Endoscopic management of pancreatic collections. Endoscopic Ultrasound Group from the Spanish Society of Digestive Endoscopy (GSEED-USE) Clinical Guidelines.

Acute pancreatitis is associated with significant morbidity and mortality. It can develop complications such as fluid collections and necrosis. Infection of necrosis occurs in about 20-40% of patients with severe acute pancreatitis, and is associated with organ failure and worse prognosis. In the past years, the treatment of pancreatic collections has shifted from open surgery to minimally invasive techniques, such as endoscopic ultrasound guided drainage. These guidelines from a selection of experts among the Endoscopic Ultrasound Group from the Spanish Society of Gastrointestinal Endoscopy (GSEED-USE) have the purpose to provide advice on the management of pancreatic collections based on a thorough review of the available scientific evidence. It also reflects the experience and clinical practice of the authors, who are advanced endoscopists or clinical pancreatologists with extensive experience in managing patients with acute pancreatitis.

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.

Long-term results after EUS gallbladder drainage in high-surgical-risk patients with acute cholecystitis: A 3-year follow-up registry.

Background and study aims Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) has become the favorite drainage option for high surgical-risk patients with acute cholecystitis. However, data on long-term outcomes regarding efficacy and security over 1 year are scarce. Patients and methods We performed a retrospective review of a prospectively maintained database to analyze the 3-year long-term outcomes of EUS-GBD with lumen apposing metal stents (LAMS) in high-surgical-risk patients with acute cholecystitis. Results Fifty patients with acute cholecystitis who underwent EUS-GBD with LAMS and 3-year follow-up or until death were included in this study. No endoscopic revisions were scheduled unless an adverse event (AE) or suspected LAMS dysfunction occurred. AEs occurred in 18%, 20%, and 26% of patients in the first, second, and third years, respectively. Thirteen patients developed at least one AE, and six presented with a second AE during follow-up. Recurrence of cholecystitis occurred in two patients (4%). Seven stent migrations (14%) occurred but all were asymptomatic. Symptomatic LAMS-related AEs (LAMS-RAEs) (37.5%) were related to gastric location of the stent compared with duodenal location (66.7% vs. 12.5%, P = 0.03). No stent-related bleeding or stent-related mortality was observed. Conclusions EUS-GBD with LAMS without scheduled removal is an effective and safe long-term treatment in high-surgical-risk patients with acute cholecystitis. Late LAMS-RAEs tend to be more asymptomatic over time. Symptomatic LAMS-RAEs are associated with gastric location, and overall, AEs tend to recur.

Endoscopic removal of lumen-apposing metal stents - risk factors for stent embedment, complex removals, and adverse events: analysis from a multicenter prospective case series.

BACKGROUND: Removing lumen-apposing metal stents (LAMSs) may be difficult and even harmful, but these features have seldom been analyzed. We aimed to generate a comprehensive assessment of the feasibility and safety of LAMS retrieval procedures. METHODS: A prospective multicenter case series including all technically successfully deployed LAMSs between January 2019 and January 2020 that underwent endoscopic stent removal. All retrieval-related data were prospectively recorded using standardized telephone questionnaires as part of centralized follow-up that ended after stent removal had been performed. Multivariable logistic regression models assessed the potential risk factors for complex removal. RESULTS: For the 407 LAMSs included, removal was attempted in 158 (38.8 %) after an indwell time of 46.5 days (interquartile range [IQR] 31-70). The median (IQR) removal time was 2 (1-4) minutes. Removal was labelled as complex in 13 procedures (8.2 %), although advanced endoscopic maneuvers were required in only two (1.3 %). Complex removal risk factors were stent embedment (relative risk [RR] 5.84, 95 %CI 2.14-15.89; P = 0.001), over-the-wire deployment (RR 4.66, 95 %CI 1.60-13.56; P = 0.01), and longer indwell times (RR 1.14, 95 %CI 1.03-1.27; P = 0.01). Partial and complete embedment were observed in 14 (8.9 %) and five cases (3.2 %), respectively. The embedment rate during the first 6 weeks was 3.1 % (2/65), reaching 15.9 % (10/63) during the following 6 weeks (P = 0.02). The adverse event rate was 5.1 %, including seven gastrointestinal bleeds (5 mild, 2 moderate). CONCLUSIONS: LAMS removal is a safe procedure, mostly requiring basic endoscopic techniques attainable in conventional endoscopy rooms. Referral to advanced endoscopy units should be considered for stents with known embedment or long indwell times, which may require more technically demanding procedures.

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.).

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.

Predictors of adverse events after endoscopic ultrasound-guided through-the-needle biopsy of pancreatic cysts: a recursive partitioning analysis.

BACKGROUND AND STUDY AIMS : Endoscopic ultrasound-guided through-the-needle biopsy (TTNB) of pancreatic cystic lesions (PCLs) is associated with a non-negligible risk for adverse events (AEs). We aimed to identify the hierarchic interaction among independent predictors for TTNB-related AEs and to generate a prognostic model using recursive partitioning analysis (RPA). PATIENTS AND METHODS : Multicenter retrospective analysis of 506 patients with PCLs who underwent TTNB. RPA of predictors for AEs was performed and the model was validated by means of bootstrap resampling. RESULTS : Mean cysts size was 36.7 mm. Most common diagnoses were intraductal papillary mucinous neoplasm (IPMN, 45 %), serous cystadenoma (18.8 %), and mucinous cystadenoma (12.8 %). Fifty-eight (11.5 %) AEs were observed. At multivariate analysis, age (odds ratio [OR] 1.32, 1.09-2.14; p = 0.05), number of TTNB passes (OR from 2.17, 1.32-4.34 to OR 3.16, 2.03-6.34 with the increase of the number of passes), complete aspiration of the cyst (OR 0.56, 0.31-0.95; p = 0.02), and diagnosis of IPMN (OR 4.16, 2.27-7.69; p < 0.001) were found to be independent predictors of AEs, as confirmed by logistic regression and random forest analyses. RPA identified three risk classes: high-risk (IPMN sampled with multiple microforceps passes, 28 % AEs rate), low-risk (1.4 % AE rate, including patients < 64 years with other-than-IPMN diagnosis sampled with ≤ 2 microforceps passes and with complete aspiration of the cyst) and middle-risk class (6.1 % AEs rate, including the remaining patients). CONCLUSION : TTNB should be selectively used in the evaluation of patients with IPMN. The present model could be applied during patient selection as to optimize the benefit/risk of TTNB.

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.

Clinical and technical outcomes of patients undergoing endoscopic ultrasound-guided gastroenterostomy using 20-mm vs. 15-mm lumen-apposing metal stents.

BACKGROUND: Most studies on endoscopic ultrasound (EUS)-guided gastroenterostomy (EUS-GE) for palliation of malignant gastric outlet obstruction (GOO) utilized a 15-mm lumen-apposing metal stent (LAMS). More recently, a 20-mm LAMS has become available. This study aimed to compare rates of technical and clinical success and adverse events (AEs) in patients undergoing EUS-GE using a 20-mm vs. 15-mm LAMS. METHODS: Patients who underwent EUS-GE with 15-mm or 20-mm LAMS for malignant GOO during the period from January 2018 to October 2020 were included. The primary outcome was clinical success, defined as an increase in the gastric outlet obstruction score (GOOS) by at least 1 point during follow-up. Secondary outcomes were technical success, maximum tolerated diet, re-intervention rate, and rate/severity of AEs. RESULTS: 267 patients (mean age 67 years, 43 % women) with malignant GOO from 19 centers underwent EUS-GE. Clinical success rates were similar for the 15-mm and 20-mm stents (89.2 % [95 %CI 84.2 %-94.2 %] vs. 84.1 % [77.4%-90.6 %], respectively). However, a significantly higher proportion of patients in the 20-mm group tolerated a soft solid/complete diet at the end of follow-up (91.2 % [84.4 %-95.7 %] vs. 81.2 % [73.9 %-87.2 %], P = 0.04). Overall, AEs occurred in 33 patients (12.4 % [8.4 %-16.3 %]), with similar rates for 15-mm and 20-mm stents (12.8 % [7.5 %-18.2 %] vs. 11.8 % [6 %-17.6 %]), including incidence of severe/fatal AEs (2 % [0.4 %-5.8 %] vs. 3.4 % [0.9 %-8.4 %]). CONCLUSIONS: The 20-mm and 15-mm LAMS show similar safety and efficacy for patients undergoing EUS-GE for malignant GOO. The 20-mm LAMS allows a more advanced diet and is, thus preferred for EUS-GE.

Head-to-head comparison between endoscopic ultrasound guided lumen apposing metal stent and plastic stents for the treatment of pancreatic fluid collections: A systematic review and meta-analysis.

BACKGROUND/AIMS: Peripancreatic fluid collections (PFCs) result from acute or chronic pancreatic inflammation that suffers a rupture of its ducts. Currently, there exists three options for drainage or debridement of pancreatic pseudocysts and walled-off necrosis (WON). The traditional procedure is drainage by placing double pigtail plastic stents (DPPS); lumen-apposing metal stent (LAMS) has a biflanged design with a wide lumen that avoids occlusion with necrotic tissue, which is more common with DPPS and reduces the possibility of migration. We performed a systematic review and meta-analyses head-to-head, including only studies that compare the two main techniques to drainage of PFCs: LAMS vs DPPS. METHODS: We conducted a systematic review in different databases, such as PubMed, OVID, Medline, and Cochrane Databases. This meta-analysis considers studies published from 2014 to 2020, including only studies that compare the two main techniques to drainage of PFCs: LAMS vs DPPS. RESULTS: Thirteen studies were included in the meta-analyses. Only one of all studies was a randomized controlled trial. These studies comprise 1584 patients; 68.2% were male, and 31.8% were female. Six hundred sixty-three patients (41.9%) were treated with LAMS, and 921 (58.1%) were treated with DPPS. Six studies included only WON in their analysis, two included only pancreatic pseudocysts, and five studies included both pancreatic pseudocysts and WON. The technical success was similar in patients treated with LAMS and DPPS (97.6% vs 97.5%, respectively, P = .986, RR = 1.00 [95% CI 0.93-1.08]). The clinical success was similar in both groups (LAMS: 90.1% vs DPPS: 84.2%, P = .139, RR = 1.063 [95% CI 0.98-1.15]). Patients treated with LAMS had a lower complication rate than the DPPS groups, with a significant statistical difference (LAMS: 16.0% vs DPPS: 20.2%, P = .009, RR = 0.746 [95% CI 0.60-0.93]). Bleeding was the most common complication in the LAMS group (33 patients, [5.0%]), whereas infection was the most common complication in the DPPS group (56 patients, [6.1%]). The LAMS migration rate was lower than in the DPPS (0.9% vs 2.2%, respectively, P = .05). The mortality rate was similar in both groups, 0.6% in the LAMS group (four patients) and 0.4% in the DPPS group (four patients; P = .640). CONCLUSION: The PFCs drainage is an indication when persistent symptoms or PFCs-related complications exist. EUS guided drainage with LAMS has similar technical and clinical success to DPPS drainage for the management of PFCs. The technical and clinical success rates are high in both groups. However, LAMS drainage has a lower adverse events rate than DPPS drainage. More randomized controlled trials are needed to confirm the real advantage of LAMS drainage over DPPS drainage.

Classification, outcomes, and management of misdeployed stents during EUS-guided gastroenterostomy.

BACKGROUND AND AIMS: Stent misdeployment (SM) has hindered the dissemination of EUS-guided gastroenterostomy (EUS-GE) for gastric outlet obstruction (GOO) management. We aimed to provide a classification system for SM during EUS-GE and study clinical outcomes and management accordingly. METHODS: This is a retrospective study involving 16 tertiary care centers (8 in the United States, 8 in Europe) from March 2015 to December 2020. Patients who developed SM during EUS-GE for GOO were included. We propose classifying SM into 4 types. The primary outcome was rate and severity of SM (per American Society for Gastrointestinal Endoscopy lexicon), whereas secondary outcomes were clinical outcomes and management of dislodgement according to the SM classification type, in addition to salvage management of GOO after SM. RESULTS: From 467 EUS-GEs performed for GOO during the study period, SM occurred in 46 patients (9.85%). Most SMs (73.2%) occurred during the first 13 EUS-GE cases by the performing operators. SM was graded as mild (n = 28, 60.9%), moderate (n = 11, 23.9%), severe (n = 6, 13.0%), or fatal (n = 1, 2.2%), with 5 patients (10.9%) requiring surgical intervention. Type I SM was the most common (n = 29, 63.1%), followed by type II (n = 14, 30.4%), type IV (n = 2, 4.3%), and type III (n = 1, 2.2%). Type I SM was more frequently rated as mild compared with type II SM (75.9% vs 42.9%, P = .04) despite an equivalent rate of surgical repair (10.3% vs 7.1%, P = .7). Overall, 4 patients (8.7%) required an intensive care unit stay (median, 2.5 days). The median length of stay was 4 days after SM. CONCLUSIONS: Although SM is not infrequent during EUS-GE, most are type I, mild/moderate in severity, and can be managed endoscopically with a surgical intervention rate of approximately 11%.

Transpancreatic precut papillotomy versus double-guidewire technique in difficult biliary cannulation: a systematic review and meta-analysis.

Background and study aims Approximately 11 % of biliary cannulations are considered difficult. The double guidewire (DGW-T) and transpancreatic sphincterotomy (TPS) are two useful techniques when difficult cannulation exists and the main pancreatic duct is unintentionally accessed. We carried out a systematic review and meta-analysis to evaluate the effectiveness and security of both DGW-T and TPS techniques in difficult biliary cannulation. Methods We conducted a systematic review in different databases, such as PubMed, OVID, Medline, and Cochrane Databases. Were included all RCT which showed a comparison between TPS and DGW in difficult biliary cannulation. Endpoints computed were successful cannulation rate, median cannulation time, and adverse events rate. Results Four studies were selected (4 RCTs). These studies included 260 patients. The mean age was 64.79 ±â€Š12.99 years. Of the patients, 53.6 % were men and 46.4 % were women. The rate of successful cannulation was 93.3 % in the TPS group and 79.4 % in the DGW-T group ( P  = 0.420). The rate of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) was lower in patients who had undergone TPS than DGW-T (TPS: 8.9 % vs DGW-T: 22.2 %, P  = 0.02). The mean cannulation time was 14.7 ±â€Š9.4 min in the TPS group and 15.1 ±â€Š7.4 min with DGW-T ( P  = 0.349). Conclusions TPS and DGW are two useful techniques in patients with difficult cannulation. They both have a high rate of successful cannulation; however, the PEP was higher with DGW-T than with TPS.

Per-oral pancreatoscopy-guided lithotripsy for the endoscopic management of pancreatolithiasis: A systematic review and meta-analysis.

OBJECTIVE: Pancreatic stones result from chronic pancreatitis and can occur in the main pancreatic duct, pancreatic branches or parenchyma. Although extracorporeal shock wave lithotripsy (ESWL) is considered the first-line treatment, per-oral pancreatoscopy (POP) has emerged as a useful method for treating pancreatic stones. The aim of this systematic review and meta-analysis was to determine the efficacy and safety of POP-guided lithotripsy, electrohydraulic lithotripsy (EHL) and laser lithotripsy (LL), in patients with pancreatolithiasis. METHODS: Literature review was conducted in PubMed, OVID, MEDLINE and Cochrane Library databases for studies published up to August 2020. RESULTS: Altogether 15 studies were analyzed, of which 11 were retrospective and four were prospective. The studies comprised 370 patients, of whom 66.4% were male. The patients underwent 218 EHL and 155 LL. The pooled technical and clinical success rate of the overall POP was 88.1% and 87.1%. For EHL-POP, the pooled technical success rate was 90.9% (95% CI 87.2%-95.2%) and the pooled clinical success rate was 89.8% (95% CI 87.2%-95.2%). While for LL-POP, the pooled technical and clinical success rate was 88.4% (95% CI 85.9%-95.1%) and 85.8% (95% CI 80.6%-91.6%). In total 43 adverse events occurred (12.1%; 95% CI 8.7%-15.5%). CONCLUSION: POP-guided lithotripsy has a high rate of technical and clinical success for managing pancreatolithiasis with a low complication rate. Both EHL-POP and LL-POP achieve similar efficacy in the endoscopic therapy of pancreatolithiasis. Further large randomized controlled trials are needed to compare EHL-POP and LL-POP with ESWL and evaluate whether POP may replace ESWL as the first-line management of pancreatolithiasis.