Long-Term Outcomes of the Excluded Rectum in Crohn's Disease: A Multicenter International Study.

BACKGROUND: Many patients with Crohn's disease (CD) require fecal diversion. To understand the long-term outcomes, we performed a multicenter review of the experience with retained excluded rectums. METHODS: We reviewed the medical records of all CD patients between 1990 and 2014 who had undergone diversionary surgery with retention of the excluded rectum for at least 6 months and who had at least 2 years of postoperative follow-up. RESULTS: From all the CD patients in the institutions' databases, there were 197 who met all our inclusion criteria. A total of 92 (46.7%) of 197 patients ultimately underwent subsequent proctectomy, while 105 (53.3%) still had retained rectums at time of last follow-up. Among these 105 patients with retained rectums, 50 (47.6%) underwent reanastomosis, while the other 55 (52.4%) retained excluded rectums. Of these 55 patients whose rectums remained excluded, 20 (36.4%) were symptom-free, but the other 35 (63.6%) were symptomatic. Among the 50 patients who had been reconnected, 28 (56%) were symptom-free, while 22(44%) were symptomatic. From our entire cohort of 197 cases, 149 (75.6%) either ultimately lost their rectums or remained symptomatic with retained rectums, while only 28 (14.2%) of 197, and only 4 (5.9%) of 66 with initial perianal disease, were able to achieve reanastomosis without further problems. Four patients developed anorectal dysplasia or cancer. CONCLUSIONS: In this multicenter cohort of patients with CD who had fecal diversion, fewer than 15%, and only 6% with perianal disease, achieved reanastomosis without experiencing disease persistence.

Patients with distal Crohn's disease often undergo colon resection with a stoma to divert the intestinal stream from the rectum in hopes of achieving sufficient healing to allow ultimate re-establishment of intestinal continuity. Patients and practitioners alike should be aware of the long-term success rates of this procedure. Our retrospective study of 197 patients found that half required later proctectomy and an additional one-quarter remained symptomatic with excluded rectums. Only 14% remained symptom-free after reanastomosis, and only 6% if perianal disease was the initial surgical indication. These data provide estimation of long-term surgical outcomes.

Clinical Outcomes of Covid-19 in Patients With Inflammatory Bowel Disease: A Nationwide Cohort Study.

BACKGROUND AND AIMS: The COVID-19 risk and disease course in inflammatory bowel disease [IBD] patients remains uncertain. Therefore, we aimed to assess the clinical presentation, disease course, and outcomes of COVID-19 in IBD patients. Second, we determined COVID-19 incidences in IBD patients and compared this with the general population. METHODS: We conducted a multicentre, nationwide IBD cohort study in The Netherlands and identified patients with COVID-19. First, we assessed the COVID-19 disease course and outcomes. Second, we compared COVID-19 incidences between our IBD study cohort and the general Dutch population. RESULTS: We established an IBD cohort of 34 763 patients. COVID-19 was diagnosed in 100/34 763 patients [0.29%]; 20/100 of these patients [20%] had severe COVID-19 defined as admission to the intensive care unit, mechanical ventilation, and/or death. Hospitalisation occurred in 59/100 [59.0%] patients and 13/100 [13.0%] died. All patients who died had comorbidities and all but one were ≥65 years old. In line, we identified ≥1 comorbidity as an independent risk factor for hospitalisation (odds ratio [OR] 4.20, 95% confidence interval [CI] 1.58-11.17,; p = 0.004). Incidences of COVID-19 between the IBD study cohort and the general population were comparable (287.6 [95% CI 236.6-349.7] versus 333.0 [95% CI 329.3-336.7] per 100000 patients, respectively; p = 0.15). CONCLUSIONS: Of 100 cases with IBD and COVID-19, 20% developed severe COVID-19, 59% were hospitalised and 13% died. A comparable COVID-19 risk was found between the IBD cohort [100/34 763 = 0.29%] and the general Dutch population. The presence of ≥1 comorbidities was an independent risk factor for hospitalisation due to COVID-19.

Dilation or biodegradable stent placement for recurrent benign esophageal strictures: a randomized controlled trial.

BACKGROUND: Dilation is the standard of care for recurrent benign esophageal strictures (BES). Biodegradable stents may prolong the effect of dilation and reduce recurrences. Efficacy and safety of dilation and biodegradable stent placement early in the treatment algorithm of recurrent BES were compared. METHODS: This multicenter, randomized study enrolled patients with BES treated with previous dilations to ≥ 16 mm. The primary end point was number of repeat endoscopic dilations for recurrent stricture within 3 and 6 months. Secondary outcomes through 12 months included safety, time to first dilation for recurrent stricture, dysphagia, and level of activity. RESULTS: At 3 months, the biodegradable stent group (n = 32) underwent significantly fewer endoscopic dilations for recurrent stricture compared with the dilation group (n = 34; P < 0.001). By 6 months, the groups were similar. The number of patients experiencing adverse events was similar between the groups. Two patients in the biodegradable stent group died after developing tracheoesophageal fistulas at 95 and 96 days post-placement; no deaths were attributed to the stent. Median time to first dilation of recurrent stricture for the biodegradable stent group was significantly longer (106 vs. 41.5 days; P = 0.003). Dysphagia scores improved for both groups. Patients in the biodegradable stent group had a significantly higher level of activity through 12 months (P < 0.001). CONCLUSION: Biodegradable stent placement is associated with temporary reduction in number of repeat dilations and prolonged time to recurrent dysphagia compared with dilation. Additional studies are needed to better define the exact role of biodegradable stent placement to treat recurrent BES.

Higher quality of life after metal stent placement compared with plastic stent placement for malignant extrahepatic bile duct obstruction: a randomized controlled trial.

OBJECTIVE: For palliation of extrahepatic bile duct obstruction, self-expandable metal stents (SEMS) are superior to plastic stents in terms of stent patency and occurrence of stent dysfunction. We assessed health-related quality of life (HRQoL) after stent placement to investigate whether this also results in a difference in HRQoL between patients treated with a plastic stent or SEMS. PATIENTS AND METHODS: This randomized multicenter trial included 219 patients who were randomized to receive plastic stent (n=73) or SEMS [uncovered (n=75) and covered (n=71); n=146] placement. HRQoL was assessed with two general questionnaires (EQ-5D-3L and QLQ-C30) and one disease-specific questionnaire (PAN-26). Scores were analyzed using linear mixed model regression and included all patients with baseline and at least one follow-up measurement. RESULTS: HRQoL data were available in 140 of 219 patients (64%); 71 patients (32%) declined participation and in eight patients (4%) only baseline questionnaires were available. On the QLQ-C30, the interaction between follow-up time and type of stent was significantly different on two of five functional scales [physical functioning (P=0.004) and emotional functioning (P=0.01)] in favor of patients with a SEMS. In addition, patients with SEMS reported significantly less frequent symptoms of fatigue (P=0.01), loss of appetite (P=0.02), and nausea and vomiting (0.04) over time. The EQ-VAS score decreased with time in both treatment groups, indicating a statistically significant decrease in HRQoL over time. CONCLUSION: In patients with inoperable malignant extrahepatic bile duct obstruction, SEMS placement results in better scores for general and disease-specific HRQoL over time compared with plastic stent placement.

Cost Efficacy of Metal Stents for Palliation of Extrahepatic Bile Duct Obstruction in a Randomized Controlled Trial.

BACKGROUND & AIMS: Endoscopic stents are placed for palliation of extrahepatic bile duct obstruction. Although self-expandable metal stents (SEMS) remain patent longer than plastic stents, they are more expensive. We aimed to evaluate which type of stent (plastic, uncovered SEMS [uSEMS], or partially covered SEMS [pcSEMS]) is the most effective and we assessed costs. METHODS: We performed a multicenter randomized trial in 219 patients at 18 hospitals in The Netherlands from February 2008 through February 2013. Patients were assigned randomly for placement of a plastic stent (n = 73), uSEMS (n = 75), or pcSEMS (n = 71) during endoscopic retrograde cholangiopancreatography. Patients were followed up for up to 1 year. Researchers were not blinded to groups. The main study end points included functional stent time and costs. RESULTS: The mean functional stent times were 172 days for plastic stents, 288 days for uSEMS, and 299 days for pcSEMS (P < .005 for uSEMS and pcSEMS vs plastic). The initial placement of plastic stents (€1042 or $1106) cost significantly less than placement of SEMS (€1973 or $2094) (P = .001). However, the total cost per patient at the end of the follow-up period did not differ significantly between plastic stents (€7320 or $7770) and SEMS (€6932 or $7356) (P = .61). Furthermore, in patients with short survival times (≤3 mo) or metastatic disease, the total cost per patient did not differ between plastic stents and SEMS. No differences in costs were found between pcSEMS and uSEMS. CONCLUSIONS: Although placement of SEMS (uncovered or partially covered) for palliation of extrahepatic bile duct obstruction initially is more expensive than placement of plastic stents, SEMS have longer functional time. The total costs after 1 year do not differ significantly with stent type. Dutch Clinical Trial Registration no: NTR1361.

A fully covered self-expandable metal stent with antimigration features for benign biliary strictures: a prospective, multicenter cohort study.

BACKGROUND: Self-expandable metal stents (SEMSs) are increasingly used for the treatment of benign biliary strictures (BBSs). A new fully covered SEMS (FCSEMS) with flared ends and high conformability was designed to prevent migration of the stent. OBJECTIVE: To evaluate the efficacy of a novel FCSEMS with antimigration features. DESIGN: Prospective cohort study. SETTING: Five hospitals in the Netherlands and Belgium. PATIENTS: Consecutive patients with BBS. INTERVENTION: FCSEMS placement for 3 months. MAIN OUTCOME MEASUREMENTS: Initial and long term clinical success, stent migration rate and safety. RESULTS: Thirty-eight patients (24 men; mean age, 53 ± 16 years) were included. Stent placement was technically successful in 37 patients (97%). Two patients died of an unrelated cause before stent removal, and no data on these patients were available on stricture resolution. Initial clinical success was achieved in 28 of 35 patients (80%). During follow-up after stent removal, a symptomatic recurrent stricture developed in 6 of 28 patients (21%). Overall, the long-term clinical success rate was 63% (22 of 35 patients). Stent migration occurred in 11 of 35 patients (31%), including 5 symptomatic (14%) and 6 asymptomatic (17%) migrations. In total, 11 serious adverse events occurred in 10 patients (29%), with cholangitis (n = 5) being most common. LIMITATIONS: Nonrandomized study design. CONCLUSIONS: Good initial clinical success was achieved after placement of this novel FCSEMS, but stricture recurrence was in the upper range compared with other FCSEMSs. The antimigration design could not prevent migration in a significant number of patients with a persisting stricture.

In vitro evaluation of the radial and axial force of self-expanding esophageal stents.

BACKGROUND AND STUDY AIMS: Technological innovation in esophageal stent design has progressed over the past decades, but the association between the mechanical properties of stent design and clinical outcome is still poorly understood. In this study the radial force and axial force of currently available stent designs were evaluated using an in vitro testing model. METHODS: A total of 10 partially and fully covered self-expanding metal stents (SEMSs), a self-expanding plastic stent (SEPS), and an uncovered biodegradable stent were evaluated. Radial force and axial force were measured using a radial force measurement machine (RX500) and a force gauge in an oven at 37°C. RESULTS: A wide range of radial force measurements were observed between the different stent designs, ranging from 4 to 83 N at 15  mm expansion. All braided nitinol stents displayed comparable mechanical characteristics with a relatively low radial force (<150 N) that gradually decreased to 0 N during expansion, whereas plastic and metal stents that were constructed in a nonbraided manner displayed an initially high radial force (>300 N) followed by a steep decline to 0 N during expansion. Conversely, peak axial force was relatively high for braided nitinol SEMSs (>1.5 N), whereas nonbraided SEMSs showed a much lower peak axial force (<1.5 N). Based on radial and axial force data, five groups of stents with comparable mechanical properties could be distinguished. CONCLUSIONS: All currently available stents have a characteristic radial and axial force pattern, which may aid in the understanding of the occurrence of specific symptoms and complications after stent placement. Nonetheless, the overall clinical behavior of a stent is probably more complex and cannot be explained by these factors alone.

Endoscopic corticosteroid injections do not reduce dysphagia after endoscopic dilation therapy in patients with benign esophagogastric anastomotic strictures.

BACKGROUND & AIMS: Benign anastomotic strictures are often difficult to treat. We assessed the efficacy of adding corticosteroid injections to endoscopic dilation therapy with Savary bougienage. METHODS: In a multicenter, double-blind trial, 60 patients (mean age, 63 ± 9 years; 78% male) with an untreated cervical anastomotic stricture after esophagectomy with gastric tube reconstruction and dysphagia for at least solid food were randomly assigned to groups given 4 quadrant injections of 0.5 mL triamcinolone (40 mg/mL, n = 29) or saline (controls, n = 31) into the stricture, followed by Savary dilation to 16 mm. Dysphagia, complications, and quality of life were assessed after 1 and 2 weeks and 1, 3, and 6 months. The primary end point was a dysphagia-free period of 6 months. RESULTS: In the corticosteroid group, 45% of the patients remained dysphagia-free for 6 months, compared with 36% of controls (relative risk, 1.26; 95% confidence interval, 0.68-2.36; P = .46). Median time to repeat dilation was 108 days (range, 15-180 days) in the corticosteroid group vs 42 days (range, 17-180 days) for controls (P = .11). A median number of 2 dilations (range, 1-7) was performed in the corticosteroid group vs 3 dilations (range, 1-9) in controls (relative risk, 0.76; 95% confidence interval, 0.42-1.38; P = .36). Two major intervention-related complications occurred, 1 submucosal laceration in the corticosteroid group and 1 hemorrhage in the control group. Four patients in the corticosteroid group, but none of the controls, developed Candida esophagitis (P = .03). CONCLUSIONS: Corticosteroid injections do not provide a statistically significant decrease in frequency of repeat dilations or prolongation of the dysphagia-free period in patients with benign anastomotic esophagogastric strictures. Dutch Trial Registration Number 2236.

Endoscopic clip-assisted feeding tube placement reduces repeat endoscopy rate: results from a randomized controlled trial.

OBJECTIVES: To determine whether endoscopic clip-assisted nasoenteral feeding tube placement is more effective than standard feeding tube placement with transnasal endoscopy. METHODS: Between August 2009 and February 2011, 143 patients referred for endoscopic nasoenteral feeding tube placement were randomized between clip-assisted and standard nasoenteral tube placement. Endoscopies were performed in the endoscopy unit and intensive care unit in a tertiary referral center in the Netherlands. For the clip-assisted procedure, the feeding tube was introduced with a suture fixed to the tip, picked up in the stomach with an endoclip and attached (as distal as possible) to the duodenal wall. In the standard group, a guide wire was placed in the duodenum using a transnasal endoscope, followed by blind insertion of a feeding tube over the guide wire. Primary end point was a repeat endoscopy for incorrect tube placement or spontaneous retrograde tube migration. Secondary end points were incorrect tube placement, spontaneous migration of feeding tube, directs medical costs, and procedure-related (serious) adverse event (SAE). RESULTS: Of the 143 patients included, 71 were randomly assigned to clip-assisted tube placement, and 72 to standard tube placement. Four (5.6%) repeat endoscopies were performed in the clip-assisted group vs. 19 (26.4%) in the standard group (relative risk reduction (RRR) 0.79; 95% confidence interval (CI) 0.40-0.92). The number needed to clip to avoid one repeat endoscopy was 4.8 (95% CI 3.1-11.3). Repeat endoscopies were mostly performed for incorrectly placed tubes, 3 (4.2%) in the clip-assisted group vs. 16 (22.2%, RRR 0.81; 95% CI 0.38-0.94) in the standard group. Spontaneous retrograde tube migration occurred in one (1.4%) clip-assisted placement and three (4.2%) standard tubes. Median costs were higher for clip-assisted tube placement (€519 vs. €423, P<0.01). Four (5.6%) SAEs occurred after clip-assisted feeding tube placement vs. one (1.4%) after standard feeding tube placement (P=0.21). CONCLUSIONS: Clip-assisted endoscopic nasoenteral feeding tube placement results in fewer repeat endoscopies than standard endoscopic nasoenteral tube placement, due to a higher success rate of initial placement. When tubes are adequately placed, retrograde tube migration rarely occurs.

Combination of biodegradable stent placement and single-dose brachytherapy is associated with an unacceptably high complication rate in the treatment of dysphagia from esophageal cancer.

BACKGROUND: For the palliative treatment of dysphagia, esophageal stent placement provides immediate improvement, whereas brachytherapy offers better long-term relief. OBJECTIVE: To evaluate safety and efficacy of concurrent brachytherapy and biodegradable stent placement. DESIGN: Prospective, single-arm study. SETTING: Two tertiary-care referral centers. PATIENTS: Nineteen consecutive patients with significant dysphagia resulting from unresectable esophageal cancer, with a life expectancy of more than 3 months. INTERVENTION: Single-dose brachytherapy (12 Gy) on day 1 followed by biodegradable stent placement on day 2. MAIN OUTCOME MEASUREMENTS: Intervention-related major complications (determined by an expert panel) and dysphagia. RESULTS: Nineteen patients (13 men, median age 66 years [interquartile range (IQR) 59-71] years) were included; 7 patients (37%) also received palliative chemotherapy. After inclusion of 19 patients, the study was ended prematurely because the safety threshold was exceeded. In total, 28 major complications occurred in 17 patients (89%). In 9 patients (47%), major complications were determined intervention-related (severe retrosternal pain with or without vomiting [n = 6], hematemesis [n = 1], recurrent dysphagia [n = 2]. Dysphagia scores decreased significantly from a median of 3 (IQR 3-4) to a median of 1 (IQR 0-3) after 1 month (P < .001). Despite adequate luminal patency in 17 patients (89%), normal diet could not be tolerated in 7 patients (37%) because of retrosternal pain and vomiting. LIMITATIONS: Lack of routine endoscopy or contrast esophagram to evaluate recurrent dysphagia during follow-up. CONCLUSION: Despite restoration of luminal patency, a combined treatment of brachytherapy and biodegradable stent placement cannot be recommended for the palliative treatment of esophageal cancer because of an unacceptably high intervention-related major complication rate.

A new fully covered metal stent for the treatment of benign and malignant dysphagia: a prospective follow-up study.

BACKGROUND: Fully covered self-expandable metal stents (FCSEMSs) are increasingly being used for malignant and benign strictures. Particularly in the latter, FCSEMSs are known for their high migration rates. A new FCSEMS with a dog-bone shape and internal covering was developed to reduce migration risk. OBJECTIVE: To evaluate recurrent dysphagia and safety of the new FC stent in benign and malignant esophageal disorders. DESIGN: Prospective follow-up study. SETTING: Tertiary referral center. PATIENTS: Between November 2009 and February 2011, 48 consecutive patients (mean age 61 years, range 28-81 years) underwent FC stent placement for malignant (n = 33) or benign (n = 15) dysphagia. INTERVENTION: FC stent placement. MAIN OUTCOME MEASUREMENTS: Recurrent dysphagia and complications. RESULTS: Indications for FC stent placement included esophageal cancer (n = 28), extrinsic malignant compression (n = 4), recurrent malignancy after esophagectomy (n = 1), and refractory benign esophageal stricture (n = 15). In malignant strictures, recurrent dysphagia occurred in 5 patients (15%) because of stent migration (n = 3), tissue overgrowth (n = 1), and acute edema (n = 1). In benign strictures, stents were prematurely removed in 9 (60%) patients because of stent migration (n = 5), tissue overgrowth (n = 3), and pain (n = 1). Recurrent dysphagia occurred in all patients after stent removal. Major complications occurred in 10 patients (30%) with malignant strictures and in 3 patients (20%) with benign strictures and included severe pain and/or vomiting (n = 8), fistula formation (n = 2), bleeding (n = 2), and aspiration pneumonia (n = 1). LIMITATION: Nonrandomized study design. CONCLUSION: Although the new FC stent effectively treats malignant dysphagia, it is associated with substantial major complications. In patients with refractory benign esophageal strictures, recurrent dysphagia occurs rapidly after removal of the new FC stent.

Technical feasibility and safety of a new, implantable reflux control system to prevent gastroesophageal reflux in patients with stents placed through the lower esophageal sphincter (with video).

BACKGROUND: When an esophageal stent is placed through the lower esophageal sphincter (LES), gastroesophageal reflux symptoms may persist despite high-dose proton pump inhibitor therapy. A recently developed, short segment, uncovered nitinol stent with a tricuspid-like valve can be placed inside a previously placed esophageal stent. OBJECTIVE: To evaluate the technical feasibility and safety of a reflux control system (RCS) in distally placed esophageal stents. DESIGN: A prospective case series. SETTING: Two tertiary-care referral centers. PATIENTS: This study involved 10 patients who had an "open" stent placed through the LES and 1 patient with severe bile reflux after esophagojejunostomy. INTERVENTION: Placement of an RCS with fluoroscopic and (in selected cases) endoscopic guidance, from April to October 2010. MAIN OUTCOME MEASUREMENTS: Technical success of RCS placement and complications. RESULTS: Placement of an RCS was successful on the first attempt in all patients; complete expansion to the wall of the host stent was confirmed by fluoroscopy in all cases. In 3 patients, the host stent migrated in <1 month with the RCS still inside. In 8 patients, the RCS was in place for a median of 134 days (range 33-225 days). Three patients died because of malignant disease progression. Eight RCSs were removed endoscopically, together with the host stent without complications. RCS migration did not occur. LIMITATIONS: Small number of patients, nonrandomized design, lack of pH measurements. CONCLUSION: Placement of an RCS in a host stent is technically feasible and safe. An RCS can be considered in symptomatic patients with open esophageal stents to prevent gastroesophageal reflux.

Stent placement for esophageal strictures: an update.

The use of stents for esophageal strictures has evolved rapidly over the past 10 years, from rigid plastic tubes to flexible self-expanding metal (SEMS), plastic (SEPS) and biodegradable stents. For the palliative treatment of malignant dysphagia both SEMS and SEPS effectively provide a rapid relief of dysphagia. SEMS are preferred over SEPS, as randomized controlled trials have shown more technical difficulties and late migration with plastic stents. Despite specific characteristics of recently developed stents, recurrent dysphagia due to food impaction, tumoral and nontumoral tissue overgrowth, or stent migration, remain a major challenge. The efficacy of stents with an antireflux valve for patients with distal esophageal cancer varies between different stent designs. Concurrent treatment with chemotherapy and/or radiotherapy seems to be safe and effective. In the future, it can be expected that removable stents will be used as a bridge to surgery to maintain luminal patency during neoadjuvant treatment. For benign strictures, new stent designs, such as fully covered SEMS and biodegradable stents, may potentially reduce complications during stent removal.

A new partially covered metal stent for palliation of malignant dysphagia: a prospective follow-up study.

BACKGROUND: Metal stents are frequently used for palliation of malignant dysphagia. Recently, a new stent design, the partially covered Wallflex stent (Boston Scientific, Natick, Mass), has been introduced. OBJECTIVE: To determine clinical effectiveness and safety of the esophageal Wallflex stent for the palliation of dysphagia. DESIGN: A prospective follow-up study evaluating a new stent design. SETTING: Three tertiary-care referral centers. PATIENTS: This study involved 37 patients with cancer of the esophagus or gastric cardia. INTERVENTIONS: Stent placement. MAIN OUTCOME MEASUREMENTS: Data were collected regarding technical and clinical outcome, complications, recurrent dysphagia, and survival. RESULTS: A total of 37 patients (median age, 67 years; range, 48-84 years; 22 men [59%]) had a Wallflex stent placed. Stent placement was technically successful in all but 1 patient. Dysphagia improved from a median dysphagia score of 3 (ability to swallow liquids only) to 1 (ability to eat some solid foods) 4 weeks after stent placement. Major complications occurred in 3 patients (8%; pneumonia in 1, severe pain in 2), and 1 patient (3%) died from a complication (pneumonia). Minor complications included mild retrosternal pain in 10 patients (27%) and regurgitation in 7 patients (19%). In total, 8 patients (22%) developed recurrent dysphagia because of stent migration (n = 2 [6%]), food impaction (n = 2 [6%]), or tissue ingrowth or overgrowth (n = 4 [10%]). LIMITATIONS: Nonrandomized study design. CONCLUSIONS: Placement of a partially covered Wallflex stent is safe and effective for the palliation of malignant dysphagia, with migration and tissue in- and overgrowth rates comparable to those of similarly designed stents. Retrosternal pain may occur more often with this stent than with other stent designs.

Performance of EUS-FNA for mediastinal lymphadenopathy: impact on patient management and costs in low-volume EUS centers.

BACKGROUND: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of mediastinal lymphadenopathy has been shown to be a valuable diagnostic tool in high-volume EUS centers (≥ 50 mediastinal EUS-FNA/endoscopist/year). Our goal was to assess the diagnostic accuracy of EUS-FNA and its impact on clinical management and costs in low-volume EUS centers (<50 mediastinal EUS-FNA/endoscopist/year). METHODS: Consecutive patients referred to two Dutch endoscopy centers in the period 2002-2008 for EUS-FNA of mediastinal lymphadenopathy were reviewed. The gold standard for a cytological diagnosis was histological confirmation or clinical follow-up of more than 6 months with repeat imaging. The impact of EUS-FNA on clinical management was subdivided into a positive impact by providing (1) adequate cytology that influenced the decision to perform surgery or (2) a diagnosis of a benign inflammatory disorder, and a negative impact which was subdivided into (1) false-negative or inconclusive cytology or (2) an adequate cytological diagnosis that did not influence patient management. Costs of an alternative diagnostic work-up without EUS-FNA, as established by an expert panel, were compared to costs of the actual work-up. RESULTS: In total, 213 patients (71% male, median age= 61 years, range = 23-88 years) underwent EUS-FNA. Sensitivity, specificity, and negative and positive predictive values were 89%, 100%, 80%, and 100%, respectively. EUS-FNA had a positive impact on clinical management in 84% of cases by either influencing the decision to perform surgery (49%) or excluding malignant lymphadenopathy (35%), and a negative impact in 7% of cases because of inadequate (3%) or false-negative (4%) cytology. In 9% of cases, EUS-FNA was performed without an established indication. Two nonfatal perforations occurred (0.9%). Total cost reduction was €100,593, with a mean cost reduction of €472 (SD = €607) per patient. CONCLUSIONS: Mediastinal EUS-FNA can be performed in low-volume EUS centers without compromising diagnostic accuracy. Moreover, EUS-FNA plays an important role in the management of patients with mediastinal lymphadenopathy and reduces total diagnostic costs.