleeding within the first 30 postprocedural days. Secondary outcomes included safety and survival. Risk and predictors of failure were assessed via competing-risk models. RESULTS: The cohort comprised 261 patients, of whom 219 (83.9%) presented with upper gastrointestinal bleeding (GIB). The most common causes were peptic ulcer (28%), malignancy (18.4%), and therapeutic endoscopy-related GIB (17.6%). TC-325 was used as rescue therapy in 191 (73.2%) patients. The rate of intraprocedural hemostasis was 93.5% (95% confidence interval [CI], 90%-96%). Risks of TC-325 failure at postprocedural days 3, 7, and 30 were 21.1%, 24.6%, and 27.4%, respectively. On multivariate analysis, spurting bleeding (P = .004), use of vasoactive drugs (P = .02), and hypotension (P = .008) were independent predictors of failure. Overall 30-day survival was 81.9% (95% CI, 76%-86%) and intraprocedural hemostasis was associated with a better prognosis (adjusted hazard ratio, 0.29; P = .006). Two severe adverse events were noted. CONCLUSION: TC-325 was safe and effective for intraprocedural hemostasis in more than 90% of patients, regardless of the cause or site of bleeding and its use as rescue therapy. In this high-risk cohort treated with TC-325, the 30-day failure rate exceeded 25% and was highest with spurting bleeding or hemodynamic instability.

Hematoma subcapsular hepático tras colangiopancreatografía retrógrada endoscópica. Una complicación rara y con elevada morbimortalidad / Subcapsular hepatic haematoma after endoscopic retrograde cholangiopancreatography. A rare complication with high morbidity and mortality

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Endoscopically placed stents: a useful alternative for the management of refractory benign cervical esophageal stenosis

Introduction: Benign esophageal strictures are relatively frequent and can severely affect the quality of life of a patient. Stenting has been proposed for the treatment of refractory cases. Lesions affecting the cervical esophagus are more difficult to treat, and the placement of stents in this location has traditionally been restricted due to potential adverse events. The aim of this study was to describe the efficacy and safety of endoscopic stenting in the management of refractory benign cervical esophageal strictures (RBCES) in a single-center cohort study. Methods: We analyzed 12 patients with RBCES (Kochman’s criteria) and severe dysphagia. We recorded previous endoscopic treatments, stricture characteristics and demographic data. The two types of stents used were fully covered self-expandable metallic stents (FCSEMS) and uncovered biodegradable stents (BDS). FCSEMS were removed eight weeks after placement, and BDS were followed-up until degradation. We assessed technical and clinical success, rate of stricture recurrence and adverse events. Results: The mean age of participants was 64 years (range 30-85). A total of 23 stents (13 FCSEMS and 10 BDS) were placed in 12 patients (median 1.92, range 1-4). The technical success rate was 96% (22/23 stents). Eight patients (66.6%) maintained adequate oral intake at the end of follow-up (median 33.3 months, range 3-84 months). Migration was recorded in 7/23 stents (30.4%) and epithelial hyperplasia in 4/23 stents (17.4%). No severe adverse events were noted. All patients complained of minor cervical pain after placement that was well controlled with mild analgesia. Conclusions: Endoscopic stent therapy seems to be effective and safe in the management of RBCES (AU)

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Endoscopically placed stents: a useful alternative for the management of refractory benign cervical esophageal stenosis.

INTRODUCTION: Benign esophageal strictures are relatively frequent and can severely affect the quality of life of a patient. Stenting has been proposed for the treatment of refractory cases. Lesions affecting the cervical esophagus are more difficult to treat, and the placement of stents in this location has traditionally been restricted due to potential adverse events. The aim of this study was to describe the efficacy and safety of endoscopic stenting in the management of refractory benign cervical esophageal strictures (RBCES) in a single-center cohort study. METHODS: We analyzed 12 patients with RBCES (Kochman's criteria) and severe dysphagia. We recorded previous endoscopic treatments, stricture characteristics and demographic data. The two types of stents used were fully covered self-expandable metallic stents (FCSEMS) and uncovered biodegradable stents (BDS). FCSEMS were removed eight weeks after placement, and BDS were followed-up until degradation. We assessed technical and clinical success, rate of stricture recurrence and adverse events. RESULTS: The mean age of participants was 64 years (range 30-85). A total of 23 stents (13 FCSEMS and 10 BDS) were placed in 12 patients (median 1.92, range 1-4). The technical success rate was 96% (22/23 stents). Eight patients (66.6%) maintained adequate oral intake at the end of follow-up (median 33.3 months, range 3-84 months). Migration was recorded in 7/23 stents (30.4%) and epithelial hyperplasia in 4/23 stents (17.4%). No severe adverse events were noted. All patients complained of minor cervical pain after placement that was well controlled with mild analgesia. CONCLUSIONS: Endoscopic stent therapy seems to be effective and safe in the management of RBCES.

Usefulness of Non-magnifying Narrow Band Imaging in EVIS EXERA III Video Systems and High-Definition Endoscopes to Diagnose Dysplasia in Barrett's Esophagus Using the Barrett International NBI Group (BING) Classification.

BACKGROUND: Narrow band imaging (NBI) allows identification of abnormal areas of Barrett's esophagus (BE) and could facilitate targeted biopsies. AIMS: We evaluated the diagnostic accuracy for dysplasia prediction using non-magnifying NBI in Evis Exera III processors and high-definition endoscopes using the Barrett International NBI Group (BING) classification, as well as inter/intraobserver agreement for dysplasia prediction and mucosal/vascular patterns. METHODS: Eight observers (4 staff endoscopists and 4 trainee endoscopists) evaluated 100 images selected from an anonymized bank of 470 photographs using the BING classification. Observers were to assign their individual assessment of the mucosal and vascular pattern, and prediction for dysplasia. Accuracy for dysplasia prediction and intra/interobserver agreement was calculated. RESULTS: Dysplasia prediction had an accuracy of 81.1%, sensitivity of 48.4%, and a specificity of 91%. Positive predictive value and negative predictive value (NPV) were 61.4 and 85.5%, respectively. Dysplasia prediction done with a high degree of confidence (vs. low degree of confidence) had better diagnostic accuracy (85.8 vs. 70.7%). Interobserver concordance for dysplasia was weak: Κ = 0.40. Agreement for mucosal and vascular patterns was 0.39 and 0.30, respectively. Intraobserver concordance (assessed 6 months after initial test) for mucosal pattern, vascular pattern, and dysplasia prediction was moderate: Κ = 0.56, Κ = 0.47 and Κ = 0.60, respectively. CONCLUSIONS: Our results showed that NBI had a significant accuracy in BE assessment for dysplasia prediction, high specificity (>90%), and NPV (>85%), with suboptimal sensitivity. NBI could be a useful additional tool for BE inspection and targeted biopsies, but cannot avoid the need for biopsies following the Seattle protocol.

Eficacia y efectividad de la terapia biológica en la Enfermedad Inflamatoria Intestinal. Estudio EFIFECT / Efficacy and effectiveness of biologic therapy in inflammatory bowel disease. EFIFECT study

INTRODUCCIÓN: Los ensayos clínicos aleatorizados proporcionan la mejor evidencia científica de la eficacia de los fármacos biológicos en la enfermedad inflamatoria intestinal (EII). Sin embargo, los resultados pueden no ser reproducibles en la práctica clínica. Los objetivos de este estudio son analizar el porcentaje de pacientes con EII tratados con fármacos biológicos que habrían podido ser elegidos para un ensayo clínico aleatorizado y comparar la eficacia teórica de los fármacos biológicos con su efectividad en la práctica clínica. MÉTODOS: Realizamos un estudio retrospectivo multicéntrico en 375 pacientes con EII tratados con anti-TNF con un seguimiento de un año. Los criterios de elegibilidad para la condición de ensayo clínico fueron extraídos de los estudios pivotales ACCENT, SONIC, ACT, CLASSIC y CHARM. Los pacientes elegibles fueron incluidos en un segundo análisis para comparar los resultados en la práctica clínica con los obtenidos tras realizar una estimación teórica si el paciente hubiese sido incluido en un estudio pivotal. RESULTADOS: Solo el 45,6% de los 375 pacientes cumplían los criterios de selección para un estudio pivotal. El beneficio clínico al año fue similar entre los pacientes elegibles y no elegibles (68,4% vs 68,6%). El beneficio clínico en los pacientes elegibles fue mayor en la práctica clínica que en la condición hipotética de un ensayo clínico (68,4% vs 44,4%, p < 0,001). CONCLUSIÓN: Más de la mitad de los pacientes con EII tratados con fármacos biológicos no estarían representados en los ensayos pivotales. La efectividad de los fármacos anti-TNF en la práctica clínica es superior a su eficacia teórica

INTRODUCTION: Randomized controlled trials provide the best scientific evidence for the efficacy of biological drugs in inflammatory bowel disease (IBD). However, findings obtained from these trials might not be reproducible in clinical practice. This study aimed to estimate the percentage of patients with IBD treated with biologics who would have been eligible for randomized controlled trials, and to compare the theoretical efficacy of biological drugs with their effectiveness in clinical practice. METHODS: We performed a retrospective multicenter study in 375 patients with IBD treated with anti-TNF agents and followed-up for 1 year. The eligibility criteria for the trial were taken from the ACCENT, SONIC, ACT, CLASSIC and CHARM trials. Eligible patients were included in a second analysis to compare results in clinical practice versus those hypothetically obtained if the patient had been included in a trial. RESULTS: Only 45.6% of 375 patients would have been eligible for pivotal trials. One-year clinical benefit (remission or response) was similar for eligible and non-eligible cohorts (68.4% vs. 68.6%, P=.608). The clinical benefit was greater for current clinical practice than for a hypothetical trial situation (68.4% vs. 44.4%, P<.001) in eligible patients. CONCLUSION: More than half of patients with IBD treated with biologic drugs would not be represented in pivotal trials. The effectiveness of anti-TNF drugs in clinical practice exceeds their theoretical efficacy

[Efficacy and effectiveness of biologic therapy in inflammatory bowel disease. EFIFECT study]. / Eficacia y efectividad de la terapia biológica en la Enfermedad Inflamatoria Intestinal. Estudio EFIFECT.

INTRODUCTION: Randomized controlled trials provide the best scientific evidence for the efficacy of biological drugs in inflammatory bowel disease (IBD). However, findings obtained from these trials might not be reproducible in clinical practice. This study aimed to estimate the percentage of patients with IBD treated with biologics who would have been eligible for randomized controlled trials, and to compare the theoretical efficacy of biological drugs with their effectiveness in clinical practice. METHODS: We performed a retrospective multicenter study in 375 patients with IBD treated with anti-TNF agents and followed-up for 1 year. The eligibility criteria for the trial were taken from the ACCENT, SONIC, ACT, CLASSIC and CHARM trials. Eligible patients were included in a second analysis to compare results in clinical practice versus those hypothetically obtained if the patient had been included in a trial. RESULTS: Only 45.6% of 375 patients would have been eligible for pivotal trials. One-year clinical benefit (remission or response) was similar for eligible and non-eligible cohorts (68.4% vs. 68.6%, P=.608). The clinical benefit was greater for current clinical practice than for a hypothetical trial situation (68.4% vs. 44.4%, P<.001) in eligible patients. CONCLUSION: More than half of patients with IBD treated with biologic drugs would not be represented in pivotal trials. The effectiveness of anti-TNF drugs in clinical practice exceeds their theoretical efficacy.

Cavitación y fístula enterocólica de gran calibre secundaria a adenocarcinoma de colon izquierdo / Rectosigmoid carcinoma presenting with a large small bowel fistula

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Outcomes of Medical and Surgical Therapy for Entero-urinary Fistulas in Crohn's Disease.

BACKGROUND AND AIMS: The aims of this study were to evaluate the frequency of entero-urinary fistulas in a cohort of Crohn's disease (CD) patients and to analyse the outcomes of medical and surgical therapy. METHODS: This multicentre retrospective study included all CD patients with entero-urinary fistulas diagnosed by the presence of clinical symptoms and confirmed at surgery or by radiological or endoscopic techniques. We evaluated outcomes of medical and surgical therapy. We defined remission as absence of clinical symptoms with a radiological confirmation of fistula closure. Cox regression analysis was performed to evaluate factors predictive of achieving remission without need for surgery. RESULTS: Of 6081 CD patients screened, 97 had entero-urinary fistulas (frequency 1.6%). Seventy-five percent of fistulas occurred in men. After a median follow-up of 91 months, 96% of patients were in sustained remission. Thirty-three patients (35%) received anti-tumour necrosis factor (TNF) therapy. Of these, 45% achieved sustained remission (median follow-up 35 months) without needing surgery. More than 80% of patients required surgery, which induced remission (median follow-up 101 months) in 99% of them. Only the use of anti-TNF agents was associated with an increased rate of remission without need for surgery (hazard ratio 0.23, 95% confidence interval 0.12-0.44; p < 0.001). CONCLUSION: In this large cohort of CD patients, the frequency of entero-urinary fistulas was lower than previously described. More than 80% of patients required surgery, and in all but one of them surgery induced sustained remission. In a selected subgroup of patients, anti-TNF may induce long-term fistula remission and radiographic closure, making it possible to avoid surgery.