Solitary fibrous tumor of the parapharyngeal space: report of 2 cases and a literature review.

The solitary fibrous tumor (SFT) is usually described as a lesion arising from the pleura. Rarely, it has been described in the parapharyngeal space (PS). This study aims to report two cases of SFT in the PS and to perform a literature review on this topic. Two patients undergoing surgical resection of a SFT in the PS, were reported. A literature review on SFT of the PS, was also performed. Two patients were analyzed. Both patients underwent surgical resection, followed by adjuvant radiotherapy, for SFT arising from the PS. The postoperative course was uneventful and both patients recovered well after the procedure. No recurrences were diagnosed during the followup. SFT of the PS is an infrequent entity. Surgical resection is the most used treatment, and adjuvant radiation should be considered in patients with recurrence risk factors or distant metastases.

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.

Is ERCP still the elective primary biliary drainage technique in patients with malignant distal biliary obstruction? Response to Garcia-Cano et al.

We have read the letter from García-Cano et al. regarding our Editorial and are very grateful for the response as it contributes to deepening the debate we aim to generate on the topic. We are aware that changing a paradigm is always difficult, takes years, and requires publication of good quality studies. However, the way to progress in medicine and provide the best for patients involves questioning existing paradigms and considering the possibility of changing them. Currently, the outcomes of endoscopic ultrasonography guided transmural biliary drainage (EUS-TBD) have been progressively improving and the rate of adverse events (AE) has considerably decreased. The data currently available suggest that primary EUS-TBD in a specific setting is not inferior to ERCP drainage and may even entail a lower rate of AE.

Is ERCP still the elective primary biliary drainage technique in patients with malignant distal biliary obstruction?

Endoscopic retrograde cholangiopancreatography (ERCP) has been established as the first line therapy for the resolution of biliary and pancreatic diseases. The main disadvantage of the procedure is the rate of adverse events, around 10%1. So, despite being a minimally invasive procedure, ERCP has a non-negligible rate of adverse effects (AEs) and secondary mortality.

Endoscopic ultrasound-guided gallbladder drainage with long-term lumen-apposing metal stent indwell: 1-year results from a prospective nationwide observational study.

BACKGROUND AND AIM: This study aimed to determine safety and risk factors for adverse events (AEs) of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with long-term indwell of lumen-apposing metal stents (LAMS). METHODS: This study is a multicenter prospective observational study on consecutive high surgical-risk patients requiring gallbladder drainage who underwent EUS-GBD with LAMS over 12 months. Centralized telephone follow-up interviews were conducted every 3 months for 1 year. Patients were censored at LAMS removal, cholecystectomy, or death. AE-free survival was determined using log-rank tests. Cumulative risks were estimated using life-table analysis. RESULTS: Eighty-two patients were included (53.7% male, median [interquartile range] age of 84.6 [76.5-89.8] years, and 85.4% with acute cholecystitis). Technical success was achieved in 79 (96.3%), and clinical success in 73 (89%). No patient was lost to follow-up; 45 patients (54.9%) completed 1-year follow-up with in situ LAMS. Median (interquartile range) LAMS indwell time was 364 (47-367) days. Overall, 12 (14.6%) patients presented 14 AEs, including 5 (6.1%) recurrent biliary events (3 acute cholangitis, 1 mild acute pancreatitis, and 1 acute cholecystitis). Patients with pancreatobiliary malignancy had an increased risk of recurrent biliary events (33% vs 1.5%, P = 0.001). The overall 1-year cumulative risk of recurrent biliary events was 9.7% (4.1-21.8%). The 1-year risk of AEs and of severe AEs was 18.8% (11-31.2%) and 7.9% (3.3-18.2%), respectively. Pancreatobiliary malignancy was the single risk factor for recurrent biliary events; LAMS misdeployment was the strongest risk factor for AEs. CONCLUSIONS: Long-term LAMS indwell does not increase the risk of delayed AEs following EUS-GBD.

Endoscopic treatment of disconnected pancreatic duct syndrome secondary to acute necrotizing pancreatitis in a patient with pancreas divisum.

A 50-year old male with acute necrotizing pancreatitis had an unfavorable evolution in the third week of disease, with development of large volume ascites and walled-off necrosis affecting the head and body of pancreas, suspected to be infected, with viable parenchyma in the tail of pancreas. Endoscopic ultrasound guided drainage of the collection was performed through placement of a lumen apposing metal stent. Selective cannulation of main pancreatic duct was only possible though the minor papilla and after contrast media injection a type 1 pancreas divisum and partial disruption of dorsal pancreatic duct were diagnosed.

Seguridad y factibilidad de la reconstrucción microquirúrgica en tumores de cabeza y cuello en pacientes mayores de 70 años / Safety and feasibility of free-flap reconstruction in head and neck tumors in patients aged 70 years or older

RESUMEN Antecedentes: debido al aumento en la expectativa de vida, se ha incrementado la incidencia de tumores de cabeza y cuello en pacientes añosos. Objetivo: evaluar los resultados de la reconstrucción con colgajos microquirúrgicos luego de la resección radical (RRMC) de tumores de cabeza y cuello en pacientes de 70 años o mayores. Material y métodos: se analizó una serie de pacientes sometidos a RRCM por tumores de cabeza y cuello en el período 2000-2020. Se dividió la muestra en dos grupos: G1: ≥ de 70 años y G2: < de 70 años. Se analizaron variables demográficas, quirúrgicas, posoperatorias y factores de riesgo de trombosis del colgajo en los pacientes ≥ de 70 años. Resultados: se incluyó un total de 178 pacientes, 61 en G1 y 117 en G2. Ambos grupos fueron homogéneos respecto del sexo, IMC (índice de masa corporal), alcoholismo, tabaquismo, tratamiento neoadyuvante e incidencia de HPV (virus del papiloma humano). Hubo mayor cantidad de pacientes con riesgo ASA ≥ III en G1 vs. G2; (p: 0,005). En G1, 33 (54%) correspondieron a estadio oncológico ≥ III vs. 99 (87%) en G2 (p: 0,001). Cuarenta y dos (69%) pacientes en G1 recibieron adyuvancia vs. 94 (83%) en G2 (p: 0,02) y no hubo diferencias en la morbimortalidad global y en fallas del colgajo. El sexo femenino fue el único factor de riesgo de trombosis del pedículo vascular (p: 0,05). Conclusión: la RRCM para tumores de cabeza y cuello es factible y segura en pacientes añosos, con una incidencia de morbimortalidad similar a la del resto de la población.

ABSTRACT Background: The higher life expectancy has increased the incidence of head and neck tumors in elder patients. Objective: the aim of this study was to evaluate the outcomes of free flap reconstructions after radical resection (FFRR) of head and neck tumors in patients aged 70 years or older. Material and methods: We analyzed a series of patients undergoing FFR due to head and neck tumors between 2000-2020. The patients were divided into two groups: G1: ≥ 70 years, and G2: < 70 years. The demographic, operative and postoperative variables and the risk factors for flap thrombosis in patients ≥ 70 years were analyzed. Results: A total of 178 patients were included, 61 in G1 and 117 in G2. Both groups were homogeneous regarding sex, BMI (body mass index), alcohol consumption, smoking habits, neoadjuvant treatment, and incidence of HPV (human papillomavirus). The incidence of ASA grade ≥ III was significantly higher in G1 vs. G2; (p: 0,005). In G1, 33 patients (54%) corresponded to cancer stage ≥ III vs. 99 (87%) in G2 (p: 0.001). Forty-two (69%) patients in G1 received adjuvant therapy vs. 94 (83%) in G2 (p = 0.02) and there were no differences in overall morbidity and mortality and in flap failure. Female sex was the only predictor of vascular flap thrombosis (p = 0.05). Conclusion: FFRR in head and neck tumors is feasible and safe in elderly patients, with morbidity and mortality rates similar to those of the general population.

Prospective multicenter assessment of the impact of EUS-guided gastroenterostomy on patient quality of life in unresectable malignant gastric outlet obstruction.

BACKGROUND AND AIMS: EUS-guided gastroenterostomy (EUS-GE) is increasingly used for malignant gastric outlet obstruction (GOO) in inoperable patients. However, the impact of EUS-GE on patient quality of life (QoL) has not been evaluated prospectively. METHODS: Consecutive patients with unresectable malignant GOO who underwent EUS-GE between August 2019 and May 2021 at 4 Spanish centers were prospectively assessed using the European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 at baseline and 1 month after the procedure. Centralized follow-up by telephone calls was undertaken. The Gastric Outlet Obstruction Scoring System (GOOSS) was used to assess oral intake, defining clinical success as a GOOSS ≥2. Differences between baseline and 30-day QoL scores were assessed using a linear mixed model. RESULTS: Sixty-four patients were enrolled, 33 (51.6%) men, with a median age of 77.3 years (interquartile range, 65.5-86.5). The most common diagnoses were pancreatic (35.9%) and gastric (31.3%) adenocarcinoma. Thirty-seven patients (57.9%) presented a 2/3 baseline Eastern Cooperative Oncology Group performance status score. Oral intake was restarted within 48 hours in 61 patients (95.3%), and the median postprocedure hospital stay was 3.5 days (interquartile range, 2-5). The 30-day clinical success rate was 83.3%. A clinically significant increase of 21.6 points (95% confidence interval, 11.5-31.7) in the global health status scale was documented, with significant improvements in nausea and vomiting, pain, constipation, and appetite loss. CONCLUSIONS: EUS-GE relieves GOO symptoms in patients with unresectable malignancy, allowing rapid oral intake and hospital discharge. It also provides a clinically relevant increase in QoL scores at 30 days from baseline. (Clinical trial registration number: NCT04660695.).

The volume of ERCP per endoscopist is associated with a higher technical success and a lower post-ERCP pancreatitis rate. A prospective analysis.

INTRODUCTION: conflicting results have been reported regarding the influence of the annual volume of endoscopic retrograde cholangiopancreatography (ERCP) on outcome. OBJECTIVE: to evaluate the influence of case volume on ERCP outcomes. PATIENTS AND METHODS: an analysis of a prospective database was performed, comparing the outcomes of ERCP in three consecutive periods defined by the number of endoscopists performing ERCP: five endoscopists in period I (P1), four in period II (P2) and three in period III (P3). Only patients with biliary ERCP in accessible and naïve papilla were included. Primary variables were cannulation rates and adverse effects (AE). The American Society of Gastrointestinal Endoscopy (ASGE) complexity grades III and IV were considered as highly complex procedures. RESULTS: a total of 2,561 patients were included: 727 (P1), 972 (P2) and 862 (P3). There were no differences in age and sex between groups (p > 0.05). The cannulation rate was significantly higher in P2 and P3: 92.4 % vs 93.3 % vs 93 % (p = 0.037). The AE rate was 13.8 %, 12.6 % and 10.3 % (p > 0.05), respectively. The rate of post-ERCP pancreatitis was significantly lower in P3: 8.5 %, 7.3 % and 5 % (p = 0.01). The rate of complex procedures was 12 %, 14.8 % and 27 % (p < 0.0001), respectively. Two endoscopists participated in all periods and only one had significantly improved outcomes. Cannulation and post-ERCP pancreatitis rates remained significantly better in P3 after adjusting for sex, complexity and endoscopist. CONCLUSION: a higher annual volume of ERCP per endoscopist was associated with a higher rate of cannulation and a lower rate of post-ERCP pancreatitis, despite the greater complexity of the procedures. These beneficial effects seem to differ between endoscopists.

El volumen de CPRE por endoscopista se asocia a mayor tasa de éxito y menor tasa de pancreatitis post-CPRE. Análisis de un registro prospectivo / The volume of ERCP per endoscopist is associated with a higher technical success and a lower post-ERCP pancreatitis rate. A prospective analysis

Introducción: la influencia del volumen anual de colangiopancreatografía retrógrada endoscópica (CPRE) en sus resultados ha sido analizada con resultados contradictorios.Objetivo: evaluar la influencia del volumen de CPRE en sus resultados. Material y métodos: análisis sobre base de datos prospectiva comparando los resultados de la CPRE en tres periodos definidos por el número de endoscopistas que la realizan: periodo I, con cinco endoscopistas; periodo II, con cuatro; y periodo III, con tres. Incluimos CPRE biliar en papila acce sible y virgen. Las variables principales fueron las tasas de canulación y los efectos adversos. Los grados de complejidad III y IV, según la clasificación de la Sociedad Americana de Endoscopia Digestiva (ASGE, por sus siglas en inglés), se consideraron procedimientos de alta complejidad. Resultados: fueron incluidos 2.561 pacientes: 727 (periodo I), 972 (periodo II) y 862 (periodo III). No hubo diferencias en edad y sexo entre grupos (p > 0,05). La tasa de canulación fue significativamente mayor en los periodos II y III: 92,4 % vs. 93,3 % vs. 93 % (p = 0,037). La tasa de efectos adver sos (EA) fue de 13,8 %, 12,6 % y 10,3 % (p > 0,05). La tasa de pancreatitis post-CPRE fue significativamente menor en el periodo III: 8,5 %, 7,3 % y 5 % (p = 0,01). El porcentaje de procedimientos de alta complejidad fue de 12 %, 14,8 % y 27 % (p < 0,0001), respectivamente. La regresión logística mostró tasas de canulación y pancreatitis post-CPRE significativamente mejores en el periodo III tras ajustar por sexo, complejidad y endoscopista. Conclusión: un mayor volumen anual de CPRE por endoscopista se asoció con mayor tasa de canulación y menor tasa de pancreatitis post-CPRE, a pesar de la mayor complejidad de los procedimientos. Estos efectos beneficiosos parecen diferir entre endoscopistas(AU)

Percutaneous transhepatic or endoscopic ultrasound-guided biliary drainage in malignant distal bile duct obstruction using a self-expanding metal stent: Study protocol for a prospective European multicenter trial (PUMa trial).

BACKGROUND: Endoscopic ultrasound-guided biliary drainage (EUS-BD) was associated with better clinical success and a lower rate of adverse events (AEs) than fluoroscopy-guided percutaneous transhepatic biliary drainage (PTBD) in recent single center studies with mainly retrospective design and small case numbers (< 50). The aim of this prospective European multicenter study is to compare both drainage procedures using ultrasound-guidance and primary metal stent implantation in patients with malignant distal bile duct obstruction (PUMa Trial). METHODS: The study is designed as a non-randomized, controlled, parallel group, non-inferiority trial. Each of the 16 study centers performs the procedure with the best local expertise (PTBD or EUS-BD). In PTBD, bile duct access is performed by ultrasound guidance. EUS-BD is performed as an endoscopic ultrasound (EUS)-guided hepaticogastrostomy (EUS-HGS), EUS-guided choledochoduodenostomy (EUS-CDS) or EUS-guided antegrade stenting (EUS-AGS). Insertion of a metal stent is intended in both procedures in the first session. Primary end point is technical success. Secondary end points are clinical success, duration pf procedure, AEs graded by severity, length of hospital stay, re-intervention rate and survival within 6 months. The target case number is 212 patients (12 calculated dropouts included). DISCUSSION: This study might help to clarify whether PTBD is non-inferior to EUS-BD concerning technical success, and whether one of both interventions is superior in terms of efficacy and safety in one or more secondary endpoints. Randomization is not provided as both procedures are rarely used after failed endoscopic biliary drainage and study centers usually prefer one of both procedures that they can perform best. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03546049 (22.05.2018).

Endoscopic ultrasound-guided drainage using lumen-apposing metal stent of malignant afferent limb syndrome in patients with previous Whipple surgery: Multicenter study (with video).

OBJECTIVES: Endoscopic ultrasound-guided digestive anastomosis (EUS-A) is a new alternative under evaluation in patients presenting with afferent limb syndrome (ALS) after Whipple surgery. The aim of the present study is to analyze the safety and effectiveness of EUS-A in ALS. METHODS: This is an observational multicenter study. All patients ≥18 years old with previous Whipple surgery presenting with ALS who underwent an EUS-A using a lumen-apposing metal stent (LAMS) between 2015 and 2021 were included. The primary outcome was clinical success, defined as resolution of the ALS or ALS-related cholangitis. Furthermore, technical success, adverse event rate, and mortality were evaluated. RESULTS: Forty-five patients (mean age: 65.5 ± 10.2 years; 44.4% male) were included. The most common underlying disease was pancreatic cancer (68.9%). EUS-A was performed at a median of 6 weeks after local tumor recurrence. The most common approach used was the direct/freehand technique (66.7%). Technical success was achieved in 95.6%, with no differences between large (≥15 mm) and small LAMS (97.4% vs. 100%, P = 0.664). Clinical success was retained in 91.1% of patients. A complementary treatment by dilation of the stent followed by endoscopic retrograde cholangiopancreatography through the LAMS was performed in three cases (6.7%). There were six recurrent episodes of cholangitis (14.6%) and two procedure-related adverse events (4.4%) after a median follow-up of 4 months. Twenty-six patients (57.8%) died during the follow-up due to disease progression. CONCLUSION: EUS-A is a safe and effective technique in the treatment of malignant ALS, achieving high clinical success with an acceptable recurrence rate.

Next-generation sequencing of bile cell-free DNA for the early detection of patients with malignant biliary strictures.

OBJECTIVE: Despite significant progresses in imaging and pathological evaluation, early differentiation between benign and malignant biliary strictures remains challenging. Endoscopic retrograde cholangiopancreatography (ERCP) is used to investigate biliary strictures, enabling the collection of bile. We tested the diagnostic potential of next-generation sequencing (NGS) mutational analysis of bile cell-free DNA (cfDNA). DESIGN: A prospective cohort of patients with suspicious biliary strictures (n=68) was studied. The performance of initial pathological diagnosis was compared with that of the mutational analysis of bile cfDNA collected at the time of first ERCP using an NGS panel open to clinical laboratory implementation, the Oncomine Pan-Cancer Cell-Free assay. RESULTS: An initial pathological diagnosis classified these strictures as of benign (n=26), indeterminate (n=9) or malignant (n=33) origin. Sensitivity and specificity of this diagnosis were 60% and 100%, respectively, as on follow-up 14 of the 26 and eight of the nine initially benign or indeterminate strictures resulted malignant. Sensitivity and specificity for malignancy of our NGS assay, herein named Bilemut, were 96.4% and 69.2%, respectively. Importantly, one of the four Bilemut false positives developed pancreatic cancer after extended follow-up. Remarkably, the sensitivity for malignancy of Bilemut was 100% in patients with an initial diagnosis of benign or indeterminate strictures. Analysis of 30 paired bile and tissue samples also demonstrated the superior performance of Bilemut. CONCLUSION: Implementation of Bilemut at the initial diagnostic stage for biliary strictures can significantly improve detection of malignancy, reduce delays in the clinical management of patients and assist in selecting patients for targeted therapies.