Plastic pigtail vs lumen-apposing metal stents for drainage of walled-off necrosis (PROMETHEUS study): an open-label, multicenter randomized trial.

BACKGROUND: Lumen-apposing metal stents (LAMS) have displaced double-pigtail plastic stents (DPS) as the standard treatment for walled-off necrosis (WON),ß but evidence for exclusively using LAMS is limited. We aimed to assess whether the theoretical benefit of LAMS was superior to DPS. METHODS: This multicenter, open-label, randomized trial was carried out in 9 tertiary hospitals. Between June 2017, and Oct 2020, we screened 99 patients with symptomatic WON, of whom 64 were enrolled and randomly assigned to the DPS group (n = 31) or the LAMS group (n = 33). The primary outcome was short-term (4-weeks) clinical success determined by the reduction of collection. Secondary endpoints included long-term clinical success, hospitalization, procedure duration, recurrence, safety, and costs. Analyses were by intention-to-treat. CLINICALTRIALS: gov, NCT03100578. RESULTS: A similar clinical success rate in the short term (RR, 1.41; 95% CI 0.88-2.25; p = 0.218) and in the long term (RR, 1.2; 95% CI 0.92-1.58; p = 0.291) was observed between both groups. Procedure duration was significantly shorter in the LAMS group (35 vs. 45-min, p = 0.003). The hospital admission after the index procedure (median difference, - 10 [95% CI - 17.5, - 1]; p = 0.077) and global hospitalization (median difference - 4 [95% CI - 33, 25.51]; p = 0.82) were similar between both groups. Reported stent-related adverse events were similar for the two groups (36 vs.45% in LAMS vs. DPS), except for de novo fever, which was significantly 26% lower in LAMS (RR, 0.26 [0.08-0.83], p = 0.015). CONCLUSIONS: The clinical superiority of LAMS over DPS for WON therapy was not proved, with similar clinical success, hospital stay and similar safety profile between both groups, yet a significant reduction in procedure time was observed. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT03100578.

Diffuse large B-cell lymphoma and gastrointestinal Kaposi's sarcoma: a rare cause of upper gastrointestinal bleeding.

A 49-year-old man with a history of human immunodeficiency virus (HIV) infection, in a state of advanced immunosuppression and current antiretroviral therapy initiation. He was admitted to the hematology department after diagnosis of diffuse large B-cell lymphoma (DLBCL) associated with Epstein-Barr virus (EBV), disseminated cytomegalovirus (CMV) infection and cutaneous Kaposi's sarcoma (KS). During admission, he presented an episode of melena with anemization, so an urgent gastroscopy was performed. In the stomach there were multiple erythematous lesions, large and elevated, suggestive of subepithelial origin. Some of them presented an umbilicated center and other were ulcerated, covered with fibrin. The bulb and second duodenal portion showed similar involvement, large violaceous ulcerated lesions. Biopsies were taken and the anatomopathological diagnosis of the duodenal lesions was KS and of the gastric lesions KS and DLBCL associated with EBV. KS is an endothelial tumor associated with HIV. The stomach is the gastrointestinal organ most frequently affected and the typical endoscopic findings are nodular lesions. The stomach is the most common site of extranodal involvement in DLBCL. In both pathologies, the manifestation as upper gastrointestinal bleeding is exceptional and endoscopic biopsies can confirm the diagnosis.