Petra G. Van Boeckel

Efficacy and safety of biodegradable stents for refractory benign esophageal strictures: the BEST (Biodegradable Esophageal Stent) study

BACKGROUND Benign esophageal strictures refractory to standard dilation therapy present a challenging problem. Temporary plastic and metal stents have been proposed with inconclusive results. OBJECTIVE To evaluate the efficacy and safety of a new biodegradable stent for the treatment of refractory benign esophageal strictures (RBESs). DESIGN AND SETTING Prospective study from 2 European endoscopy centers. PATIENTS AND INTERVENTION Twenty-one patients (11 men/10 women, mean age 60.2 ± 17.6 years) with RBESs defined according to the Kochman criteria treated by placement of a biodegradable stent (Ella stent). MAIN OUTCOME MEASUREMENTS Clinical and endoscopic follow-up was scheduled at 1, 2, 3, and 6 months and later only in case of dysphagia recurrence. Pre- and poststenting dysphagia status was graded according to a 5-point scale. Minor and major complication rates were prospectively assessed. RESULTS Stent insertion was technically successful in all of the patients. At 4 and 7 weeks, stent migration occurred in 2 patients (9.5%). At 3-month endoscopy, the stent appeared to be almost completely fragmented in all remaining patients. The median pre- and poststenting dysphagia scores were 3 (range 3-4) and 1 (range 0-2), respectively (P < .01), with a median follow-up of 53 weeks (range 25-88 weeks). In detail, 9 of 20 patients (45%) were dysphagia free at the end of the follow-up. No major complications occurred. Severe poststenting pain requiring analgesics developed in 3 patients, and minor bleeding was observed in 1 patient. LIMITATIONS Limited follow-up; nonrandomized study. CONCLUSIONS In this preliminary study, the biodegradable stent showed a favorable risk/benefit ratio, achieving complete relief of dysphagia in nearly 50% of RBES patients without the occurrence of major complications. The use of this stent may be a valuable alternative to repeat endoscopic dilation. Larger studies with longer follow-up are needed.

Fully covered self-expandable metal stents (SEMS), partially covered SEMS and self-expandable plastic stents for the treatment of benign esophageal ruptures and anastomotic leaks

BackgroundBenign esophageal ruptures and anastomotic leaks are life-threatening conditions that are often treated surgically. Recently, placement of partially and fully covered metal or plastic stents has emerged as a minimally invasive treatment option. We aimed to determine the clinical effectiveness of covered stent placement for the treatment of esophageal ruptures and anastomotic leaks with special emphasis on different stent designs.MethodsConsecutive patients who underwent placement of a fully covered self-expandable metal stent (FSEMS), a partially covered SEMS (PSEMS) or a self-expanding plastic stent (SEPS) for a benign esophageal rupture or anastomotic leak after upper gastrointestinal surgery in the period 2007-2010 were included. Data on patient demographics, type of lesion, stent placement and removal, clinical success and complications were collectedResultsA total of 52 patients received 83 esophageal stents (61 PSEMS, 15 FSEMS, 7 SEPS) for an anastomotic leak (n = 32), iatrogenic rupture (n = 13), Boerhaaves syndrome (n = 4) or other cause (n = 3). Endoscopic stent removal was successful in all but eight patients treated with a PSEMS due to tissue ingrowth. Clinical success was achieved in 34 (76%, intention-to-treat: 65%) patients (PSEMS: 73%, FSEMS: 83%, SEPS: 83%) after a median of 1 (range 1-5) stent and a median stenting time of 39 (range 7-120) days. In total, 33 complications in 24 (46%) patients occurred (tissue in- or overgrowth (n = 8), stent migration (n = 10), ruptured stent cover (all Ultraflex; n = 6), food obstruction (n = 3), severe pain (n = 2), esophageal rupture (n = 2), hemorrhage (n = 2)). One (2%) patient died of a stent-related cause.ConclusionsCovered stents placed for a period of 5-6 weeks may well be an alternative to surgery for treating benign esophageal ruptures or anastomotic leaks. As efficacy between PSEMS, FSEMS and SEPS is not different, stent choice should depend on expected risks of stent migration (SEPS and FSEMS) and tissue in- or overgrowth (PSEMS).

Plastic or metal stents for benign extrahepatic biliary strictures: a systematic review

BackgroundBenign biliary strictures may be a consequence of surgical procedures, chronic pancreatitis or iatrogenic injuries to the ampulla. Stents are increasingly being used for this indication, however it is not completely clear which stent type should be preferred.MethodsA systematic review on stent placement for benign extrahepatic biliary strictures was performed after searching PubMed and EMBASE databases. Data were pooled and evaluated for technical success, clinical success and complications.ResultsIn total, 47 studies (1116 patients) on outcome of stent placement were identified. No randomized controlled trials (RCTs), one non-randomized comparative studies and 46 case series were found. Technical success was 98,9% for uncovered self-expandable metal stents (uSEMS), 94,8% for single plastic stents and 94,0% for multiple plastic stents. Overall clinical success rate was highest for placement of multiple plastic stents (94,3%) followed by uSEMS (79,5%) and single plastic stents (59.6%). Complications occurred more frequently with uSEMS (39.5%) compared with single plastic stents (36.0%) and multiple plastic stents (20,3%).ConclusionBased on clinical success and risk of complications, placement of multiple plastic stents is currently the best choice. The evolving role of cSEMS placement as a more patient friendly and cost effective treatment for benign biliary strictures needs further elucidation. There is a need for RCTs comparing different stent types for this indication.

A Comparison of Temporary Self-Expanding Plastic and Biodegradable Stents for Refractory Benign Esophageal Strictures

BACKGROUND & AIMS It is a challenge to manage refractory benign esophageal strictures (RBES). We compared the efficacy and safety of self-expanding plastic stents (SEPSs) with placement of biodegradable stents for the treatment of RBES. METHODS We studied 2 groups of consecutive patients with RBES who received temporary placement (6 weeks) of SEPSs (n = 20) or biodegradable stents (n = 18). Data were collected with respect to clinical outcome, complications, recurrent dysphagia, and reinterventions. RESULTS SEPSs were removed in 16 (80%) patients. Stent placement was not successful in 1 patient, while stent removal was not performed in another 3 patients. Six (30%) patients with an SEPS were dysphagia-free after a median follow-up of 385 days (range, 77-924 days). Ten (50%) developed recurrent dysphagia. Major complications occurred in 2 patients (10%; 1 with hemorrhage and 1 with perforation). Six patients (33%) with a biodegradable stent were dysphagia-free after a median follow-up of 166 days (range 21-559 days) (P = .83 compared with SEPS). Twelve patients (67%) had recurrent dysphagia. Major complications occurred in 4 patients (22%; 2 with hemorrhage, 2 with severe retrosternal pain) with a biodegradable stent (P = .30 compared with SEPS). Reinterventions were less frequently indicated after biodegradeble stent than after SEPS placement (15 [mean, 0.8 ± 0.6 per stent placed] vs 21 [mean, 1.3 ± 0.4 per stent placed], respectively; P = .03). CONCLUSIONS Placement of SEPSs or biodegradable stents provides long-term relief of dysphagia in 30% and 33%, respectively, of patients with RBES. Biodegradable stents require fewer procedures than SEPSs, offering an advantage. Although stent placement is a viable strategy in patients with RBES, the ideal strategy still needs to be defined.

The association of education with body mass index and waist circumference in the EPIC-PANACEA study

BackgroundTo examine the association of education with body mass index (BMI) and waist circumference (WC) in the European Prospective Investigation into Cancer and Nutrition (EPIC).MethodThis study included 141,230 male and 336,637 female EPIC-participants, who were recruited between 1992 and 2000. Education, which was assessed by questionnaire, was classified into four categories; BMI and WC, measured by trained personnel in most participating centers, were modeled as continuous dependent variables. Associations were estimated using multilevel mixed effects linear regression models.ResultsCompared with the lowest education level, BMI and WC were significantly lower for all three higher education categories, which was consistent for all countries. Women with university degree had a 2.1 kg/m2 lower BMI compared with women with lowest education level. For men, a statistically significant, but less pronounced difference was observed (1.3 kg/m2). The association between WC and education level was also of greater magnitude for women: compared with the lowest education level, average WC of women was lower by 5.2 cm for women in the highest category. For men the difference was 2.9 cm.ConclusionIn this European cohort, there is an inverse association between higher BMI as well as higher WC and lower education level. Public Health Programs that aim to reduce overweight and obesity should primarily focus on the lower educated population.

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

A new metal stent with a controlled-release system for palliation of malignant dysphagia: a prospective, multicenter study

1106) cost significantly less than placement of SEMS (€1973 or

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

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

Refractory esophageal strictures: what to do when dilation fails.

7770) and SEMS (€6932 or

Biodegradable stent placement in the esophagus

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.