Fully Covered Self-expandable Metal Stents Research Articles

S1101 Safety and Efficacy of LAMS versus FCSEMS in Endoscopic Ultrasound-Guided Gallbladder Drainage in Acute Cholecystitis: A Meta-Analysis

Introduction: EUS-guided gallbladder drainage (EUS-GBD) is well established as a safe alternative to percutaneous cholecystostomy (PT-GBD) for acute cholecystitis. However, there have been no studies to date comparing the safety and efficacy of the different types of stents for EUS-GBD. Therefore, we conducted a systematic review and meta-analysis to compare the safety and efficacy of lumen-apposing metal stent (LAMS) to Fully covered self-expandable metal stent (FCSEMS) for EUS-GBD. Methods: A comprehensive literature search was conducted from electronic databases, including PubMed, Embase, and Scopus, from inception until 6/2022. A single-arm meta-analysis was performed using a random-effects approach using restricted maximum likelihood (REML) method comparing proportional data. In addition, subgroup analysis was performed based on the type of stent and comparing the outcomes. All the statistical analysis was conducted using Stata16. Results: Pooled data from 463 LAMS and 199 FCSEMS across 11 and 6 studies respectively were included in the final analysis (Table). There was no significant difference in the technical success rate between FCSEMS vs LAMS (97.61% vs 96.45%, I2 = 8.04%, p= 0.36) However, when compared to LAMS, FCSEMS had a 6% higher clinical success rate (99.2 % versus 93.3%, I2 = 43.87%, p = 0.03) FCSEMS had significantly lower adverse rate of 12.7% when compared to 17.7% LAMS, a difference of 5% (I2 = 54.5%, P = 0.0000). There was no significant difference in recurrent cholecystitis rates between the groups (FCSEMS= 1% vs 1.7%, I2= 3.7%, p =0.41). Although there was a lower mortality seen while using FCSEMS compared to LAMS, it was not statistically significant (I2 = 24.2%, p = 0.17) (Figure). Conclusion: Strengths and limitations: To the best of our knowledge, our study is the first meta-analysis to compare the safety and efficacy of LAMS versus FCSEMS for EUS-GBD. Patient factors such as comorbidities, health conditions while undergoing the procedure, etc., could not be compared between the groups. There was inadequate data to classify adverse events as severe or mild-moderate. Moderate heterogeneity was noted. Discussion: FCSEMS had a higher clinical success rate and fewer adverse events than LAMS for EUS-GBD. There was no difference in technical success, recurrent cholecystitis, or mortality among the two groups. RCTs and observational studies comparing LAMS vs. FCSEMS head-to-head are required to further our understanding in this regard.Figure 1.: Forest plots comparing the outcomes of LAMS versus FCSEMS in Endoscopic ultrasound-guided gallbladder drainage in acute cholecystitis. Table 1. - LAMS versus FCSEMS for Endoscopic ultrasound-guided gallbladder drainage in acute cholecystitis FCSEMS LAMS No. of patients (n) 199 463 Technical success rate (%) 99.6 94.4 Clinical success rate (%) 99.2 93.3 Total adverse events (n) 21 84 Bleeding (n) 0 19 Perforation (n) 2 4 Mortality (n) 4 12

S2891 A Case of Endoscopic Ultrasound-Guided Gastrojejunostomy for Gastric Outlet Obstruction in a Patient With a Migrated FCSEMS

Introduction: Fully covered self-expandable metal stents (FCSEMS) are often used to resolve benign strictures causing gastric outlet obstruction (GOO). With a short length and anti-migration waist, the TaeWoong Medical FCSEMS is designed to produce radial force against the stricture and greatly reduce stent migration. We report the case of a patient with a retroperitoneal hematoma causing GOO secondary to a duodenal stricture. The FCSEMS placed across the stricture was complicated by stent migration to the stomach, and a gastrojejunostomy (GJ) was performed using a lumen-apposing metal stent (LAMS) and LAMS dilation. Case Description/Methods: A 47-year-old man with no significant history was admitted for GOO secondary to spontaneous non-traumatic hemorrhagic retroperitoneal bleeding. He presented with recurrent episodes of acute epigastric pain radiating to his back, nausea, and vomiting and was found to have pancreatitis with an elevated lipase of 661. Computed tomography (CT) showed a retroperitoneal hematoma surrounding a severely thickened descending and proximal duodenum and the head of the pancreas. Marked distention of the stomach was consistent with GOO. The patient was evaluated by the gastroenterology service, and an esophagogastroduodenoscopy (EGD) revealed a stricture involving the distal D2 and proximal D3 that could not be traversed with the endoscope. An 18 mm x 140mm FCSEMS was placed across the stricture and secured to the antral wall. Three days after discharge, he developed a recurrence of symptoms after advancing his diet to solids. Repeat x-ray and an endoscopic ultrasound (EUS) guided EGD showed the complete migration of the duodenal FCSEMS into the stomach (Panels 1 and 2). The FCSEMS was removed using rat-toothed forceps and an EUS GJ was performed using a 20 mm x 10 mm cautery enhanced LAMS (Panel 3). The patient was able to tolerate both solids and liquids before discharge. Discussion: Despite previously reported benefits of stent anchoring and favorable outcomes of the TaeWoong FCSEMS design, migration occurred. GJ to relieve GOO has emerged as an alternative to refractory cases of endoscopic stenting or surgical GJ, with lower reintervention rates. The use of LAMS to create a GJ successfully mitigated the obstruction in this patient with a complicated hospital course. EUS GJ to relieve obstruction has shown to be promising, and continued research on its safety and efficacy compared to standard therapies (namely FCSEMS) is merited.Figure 1.: 1) X-ray abdomen and pelvis showing the migrated duodenal stent. 2) - Endoscopic view of the migrated FCSEMS in the stomach. 3) - Endoscopic view of the fully deployed LAMS showing the anastomotic connection between the stomach and jejunum, bypassing the duodenal stricture.

S91 Management of Biliary Complications in Liver Transplant Recipients Using a Fully Covered Self-expandable Metal Stent With Antimigration Features

Introduction: Following liver transplant (LT) with duct-to-duct anastomosis, biliary strictures and leaks are typically managed with endoscopic retrograde cholangiopancreatography (ERCP) and stenting. While multiple plastic stents are typically used for strictures, self-expandable metal stents (SEMS) can be used to decrease the number of ERCPS with longer periods of stent patency. However, their use is limited by stent migration. The use of fully covered SEMS (FCSEMS), with antimigration fins to manage benign biliary complications following LT may provide stricture resolution with limited adverse events. As such we aimed to describe clinical outcomes of FCSEMS in LT recipients using one type of FCSEMS. Methods: This was a single center retrospective study of consecutive adult LT patients undergoing FCSEMS from January 2014 to April 2022. Primary outcomes were stricture resolution and recurrence. Secondary outcomes included rates of stent migration, stent occlusion, and number of ERCPs required. Results: 46 LT patients with anastomotic strictures (n=40), bile leaks (n=4) or both (n=2) (average age 55.8 years, 33% women) were treated with a FCSEMS with antimigration features (Viabil, W.L. Gore, Flagstaff, AZ) approved for malignant strictures. The median time from LT to FCSEMS placement was 132.5 days. Within one year of LT, 32 patients (69.5%) required intervention; early intervention at less than 30 and 90 days was needed in 7 and 20 patients, respectively. At the time of study conclusion there were 3 patients with stents in situ. Stricture resolution was seen in 34 patients (74%) after an average stent dwell time of 134.5 ± 71 days; recurrence was observed in 8 patients (17%). There were three instances of partial proximal stent migration that did not require reintervention or interfere with removability. Procedural details are listed in Table: The total mean number of ERCPS required was 2.48 (range 1-5). Conclusion: The use of a FCSEMS with antimigration features offers an opportunity to enhance stricture resolution with longer stent dwell times and fewer ERCPs. In our cohort there were no instances of clinically significant stent migration, dysfunction, or procedure related adverse events. Furthermore, these stents provide an opportunity reduce procedure related costs. Additional studies are needed to identify suitable patients for FCSEMS placement. Table 1. - Procedure related details and stent outcomes Stent Dwell Time +/- Standard Deviation (days) 134.5 +/- 71.8 Stent Placement transpapillary vs intraductally, n (%) 36 (78.3%) vs 10 (21.7%) Prior Sphincterotomy, n (%) 17 (40%) Stricture Recurrence, n (%) 8 (17%) Average Number ERCPs, n (range) 2.48 (1-5) Stent Migration, n (%) 3 (6.5 %) Stent Occlusion, n (%) 8 (17%)

S1690 A Slow Gut Can Hold up Recovery for Cholecystectomy-Induced Bile Leak

Introduction: Bile leak (BL) can occur in up to 0.5% of open cholecystectomies (CCY) and up to 2.7% of laparoscopic CCY. Strasberg types A and D post-CCY BL can be treated with endoscopic retrograde cholangiopancreatography (ERCP) with excellent success rates > 90%. ERCP interventions can decrease the pressure gradient between the bile duct and duodenum and facilitate transpapillary flow of bile. Case Description/Methods: An 81-year-old woman with dementia, recurrent deep vein thrombosis and coronary artery disease presented to an outside hospital with severe abdominal pain and was diagnosed with acute cholecystitis. CCY was delayed by 6 days because she was on ticagrelor and rivaroxaban. Intraoperatively, a gangrenous perforated gallbladder was found, and a surgical drain (SD) was left in-situ. Post CCY she had persistent output from her SD and was transferred to our center for ERCP evaluation of suspected BL. On initial ERCP we found a high-grade Strasberg type A BL from the cystic duct (Figure A). Her major papilla was entirely located within a large duodenal diverticulum. Due to difficulty identifying safe cutting margins within the diverticulum, biliary sphincterotomy (Bsc) was not performed, and a 7 Fr plastic biliary stent was placed which resulted in good flow of bile into the duodenum. Her SD output decreased, and she was discharged the next day. Unfortunately, she was re-admitted to another hospital 3 days later with bile leakage around her SD, vomiting and constipation. An upper gastrointestinal (GI) series excluded a gastric outlet obstruction (Figure B). She was transferred back to our center for ERCP. The scout film showed that oral contrast that was ingested 3 days prior was still present within the proximal jejunum (Figure C). The biliary stent was patent and in good position, but a persistent high-grade BL was seen. Bsc was performed, and an 8mm by 6 cm fully covered self-expanding metal stent (FCSEMS) was placed. The patient was started on an aggressive bowel regimen with resolution of ileus. The SD output ceased, and the SD was removed 3 days later. Unfortunately, patient passed away in hospice before her follow-up ERCP from other causes. Discussion: Despite successful diversion of bile to the duodenum via a biliary stent, small bowel ileus can increase the pressure gradient across the major papilla, resulting in a persistent BL. More aggressive ERCP interventions using FCSEMS, along with aggressive medical treatment of ileus, allowed the BL to heal expeditiously.Figure 1.: A: High-grade cystic duct bile leak on initial ERCP evaluation. B: Contrast flowing from stomach to duodenum in upper gastrointestinal series. The plastic biliary stent is in-situ. C: the oral contrast ingested approximately 3 days prior is still visible within the proximal jejunum on ERCP scout film.

S2852 Dislodged Esophageal Stent Extracted via PEG Tube Site: An Uncommon Solution for a Real Life Problem

Introduction: Esophageal stents have been used for management of refractory benign strictures and has risk of stent migration even with endoscopic suturing or clipping techniques. With esophageal stricture present, the retrieval of the migrated stent becomes a dilemma. We present one such case that required retrieval of the migrated stent through a pre-existing percutaneous endoscopic gastrostomy (PEG) tube site. Case Description/Methods: A 62-year-old man with history of supraglottic small cell carcinoma treated with chemo-radiation therapy developed a severe benign esophageal stricture. He had multiple esophageal dilations and steroid injections which failed and eventually treated by esophageal stent placement with stent fixation via endoscopic suturing. He presented with food impaction and esophagogastroduodenoscopy (EGD) found a severe distal esophageal stricture which could only be traversed with a pediatric gastroscope. The previously placed 20mmx80mm fully covered self-expanding metal stent (FCSEMS) had migrated into the stomach (Figure 1a). Exhaustive attempts at endoscopic retrieval past the esophageal stricture was unsuccessful. He had a pre-existing 20Fr PEG tube and the PEG tract was gradually dilated to 15mm. An adult gastroscope was passed through the PEG site and a raptor forceps was used to grab and extract the forceps successfully (Figure 1b-c). A new 24Fr PEG tube was placed. Mild oozing was seen in the tract, otherwise patient tolerated the procedure well. He was referred to discuss surgical options for further treatment of his esophageal stricture. (Figure) Discussion: Esophageal stents are being increasingly utilized in the management of not only malignant strictures, but also benign esophageal disease such as recurrent esophageal strictures, anastomotic leaks, perforations and fistulae. Stent migration may occur frequently in benign disease with risk factors being use of FCSEMS, distal location and previous migration. An unretrieved stent may cause small bowel obstruction. Anchoring stents with endoscopic suturing, and clips may reduce the risk of migration. If unable to be removed endoscopically then a surgical approach will be needed. Luckily, the presence of a mature gastrostomy tract provided an alternate extraction route for our patient. Risks associated with this modality include bleeding, gastrostomy site disruption, gastric perforation and peritonitis. Increased physician awareness of endoscopic options in such a case may obviate the need for surgical intervention.Figure 1.: Endoscopic image of dislodged esophageal stent in stomach (a). Endoscopic image of adult gastroscope passed through PEG site dilated with CRE balloon (b). Image of dislodged esophageal stent retrieved via dilated PEG site (c).

Potential significance of uncovered self-expandable metal stents for distal malignant biliary obstruction: A propensity score-adjusted competing risk regression analysis.

ObjectivesSelection criteria for self‐expandable metal stents (SEMSs) with or without cover during palliative treatment of distal malignant biliary obstruction (DMBO) remain unclear. We evaluated factors associated with time to recurrent biliary obstruction (TRBO) in fully covered SEMSs (FCSEMSs) and uncovered SEMSs (UCSEMSs).MethodsWe retrospectively analyzed consecutive patients with DMBO who received a SEMS. TRBO was determined using the Kaplan–Meier analysis, and complications were compared between the FCSEMS and UCSEMS groups. After TRBO‐associated factors were extracted using multivariate competing‐risks regression (CRR), propensity score‐adjusted CRRs were performed to verify their robustness.ResultsThere were 180 patients (66 FCSEMSs and 114 UCSEMSs) enrolled in this study. There was no significant difference between median TRBO in the FCSEMS and UCSEMS groups (275 vs. 255 days, p = 0.67). Complications were more frequent in the FCSEMS than UCSEMS group (21.2% vs. 8.8%; p = 0.023). Multivariate CRR for TRBO‐associated factors revealed that “pancreatic ductal carcinoma (PDAC) treated with UCSEMS” was the only independent predictor of TRBO (p = 0.03). Similarly, the propensity score‐adjusted CRRs showed no significant difference in TRBO in “FCSEMS” vs “UCSEMS” (p = 0.96); however, there was a significant difference in “PDAC using UCSEMS” vs “other” (p = 0.043). In the palliative care group including any DMBO without chemotherapy, the first quartile of the TRBO of UCSEMS was 100 days.ConclusionsUCSEMSs are a possible option for both patients with DMBO arising from PDAC and for patients with any DMBO receiving palliative care who should avoid SEMS‐related complications.

Endoscopic therapy using a self-expandable metallic stent with an anti-migration system for postorthotopic liver transplantation anastomotic biliary stricture.

BACKGROUNDEndoscopic therapy using multiple plastic stents (MPSs) is the standard therapy for postorthotopic liver transplantation (p-OLT) anastomotic biliary stricture (ABS). However, this approach demands repeated procedures. Recent studies using fully covered self-expandable metallic stents (FCSEMS) have shown encouraging results, but migration occurs in 10% to 40% of cases. The objective of this retrospective study was to evaluate the efficacy of endoscopic treatment using FCSEMS with an anti-migration system (Am-FCSEMS) in patients with p-OLT ABS.AIMTo evaluate the efficacy of endoscopic treatment using an Am-FCSEMS in patients with p-OLT ABS.METHODSThis study was conducted in a private tertiary care centre in São Paulo, Brazil and was approved by our institution's Human Research Committee. From April 2018 to October 2020, regardless of previous endoscopic treatment (MPS or FCSEMS), 17 patients with p-OLT ABS and indications for endoscopic therapy were included in this study. The exclusion criteria were pregnancy, nonanastomotic biliary or hilar stricture, hepatic artery stenosis/thrombosis, isolated biliary fistulae, a distance shorter than 2 cm from the stricture to the hepatic hilum, and patient refusal. The primary endpoint was the efficacy of p-OLT ABS endoscopic treatment using an Am-FCSEMS that remained in place for a 12-mo period. Biliary sphincterotomy was performed in patients with native papilla, and an Am-FCSEMS (10 mm in final diameter and 60 or 80 mm in length) was placed (HanarostentTM MI Tech, Co). Balloon stricture dilation was performed only if necessary to introduce the stent.RESULTSThree patients were excluded due to loss to follow-up before stent removal. Among the 14 patients included and followed, 7 were women, and the average age was 56 years (range: 28-76). The average period of Am-FCSEMS placement was 362 ± 109 d. Technical success occurred in all 14 patients (100%). There were no cases of distal stent migration. Complete resolution of the stricture occurred in 13/14 patients (92.85%). Adverse events occurred in 3/14 patients (21.42%): 2 patients with mild acute pancreatitis (14.28%) and 1 patient (7.14%) with stent dysfunction (occlusion by biliary sludge and stones, which was treated endoscopically without the need for stent removal). No deaths occurred related to therapy. All stents were removed using foreign body forceps or snares without difficulty. After Am-FCSEMS removal, all 13 patients who had ABS resolution were followed-up for an average of 411 ± 172 d, and there was no stricture recurrence or need for further endoscopic therapy.CONCLUSIONIn this retrospective study, endoscopy therapy using an Am-FCSEMS for p-OLT ABS was safe and effective, with a high stricture resolution rate that was probably due to the absence of stent migration.

Transabdominal self-expandable metal stent placement as a rescue therapy for drainage of walled-off necrosis.

Video 1CT scan of a walled-off necrosis in the right pararenal space extended to the iliac area.

Effect of fully covered self-expandable metal stents completely inserted into the common bile duct in the treatment of benign biliary stricture

Objective: To investigate the safety and efficacy of fully covered self-expandable metal stents(FCSEMS) completely inserted into the common bile duct in the treatment of benign biliary stricture(BBS). Methods: From December 2018 to December 2020, 22 cases of BBS treated by FCSEMS completely inserted into the common bile duct were analyzed retrospectively in the cholelithic center of Shanghai East Hospital Affiliated to Tongji University, including 12 males and 10 females, with average ages of (50.9±8.6) years. Results: All 22 cases of FCSEMS insertion were successful. The average indwelling time was (221.9±19.8) d. There were no complications of enterobiliary reflux such as liver abscess, acute cholangitis, and common bile duct obstruction. FSCEMS proximal displacement occurred in 2 cases (9.1%) with the removal time of 62 min and 115 min, respectively. There was no FCSEMS proximal displacement in 20 cases (90.9), with an average removal time of (29.7±6.3) min. All the 22 cases were followed up for 16.0 (8.0, 25.3) months, and there was no recurrence of stenosis. Conclusion: FCSESM completely inserted into the common bile duct is an effective method for the treatment of BBS, which can avoid the occurrence of enterobiliary reflux.

Fully covered self-expandable metal stent for intraprocedural or late-diagnosed Type-II endoscopic retrograde cholangiopancreatography-related perforations

BackgroundPerforations related to endoscopic retrograde cholangiopancreatography (ERCP) are rare but life-threatening complications. The treatment of Type-II-periampullary perforations that develop during endoscopic sphincterotomy remains a topic of discussion. This study aimed to evaluate the usefulness of fully covered self-expanding metal stenting (FCSEMS) for treating Type-II perforations.MethodsThe files of all patients who underwent the ERCP procedures between January 2015 and October 2021 were retrospectively reviewed; patients with Stapher Type-II perforation were included in the current study. Patients with FCSEMS were classified into two groups: those who underwent FCSEMS and those who were conventionally followed up. Moreover, patients with FCSEMS were classified into two subgroups: those who underwent simultaneous stenting and those who underwent late stenting. Mortality, surgical intervention, percutaneous drainage, length of hospital stay, and inflammatory markers were all compared between the groups.ResultsOf the 9253 patients undergoing ERCP during the study period, 28 patients (0.3%) were found to have Type-II perforation. The mean age of these patients was 67.7 ± 3.9 years, and 15 patients were female. FCSEMS was performed on 19 patients, whereas 9 patients were on conventional follow-up. None of the patients developed mortality. In the conventional follow-up group, one patient required percutaneous drainage and one required surgical intervention. In contrast, none of the patients in the FCSEMS group required additional intervention. At a statistically significant level, the length of hospital stay was found to be shorter in the FCSEMS group. There was no difference in inflammatory markers between the two groups. In nine patients, FCSEMS was performed simultaneously, whereas, in ten patients, FCSEMS was performed later because they required a second intervention. These two subgroups did not differ in terms of outcomes.ConclusionsFCSEMS is a safe and effective treatment modality for patients with Type-II perforation. Moreover, it can be safely used in patients whose perforations are diagnosed during the ERCP procedure and in patients whose diagnoses are made after the procedure.

Comparison of an Inside Stent and a Fully Covered Self-Expandable Metallic Stent as Preoperative Biliary Drainage for Patients with Resectable Perihilar Cholangiocarcinoma.

Background There is a need for a more tolerable preoperative biliary drainage (PBD) method for perihilar cholangiocarcinoma (PHCC). In recent years, inside stents (ISs) have attracted attention as a less suffering PBD method. Few studies have compared IS with a fully covered self-expandable metallic stent (FCSEMS) as PBD for resectable PHCC. The aim of this study is to compare them. Methods This study involved 86 consecutive patients (IS: 51; FCSEMS: 35). The recurrent biliary obstruction (RBO) rate until undergoing surgery or being diagnosed as unresectable, time to RBO, factors related to RBO, incidence of adverse events related to endoscopic retrograde cholangiography, and postoperative complications associated with each stent were evaluated retrospectively. Results There was no significant difference between the two groups in the incidence of adverse events after stent insertion. After propensity score matching, the mean (SD) time to RBO was 37.9 (30.2) days in the IS group and 45.1 (35.1) days in the FCSEMS group, with no significant difference (P=0.912, log-rank test). A total of 7/51 patients in the IS group and 3/35 patients in the FCSEMS group developed RBO. The only risk factor for RBO was bile duct obstruction of the future excisional liver lobe(s) due to stenting (HR 29.8, P=0.008) in the FCSEMS group, but risk factors could not be indicated in the IS group. There was no significant difference in the incidence of bile leakage or liver failure. In contrast, pancreatic fistula was significantly more common in the FCSEMS group (13/23 patients) than in the IS group (3/28 patients) (P < 0.001), especially in patients who did not undergo pancreatectomy (P=0.001). Conclusions As PBD, both IS and FCSEMS achieved low RBO rates. Compared with FCSEMS, IS shows no difference in RBO rate, is associated with fewer postoperative complications, and is considered an appropriate means of PBD for resectable PHCC. This trail is registered with UMIN000025631.

Comparison of no stent fixation, endoscopic suturing, and a novel over-the-scope clip for stent fixation in preventing migration of fully covered self-expanding metal stents: a retrospective comparative study (with video)

Endoscopic suturing and over-the-scope clips (OTSCs) are used to prevent migration of fully covered self-expandable metal stents (FCSEMSs). Recently, a dedicated OTSC was developed for securing FCSEMSs. Our primary aim was to compare the frequency of stent migration without stent fixation versus fixation with suturing or OTSCs, and out secondary aims were to compare clinical success, procedure duration, and adverse events. A retrospective cohort study evaluated the outcome of stent placement throughout the entire GI tract from 2013 to 2021. Stent migration was determined as stent displacement≥2 cm endoscopically or radiographically. Clinical success was defined as resolution of indication at follow-up. Four hundred thirty-three procedures were performed, 239 (55%) without fixation, 140 (32%) with suturing, and 54 (12%) with OTSCs. Stent migration rates were 62% without fixation, 57% with suturing, and 35% with OTSCs (P= .013). The median time to stent migration was 3 weeks without fixation, 5 weeks with suturing, and 6 weeks with OTSCs (P= .023). The clinical success rate was 43%. The median procedure time for OTSCs was shorter compared with suturing (42 vs 68 minutes, P= .002). Adverse event rates trended toward being lowest with OTSCs at 9% compared with 21% without fixation and 18% with suturing (P > .05). OTSCs for stent fixation were found to have significantly lower migration rates compared with no fixation and suturing. Moreover, OTSCs were associated with decreased overall procedure time and total costs per procedure while trending to be associated with fewer adverse events.

Biliary stones or ulcers at the choledochojejunal anastomotic site involving the jejunal mucosa at stent removal may be recurrent factors in patients with benign choledochojejunal anastomotic stenosis undergoing endoscopic biliary stenting using fully covered self-expandable metal stents.

Temporary fully covered self-expandable metal stent (FCSEMS) placement is performed for benign choledochojejunal anastomotic stenosis (bCJS). However, recurrence may develop after stricture resolution. We investigated endoscopic biliary stenting using FCSEMS for bCJS. Sixteen bCJS patients with FCSEMS placement were retrospectively analyzed. FCSEMS was removed endoscopically after 2months. Technical success, stricture resolution, recurrence, and adverse events were evaluated. The technical success rate for FCSEMS placement was 94% (15/16). Biliary stones were detected and extracted in four patients. FCSEMS removal was successfully performed on 14 patients, excluding one with stent migration. At FCSEMS removal, stricture resolution was noted in 14 patients; however, four had anastomotic ulcers. The median follow-up was 319 days. Three patients with a history of repeated plastic stent placement had no recurrence. Four out of 15 patients (27%) had recurrence, and three had no recurrence after additional interventions. Biliary stones before first FCSEMS placement (P=.003) or anastomotic ulcers at FCSEMS removal (P=.018) were associated with recurrence. Although FCSEMS placement was useful for stricture resolution, recurrence was detected in patients with biliary stones before first FCSEMS placement or anastomotic ulcers at FCSEMS removal. Anastomotic ulcers are a risk factor for recurrence and only detected by endoscopy.

Preclinical evaluation of endoscopic placement of a steroid-eluting metal stent in an in vivo porcine benign biliary stricture model

Treatment of benign biliary strictures (BBS) using fully covered self-expandable metal stents (FCSEMS) has a high success rate, but recurrence can occur. Corticosteroids may be useful based on their anti-fibrotic and anti-inflammatory effects. We investigated the safety and efficacy of corticosteroid-eluting FCSEMS in an animal model. BBSs were created by radiofrequency ablation in 12 mini-pigs. Four weeks later, FCSEMS coated with 0 mg (control), 15 mg (steroid 1 × group), or 30 mg (steroid 2 × group) triamcinolone were inserted endoscopically. The in vitro drug release assay revealed that the optimal stent had 15 mg of triamcinolone and a hydrophilic membrane. No transmural necrosis or perforation occurred in any animal. Fibrous wall thickness tended to decrease macroscopically and microscopically in a triamcinolone dose-dependent manner (control vs. steroid 2 × group: 773.1 vs. 468.5 µm, P = 0.037). Thickness also decreased over time in the steroid 2 × group (3 days vs. 4 weeks: 907.9 vs. 468.5 µm, P = 0.025). Blood parameters tended to improve after stent insertion. In a porcine BBS model, steroid-eluting FCSEMS showed potential as a safe and effective treatment modality to reduce fibrotic tissue. Studies are required to confirm their safety and efficacy in humans with refractory BBS.

Usefulness of the laser-cut, fully covered, self-expandable metallic stent for endoscopic ultrasound-guided hepaticogastrostomy.

Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) has many associated adverse events. We evaluated the clinical efficacy and safety of the laser-cut, fully covered, self-expandable metallic stent (FCSEMS) for this procedure. This single-center, retrospective study included cases where EUS-HGS with a laser-cut FCSEMS was performed for malignant biliary obstruction. Technical and clinical success, time to recurrent biliary obstruction (TRBO), procedure time, adverse events, and re-interventions were evaluated. There were 95 eligible cases. Technical and clinical success rates were 100.0% and 95.8%, respectively. Median TRBO was 398 days. RBO causes were hyperplasia (7.4%), debris (3.2%), and migration (4.2%). Adverse events occurred in nine cases (9.5%). Non-occlusion and focal cholangitis occurred in four cases (4.2%) each. Nineteen patients (20%) underwent combined EUS-HGS (CH) procedures: antegrade stenting, bridging methods, plastic stent anchoring in SEMS, and EUS-hepaticoduodenostomy. The solely EUS-HGS (SH) group had significantly longer median TRBO than the CH group (398 vs 246 days, P=.04). There were no significant differences in adverse events between the two groups. Re-intervention was performed in 29 cases (technical success rate: 100.0%). Laser-cut FCSEMS can be safely placed in the bile duct and easily applied during re-intervention, making it useful in EUS-HGS.

Endoscopic Management of Biliary Strictures after Orthotopic Liver Transplantation: A Single Center Experience Study.

Background and Aim. Endoscopic therapy is the method of choice in the management of biliary strictures after orthotopic liver transplantation (OLT). Even though the mainstay approach for OLT stricture complications is represented by consecutive procedures of multiple plastic stents (MPS) insertion, a valuable alternative is the use of fully covered self-expandable metal stents (FCSEMS). The aim of the study was to compare MPS with FCSEMS used in the management of OLT biliary strictures, in terms of clinical outcomes and complications. Material and Methods. This is a retrospective, single-center study conducted between February 2014 and November 2019 in the Clinical Emergency Hospital of Bucharest, Romania. We enrolled all consecutive patients who developed biliary strictures after OLT and were treated by endoscopic retrograde cholangiopancreatography (ERCP) either with MPS or FCSEMS. Results. Thirty-six patients were included in the study, 27 patients had MPS and nine patients had FCSEMS. 106 ERCP procedures were performed and 159 stents were inserted. The mean number of ERCP procedures required per patient was significantly higher for MPS than for FCSEMS (3.34 ± 1.46 vs. 2.11 ± 0.33, p < 0.001). In the FCSEMS group only one patient had three procedures, due to stent migration. Difficult cannulation was encountered in 22 patients, 18 patients from MPS group and four patients from FCSEMS group. Dilation was performed in 20 (77%) MPS patients and in four FCSEMS patients (44%). Overall, we used 159 stents for stricture resolution, 149 plastic stents and 10 FCSEMS. Mean number of stents inserted was significantly lower in the FCSEMS group compared to MPS group (1.16 ± 0.40 vs. 5.73 ± 2.64, p < 0.001). Conclusions. Stricture resolution using FCSEMS is comparable to MPS and even has some advantages. In line with prior studies, FCSEMS are effective, with fewer complications and similar outcome compared to plastic stents. Other particular aspects should be further assessed, especially long-term follow up of FCSEMS and their cost efficiency.

Acellular Dermal Matrix Prevents Esophageal Stricture After Full Circumferential Endoscopic Submucosal Dissection in a Porcine Model.

Esophageal stricture is a common complication after endoscopic submucosal dissection (ESD), especially in full circumferential ESD. This study investigated fully covered self-expanding metal stent (FCSEMS) placement with an acellular dermal matrix (ADM) for preventing post-ESD esophageal stricture. Twelve Bama minipigs were randomly divided into two groups, which underwent full circumferential ESD in the distal esophagus. In group A, an FCSEMS with ADM was placed at the mucosal defect, whereas group B underwent standard FCSEMS placement. The stent was removed during gastroscopy 2 weeks after the ESD procedure. At the fourth week, gastroscopy was repeated to evaluate local healing and stenosis. The animals were sacrificed, esophageal specimens were obtained for macroscopic and histological evaluation, and serum C-reactive protein (CRP) levels were quantified. Four weeks post ESD, dysphagia occurrence was lesser in group A than in group B. Group A demonstrated lesser esophageal stricture on macroscopic evaluation (21.02 ± 16.65% vs. 57.41 ± 8.48%, p = 0.001) in the form of enhanced re-epithelization (99.13 ± 0.98% vs. 96.63 ± 1.64%, p = 0.009), diminished submucosal fibrosis (1117.53 ± 188.83 um vs. 1834.69 ± 421.99 um, p = 0.003), and attenuated inflammatory infiltration (121.00 ± 30.66 vs. 188.17 ± 64.92, p = 0.045). The increase in the serum CRP level was lower in group A than in group B at 4 weeks post-ESD. FCSEMS combined with ADM can enhance re-epithelization in the process of wound healing and significantly reduce the degree of esophageal stenosis after circumferential ESD. This study provided important preclinical findings for subsequent clinical trials.

Fully covered self-expandable metal stent placed over a stapled colon anastomosis in an animal model: A pilot study of colon metabolism over the stent.

Background and AimAnastomotic leakage (AL) in colorectal resection and primary anastomosis is a common and feared complication. Fully covered self‐expandable metal stents (FCSEMSs) have been used for the treatment of AL. It is still unknown whether FCSEMSs affect anastomosis healing negatively by causing ischemia. In an animal study, we investigated the metabolic effects over a FCSEMS covering a stapled colon anastomosis.MethodsSeven pigs were investigated using microdialysis after laparotomy, colon resection, and anastomosis with stent placement. Measurements were done at the proximal and distal ends of the anastomosis and at a reference catheter placed at the small intestine. Measurements of glucose, pyruvate, lactate, glycerol, and the lactate/pyruvate ratio (L/P) were carried out.ResultsLactate and L/P were significantly higher at the oral part of the anastomosis, while glucose showed a small declining tendency. At the distal part of the anastomosis, glucose decreased significantly after the resection but did not reach zero. Lactate increased significantly whereas L/P increased only slightly. Glycerol levels were stable.ConclusionColon resection caused initially hypermetabolism in the intestinal ends next to the resection site. This hypermetabolism neither deteriorated nor turned into ischemia during the initial postoperative course, but the start of hypoxemia could not be excluded during the study and after the placement of an FCSEMS.

A prospective study of fully covered self-expandable metal stents for refractory benign pancreatic duct strictures.

Fully covered self-expanding metal stents (FCSEMSs) are a relatively novel option for treating painful main pancreatic duct refractory strictures in patients with chronic pancreatitis. Herein, we aimed to assess the efficacy, feasibility, and safety of FCSEMSs in this patient group. This prospective single-center study included patients who underwent endoscopic retrograde pancreatography with FCSEMS placement. The primary endpoints were the technical and clinical success rates. A reduction in visual analog scale pain score of >50% compared with that before stent placement was defined as clinical success. Secondary endpoints were resolution of pancreatic strictures on fluoroscopy during endoscopic retrograde pancreatography and the development of stent-related adverse events. Thirty-six patients were included in the analysis. The technical success rate was 100% (n=36) and the clinical success rate was 86.1% (n=31). There was a significant increase in stricture diameter from 1.7 mm to 3.5 mm (p<0.001) after stent removal. The mean visual analog scale pain score showed statistically significant improvement. At 19 months of follow-up, 55.6% of the patients were asymptomatic. Stent migration (16.7%), intolerable abdominal pain (8.3%), development of de novo strictures (8.3%), and mild pancreatitis (2.8%) were the most common adverse events. FCSEMS placement showed good technical and clinical success rates for achieving pain relief in patients with refractory main pancreatic duct strictures.

The role of a novel self-expanding metal stent in variceal bleeding: a multicenter Australian and New Zealand experience.

Background and study aims Refractory variceal bleeding is associated with high mortality in patients with chronic liver disease. A fully-covered self-expanding metal stent (SEMS) has been reported to have excellent rates of technical success and initial bleeding control; however, studies to date are small and limited to Europe and Asia. Our aim was to evaluate the efficacy and safety of this SEMS for control of refractory variceal bleeding (VB). Patients and methods A retrospective analysis was undertaken of all patients who received the SX-ELLA Danis SEMS for management of VB at 9 tertiary centers across Australia and New Zealand. A total of 32 SEMS had been deployed in 30 patients (median age 53.3). Results Technical success of SEMS placement was achieved in 100 % of cases, resulting in immediate control of bleeding across 31 of 32 cases (96.9 %). Re-bleeding with SEMS in situ occurred in three of 32 cases (9.4 %). Mean SEMS in-dwelling time was 6.4 days. Delayed SEMS migration occurred in 6.3 % of cases. Interventional radiological therapy for management of varices within 6 weeks was performed in 12 of 30 patients (40 %). Death with SEMS in situ occurred in seven of 30 patients (23.3 %). Seven-day bleeding-related mortality was 16.7 %, 14-day mortality 23.3 %, and 6-week mortality 33.3 %. Three of 30 patients (10 %) received orthotopic liver transplantation following SEMS insertion, including two patients within 6 weeks. Conclusions SX-Danis Ella SEMS is highly effective for immediate control of refractory VB and bridging to definitive therapy because it has excellent technical success rates, appears to be relatively easy to use, and has low rates of serious adverse events.