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. © 2010 American Society for Gastrointestinal Endoscopy.
Repici A., Vleggaar F.P., Hassan C., Van Boeckel P.G., Romeo F., Pagano N., et al. (2010). Efficacy and safety of biodegradable stents for refractory benign esophageal strictures: The BEST (Biodegradable Esophageal Stent) study. GASTROINTESTINAL ENDOSCOPY, 72(5), 927-934 [10.1016/j.gie.2010.07.031].
Efficacy and safety of biodegradable stents for refractory benign esophageal strictures: The BEST (Biodegradable Esophageal Stent) study
Pagano N.;
2010
Abstract
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. © 2010 American Society for Gastrointestinal Endoscopy.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
