Fully Covered Self-expandable Metal Stents Placement Research Articles

Treatment of biliary strictures with fully covered self-expandable metal stents after pancreaticoduodenectomy.

Background and study aims Anastomotic stricture is a late complication after biliary reconstructive surgery, but standard treatments are currently lacking. We selected patients who had undergone pancreaticoduodenectomy and Child's procedure, and aimed to evaluate the safety and efficacy of temporary placement of fully covered self-expandable metal stents (FCSEMSs) to treat postoperative anastomotic stricture. Patients and methods This study retrospectively analyzed 13 patients who underwent treatment with FCSEMSs for anastomotic stricture between June 2011 and March 2016. We evaluated technical and clinical success, complications, duration of patency after FCSEMS removal, and re-stenosis. Results All of the anastomotic strictures were improved by FCSEMS placement and luminal patency was maintained throughout the follow-up period, with no complications. After 2 months, the FCSEMSs were removed endoscopically in nine patients, and in four patients the stent had been expelled spontaneously per rectum. Median duration of follow-up was 225 days (range 30 - 935 days). No re-stenosis occurred in any of the 13 cases following stent removal. Conclusion Deployment of FCSEMSs for anastomotic stricture offers a safe and promising treatment that may replace percutaneous transhepatic biliary drainage and deployment of multiple plastic stents as the first-line treatment.

Endoscopic Management of Post-Liver Transplantation Biliary Strictures With the Use of Fully Covered Metallic Stents.

The aim of this work was to evaluate the safety and efficacy of a fully covered self-expandable metal stent (FCSEMS) in the treatment of post-liver transplantation biliary strictures. From October 2009 to October 2014, 44 patients with post-liver transplantation biliary stenosis were treated with the use of endoscopic retrograde cholangiography and placement of FCSEMS after informed consent. The FCSEMS was scheduled to remain in situ for 3-6 months. Patients were followed at regular intervals to evaluate for symptoms and liver function tests. Technical success, complications, and patient outcome were analyzed. All of the strictures were anastomotic, 52% having occurred within the 1st year following the transplantation. Placement of the FCSEMS was possible on the 1st attempt in 54% of patients. Stricture resolution at the time of stent removal was seen in 100% of the cases. During an average follow-up of 27.83 ± 18.3 months after stent removal, stenosis recurred in 9 out of 41 patients (21.9%). The average time of recurrence was 11.78±13.3 months. In all of these cases, the recurrence was resolved by means of placement of another FCSEMS. In 4 cases, the recurrence was associated with a migration of the prosthesis, partial in 2 cases and total in 2 cases. Stent migration occurred in a total of 17 of the 41 patients (41.4%), in 13 of the 32 (40.6%) who had no recurrence of stenosis and in 4 of the 9 (44.4%) of those who experienced recurrence. The average numbers of endoscopic retrograde cholangiography studies required per patient were 2.8 in those with no recurrence and 3.3 in those with recurrence. No death was associated with the process. FCSEMS is a safe effective alternative to plastic stents in the treatment of post-transplantation biliary strictures, resulting in a lower risk of complications and better patient acceptance.

OC-076 Endoscopic Placement of Fully Covered Self Expanding Metal Stents (FC-SEMS) into the Pancreatic Duct of Patients With Painful Chronic Pancreatitis

Introduction Endoscopic placement of plastic stents into the pancreatic duct (PD) has achieved disappointing outcomes in the treatment of painful chronic pancreatitis (CP), when compared to surgery. However, pancreatic bypass surgery or resection is associated with significant morbidity. Recently, FC-SEMS have proven more effective than plastic stents in the management of strictures of the bile duct. We aimed to assess feasibility, safety and efficacity of PD FC-SEMS in the management of painful CP. Methods Patients were recruited at a single tertiary UK pancreatobiliary centre. Patients were considered for PD FC-SEMS after demonstration of i) CT/MR imaging criteria of chronic pancreatitis including dilatation of the main PD and ii) characteristic pancreatic pain resistant to analgesia. Patients’ treatment plans were all determined in a MDT meeting. All patients gave informed consent. Visual analogue pain scores and analgesia requirements were documented prior to intervention and at each follow up appointment. At ERCP, PD cannulation was attempted from the major papilla in all cases. In cases of pancreas divisum, or where PD cannulation via the major papilla failed, cannulation of the minor papilla was attempted. On cannulation of the PD, a pancreatic sphincterotomy was performed before deployment of a 60 mm by 8 mm FC-SEMS. Stent removal was scheduled between 10 and 14 weeks after placement. Results 35 patients (22 M) had FC-SEMS placed into the PD. The median age at time of stent placement was 55 y (range 21–71). In 24 cases the stent was placed via the major papilla, 11 were placed via the minor papilla. The median interval between stent placement and removal was 86 days (13–252) with median follow up of 22 months (3–33). One patient developed a Santorini duct abscess, which precipitated early stent removal but was otherwise managed conservatively. One instance of retrograde stent migration was noted and was managed endoscopically. 20 (57%) patients reported a complete resolution of pancreatic pain, 10 (29%) a partial response and 5 (14%) no response. A concomitant cessation or decline in the use of opiate analgesia was demonstrated. Of the five non- responders, three proceeded to lateral pancreatojejunostomy – two of whom reported a full symptomatic response. Conclusion Placement of FC-SEMS into the pancreatic duct of patients with painful chronic pancreatitis appears to be feasible and safe and does not preclude subsequent surgical intervention. The lengthy follow up data presented suggests that this endoscopic approach may be more effective than would be expected from historical studies of the use of plastic pancreatic duct stents. A controlled trial is warranted. Disclosure of Interest None Declared

A fully covered self-expandable metal stent anchored by a 10-Fr double pigtail plastic stent: an effective anti-migration technique.

BackgroundFully covered self-expandable metal stents (FCSEMS) have been used successfully in the treatment of malignant and benign biliary strictures. However, stent migration is a major complication. We investigated the efficacy of anchoring FCSEMS with a 10-Fr double-pigtail plastic stent to prevent migration in patients with biliary strictures.MethodsBetween January 2012 and May 2013, 10 patients with malignant biliary strictures and one patient with a suprapapillary benign biliary stenosis were enrolled in the study. The primary endpoint of the study was to record the migration rate of FCSEMS.ResultsThe placement of FCSEMSs and the anchoring with a 10-Fr double-pigtail plastic stent were successful in all patients. During a median follow-up period of eight months, proximal or distal migration of FCSEMS was not observed. No procedural complications related to the placement of FCSEMS and/or the anchoring plastic stent were recorded.ConclusionsThe placement of an anchoring 10-Fr double-pigtail stent is a simple and effective anti-migration technique for FCSEMS in patients with malignant biliary strictures.

Feasibility and safety of a fully covered self-expandable metal stent with antimigration properties for EUS-guided pancreatic duct drainage: early and midterm outcomes (with video)

Recently, EUS-guided pancreatic duct drainage (EUS-PD) has been used for patients in whom endoscopic retrograde pancreatography (ERP) has failed. Stent-related adverse events such as stent migrations, failures in stent placement, or pancreatic fluid leakages have been of concern in transmural plastic stenting procedures. The aim of this study is to evaluate the feasibility and safety of EUS-PD with a fully covered self-expandable metal stent (FCSEMS) for patients with obstructive pancreatitis who failed ERP. Twenty-five consecutive patients with painful obstructive pancreatitis underwent EUS-PD with a FCSEMS after failed ERP. Technical and clinical success, adverse events, and stent patency were assessed. EUS-PD was successful in all 25 patients (technical success rate, 100%), and symptoms improved in all patients (clinical success rate, 100%). EUS-guided pancreaticogastrostomy (n = 23), pancreaticoduodenostomy (n = 1), and pancreaticojejunostomy (n = 1) were performed. Pain scores improved significantly after FCSEMS placement (P = .001). Early mild grade adverse events occurred in 5 patients (20%), 4 with self-limited abdominal pain and 1 with minor bleeding. No other adverse events related to FCSEMS, including stent migration, stent clogging, pancreatic sepsis, and stent-induced ductal stricture, were observed during follow-up periods. Mean stent patency duration was 126.9 days during mean follow-up periods (221.1 days). EUS-PD with an FCSEMS may be technically feasible and relatively safe for patients who fail conventional ERP. Further randomized trials comparing EUS-PD with long-term FCSEMS and plastic stents for patients with painful obstructive pancreatitis after failed ERCP should be encouraged.

PTH-007 Fully-covered metal stents in the endoscopic treatment of malignant distal biliary obstruction – review of outcome in a large acute hospital: Abstract PTH-007 Table 1

Introduction Endoscopic Retrograde Cholangiopancreatograpy (ERCP) and stent insertion is a mainstay of treatment for malignant distal biliary obstruction. Choice of stent remains controversial with plastic, uncovered and more recently introduced fully-covered self-expanding metal stents (SEMS) in use. Our aim was to examine the outcome of ERCP stent insertion using different stent types, in a large acute hospital. Method We performed retrospective review of all cases of ERCP stent insertion in our unit for malignant distal biliary obstruction over a 5 year period to September 2013. Outcome data were collected for each case at 3, 6 and 12 months following stent insertion and statistical analysis performed using Fisher’s exact test. Results 301 stents were placed for confirmed malignant obstruction in 237 patients; median age 73 years (range 35–98). Cumulative stent occlusion rates were significantly higher with plastic stents versus fully-covered SEMS at 3 months (15% vs 4%, p = 0.006), 6 months (30% vs 8%, p = 0.001) and 12 months (37% vs 12%, p = 0.001). Ascending cholangitis was significantly more frequent following plastic stent insertion than fully-covered SEMS at 6 months (20% vs 9%, p = 0.027) and 12 months (23% vs 12%, p = 0.017). There were no significant differences in rates of stent migration or cholecystitis between the stent types (Table 1), or in survival at 12 months. Compared with covered SEMS, unplanned repeat ERCP was significantly more likely following insertion of a plastic stent (32% vs 6%, p Conclusion In this case series plastic stents were associated with significantly greater rates of stent occlusion and ascending cholangitis than fully-covered SEMS. There were no significant differences in rates of stent migration or gallbladder complications. Overall need for repeat unplanned ERCP was markedly reduced by fully-covered SEMS placement. Disclosure of interest None Declared.

EUS-guided pseudocyst drainage: prospective evaluation of early removal of fully covered self-expandable metal stents with pancreatic ductal stenting in selected patients

EUS-guided pseudocyst drainage with fully covered self-expandable metal stents (FCSEMSs) was recently described. The appropriate period for stent removal is not known. To assess the safety and efficacy of EUS-guided FCSEMS placement for 3 weeks, along with pancreatic ductal stenting in selected patients. Prospective, single-center evaluation. Tertiary referral center. Symptomatic pseudocysts in the body and tail region of the pancreas. EUS-guided transgastric placement of FCSEMS. MRCP was performed after 3 weeks. Patients with a suspected pancreatic duct leak underwent ERCP and plastic stent placement. The FCSEMSs were removed at 3 weeks. Success of FCSEMS placement, adverse events, and recurrence rate. Forty-seven patients met the eligibility criteria. Technical and functional success was achieved in 43 patients (intention to treat, 91.48% and 95.34% patients [per protocol, 41/43, respectively]). Adverse events occurred in 2 patients (cyst infections, 4.6%). Follow-up of 42 patients at 3 weeks was performed. MRCP detected a ductal leak in 3 patients (7.1%) and a disconnected duct in 2 patients (4.7%). ERCP and stenting were successful in all 3 patients with a ductal leak. During a median follow-up of 306 days in 42 patients, 2 recurrences (4.7%) were detected, both in patients with disconnected duct. Multivariate analysis showed that pancreatic ductal leak or disconnection was an independent factor affecting pseudocyst resolution at 3 weeks (P = .0001). Single-center study. Short-term placement of FCSEMSs with pancreatic ductal stenting in selected patients appears safe and effective for the treatment of pseudocysts.

Su1711 Management of Pancreatic Ductal Leaks in Patients With Chronic Pancreatitis

Su1711 Management of Pancreatic Ductal Leaks in Patients With Chronic Pancreatitis

Placement of a New Fully Covered Self-expanding Metal Stent for Postoperative Biliary Strictures and Leaks Not Responding to Plastic Stenting

Fully covered self-expanding metal stents (FCSEMSs) are now being used to treat postoperative biliary strictures (BSs) and biliary leaks (BLs). The aim of this study was to assess the safety and effectiveness of a new FCSEMS (Wallflex) in patients with postoperative BSs and BLs after failure of traditional endoscopic treatment. Between January 2010 and December 2011, 16 patients (10 patients with postcholecystectomy BSs, 4 with postcholecystectomy BLs, and 2 with postorthotopic liver transplantation BSs) were enrolled. The technical and clinical success rate was 100%. All FCSEMSs were removed after a mean of 141 days. Complications occurred in 7 cases: 2 postprocedure pain, 2 mild pancreatitis, 1 early distal, and 2 late proximal FCSEMS migration. The overall long-term clinical success rate was 94% after a mean follow-up of 13 months. In our experience, the placement of FCSEMSs is an effective and secure method of treating refractory postoperative BSs or BLs.

Fully covered self-expandable metallic stents in benign biliary strictures: a multicenter study on efficacy and safety

Benign biliary diseases include benign biliary stricture (BBS), lithiasis, and leaks. BBSs are usually treated with plastic stent placement; use of uncovered or partially covered metallic stents has been associated with failure related to mucosal hyperplasia. Some recently published series suggest the efficacy of fully covered self-expandable metal stents (FCSEMSs) in BBS treatment. We aimed to assess the efficacy and safety of FCSEMS in a large series of patients with BBS and a long follow-up. Prospective multicenter clinical study at three tertiary referral centers: ISMETT/UPMC Italy, Palermo, San Paolo Hospital, Milan, and the ARNAS Civico Hospital, Palermo, Italy. All consecutive patients with BBS were treated with placement of FCSEMS rather than plastic stents, as first approach (11 patients, 17.7 %), or as a second approach after failure of other treatments (51 patients, 82.2 %). From January 2008 to March 2011, 62 patients (40 male) were included. Mean period of FCSEMS indwelling was 96.7 days (standard deviation [SD] 6.5 days). In 15 patients (24.2 %) the SEMS migrated. Resolution of BBS occurred in 56 patients (90.3 %), while in 6 (9.6 %) the treatment failed. Mean (SD) follow-up after SEMS removal was 15.9 (10) months. FCSEMS placement as first- or second-line approach showed no difference in failure. Recurrence was observed in 4 /56 patients (7.1 %); all were transplant recipients: P = 0.01; odds ratio (OR) 1.2, confidence interval (CI) 1.1 - 1.3. Despite the noteworthy migration rate, FCSEMSs should be considered effective for refractory benign biliary strictures. Further studies are needed to assess their role as a first approach in the management of BBS.

Endoscopic ultrasound-guided drainage of pancreatic fluid collections with indeterminate adherence using temporary covered metal stents

Transenteric drainage of a pancreatic fluid collection (PFC) with poor adherence to the bowel wall risks leakage and perforation. Elimination of tract dilation and the use of a fully covered self-expanding metal stent (FCSEMS) may improve safety. We evaluated endoscopic ultrasound (EUS)-guided drainage of PFCs using a one-step access device followed by placement of a FCSEMS. Eighteen patients (12 males; median age 50) with PFCs (median size 135 mm) meeting the criteria for indeterminate adherence were enrolled. After 7 - 10 days, the FCSEMSs were removed and exchanged for double-pigtail stents. When indicated, tract dilation and endoscopy-guided cyst debridement was performed. FCSEMS placement was technically successful in all patients without complications. Median procedure time was 37.5 minutes. Cystgastrostomy dilation resulted in dehiscence in one patient and was treated with repeat FCSEMS placement. Cyst resolution was achieved in 78 % of patients. FCSEMS placement without tract dilation enables safe initial drainage of PFCs with indeterminate adherence.

Placement of fully covered self-expandable metal stents in patients with locally advanced esophageal cancer before neoadjuvant therapy

Most patients with locally advanced esophageal cancer requiring neoadjuvant therapy have significant dysphagia. To report our experience in using a fully covered self-expandable metal stent (FCSEMS) to treat malignant dysphagia and for maintenance of nutritional support during neoadjuvant therapy. Retrospective study. Two tertiary-care referral centers. This study involved 55 patients with locally advanced esophageal cancer (50 adenocarcinoma, 5 squamous cell carcinoma). Forty-three patients were men, and the mean age was 65.8 years. EUS followed by FCSEMS placement. Procedural success, dysphagia scores, patient weights, stent migration, and stent-related complications. All stents were successfully placed. Tumors were located in the middle esophagus (n = 10) and distal esophagus (n = 45). The mean dysphagia score obtained at 1 week after stent placement had improved significantly from baseline (2.4 and 1, respectively; P < .001). Patients maintained their weights at 1 month follow-up when compared with baseline (153 and 149 pounds, respectively; P = .58). Immediate complications included chest discomfort in 13 patients; 2 patients required stent removal because of intractable pain. One patient had stent removal because of significant acid reflux. Stent migration occurred at some point in 17 of 55 patients (31%). There was a delayed perforation in 1 patient. Because of disease progression or the discovery of metastasis after neoadjuvant therapy, only 8 of 55 patients underwent curative surgery. Retrospective study. Placement of FCSEMSs in patients with locally advanced esophageal cancer significantly improves dysphagia and allows for oral nutrition during neoadjuvant therapy. FCSEMSs appear to be effective for palliating dysphagia. Migration was not associated with injury or harm to the patient and usually represented a positive response to neoadjuvant therapy. Few patients undergoing stenting in this situation ultimately undergo surgery because of disease progression or poor operative candidacy.

Feasibility and safety of placement of a newly designed, fully covered self-expandable metal stent for refractory benign pancreatic ductal strictures: a pilot study (with video)

Painful chronic pancreatitis with main pancreatic ductal strictures is usually managed with endotherapy with a plastic stent. To date, the role of placement of metallic stents, especially uncovered ones in benign pancreatic ductal stricture, has been unsatisfactory as a result of stent dysfunction related to mucosal hyperplasia. We explored the feasibility and safety of temporary placement of a newly designed, fully covered self-expandable metal stent (FCSEMS) in painful chronic pancreatitis and refractory benign pancreatic ductal strictures. A prospective pilot and feasibility study. A tertiary academic center. Thirteen patients with chronic painful pancreatitis of alcoholic (8) or idiopathic (5) etiology. ERCP with temporary FCSEMS placement (2 months). Endoscopic removal of FCSEMSs was performed with a snare or rat-tooth forceps. End points were feasibility, safety, and morbidity. Successful FCSEMS placement was performed in all enrolled patients. After immediate placement of FCSEMS, 2 patients had mild acute pancreatitis related mainly to the stricture dilation procedure (Soehendra stent retriever or balloon dilation). Complications associated with stent placement included 5 migrations (39%, 1 proximal and 4 distal) and 2 incidents of cholestatic liver dysfunction associated with the compression of the bile duct orifice by expansion of FCSEMSs. In 1 patient with proximal migration, the stent was repositioned by an inflated retrieval balloon. Additional endoscopic biliary sphincterotomy with or without biliary stenting was performed in 2 patients with cholestatic liver dysfunction. There was no occurrence of pancreatic sepsis among any patients. FCSEMSs were removed from 9 of 9 patients without stent migration (100% [9/9] as per protocol, and 69% [9/13] as intention to treat, respectively). Improvement or resolution of the pancreatic ductal strictures was confirmed in all 13 patients on follow-up ERCP (2 months after stent placement), regardless of stent migration. Small patient populations without long-term follow-up. Two-month placement of FCSEMSs in patients with refractory benign pancreatic ductal strictures may be feasible and relatively safe. However, stent migration was not uncommon. A further investigation with ideal stent design may therefore be needed before recommending FCSEMSs as a therapeutic option for refractory benign pancreatic ductal strictures.