Treatment of refractory benign gastroenteral strictures with fully covered metal stents.
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ABSTRACT:
SUBMITTER: Singh A
PROVIDER: S-EPMC8267956 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundEndoscopic treatment of benign biliary strictures (BBS) can be challenging.ObjectiveTo evaluate the efficacy of fully covered self-expandable metal stents (FCSEMS) in BBS.MethodsNinety-two consecutive patients with BBS (chronic pancreatitis (n = 42), anastomotic after liver transplantation (n = 36), and post biliary surgical procedure (n = 14)) were included. FCSEMS were placed across strictures for 6 months before endoscopic extraction. Early success rate was defined as the absence of biliary stricture or as a minimal residual anomaly on post-stent removal endoscopic retrograde cholangiopancreatography (ERCP). Secondary outcomes were the final success and stricture recurrence rates as well as procedure-related morbidity.ResultsStenting was successful in all patients. Stenting associated complications were minor and occurred in 22 (23.9%) patients. Migration occurred in 23 (25%) patients. Stent extraction was successful in all but two patients with proximal stent migration. ERCP after the 6 months stenting showed an early success in 84.9% patients (chronic pancreatitis patients: 94.7%, liver transplant: 87.9%, post-surgical: 61.5%) (p = 0.01). Final success was observed in 57/73 (78.1%) patients with a median follow-up of 12 ± 3.56 months. Recurrence of biliary stricture occurred in 16/73 (21.9%) patients.ConclusionsFCSEMS placement is efficient for patients with BBS, in particular for chronic pancreatitis patients. Stent extraction after 6 months indwelling, although generally feasible, may fail in a few cases.
| S-EPMC4924429 | biostudies-literature
Project description:Background. In patients with benign biliary strictures, the use of fully covered self-expandable metal stents (SEMS) has been proposed as an alternative to plastic stenting, but high quality prospective data are sparse. This study was performed to evaluate the long-term effectiveness and safety of a new fully covered SEMS for benign biliary strictures. Methods. All consecutive patients with benign biliary strictures were treated with placement of a fully covered SEMS (WallFlex) for 6 months. Short- and long-term stricture resolution, adverse events, and ease of stent removal were recorded. Results. 23 patients were enrolled. Stricture etiology was chronic pancreatitis (14), postorthotopic liver transplant (4), idiopathic (4), and biliary stones (1). All ERCPs were technically successful. All stents were successfully removed. Short-term stricture resolution was seen in 22/23 (96%) patients. Long-term success was 15/18 (83.3%). All 3 failures were patients with biliary strictures in the setting of chronic calcific pancreatitis. Conclusions. The use of the new SEMS for the treatment of benign biliary strictures led to short-term stricture resolution in the vast majority of patients. Over a long-term followup the success rate appears favorable compared to historical results achieved with multiple plastic stenting, particularly in patients with chronic pancreatitis. The study was registered with ClinicalTrials.gov (NCT01238900).
| S-EPMC3727195 | biostudies-literature
Project description:The treatment success of benign biliary strictures with fully covered metal stents (CSEMS) is altered by high stent dislocation rates. We aimed to evaluate a new stent design to prevent dislocation.Patients with benign biliary strictures were treated with a newly designed double-coned stent (dcSEMS). Mechanical analysis of the new stent was performed and it was compared with a cylindrical stent.A total of 13 dcCSEMS were implanted in 11 patients (2 female, 9 male, median age 47, range 33 - 71). All patients had distal biliary strictures due to chronic pancreatitis. No stent migration occurred. In all but one patient the stents were removed. One patient refused stent extraction and was lost to follow up. Stent occlusion occurred twice leading to cholangitis in both cases. The duration of stent treatment was 170 days (range 61 - 254). After extraction only one patient had early recurrent stricture and received the same stent again. Three stents showed minimal tissue granulation at the papilla. One stent presented ingrowth at the proximal end and was removed after implantation of a second fully covered stent. Mechanical examination revealed significantly lower radial expansion force of the new stent as compared to the cylindrical stent.The new stent design has a low rate of migration. Biomechanical properties may explain this effect.
| S-EPMC4713183 | biostudies-other
Project description:IntroductionThe current endoscopic treatment for postoperative benign hepaticojejunostomy anastomotic stricture (HJAS) has a high technical success rate and is highly effective in the short term. However, long-term results have shown a high rate of stenosis recurrence, which indicates an insufficient response to treatment. Three prospective studies on fully covered self-expandable metallic stent (FC-SEMS) treatment for benign HJAS used the stenosis resolution rate as the primary endpoint, and no study has yet used the long-term non-stenosis rate (at 12 months) as the primary endpoint.Methods and analysisWe launched the 'saddle-cross study', which will be conducted as a multicentre, prospective intervention of endoscopic treatment using two modified FC-SEMSs (BONASTENT️ M-Intraductal) that have been improved for benign stenosis in patients with benign HJAS, with the long-term non-restenosis rate (at 12 months) as the primary endpoint. This study aims to evaluate the long-term non-restenosis rate (at 12 months) and safety of the saddle-cross technique for benign HJAS. We plan to enrol 50 participants.Ethics and disseminationThis study has been approved by the Certified Review Board of the National Cancer Center, Japan (CRB3180009). The results will be reported at various conferences and published in international peer-reviewed journals.
| S-EPMC10729169 | biostudies-literature
Project description:Background and aimsEndoscopic stent placement in luminal GI strictures is not always feasible with traditional stents. For example, standard luminal stent delivery catheters may not successfully traverse severe strictures, and enteral stents may not be suitable for sites in the GI tract that pose significant adverse events if downstream migration were to occur. We demonstrate extrabiliary applications of specialized, fully covered antimigration biliary metal stents.MethodsThis is a retrospective series of 4 patients with different benign and malignant luminal GI strictures who underwent placement of fully covered antimigration biliary metal stents in different configurations as a bridge or destination therapy.ResultsLuminal obstruction resolved without adverse events in all cases.ConclusionsAlthough off label, extrabiliary use of these stents can successfully address scenarios of complex luminal pathology. To compensate for the small stent caliber, two stents may be placed side by side in a double-barrel configuration. Strict diet modifications are necessary when applying this therapeutic paradigm.
| S-EPMC7483763 | biostudies-literature
Project description:Chronic pancreatitis (CP) related main pancreatic duct (MPD) stricture has been a challenge for endoscopists. Fully covered self-expandable metal stents (FC-SEMS) has been tried in CP patients, but the efficacy and safety are still controversial. Thus, we aim to compare the long-term clinical efficacy of FC-SEMS vs. plastic stent placement in persistent MPD strictures secondary to CP. Between 2007 and 2018, 80 chronic pancreatitis patients (58 males, median age 49 years), who underwent endoscopic placement of FC-SEMS (n = 26) and plastic stent (n = 54) for persistent MPD strictures after at least 3 months of initial single plastic stenting, were retrospectively analyzed during a median follow-up duration of 33.7 months. As a result, MPD stricture resolution rate was statistically higher in FC-SEMS group (87.0% vs. 42.0%, p < 0.001). Although immediate complications occurred similarly (38.5% vs. 37.0%, p = 0.902), spontaneous migration (26.9%) and de novo strictures (23.1%) were pronounced delayed complications in FC-SEMS group. Pain relief during follow-up was significantly higher in FC-SEMS group (76.9% vs. 53.7%, p = 0.046). The total procedure cost was similar in both groups ($1,455.6 vs. $1,596.9, p = 0.486). In comparison with plastic stent, FC-SEMS placement for persistent MPD strictures had favorable long-term clinical efficacy, with its typical complications like spontaneous migration and de novo strictures.
| S-EPMC8329149 | biostudies-literature
Project description:Background and study aims Fully covered self-expanding metal stents (FCSEMS) provide an alternative to bougie dilation (BD) for refractory benign esophageal strictures. Controlled studies comparing temporary placement of FCSES to repeated BD are not available. Patients and methods Patients with refractory anastomotic esophageal strictures, dysphagia scores ≥ 2, and two to five prior BD were randomized to 8 weeks of FCSEMS or to repeated BD. The primary endpoint was the number of BD during the 12 months after baseline treatment. Results Eighteen patients were included (male 67 %, median age 66.5; 9 received metal stents, 9 received BD). Technical success rate of stent placement and stent removal was 100 %. Recurrent dysphagia occurred in 13 patients (72 %) during follow-up. No significant difference was found between the stent and BD groups for mean number of BD during follow-up (5.4 vs. 2.4, P = 0.159), time to recurrent dysphagia (median 36 days vs. 33 days, Kaplan-Meier: P = 0.576) and frequency of reinterventions per month (median 0.3 vs. 0.2, P = 0.283). Improvement in quality of life score was greater in the stent group compared to the BD group at month 12 (median 26 % vs. 4 %, P = 0.011). Conclusions The current data did not provide evidence for a statistically significant difference between the two groups in the number of BD during the 12 months after initial treatment. Metal stenting offers greater improvement in quality of life from baseline at 12 months compared to repeated BD for patients with refractory anastomotic esophageal strictures.
| S-EPMC6338544 | biostudies-literature
Project description:Self-expanding metal stents (SEMS) are safe and effective for endoscopic management of malignant gastrointestinal strictures, but there is limited experience with their use in refractory benign strictures. We assessed the use of a new lumen-apposing covered SEMS for the management of benign gastrointestinal strictures.A single-center case-series of five patients who underwent lumen-apposing covered SEMS placement for benign gastrointestinal strictures.Three patients had a benign gastroduodenal stricture, one had a distal colonic anastomotic stricture, and one with complete gastrojejunal anastomotic stenosis underwent endoscopic creation of a new gastrojejunostomy. None of the patients developed any immediate or delayed stent-related adverse events. In two patients, the stents were left in place indefinitely. Stents were removed from the other three patients with successful resolution of their symptoms during follow-up.Lumen-apposing, fully covered SEMS appear to be safe and effective for management of selected benign gastrointestinal strictures.
| S-EPMC4713186 | biostudies-other
Project description: Not available
| S-EPMC6895758 | biostudies-literature
Project description:Endoscopic placement of multiple plastic stents in parallel is the first-line treatment for most benign biliary strictures; it is possible that fully covered, self-expandable metallic stents (cSEMS) may require fewer endoscopic retrograde cholangiopancreatography procedures (ERCPs) to achieve resolution.To assess whether use of cSEMS is noninferior to plastic stents with respect to stricture resolution.Multicenter (8 endoscopic referral centers), open-label, parallel, randomized clinical trial involving patients with treatment-naive, benign biliary strictures (N?=?112) due to orthotopic liver transplant (n?=?73), chronic pancreatitis (n?=?35), or postoperative injury (n?=?4), who were enrolled between April 2011 and September 2014 (with follow-up ending October 2015). Patients with a bile duct diameter less than 6 mm and those with an intact gallbladder in whom the cystic duct would be overlapped by a cSEMS were excluded.Patients (N?=?112) were randomized to receive multiple plastic stents or a single cSEMS, stratified by stricture etiology and with endoscopic reassessment for resolution every 3 months (plastic stents) or every 6 months (cSEMS). Patients were followed up for 12 months after stricture resolution to assess for recurrence.Primary outcome was stricture resolution after no more than 12 months of endoscopic therapy. The sample size was estimated based on the noninferiority of cSEMS to plastic stents, with a noninferiority margin of -15%.There were 55 patients in the plastic stent group (mean [SD] age, 57 [11] years; 17 women [31%]) and 57 patients in the cSEMS group (mean [SD] age, 55 [10] years; 19 women [33%]). Compared with plastic stents (41/48, 85.4%), the cSEMS resolution rate was 50 of 54 patients (92.6%), with a rate difference of 7.2% (1-sided 95% CI, -3.0% to ?; P?<?.001). Given the prespecified noninferiority margin of -15%, the null hypothesis that cSEMS is less effective than plastic stents was rejected. The mean number of ERCPs to achieve resolution was lower for cSEMS (2.14) vs plastic (3.24; mean difference, 1.10; 95% CI, 0.74 to 1.46; P?<?.001).Among patients with benign biliary strictures and a bile duct diameter 6 mm or more in whom the covered metallic stent would not overlap the cystic duct, cSEMS were not inferior to multiple plastic stents after 12 months in achieving stricture resolution. Metallic stents should be considered an appropriate option in patients such as these.clinicaltrials.gov Identifier: NCT01221311.
| S-EPMC5544902 | biostudies-literature