Impact of biliary stents in the performance of the EUS-guided tissue acquisition: A systematic review and meta-analysis.

INTRODUCTION AND AIM: Pancreatobiliary tumours are challenging to diagnose exclusively by imaging methods. Although the optimum moment for carrying out the EUS is not well defined, it has been suggested that the presence of biliary stents may interfere with the proper staging of tumours and the acquisition of samples. We performed a meta-analysis to evaluate the impact of biliary stents on EUS-guided tissue acquisition yield. MATERIAL AND METHODS: We conducted a systematic review in different databases, such as PubMed, Cochrane, Medline, and OVID Database. A search was made of all studies published up to February 2022. RESULTS: Eight studies were analyzed. A total of 3185 patients were included. The mean age was 66.9±2.7 years; 55.4% were male gender. Overall, 1761 patients (55.3%) underwent EUS guided tissue acquisition (EUS-TA) with stents in situ, whereas 1424 patients (44.7%) underwent EUS-TA without stents. The technical success was similar in both groups (EUS-TA with stents: 88% vs EUS-TA without stents: 88%, OR=0.92 [95% CI 0.55-1.56]). The type of stent, the needle size and the number of the passes were similar in both groups. CONCLUSIONS: EUS-TA has similar diagnostic performance and technical success in patients with or without stents. The type of stent (SEMS or plastic) does not seem to influence the diagnostic performance of EUS-TA. Future prospectives and RCT studies are needed to strengthen these conclusions.

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.).

Intracystic Glucose and Carcinoembryonic Antigen in Differentiating Histologically Confirmed Pancreatic Mucinous Neoplastic Cysts.

INTRODUCTION: Differentiating mucinous neoplastic pancreatic cysts (MNPC) from cysts without malignant potential can be challenging. Guidelines recommend using fluid carcinoembryonic antigen (CEA) to differentiate MNPC; however, its sensitivity and specificity vary widely. Intracystic glucose concentration has shown promise in differentiating MNPC, but data are limited to frozen specimens and cohorts of patients without histologic diagnoses. This study aimed to compare glucose and CEA concentrations in differentiating MNPC using fresh fluid obtained from cysts with confirmatory histologic diagnoses. METHODS: This multicenter cohort study consisted of patients undergoing endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) for pancreatic cysts during January 2013-May 2020. Patients were included if the cyst exhibited a histologic diagnosis and if both CEA and glucose were analyzed from fresh fluid. Receiver operating curve (ROC) characteristics were analyzed, and various diagnostic parameters were compared. RESULTS: Ninety-three patients, of whom 59 presented with MNPC, met the eligibility criteria. The area under the receiver operating curve (AUROC) was 0.96 for glucose and 0.81 for CEA (difference 0.145, P = 0.003). A CEA concentration of ≥192 ng/mL had sensitivity of 62.7% and specificity of 88.2% in differentiating MNPC, whereas glucose concentration of ≤25 mg/dL had sensitivity and specificity of 88.1% and 91.2%, respectively. DISCUSSION: Intracystic glucose is superior to CEA concentration for differentiating MNPC when analyzed from freshly obtained fluid of cysts with histologic diagnoses. The advantage of glucose is augmented by its low cost and ease of implementation, and therefore, its widespread adoption should come without barriers. Glucose has supplanted CEA as the best fluid biomarker in differentiating MNPC.

EUS-guided gastroenterostomy versus duodenal self-expandable metal stent for malignant gastric outlet obstruction: results from a nationwide multicenter retrospective study (with video).

BACKGROUND AND AIMS: Traditionally, palliative treatment of malignant gastric outlet obstruction (GOO) has been surgical, but surgical treatment carries significant morbidity and mortality rates. Endoscopic placement of a duodenal self-expandable metal stent (D-SEMS) has been proven to be successful for this indication in the short term. However, D-SEMSs are likely to malfunction over time. EUS-guided gastroenterostomy (EUS-GE) may help overcome these limitations. We aimed to evaluate stent failure-free survival at 3 months. METHODS: A nationwide multicenter, observational study of D-SEMS and EUS-GE procedures for patients with malignant GOO was conducted at 7 academic centers from January 2015 to June 2020. Stent failure-free survival at 1, 3, and 6 months; technical and clinical success; adverse events (AEs); and patient survival were evaluated in both groups and compared. RESULTS: Ninety-seven patients were included in the D-SEMS group and 79 in the EUS-GE group. Pancreatic cancer was the main underlying malignancy in 53.4%. No statistically significant differences regarding technical (92.8% vs 93.7%) or clinical success (83.5% vs 92.4%) were found. AE rates did not differ between groups (10.3% vs 10.1%), although 2 events in the EUS-GE group required surgical management. Patients in the EUS-GE group had improved stent patency when compared with those patients in the D-SEMS group at 3 months (92.23% vs 80.6%; adjusted hazard ratio, .37; P = .033). CONCLUSIONS: EUS-GE seems to have improved patency outcomes when compared with D-SEMS placement for palliative treatment of malignant GOO. Prospective trials are needed to fully compare their efficacy and AE profile.

Intracystic Glucose Levels Appear Useful for Diagnosis of Pancreatic Cystic Lesions: A Systematic Review and Meta-Analysis.

BACKGROUND: Carcinoembryonic antigen (CEA) in the pancreatic cystic fluid is the most important biomarker for differentiating mucinous from non-mucinous pancreatic cystic lesions (PCLs). However, recent studies have shown that glucose levels in pancreatic cystic fluid can discriminate mucinous from non-mucinous cysts. AIMS: To perform a meta-analysis to determine the utility of intracystic fluid glucose of pancreatic mucinous cysts compared with intracystic CEA. METHODS: We conducted a systematic review of the literature in the PubMed, OVID Medline, and Cochrane databases. This meta-analysis considers studies published up to October 2020. RESULTS: Six studies comprising 506 patients were selected; 61.2% of the population was female. Of the 480 PCLs, 287 (59.7%) were mucinous. Pooled sensitivity and specificity of cystic fluid glucose levels for mucinous PCLs were 91% and 85%, respectively. The positive likelihood ratio (PLR) and negative likelihood ratio (NLR) were 6.33 and 0.11, respectively. Pooled diagnostic odds ratio (DOR) was 60.94. The pooled area under the summary receiver operating characteristic (SROC) curve was 0.959. Pooled sensitivity and specificity of pancreatic cystic fluid CEA levels were 61% and 93%. The PLR and NLR were 8.51 and 0.40, respectively. Pooled DOR was 23.52, and the pooled area under the SROC curve was 0.861. CONCLUSION: Glucose has become a useful method and appears to be better than CEA for differentiating between mucinous PCLs and non-mucinous PCLs. We suggest that the analysis of glucose in PCLs be routinely performed for the differential diagnosis of these lesions.

The safety and efficacy of a new 20-mm lumen apposing metal stent (lams) for the endoscopic treatment of pancreatic and peripancreatic fluid collections: a large international, multicenter study.

BACKGROUND: Lumen apposing metal stent (LAMS) allows an easy access to peripancreatic fluid collections (PPFCs) and the possibility of performing direct endoscopic necrosectomy (DEN). The aim of our study was to evaluate the safety and efficacy of a new 20-mm LAMS in the management of PPFCs. This novel stent represents the largest diameter LAMS available on the market to date. METHODS: This is an international, multicenter retrospective study involving 20 centers. Consecutive patients who underwent EUS-guided PPFC drainage using a 20-mm LAMS were included. Primary outcomes were technical and clinical success. Secondary outcomes were rate and the severity of adverse events. RESULTS: A total 105 patients underwent PPFC drainage using the new 20-mm LAMS and 106 LAMS were placed. Technical success was 100% (106/106). 7/105 patients died due to causes not related to the stent. Clinical success was achieved in 92/98 patients (93.9%). Significant adverse events occurred in 8/98 patients (8.16%): 4 cases (4.08%) of bleeding, 3 cases (3.06%) of suprainfection, 1 case of gastric outlet obstruction. CONCLUSIONS: This multicenter study demonstrated acceptable rates of technical and clinical success using a new 20-mm LAMS for PPFC, including walled-off pancreatic necrosis (WOPN). The results of our study suggest that a new 20-mm LAMS is non-inferior in terms of safety, efficacy, and adverse events as compared to smaller diameter LAMS in the management of PPFCs, including pancreatic psuedocysts (PP) and WOPN. Randomized controlled studies will be needed to determine the ideal size of LAMS need to achieve the greatest clinical benefit with the minimized risk exposure for this high-risk patient population.

International multicenter comprehensive analysis of adverse events associated with lumen-apposing metal stent placement for pancreatic fluid collection drainage.

BACKGROUND AND AIMS: High rates of technical and clinical success were reported for lumen-apposing metal stent (LAMS) placement for peripancreatic fluid collection (PFC) drainage. However, data on the adverse event (AE) rates are heterogeneous. The aim of this study was to evaluate the incidence, severity, management, and risk factors of AEs related to the use of LAMSs for drainage of PFCs in a large cohort of patients. METHODS: This is a multicenter, international, retrospective review from 15 centers of all patients who underwent placement of LAMSs for the management of PFCs. A nested case-control study was conducted in patients with (case) or without (control) AEs. RESULTS: Three hundred thirty-three procedures in 328 patients were performed (5 patients treated with 2 LAMSs). Technical success was achieved in 321 patients (97.9%). Three hundred four patients were finally included in the study (7 excluded for lost to follow-up information; 10 excluded for deaths unrelated to LAMSs). The rate of clinical success was 89.5%. Seventy-nine LAMS-related AEs occurred in 74 of 304 patients (24.3%), after a mean time of 25.3 days (median, 18 days; interquartile range, 6-30) classified as 20 (25.3%) mild, 54 (68.4%) moderate, or 5 (6.3%) severe. On multivariable analysis compared with control subjects, cases were more likely to have walled-off necrosis (WON) versus pancreatic pseudocysts (odds ratio, 2.18; 95% confidence interval, 1.09-4.46; P = .028), whereas cases were less likely to have undergone tract (balloon) dilation (yes vs no; odds ratio, .47; 95% confidence interval, .22-.93; P = .034). CONCLUSIONS: Data from this large international retrospective study confirm that the use of LAMSs for management of PFCs has excellent technical and good clinical success rates. The rate of AEs, however, is not negligible and should be carefully considered before using these stents for drainage of PFCs and in particular for WON. Further prospective studies are needed to confirm these findings. (Clinical trial registration number: NCT03544008.).

Endoscopic ultrasound-guided drainage of pancreatic walled-off necrosis using 20-mm versus 15-mm lumen-apposing metal stents: an international, multicenter, case-matched study.

BACKGROUNDS: Endoscopic ultrasound (EUS)-guided placement of lumen-apposing metal stents (LAMSs) has gained popularity for the treatment of pancreatic walled-off necrosis (WON). We compared the 20-mm and 15-mm LAMSs for the treatment of symptomatic WON in terms of clinical success and adverse events. METHODS: We conducted a retrospective, case-matched study of 306 adults at 22 tertiary centers from 04/2014 to 10/2018. A total of 102 patients with symptomatic WON who underwent drainage with 20-mm LAMS (cases) and 204 patients who underwent drainage with 15-mm LAMS (controls) were matched by age, sex, and drainage approach. Conditional logistic regression analysis was performed to compare clinical success (resolution of WON on follow-up imaging without reintervention) and adverse events (according to American Society for Gastrointestinal Endoscopy criteria). RESULTS: Clinical success was achieved in 92.2 % of patients with 20-mm LAMS and 91.7 % of patients with 15-mm LAMS (odds ratio 0.92; P = 0.91). Patients with 20-mm LAMS underwent fewer direct endoscopic necrosectomy (DEN) sessions (mean 1.3 vs. 2.1; P < 0.001), despite having larger WON collections (transverse axis 118.2 vs. 101.9 mm, P = 0.003; anteroposterior axis 95.9 vs. 80.1 mm, P = 0.01). There was no difference in overall adverse events (21.6 % vs. 15.2 %; P = 0.72) and bleeding events (4.9 % vs. 3.4 %; P = 0.54) between the 20-mm and 15-mm LAMS groups, respectively. CONCLUSIONS: The 20-mm LAMS showed comparable clinical success and safety profile to the 15-mm LAMS, with the need for fewer DEN sessions for WON resolution.

Endoscopic ultrasound-guided percutaneous endoscopic gastrostomy.

Percutaneous endoscopic gastrostomy (PEG) is the method of choice for feeding and nutritional support in patients with a normal gastrointestinal function who require long-term enteral nutrition. We report our experience regarding an alternative endoscopic ultrasound (EUS)-guided PEG technique. A retrospective clinical experience case series study was conducted from January 2019 to November 2019 at a tertiary center. Adult patients deemed unfit for conventional PEG due to absence of transillumination or previous gastric surgery were enrolled. An EUS target was created by filling a glove with saline and placing it in the abdomen. EUS was performed and the target identified from the stomach. The abdominal wall was punctured from the stomach and a guidewire was advanced. The guidewire was knotted to a string, which was passed into the stomach and drawn back through the mouth. The procedure was continued following the traditional technique. Four patients underwent EUS-PEG in our center during the study period. Mean age was 65 years and 50% were male. Two patients (50%) had a body mass index over 30. PEG indications were tongue malignancies (50%), cerebrovascular disease (25%) and dementia (25%). One patient had a Roux-en-Y gastric bypass and percutaneous endoscopic jejunostomy was performed. Technical success rate was 100% and no complications occurred. This case series shows that the EUS-guided PEG technique is a safe alternative in patients deemed unfit for conventional PEG.

Over-the-scope clip for acute esophageal variceal bleeding.

Over-the-scope clip (OTSC) has been reported to control non-variceal bleeding; however, the use of this device for acute variceal hemorrhage (AVH) is very limited. We report our experience regarding the use of OTSC in patients with AVH in terms of technical success and safety. A retrospective clinical experience case series study was conducted from October 2017 to June 2019 at two tertiary care centers. Adult patients with AVH as a result of small varices managed with OTSC after endoscopic band ligation (EBL) failure were enrolled. Standard gastroscope and OTSC 'type a' with a cap of 11 mm in diameter were used in all procedures. Total of five patients with chronic liver disease (Child-Pugh score ≤8) and portal hypertension (hepatic venous pressure gradient, mean 14.4 ± 1.3 mmHg) were included. Four of them presented collapse of the bleeding varix, and one had wall disruption associated with fibrosis secondary to prior banding. We were able to stop AVH in all patients without clip-related adverse events during a 30-day follow-up period. Two patients developed solid food dysphagia after 3 months of clip deployment that resolved after removal using a bipolar cutting device. Twin grasper or anchor were not used to aid or facilitate the approximation of opposite edges in any patient. No additional local therapies or new endoscopic session for variceal eradication were required. This case series shows preliminary success controlling AVH with OTSC after EBL failure in patients with small varices. Esophageal dysphagia may appear as a complication during follow up but it can be resolved by clip removal.

The current situation of digestive endoscopy units in the Valencian Community.

INTRODUCTION AND OBJECTIVES: in view of the advances made over the past few years, digestive endoscopy units must adapt to an increased demand and the development of novel techniques. However, the actual status of these units is virtually unknown and is limited to few surveys from over a decade ago. Thus, a new survey was performed of the current situation of endoscopy units in the Valencian Community. MATERIAL AND METHODS: a specific survey was designed to assess the status of endoscopy units within public hospitals and privately managed public hospitals in the Valencian Community. The survey included the following items: hospital data, unit architectural structure, equipment, human resources, functional structure, sedation, procedures performed, advanced therapies and ongoing care. RESULTS: twenty-four of the 25 public hospitals or privately funded public hospitals in the Valencian Community responded to the survey, corresponding to a 96% participation. The number of physicians in gastroenterology services or sections ranged from 2 to 21. Endoscopist-controlled propofol sedation was used in 13 hospitals (54.2%). Most centers performed 1,000 to 3,000 gastroscopies per year. Fourteen units (58.3%) performed 2,000 to 3,000 colonoscopies and endoscopic retrograde cholangiopancreatography (ERCP) was performed in 22 hospitals (91.7%). CONCLUSIONS: the results of the survey revealed large differences in infrastructure and organization among public hospital endoscopy units in the Valencian Community. Organization is highly heterogeneous and independent of hospital size.

EUS-FNA cytological material from pancreatic lesions: the expression of cathepsins and its predictive value of malignancy.

AIMS: To assess the expression of cathepsins in pancreatic samples obtained by endoscopic ultrasonography and fine needle aspiration (EUS-FNA) and to investigate their relationship with the staging of the pancreatic ductal adenocarcinoma (PDAC). METHODS: We prospectively included patients with solid pancreatic masses, in which EUS-FNA were performed. Cathepsins B, L, S and H expression was determined in FNA samples. RESULTS: Seventeen FNA were performed. All cytological material was from PDAC. Expression of cathepsins was predominantly low (B 65%, L 23%, S 76%, and H 41%). We found no correlation between the expression levels and the extension of the neoplasm. CONCLUSION: Expression of cathepsins in the cytological material of PDAC is diverse but still poor to be useful in the pre-operative diagnosis. There is no correlation between the expression levels of cathepsins and the extension of the PDAC.

Evaluation of the short- and long-term effectiveness and safety of fully covered self-expandable metal stents for drainage of pancreatic fluid collections: results of a Spanish nationwide registry.

BACKGROUND AND AIMS: Initial reports suggest that fully covered self-expandable metal stents (FCSEMSs) may be better suited for drainage of dense pancreatic fluid collections (PFCs), such as walled-off pancreatic necrosis. The primary aim was to analyze the effectiveness and safety of FCSEMSs for drainage of different types of PFCs in a large cohort. The secondary aim was to investigate which type of FCSEMS is superior. METHODS: This was a retrospective, noncomparative review of a nationwide database involving all hospitals in Spain performing EUS-guided PFC drainage. From April 2008 to August 2013, all patients undergoing PFC drainage with an FCSEMS were included in a database. The main outcome measurements were technical success, short-term (2 weeks) and long-term (6 months) effectiveness, adverse events, and need for surgery. RESULTS: The study included 211 patients (pseudocyst/walled-off pancreatic necrosis, 53%/47%). The FCSEMSs used were straight biliary (66%) or lumen-apposing (34%). Technical success was achieved in 97% of patients (95% confidence interval [CI], 93%-99%). Short-term- and long-term clinical success was obtained in 94% (95% CI, 89%-97%) and 85% (95% CI, 79%-89%) of patients, respectively. Adverse events occurred in 21% of patients (95% CI, 16%-27%): infection (11%), bleeding (7%), and stent migration and/or perforation (3%). By multivariate analysis, patient age (>58 years) and previous failed drainage were the most important factors associated with negative outcome. CONCLUSIONS: An FCSEMS is effective and safe for PFC drainage. Older patients with a history of unsuccessful drainage are more likely to fail EUS-guided drainage. The type of FCSEMS does not seem to influence patient outcome.

Study of the expression of cathepsins in histological material from pancreatic lesions.

BACKGROUND AND AIMS: To assess the expression levels of cathepsins in malignant and premalignant lesions. METHODS: We retrospectively included patients who underwent pancreatic surgery on pancreatic solid or cystic masses. The expression of cathepsin H, L, B and S was determined in both types of samples. Lesions were divided into three categories: malignant (pancreatic adenocarcinoma and malignant mucinous neoplasms), premalignant (mucinous neoplasms) and benign (other lesions). RESULTS: Thirty-one surgical resection samples were studied. The expression of cathepsins was significantly higher in malignant lesions than in premalignant and benign lesions (H 75%, 27%, 37% p = 0.05; L 92%, 36%, 37% p = 0.011; B 83%, 36%, 62% p = 0.069; S 92%, 36%, 25% p = 0.004, respectively). CONCLUSIONS: Cathepsins are overexpressed in histological samples of malignant lesions compared to premalignant and benign lesions. However, the expression of cathepsins is similar in both premalignant and benign lesions.