Digital single-operator cholangioscopy interobserver study using a new classification: the Mendoza Classification (with video).

BACKGROUND AND AIMS: Digital single-operator cholangioscopy (DSOC) allows direct visualization of the biliary tree for evaluation of biliary strictures. Our objective was to assess the interobserver agreement (IOA) of DSOC interpretation for indeterminate biliary strictures using newly refined criteria. METHODS: Fourteen endoscopists were asked to review an atlas of reference clips and images of 5 criteria derived from expert consensus. They then proceeded to score 50 deidentified DSOC video clips based on the visualization of tortuous and dilated vessels, irregular nodulations, raised intraductal lesions, irregular surface with or without ulcerations, and friability. The endoscopists then diagnosed the clips as neoplastic or non-neoplastic. Intraclass correlation (ICC) analysis was done to evaluate inter-rater agreement for both criteria sets and final diagnosis. RESULTS: Clips of 41 malignant lesions and 9 benign lesions were scored. Three of 5 revised criteria had almost perfect agreement. ICC was almost perfect for presence of tortuous and dilated vessels (.86), raised intraductal lesions (.90), and presence of friability (.83); substantial agreement for presence of irregular nodulations (.71); and moderate agreement for presence of irregular surface with or without ulcerations (.44). The diagnostic ICC was almost perfect for neoplastic (.90) and non-neoplastic (.90) diagnoses. The overall diagnostic accuracy using the revised criteria was 77%, ranging from 64% to 88%. CONCLUSIONS: The IOA and accuracy rate of DSOC using the new Mendoza criteria shows a significant increase of 16% and 20% compared with previous criteria. The reference atlas helps with formal training and may improve diagnostic accuracy. (Clinical trial registration number: NCT02166099.).

Learning Curve for Endoscopic Submucosal Dissection With an Untutored, Prevalence-Based Approach in the United States.

BACKGROUND & AIMS: Endoscopic submucosal dissection (ESD) is widely used in Asia to resect early-stage gastrointestinal neoplasms, but use of ESD in Western countries is limited. We collected data on the learning curve for ESD at a high-volume referral center in the United States to guide development of training programs in the Americas and Europe. METHODS: We performed a retrospective analysis of consecutive ESDs performed by a single operator at a high-volume referral center in the United States from 2009 through 2017. ESD was performed in 540 lesions: 449 mucosal (10% esophageal, 13% gastric, 5% duodenal, 62% colonic, and 10% rectal) and 91 submucosal. We estimated case volumes required to achieve accepted proficiency benchmarks (>90% for en bloc resection and >80% for histologic margin-negative (R0) resection) and resection speeds >9cm2/hr. RESULTS: Pathology analysis of mucosal lesions identified 95 carcinomas, 346 premalignant lesions, and 8 others; the rate of en bloc resection increased from 76% in block 1 (50 cases) to a plateau of 98% after block 5 (250 cases). The rate of R0 resection improved from 45% in block 1 to >80% after block 5 (250 cases) and ∼95% after block 8 (400 cases). Based on cumulative sum analysis, approximately 170, 150, and 280 ESDs are required to consistently achieve a resection speed >9cm2/hr in esophagus, stomach, and colon, respectively. CONCLUSIONS: In an analysis of ESDs performed at a large referral center in the United States, we found that an untutored, prevalence-based approach allowed operators to achieve all proficiency benchmarks after ∼250 cases. Compared with Asia, ESD requires more time to learn in the West, where the untutored, prevalence-based approach requires resection of challenging lesions, such as colon lesions and previously manipulated lesions, in early stages of training.

Endoscopic suturing for the prevention of stent migration in benign upper gastrointestinal conditions: a comparative multicenter study.

BACKGROUND AND STUDY AIMS: Fully covered self-expandable metal stents (FCSEMSs) have increasingly been used in benign upper gastrointestinal (UGI) conditions; however, stent migration remains a major limitation. Endoscopic suture fixation (ESF) may prevent stent migration. The aims of this study were to compare the frequency of stent migration in patients who received endoscopic suturing for stent fixation (ESF group) compared with those who did not (NSF group) and to assess the impact of ESF on clinical outcome. PATIENTS AND METHODS: This was a retrospective study of patients who underwent FCSEMS placement for benign UGI diseases. Patients were divided into either the NSF or ESF group. Outcome variables, including stent migration, clinical success (resolution of underlying pathology), and adverse events, were compared. RESULTS: A total of 125 patients (44 in ESF group, 81 in NSF group; 56 benign strictures, 69 leaks/fistulas/perforations) underwent 224 stenting procedures. Stent migration was significantly more common in the NSF group (33 % vs. 16 %; P = 0.03). Time to stent migration was longer in the ESF group (P = 0.02). ESF appeared to protect against stent migration in patients with a history of stent migration (adjusted odds ratio [OR] 0.09; P = 0.002). ESF was also significantly associated with a higher rate of clinical success (60 % vs. 38 %; P = 0.03). Rates of adverse events were similar between the two groups. CONCLUSIONS: Endoscopic suturing for stent fixation is safe and associated with a decreased migration rate, particularly in patients with a prior history of stent migration. It may also improve clinical response, likely because of the reduction in stent migration.

A Large Multicenter Experience With Endoscopic Suturing for Management of Gastrointestinal Defects and Stent Anchorage in 122 Patients: A Retrospective Review.

GOALS: To describe a multicenter experience using an endoscopic suturing device for management of gastrointestinal (GI) defects and stent anchorage. BACKGROUND: Endoscopic closure of GI defects including perforations, fistulas, and anastomotic leaks as well as stent anchorage has improved with technological advances. An endoscopic suturing device (OverStitch; Apollo Endosurgery Inc.) has been used. STUDY: Retrospective study of consecutive patients who underwent endoscopic suturing for management of GI defects and/or stent anchorage were enrolled between March 2012 and January 2014 at multiple academic medical centers. Data regarding demographic information and outcomes including long-term success were collected. RESULTS: One hundred and twenty-two patients (mean age, 52.6 y; 64.2% females) underwent endoscopic suturing at 8 centers for stent anchorage (n=47; 38.5%), fistulas (n=40; 32.7%), leaks (n=15; 12.3%), and perforations (n=20; 16.4%). A total of 44.2% underwent prior therapy and 97.5% achieved technical success. Immediate clinical success was achieved in 79.5%. Long-term clinical success was noted in 78.8% with mean follow-up of 68 days. Clinical success was 91.4% in stent anchorage, 93% in perforations, 80% in fistulas, but only 27% in anastomotic leak closure. CONCLUSIONS: Endoscopic suturing for management of GI defects and stent anchoring is safe and efficacious. Stent migration after stent anchoring was reduced compared with published data. Long-term success without further intervention was achieved in the majority of patients. The role of endoscopic suturing for repair of anastomotic leaks remains unclear given limited success in this retrospective study.

Endoscopic gallbladder drainage compared with percutaneous drainage.

BACKGROUND: High-risk patients with cholecystitis have conventionally been offered percutaneous gallbladder drainage (PGBD) for treatment. A growing experience of endoscopic gallbladder drainage (EGBD) has been reported to be effective and safe. OBJECTIVE: To compare the short- and long-term outcomes of EGBD and PGBD. DESIGN: A retrospective review. SETTING: Single academic tertiary care center. PATIENTS: Inpatients diagnosed with cholecystitis. INTERVENTIONS: Any patient deemed a nonsurgical candidate and who has undergone either PGBD or EGBD was included in the analysis. MAIN OUTCOME MEASUREMENTS: Patient demographics along with procedural and clinical outcomes were recorded for each group. RESULTS: Forty-three patients underwent PGBD and 30 underwent EGBD (24 transpapillary, 6 transmural). Technical (97.6% vs 100%) and clinical (97.6% vs 86.7%) success rates of PGBD and EGBD were similar. However, postprocedure hospital length of stay (16.3 vs 7.6 days), time to clinical resolution (4.6 vs 3.0 days), adverse event rate (39.5% vs 13.3%), number of sessions (2.0 vs 1.0), number of repeat interventions (53.4% vs 13.3%), and postprocedure pain scores (3.8 vs 2.1) were significantly higher for PGBD than EGBD. LIMITATIONS: Retrospective analysis. CONCLUSION: Although EGBD has similar technical and clinical success compared with PGBD, it uses fewer hospital resources and results in fewer adverse events, improved pain scores, and decreased need for repeat gallbladder drainage. EGBD may provide a less-invasive, safer, cost-effective option for gallbladder drainage than PGBD with improved clinical outcomes.

Endoscopic ultrasound-directed transgastric ERCP (EDGE) for Roux-en-Y anatomy: a novel technique.

BACKGROUND: Patients with Roux-en-Y gastric bypass (RYGB) anatomy pose challenges when endoscopic retrograde cholangiopancreatography (ERCP) is required. Deep enteroscopy-assisted ERCP can allow pancreaticobiliary intervention in these patients, but with limited success. This case series describes endoscopic ultrasound-directed transgastric ERCP (EDGE) for patients following RYGB. METHODS: Patients with RYGB anatomy undergoing EDGE at a tertiary care center were included in this prospective single-arm feasibility study. All procedures were performed in two stages. First a 16-Fr percutaneous endoscopic gastrostomy (PEG) was placed in the excluded stomach using endoscopic ultrasound (EUS) guidance. Second, ERCP was performed through the newly fashioned gastrostomy and a transcutaneous fully covered metal esophageal stent. RESULTS: Six patients (5 women, 1 man) with RYGB anatomy underwent EDGE. EUS-guided PEG placement was successful in all six patients (100 %). Antegrade ERCP was successful in all six patients (100 %) with the stages being separated by a mean of 5.8 days. The mean procedure times for the two stages were 81 minutes and 98 minutes. Two patients (33 %) had localized PEG site infections that were managed with oral antibiotics. There were no adverse events related to ERCP. CONCLUSIONS: EDGE is both feasible and safe to perform in RYGB patients. Given the high success rates of our recent experience, we suspect that this technique can be performed as a one-stage procedure to provide a cost-effective, minimally invasive option for a common problem in a growing patient population.

Esophageal Stenting With Sutures: Time to Redefine Our Standards?

BACKGROUND AND STUDY AIMS: Migration is the most common complication of the fully covered metallic self-expanding esophageal stent (FCSEMS). Recent studies have demonstrated migration rates between 30% and 60%. The aim of this study was to determine the effect of fixation of the FCSEMS by endoscopic suturing on migration rate. PATIENT AND METHODS: Patients who underwent stent placement for esophageal strictures and leaks over the last year were captured and reviewed retrospectively. Group A, cases, were patients who underwent suture placement and group B, controls, were patients who had stents without sutures. Basic demographics, indications, and adverse events (AEs) were collected. Kaplan-Meier analysis and Cox regression modeling were conducted to determine estimates and predictors of stent migration in patients with and without suture placement. RESULTS: Thirty-seven patients (18 males, 48.65%), mean age 57.2 years (±16.3 y), were treated with esophageal FCSEMS. A total of 17 patients received sutures (group A) and 20 patients received stents without sutures (group B). Stent migration was noted in a total of 13 of the 37 patients (35%) [2 (11%) in group A and 11 (55%) in group B]. Using Kaplan-Meier analysis and log-rank analysis, fixation of the stent with suturing reduced the risk of migration (P=0.04). There were no AEs directly related to suture placement. CONCLUSIONS: Anchoring of the upper flare of the FCSEMS with endoscopic sutures is technically feasible and significantly reduces stent migration rate when compared with no suturing, and is a safe procedure with very low AEs rates.

Impact of Radiofrequency Ablation on Malignant Biliary Strictures: Results of a Collaborative Registry.

BACKGROUND: Radiofrequency ablation of malignant biliary strictures has been offered for the last 3 years, but only limited data have been published. AIM: To assess the safety, efficacy, and survival outcomes of patients receiving endoscopic radiofrequency ablation. METHODS: Between April 2010 and December 2013, 69 patients with unresectable neoplastic lesions and malignant biliary obstruction underwent 98 radiofrequency ablation sessions with stenting. RESULTS: A total of 69 patients (22 male, aged 66.1 ± 13.3) were included in the registry. The etiology of malignant biliary stricture included unresectable cholangiocarcinoma (n = 45), pancreatic cancer (n = 19), gallbladder cancer (n = 2), gastric cancer (n = 1), and liver metastasis from colon cancer (n = 3). Seventy-eight percentage of patients had prior chemotherapy. All strictures were stented post-radiofrequency ablation with either plastic stents or metal stents. The mean stricture length treated was 14.3 mm. There was a statistically significant improvement in stricture diameter post-ablation (p < 0.0001). The likelihood of stricture improvement was significantly greater in pancreatic cancer-associated strictures [RR 1.8 (95 % 1.03-5.38)]. Seven patients (10 %) had adverse events, not linked directly to radiofrequency ablation. Median survival was 11.46 months (6.2-25 months). CONCLUSION: Radiofrequency ablation is effective and safe in malignant biliary obstruction and seems to be associated with improved survival.

Pancreatic necrosectomy using covered esophageal stents: a novel approach.

BACKGROUND: Endoscopic necrosectomy for necrotizing pancreatitis has been increasingly used as an alternative to surgical or percutaneous interventions. The use of fully covered esophageal self-expandable metallic stents may provide a safer and more efficient route for internal drainage. The aim of this study was to evaluate the safety and efficacy of endoscopic treatment of pancreatic necrosis with these stents. METHODS: A retrospective study at 2 US academic hospitals included patients with infected pancreatic necrosis from July 2009 to November 2012. These patients underwent transgastric placement of fully covered esophageal metallic stents draining the necrosis. After necrosectomy, patients underwent regular sessions of endoscopic irrigation and debridement of cystic contents. The efficacy endpoint was successful resolution of infected pancreatic necrosis without the need for surgical or percutaneous interventions. RESULTS: Seventeen patients were included with the mean age of 41±12 years. A mean of 5.3±3.4 sessions were required for complete drainage and the follow-up period was 237.6±165 days. Etiology included gallstone pancreatitis (6), alcohol abuse (6), s/p distal pancreatectomy (2), postendoscopic retrograde cholangiopancreatography pancreatitis (1), medication-induced pancreatitis (1), and hyperlipidemia (1). Mean size of the necrosis was 14.8 cm (SD 5.6 cm), ranging from 8 to 19 cm. Two patients failed endoscopic intervention and required surgery. The only complication was a perforation during tract dilation, which was managed conservatively. Fifteen patients (88%) achieved complete resolution. CONCLUSIONS: Endoscopic necrosectomy with covered esophageal metal stents is a safe and successful treatment option for infected pancreatic necrosis.

Comparison of metal stenting with radiofrequency ablation versus stenting alone for treating malignant biliary strictures: is there an added benefit?

BACKGROUND: Radiofrequency ablation (RFA) has been reported to be a beneficial treatment option for palliation of malignant biliary strictures. Biliary obstruction is a common complication in pancreatic and cholangiocarcinoma and many patients require stenting for definitive decompression. The objective of this study was to compare the survival duration of patients as well as safety and efficacy of RFA and metal stent versus stent alone. METHODS: A prospectively established database was analyzed retrospectively and extracted 64 patients with malignant biliary strictures. Patients who underwent RFA with metal stenting were compared to those who were treated conventionally with metal stenting alone. The groups were matched on age, diagnosis, performance status, and palliative chemotherapy. Immediate and 30-day adverse events were recorded. Survival and Cox proportional hazard analyses were calculated. RESULTS: RFA and control groups were closely matched in terms of age (65.5 ± 13.4 vs. 66.8 ± 12.16 years, p = 0.069) and diagnosis [cholangiocarcinoma (36) and pancreatic cancer (28)]. Technical success rate for both groups was 100 %. Multivariable Cox proportional regression analysis showed RFA to be an independent predictor of survival [HR 0.29 (0.11-0.76), p = 0.012] as well as age and receipt of chemotherapy [HR 1.04 (1.01-1.07), p = 0.011; HR 0.26 (0.10-0.70), p = 0.007]. Overall self-expanding metal stent patency rates were the same across both groups. CONCLUSION: RFA appears to improve survival in patients with end-stage cholangiocarcinoma and pancreatic cancer. In a disease with limited treatment options, this modality may prove to be beneficial compared to stenting alone. Randomized controlled trials and evaluation of quality of life measures should be performed to confirm these findings.

Endoscopic ultrasound-guided endoluminal drainage of the gallbladder.

For patients with acute cholecystitis who are not suitable for surgery, endoscopic ultrasound-guided endoluminal drainage of the gallbladder (EUS-GBD) has been developed to overcome the limitations of percutaneous transhepatic gallbladder drainage when endoscopic transpapillary gallbladder drainage is not feasible. In the present review we have summarized the studies describing EUS-GBD. Indications, techniques, accessories, endoprostheses, limitations and complications reported in the different studies are discussed. There were 90 documented cases in the literature. The overall reported technical success rate was 87/90 (96.7%). All patients with technical success were clinically successful. A total of 11/90 (12.2%) patients had complications including pneumoperitoneum, bile peritonitis and stent migration. The advantage of EUS-GBD is its ability to provide gallbladder drainage especially in situations where percutaneous or transpapillary drainage is not feasible or is technically challenging. It also provides the option of internal drainage and the ability to carry out therapeutic maneuvers via cholecystoscopy.

Endoscopic ultrasonography-guided cholecystogastrostomy in patients with unresectable pancreatic cancer using anti-migratory metal stents: a new approach.

Cholecystectomy is contraindicated in patients with comorbidities or unresectable cancer. Percutaneous transhepatic gallbladder drainage (PTGBD) is typically offered with response rates ranging from 56% to 100%, but has several risks such as bleeding, pneumothorax, pneumoperitoneum, bile leak, and/or catheter migration. Endoscopic transpapillary gallbladder drainage (ETGD) and endoscopic ultrasound-guided transmural gallbladder drainage (EUS-GBD) are alternative endoscopic modalities that have a technical feasibility, efficacy and safety profile comparable with PTGBD. In this report, we present the first case series of transgastric EUS-GBD with placement of a fully covered self-expandable metal stent with anti-migratory fins. In three pancreatic cancer cases with acute cholecystitis when ETGD was unsuccessful, there were no bile leaks or procedurally related complications. There were no acute cholecystitis recurrences. In conclusion, EUS-GBD is a promising, minimally invasive treatment for acute cholecystitis. Additional comparative studies are needed to validate the benefit of this technique.

Enhanced Complement Expression in the Tumor Microenvironment Following Neoadjuvant Therapy: Implications for Immunomodulation and Survival in Pancreatic Ductal Adenocarcinoma.

Background: Neoadjuvant therapy (NAT) is increasingly being used for pancreatic ductal adenocarcinoma (PDAC) treatment. However, its specific effects on carcinoma cells and the tumor microenvironment (TME) are not fully understood. This study aims to investigate how NAT differentially impacts PDAC's carcinoma cells and TME. Methods: Spatial transcriptomics was used to compare gene expression profiles in carcinoma cells and the TME between 23 NAT-treated and 13 NAT-naïve PDAC patients, correlating with their clinicopathologic features. Analysis of an online single-nucleus RNA sequencing (snRNA-seq) dataset was performed for validation of the specific cell types responsible for NAT-induced gene expression alterations. Results: NAT not only induces apoptosis and inhibits proliferation in carcinoma cells but also significantly remodels the TME. Notably, NAT induces a coordinated upregulation of multiple key complement genes (C3, C1S, C1R, C4B and C7) in the TME, making the complement pathway one of the most significantly affected pathways by NAT. Patients with higher TME complement expression following NAT exhibit improved overall survival. These patients also exhibit increased immunomodulatory and neurotrophic cancer-associated fibroblasts (CAFs); more CD4+ T cells, monocytes, and mast cells; and reduced immune exhaustion gene expression. snRNA-seq analysis demonstrates C3 complement was specifically upregulated in CAFs but not in other stroma cell types. Conclusions: NAT can enhance complement production and signaling within the TME, which is associated with reduced immunosuppression in PDAC. These findings suggest that local complement dynamics could serve as a novel biomarker for prognosis, evaluating treatment response and resistance, and guiding therapeutic strategies in NAT-treated PDAC patients.

EUS-guided biliary drainage by using a standardized approach for malignant biliary obstruction: rendezvous versus direct transluminal techniques (with videos).

BACKGROUND: EUS-guided biliary drainage (EGBD) can be performed via direct transluminal or rendezvous techniques. It is unknown how both techniques compare in terms of efficacy and adverse events. OBJECTIVE: To describe outcomes of EGBD performed by using a standardized approach and compare outcomes of rendezvous and transluminal techniques. DESIGN: Retrospective analysis of prospectively collected data. SETTING: Two tertiary-care centers. PATIENTS: Consecutive jaundiced patients with distal malignant biliary obstruction who underwent EGBD after failed ERCP between July 2006 and December 2012 were included. INTERVENTION: EGBD by using a standardized algorithm. MAIN OUTCOME MEASUREMENTS: Technical success, clinical success, and adverse events. RESULTS: During the study period, 35 patients underwent EGBD (rendezvous n = 13, transluminal n = 20). Technical success was achieved in 33 patients (94%), and clinical success was attained in 32 of 33 patients (97.0%). The mean postprocedure bilirubin level was 1.38 mg/dL in the rendezvous group and 1.33 mg/dL in the transluminal group (P = .88). Similarly, length of hospital stay was not different between groups (P = .23). There was no significant difference in adverse event rate between rendezvous and transluminal groups (15.4% vs 10%; P = .64). Long-term outcomes were comparable between groups, with 1 stent migration in the rendezvous group at 62 days and 1 stent occlusion in the transluminal group at 42 days after EGBD. LIMITATIONS: Retrospective analysis, small number of patients, and selection bias. CONCLUSION: EGBD is safe and effective when the described standardized approach is used. Stent occlusion is not common during long-term follow-up. Both rendezvous and direct transluminal techniques seem to be equally effective and safe. The latter approach is a reasonable alternative to rendezvous EGBD.

Management of severe acute pancreatitis in 2019.

Pancreatic fluid collections (PFCs) are frequent complications in severe acute pancreatitis that are the result of damage to the pancreas to include but not limited to trauma, surgery, autoimmune diseases, alcohol abuse, infections, medications, gallstones, metabolic disorders, and premalignant or malignant conditions. The majority of these collections resolve spontaneously; however, if the collection is infected or causes symptoms to include abdominal pain, nausea, vomiting, diarrhea, fevers, and tachycardia, drainage is indicated. Drainage of PFCs can be accomplished surgically, percutaneously, or endoscopically and should be approached in a multidisciplinary fashion for best overall patient care and outcomes. Before the introduction of endoscopic procedures, surgical and percutaneous drainage was the preferred modality. Today a minimally-invasive "step-up" approach is generally accepted depending upon the specific characteristics of the PFC and clinical presentation. Endoscopic ultrasound-guided PFC drainage is favored due to high success rates, shorter hospital stays, and lower cost. Direct debridement of walled-off pancreatitis can now be performed endoscopically with higher success rates with larger caliber fully covered metal stents. At large, the field of endoscopic techniques has evolved, and more specifically, the management of PFCs continues to evolve with increasing experience and with the advent of new stents and accessories, leading to increased efficacy with less adverse events.

EUS guided gallbladder drainage.

Cholecystectomy is the gold standard treatment for acute cholecystitis, but it may not be appropriate for patients with significant comorbidities. Percutaneous gallbladder drainage (PT-GBD) and endoscopic transpapillary gallbladder drainage (ET-GBD) are alternatives with good technical and clinical success rates, but are limited by technical challenges and the need for definitive therapy. EUS-guided gallbladder drainage (EUS-GBD) is quickly becoming the preferred modality of treatment at expert centers in this cohort of patients due to increased efficacy and minimal adverse events. Technicalities of the procedure, including selection of access site, should be informed by the ultimate needs and anatomy of each patient. With the evolution of new stents and accessories, including a cautery-enhanced lumen apposing metal stent deployment system, success rates and adverse events are favorable. A review of published case series demonstrates an overall clinical success rate of approximately 97% for EUS-GBD. The most common complication is pneumoperitoneum, so the evolution of self-expanding LAMS is promising. EUS-GBD has been successfully described in cases where definitive therapy or a bridge to cholecystectomy is needed. As the procedure's applications continue to evolve, there should be greater discussion about specific details including access site and stent selection.

Fully-covered metal stents with endoscopic suturing vs. partially-covered metal stents for benign upper gastrointestinal diseases: a comparative study.

BACKGROUND AND STUDY AIMS: Self-expandable metallic stents (SEMS) have been increasingly used in benign conditions (e. g. strictures, fistulas, leaks, and perforations). Fully covered SEMS (FSEMS) were introduced to avoid undesirable consequences of partially covered SEMS (PSEMS), but come with higher risk of stent migration. Endoscopic suturing (ES) for stent fixation has been shown to reduce migration of FSEMS. Our aim was to compare the outcomes of FSEMS with ES (FS/ES) versus PSEMS in patients with benign upper gastrointestinal conditions. PATIENTS AND METHODS: We retrospectively identified all patients who underwent stent placement for benign gastrointestinal conditions at seven US tertiary-care centers. Patients were divided into two groups: FSEMS with ES (FS/ES group) and PSEMS (PSEMS group). Clinical outcomes between the two groups were compared. RESULTS: A total of 74 (FS/ES 46, PSEMS 28) patients were included. On multivariable analysis, there was no significant difference in rate of stent migration between FS/ES (43 %) and PSEMS (15 %) (adjusted odds ratio 0.56; 95 % CI 0.15 - 2.00). Clinical success was similar [68 % vs. 64 %; P  = 0.81]. Rate of adverse events (AEs) was higher in PSEMS group [13 (46 %) vs. 10 (21 %); P  = 0.03). Difficult stent removal was higher in the PSEMS group (n = 5;17 %) vs. 0 % in the FS/ES group; P  = 0.005. CONCLUSIONS: The proportion of stent migration of FS/ES and PSEMS are similar. Rates of other stent-related AEs were higher in the PSEMS group. PSEMS was associated with tissue ingrowth or overgrowth leading to difficult stent removal, and secondary stricture formation. Thus, FSEMS with ES for stent fixation may be the preferred modality over PSEMS for the treatment of benign upper gastrointestinal conditions.