Management of small subepithelial tumors by endoscopic banding without resection and single-incision needle-knife-assisted biopsy sampling: a prospective multicenter study.

BACKGROUND AND AIMS: Endoscopic band ligation (EBL) without resection combined with single-incision needle-knife (SINK) biopsy sampling may have a positive impact on small GI subepithelial tumor (SET) management, but the method needs to be tested. The aim was to evaluate the feasibility of this strategy in small-sized SETs. METHODS: This prospective multicenter observational cohort study in 7 centers included patients with SETs ≤15 mm (confirmed by EUS) between March 2017 and March 2020. The primary outcome was clinical success at 4 weeks, defined as complete SET disappearance on EUS. Secondary outcomes were long-term (1-year) clinical success, technical difficulty level, clinical impact, yield pathology, and safety. RESULTS: Of 273 patients screened, 122 (62.3% women; mean age, 60.9 ± 13.2 years) were included with SETs (mean size, 9 ± 2.8 mm; gastric location, 77%; superficial layer dependence, 63%). The primary endpoint was achieved in 73.6% of patients (95% confidence interval [CI], 64.8-81.2). At the 1-year follow-up, the success rate was 68.4% (95% CI, 59.1-76.8). A favorable clinical impact was observed in 97 cases (79.5%; 95% CI, 71.3-86.3). Pathology diagnosis was known in 70%. Potentially malignant lesions were present in 24.7%. The related adverse events rate was 4.1% (95% CI, 1.3-9.3; all mild: 2 bleeding, 2 abdominal pain). On multivariable analysis, the ≤10-mm SET group was associated with a greater success rate (1 year, 87%; relative risk, 5.07; 95% CI, 2.63-9.8) and clinical impact rate (92.7%; relative risk, 6.15; 95% CI, 2.72-13.93). CONCLUSIONS: EBL plus SINK biopsy sampling seems to be feasible and safe, and it may offer a favorable clinical impact in small-sized SETs. In particular, SETs ≤10 mm are the best candidates. (Clinical trial registration number: NCT03247231.).

Persistent Villous Atrophy in De Novo Adult Patients With Celiac Disease and Strict Control of Gluten-Free Diet Adherence: A Multicenter Prospective Study (CADER Study).

INTRODUCTION: A substantial proportion of adult patients with celiac disease on a gluten-free diet exhibit persistent villous atrophy, and inadvertent gluten exposure may be one of the causes. The aim of the present study was to evaluate villous atrophy persistence after 2 years on a gluten-free diet in de novo adult patients with celiac disease with strict control of gluten exposure. METHODS: Symptomatic de novo adult patients with celiac disease were prospectively included. Clinical visits and dietary surveillance were scheduled every 6 months during a 2-year follow-up period. At each visit, fecal samples were collected and stored at -20 °C until analysis for gluten immunogenic peptides (f-GIPs). A follow-up duodenal biopsy was performed at 2 years. We evaluated the variables associated with persistent villous atrophy. RESULTS: Seventy-six patients completed the study (36.5 ± 1.6 years, 73% women); persistent villous atrophy was observed in 40 (53%), whereas 72.5% were asymptomatic and 75% had negative serology. Detectable f-GIP >0.08 µg/g in at least 1 fecal sample was seen in 69% of patients. There were no significant differences in the median f-GIP at each visit and median area under the curve over the serial measurements between patients with persistent villous atrophy and those who recovered. On multivariate analysis, only older age was associated with persistent villous atrophy (32% for 16-30 years; 67% for >30 years; P = 0.016). DISCUSSION: The rate of persistent villous atrophy after 2 years was high in adult patients with celiac disease on an intentionally strict gluten-free diet. Low-level ongoing inadvertent gluten exposure could be a contributing factor to persistent villous atrophy.

Efficacy and Safety of Treatment With Ferric Carboxymaltose in Patients With Cirrhosis and Gastrointestinal Bleeding.

Background: Patients with liver cirrhosis and gastrointestinal bleeding (GIB) often develop anemia. Ferric carboxymaltose (FCM) is an intravenous (i.v.) iron formulation approved for use in patients with iron deficiency with inadequate response to oral iron therapy or when oral iron cannot be used. Here we analyzed the efficacy and safety of FCM treatment in cirrhotic patients with anemia and GIB. Methods: Retrospective observational study of patients with cirrhosis and acute or chronic GIB treated with 1,000 mg FCM at the University Hospital Arnau de Vilanova (Lleida, Spain) that follows a restrictive-transfusion strategy. All data were obtained from the patients' medical records. We used the Wilcoxon test to evaluate statistical significance. Results: Patients with cirrhosis and GIB (n = 34) were treated with 1,000 mg FCM. Portal hypertension were present in 88.2% of the patients. For hospitalized patients (n = 21), median serum hemoglobin (s-Hb) levels increased by 3.0 g/dL (p < 0.02) and 3.9 g/dL (p < 0.07) for patients treated with FCM who had or had not received also a transfusion, respectively, compared to levels recorded upon admission. For outpatients (n = 13) the mean s-Hb levels was 9.8 ± 1.6 g/dL before FCM treatment and 11.3 ± 2.1 g/dL after treatment, demonstrating a mean increase of 1.5 g/dL (p < 0.001). No serious adverse reactions to FCM were observed. Conclusion: FCM administration achieved optimal s-Hb levels in most cirrhotic patients with acute or chronic GIB, suggesting that early FCM infusion improves and maintains optimal s-Hb levels in these patients and may be an appropriate first-line therapy to treat their anemia.

Clinical experience with ferric carboxymaltose in the management of anemia in acute gastrointestinal bleeding.

OBJECTIVE: The aim of this study was to assess the efficacy and safety of intravenous ferric carboxymaltose (FCM) following hospitalization for acute gastrointestinal bleeding (AGIB) in the context of a restrictive transfusion strategy. PATIENTS AND METHODS: A retrospective single-center study analyzed patients with AGIB (excluding AGIB secondary to portal hypertension) administered a single FCM dose with or without blood transfusion. RESULTS: Eighty-six episodes in 84 patients were analyzed. Seventy-nine patients had upper AGIB. Nineteen episodes were associated with hemodynamic instability. FCM was administered during hospitalization as a single dose of 1000 mg iron in 84/86 episodes and as a single dose of 500 mg iron in two episodes, with blood transfusion in 60/86 (69.8%) episodes. The mean hemoglobin (Hb) was 9.0 g/dl at admission, 7.6 g/dl at the lowest in-hospital value, 9.4 g/dl at discharge, and 12.7 g/dl at follow-up (mean: 55 days postdischarge) (P<0.001 for follow-up vs. all other timepoints). The lowest mean in-hospital Hb value was 7.2 and 8.8 g/dl, respectively, in patients with transfusion+FCM versus FCM alone; the mean Hb was 12.4 versus 13.7 g/dl at follow-up. In patients administered FCM alone, the mean Hb at follow-up in the subpopulations aged older than or equal to 75 years (n=33), Charlson comorbidity index of at least 3 (n=48), and Hb of up to 10 g/dl at admission (n=47) were 12.6, 13.1, and 13.3 g/dl, respectively. No adverse effects were detected. CONCLUSION: Treatment with FCM for AGIB is associated with a good erythropoietic response and anemia correction after hospitalization, even in severe episodes or when transfusion is needed. FCM is safe and well tolerated, and may support a restrictive transfusion policy.

Incidencia y factores predictivos de anemia ferropénica tras una hemorragia digestiva alta no asociada a hipertensión portal / Incidence and predictive factors of iron deficiency anemia after acute non-variceal upper gastrointestinal bleeding without portal hypertension

Introducción: Se desconoce la incidencia de anemia ferropénica (AF) tras un episodio de hemorragia digestiva no asociada a hipertensión portal (HDA). Objetivos: El objetivo principal fue estudiar la incidencia de AF tras una HDA, y los secundarios describir los factores predictivos de AF y elaborar modelos que permitan detectar aquellos pacientes que se beneficiarían de ferroterapia. Material y método: Desde abril de 2007 hasta mayo de 2009 se valoraron de forma prospectiva 391 pacientes con HDA. Se excluyeron todas las hemorragias secundarias a hipertensión portal y pacientes con condiciones clínicas y/o biológicas que pudieran artefactuar el patrón ferrocinético. Se practicó una analítica con parámetros férricos al ingreso, al 5.° y al 30.° día de la HDA. Se utilizó un modelo de regresión logística múltiple y un modelo de árboles de decisión. Resultados: De los 124 pacientes incluidos 76 (61,3%) presentaron AF a los 30 días de la HDA. Las variables predictoras de AF: edad > 75 años (p = 0,037; OR 3,9; IC 95%: 1,3-11,6), urea inicial > 80 mg/dl (p = 0,027; OR 2,9; IC 95%: 1,1-7,6), ferritina inicial ≤ 65 ng/dl (p = 0,002; OR 7,6; IC 95%: 2,9-18,5), Hb inicial ≤ 100 g/l (p = 0,003; OR 3,2; IC 95%: 1,3-8,0), Hb al 5.° día ≤ 100 g/l (p < 0,001; OR 14,9; IC 95%: 3,6-61,1) e índice de saturación de transferrina al 5.° día < 10% (p < 0,001; OR 7,2; IC 95%: 2,6-20,3). Conclusiones: La mayoría de pacientes con HDA presentan AF a los 30 días del episodio hemorrágico. La identificación de los factores predictivos de la misma permite establecer una indicación de ferroterapia tras la HDA (AU)

Introduction: There are few studies on iron deficiency anemia (IDA) after non-variceal acute upper gastrointestinal bleeding (UGIB) in patients without portal hypertension. Objectives: To define the incidence of IDA after UGIB, to characterize the predictive factors for IDA and to design algorithms that could help physicians identify those patients who could benefit from iron therapy. Material and method: We registered 391 patients with UGIB between April 2007 and May 2009. Patients with portal hypertension and those with clinical or/and biological conditions that could affect the ferrokinetic pattern were excluded. Blood analyses were performed, including ferric parameters upon admission, on the 5 th day, and on the 30th day after the hemorrhage episode. We used a multiple logistic regression model and a classification and regression tree model. Results: A total of 124 patients were included, of which 76 (61.3%) developed IDA 30 days after UGIB. The predictive variables were age > 75 years (P = .037; OR 3.9; 95% CI: 1.3-11.6), initial urea level > 80 mg/dL (P = .027; OR 2.9; 95% CI: 1.1-7.6), initial ferritin level ≤ 65 ng/dL (P = .002; OR 7.6; 95% CI: 2.9-18.5), initial hemoglobin level ≤ 100 g/L (P = .003; OR 3.2; 95% CI: 1.3-8.0), hemoglobin level on the 5 th day ≤ 100 g/L (P < .001; OR 14.9; 95% CI: 3.6-61.1) and the value of the transferrin saturation index on the 5 th day < 10% (p < 0.001; OR 7.2; 95% CI: 2.6-20.3). Conclusions: Most patients with UGIB developed IDA 30 days after the episode. Identification of the predictive factors for IDA may help to establish guidelines for the administration of iron therapy (AU)

[Incidence and predictive factors of iron deficiency anemia after acute non-variceal upper gastrointestinal bleeding without portal hypertension]. / Incidencia y factores predictivos de anemia ferropénica tras una hemorragia digestiva alta no asociada a hipertensión portal.

INTRODUCTION: There are few studies on iron deficiency anemia (IDA) after non-variceal acute upper gastrointestinal bleeding (UGIB) in patients without portal hypertension. OBJECTIVES: To define the incidence of IDA after UGIB, to characterize the predictive factors for IDA and to design algorithms that could help physicians identify those patients who could benefit from iron therapy. MATERIAL AND METHOD: We registered 391 patients with UGIB between April 2007 and May 2009. Patients with portal hypertension and those with clinical or/and biological conditions that could affect the ferrokinetic pattern were excluded. Blood analyses were performed, including ferric parameters upon admission, on the 5th day, and on the 30th day after the hemorrhage episode. We used a multiple logistic regression model and a classification and regression tree model. RESULTS: A total of 124 patients were included, of which 76 (61.3%) developed IDA 30 days after UGIB. The predictive variables were age >75 years (P=.037; OR 3.9; 95% CI: 1.3-11.6), initial urea level >80mg/dL (P=.027; OR 2.9; 95% CI: 1.1-7.6), initial ferritin level ≤65ng/dL (P=.002; OR 7.6; 95% CI: 2.9-18.5), initial hemoglobin level ≤100g/L (P=.003; OR 3.2; 95% CI: 1.3-8.0), hemoglobin level on the 5th day ≤100g/L (P<.001; OR 14.9; 95% CI: 3.6-61.1) and the value of the transferrin saturation index on the 5th day <10% (p<0.001; OR 7.2; 95% CI: 2.6-20.3). CONCLUSIONS: Most patients with UGIB developed IDA 30 days after the episode. Identification of the predictive factors for IDA may help to establish guidelines for the administration of iron therapy.