Hemospray® (hemostatic powder TC-325) as monotherapy for acute gastrointestinal bleeding: a multicenter prospective study.

Background: Hemostatic powders are used as second-line treatment in acute gastrointestinal (GI) bleeding (AGIB). Increasing evidence supports the use of TC-325 as monotherapy in specific scenarios. This prospective, multicenter study evaluated the performance of TC-325 as monotherapy for AGIB. Methods: Eighteen centers across Europe and USA contributed to a registry between 2016 and 2022. Adults with AGIB were eligible, unless TC-325 was part of combined hemostasis. The primary endpoint was immediate hemostasis. Secondary outcomes were rebleeding and mortality. Associations with risk factors were investigated (statistical significance at P≤0.05). Results: One hundred ninety patients were included (age 51-81 years, male: female 2:1), with peptic ulcer (n=48), upper GI malignancy (n=79), post-endoscopic treatment hemorrhage (n=37), and lower GI lesions (n=26). The primary outcome was recorded in 96.3% (95% confidence interval [CI]: 92.6-98.5) with rebleeding in 17.4% (95%CI 11.9-24.1); 9.9% (95%CI 5.8-15.6) died within 7 days, and 21.7% (95%CI 15.6-28.9) within 30 days. Regarding peptic ulcer, immediate hemostasis was achieved in 88% (95%CI 75-95), while 26% (95%CI 13-43) rebled. Higher ASA score was associated with mortality (OR 23.5, 95%CI 1.60-345; P=0.02). Immediate hemostasis was achieved in 100% of cases with malignancy and post-intervention bleeding, with rebleeding in 17% and 3.1%, respectively. Twenty-six patients received TC-325 for lower GI bleeding, and in all but one the primary outcome was achieved. Conclusions: TC-325 monotherapy is safe and effective, especially in malignancy or post-endoscopic intervention bleeding. In patients with peptic ulcer, it could be helpful when the primary treatment is unfeasible, as bridge to definite therapy.

High incidence of surgery and initiation of medical therapies after colectomy for ulcerative colitis or inflammatory bowel disease unclassified / Necesidad de reintervención o tratamiento inmunosupresor o biológico tras colectomía en pacientes con colitis ulcerosa y enfermedad inflamatoria intestinal no clasificada

Background and aims: Despite novel medical therapies, colectomy has a role in the management of patients with ulcerative colitis (UC) and inflammatory bowel disease unclassified (IBDU). This study aimed to determine the incidence of unplanned surgery and initiation of immunomodulatory or biologic therapy (IMBT) after colectomy in patients with UC or IBDU, and identify associated factors. Methods: Data of patients with preoperative diagnosis of UC or IBDU who underwent colectomy and were followed up at a single tertiary centre was retrospectively collected. The primary outcome was the risk of unplanned surgery and initiation of IMBT during follow-up after colectomy. Secondary outcomes were development of Crohn's disease-like (CDL) complications and failure of reconstructive techniques. Results: 68 patients were included. After a median follow-up of 9.9 years, 32.4% of patients underwent unplanned surgery and IMBT was started in 38.2%. Unplanned surgery-free survival was 85% (95% confidence interval [CI] 73.8–91.6%) at 1 year, 76% (95% CI 63.2–84.9%) at 5 years and 69.1% (95% CI 55–79.6%) at 10 years. IMBT-free survival was 96.9% (95% CI 88.2–99.2%) at 1 year, 77.6% (95% CI 64.5–86.3%) at 5 years and 63.3% (95% CI 48.8–74.7%) at 10 years. 29.4% of patients met criteria for CDL complications. CDL complications were significantly associated to IMBT (hazard ratio 4.5, 95% CI 2–10.1). Conclusion: In a retrospective study, we found a high incidence of unplanned surgery and IMBT therapy initiation after colectomy among patients with UC or IBDU. These results further question the historical concept of surgery as a “definitive” treatment.(AU)

Objetivo: La colectomía continúa teniendo un rol terapéutico en pacientes con colitis ulcerosa (CU) y enfermedad inflamatoria intestinal no clasificada (EII-noC). El objetivo de este estudio fue determinar la incidencia de cirugía no planificada e inicio de terapias inmunomoduladoras/biológicas (TIMB) tras colectomía en pacientes con CU o EII-noC, e identificar factores de riesgo. Métodos: Se analizaron retrospectivamente los datos de pacientes con CU o EII-noC y colectomía seguidos en un centro terciario. El objetivo primario fue evaluar el riesgo de reintervención e inicio de TIMB. Los objetivos secundarios fueron analizar la incidencia de Crohn “de novo” y el fracaso de las técnicas reconstructivas. Resultados: 68 pacientes fueron incluidos. Tras una mediana de seguimiento de 9.9 años, el 32.4% de los pacientes fueron reintervenidos y el 38.2% inició TIMB. La supervivencia libre de reintervención fue 85% (intervalo confianza 95% [IC] 73.8-91.6%) al año, 76% (IC 95% 63.2-84.9%) a los 5 años y 69.1% (IC 95% 55-79.6%) a los 10 años. La supervivencia libre de TIMB fue 96.9% (IC 95% 88.2-99.2%) al año, 77.6% (IC 95% 64.5-86.3%) a los 5 años y 63.3% (IC 95% 48.8-74.7%) a los 10 años. 29.4% de los pacientes cumplieron criterios de Crohn “de novo”. Crohn “de novo” fue factor de riesgo para inicio de TIMB (Hazard ratio 4.5%, IC 95% 2-10.1). Conclusión: En una cohorte retrospectiva, encontramos una alta incidencia de cirugía e inicio de TIMB tras colectomía en CU o EII-noC. Estos resultados cuestionan el concepto clásico de colectomía como tratamiento definitivo.(AU)

AEG-SEED position paper for the resumption of endoscopic activity after the peak phase of the COVID-19 pandemic. / Documento de posicionamiento AEG-SEED para el reinicio de la actividad endoscópica tras la fase pico de la pandemia de COVID-19.

INTRODUCTION: The COVID-19 pandemic has led to the suspension of programmed activity in most of the Endoscopy Units in our environment. The aim of this document is to facilitate the resumption of elective endoscopic activity in an efficient and safe manner. MATERIAL AND METHODS: A series of questions considered to be of clinical and logistical relevance were formulated. In order to elaborate the answers, a structured bibliographic search was carried out in the main databases and the recommendations of the main Public Health and Digestive Endoscopy institutions were reviewed. The final recommendations were agreed upon through telematic means. RESULTS: A total of 33 recommendations were made. The main aspects discussed are: 1) Reassessment and prioritization of the indication, 2) Restructuring of spaces, schedules and health personnel, 3) Screening for infection, 4) Hygiene measures and personal protective equipment. CONCLUSION: The AEG and SEED recommend restarting endoscopic activity in a phased, safe manner, adapted to local resources and the epidemiological situation of SARS-CoV-2 infection.