Fully covered removable nitinol self-expandable metal stents (SEMS) in malignant strictures of the esophagus: a multicenter analysis

Background

Fully covered esophageal self-expandable metallic stents (SEMS) often are used for palliation of malignant dysphagia. However, experience and data on these stents are still limited. The purpose of this multicenter study was to evaluate the efficacy and safety of fully covered nitinol SEMS in patients with malignant dysphagia.

Methods

37 patients underwent placement of a SEMS during a 3?year period. Five patients underwent SEMS placement as a bridge to surgery: one for tracheoesophageal fistula in the setting of squamous cell carcinoma of the esophagus, one for perforation in setting of esophageal adenocarcinoma, 27 for unresectable esophageal cancer (16 adenocarcinoma, 11 squamous cell carcinoma), two for lung cancer, and one for breast-cancer-related esophageal strictures.

Results

SEMS placement was successful in all 37 patients. Immediate complications after stent deployment included chest pain (n?=?6), severe heartburn (n?=?1), and upper gastrointestinal bleeding requiring SEMS revision (n?=?1). Dysphagia scores improved significantly from 3.2?±?0.4 before stent placement to 1.4?±?1.0 at 1?month (P?P?P?=?0.0018) at 6?months. The stent was removed in 11 patients (30%) for the following indications: resolution of stricture (n?=?3), stent malfunction (n?=?5), and stent migration (n?=?3). After stent removal, three patients were restented, three underwent dilation, and two underwent PEG placement. Mean survival for the 37 patients after stent placement was 146.3?±?143.6 (range, 13–680) days.

Conclusions

Our study suggests that fully covered SEMS placement improve dysphagia scores in patients with malignant strictures, particularly in the unresectable population. Further technical improvements in design to minimize long-term malfunction and migration are required.     

Esophageal Stenting and Radiotherapy: A Multimodal Approach for the Palliation of Symptomatic Malignant Dysphagia

Background

Esophageal stents provide immediate palliation of malignant dysphagia; however, radiotherapy (RT) is a superior long-term option. We review the outcomes of combined esophageal stenting and RT for patients with malignant dysphagia.

Methods

We retrospectively reviewed patients with esophageal stents placed for palliation of malignant dysphagia from esophageal stricture, esophageal extrinsic compression, or malignant tracheoesophageal fistula (TEF). We excluded patients with radiation-induced TEF in the absence of tumor. We analyzed and compared outcomes between patients with no RT, RT before stent placement, and RT after stent placement.

Results

We placed stents in 45 patients for esophageal stricture from esophageal cancer (n?=?30; 66.7?%), malignant TEF (n?=?8; 17.7?%), and esophageal compression from airway, mediastinal, or metastatic malignancies (n?=?7; 15.6?%). Twenty patients (44.4?%) had no RT; 25 patients had RT before stent placement (n?=?16; 35.6?%), RT after stent placement (n?=?8; 17.8?%), or both (n?=?1; 2.2?%). Median follow-up was 30?days. Complications requiring stent revision were similar with or without RT. Subjective symptom relief was achieved in 68.9?% of all patients, with no differences noted between groups (p?=?0.99). The 30-day mortality was 15.6?%. Patients with RT after stent placement had a longer median survival compared to those without RT (98 vs. 38?days).

Conclusions

Esophageal stent placement with RT is a safe approach for malignant dysphagia.     

Endoscopic therapy for esophageal perforation or anastomotic leak with a self-expandable metallic stent

Background

Leaks of the esophagus are associated with a high mortality rate and need to be treated as soon as possible. Therapeutic options are surgical repair or resection or conservative management with cessation of oral intake and antibiotic therapy. We evaluated an alternative approach that uses self-expandable metallic stents (SEMS).

Methods

Between 2002 and 2007, 31 consecutive patients with iatrogenic esophageal perforation (n = 9), intrathoracic anastomotic leak after esophagectomy (n = 16), spontaneous tumor perforation (n = 5), and esophageal ischemia (n = 1) were treated at our institution. All were treated with endoscopic placement of a covered SEMS. Stent removal was performed 4 to 6 weeks after implantation. To exclude continuous esophageal leak after SEMS placement, radiologic examination was performed after stent implantation and removal.

Results

SEMS placement was successful in all patients and a postinterventional esophagogram demonstrated full coverage of the leak in 29 patients (92%). In two patients, complete sealing could not be achieved and they were referred to surgical repair. Stent migration was seen in only one patient (3%). After removal, a second stent with larger diameter was placed and no further complication occurred. Two patients died: one due to myocardial infarction and one due to progressive ischemia of the esophagus and small bowl as a consequence of vascular occlusion. Stent removal was performed within 6 weeks, and all patients had radiologic and endoscopic evidence of esophageal healing.

Conclusions

Implantation of covered SEMS in patients with esophageal leak or perforation is a safe and feasible alternative to operative treatment and can lower the interventional morbidity rate.     

Efficacy and safety of covered self-expandable metal stents for management of distal malignant biliary obstruction due to lymph node metastases

Background

Distal malignant biliary obstruction (MBO) due to lymph node metastases (LNM) is a common problem in advanced malignant disease. However, the role of covered self-expandable metal stents (SEMS) in treating MBO has not been studied. The aim of this study was to evaluate the efficacy and safety of covered SEMS for the treatment of distal MBO due to LNM.

Methods

Between November 1994 and December 2009, a total of 65 patients with distal MBO due to LNM underwent covered (n?=?44) and uncovered (n?=?21) SEMS placement.

Results

Successful drainage was achieved in all patients. There was no significant difference in patient survival. The cumulative stent patency of covered SEMS was significantly higher than that of uncovered SEMS (P?=?0.0020). Stent occlusion occurred in 5 patients (11%) with covered SEMS and in 8 (38%) with uncovered SEMS. There was no tumor ingrowth in covered SEMS, but seven in the uncovered SEMS group showed some ingrowth. Cholecystitis was not observed, but mild pancreatitis was observed in 6 (14%) of those with covered SEMS. No stent-insertion-related deaths occurred.

Conclusions

Covered SEMS are safe and effective for treatment of distal malignant biliary obstruction due to LNM.     

Outcome of palliative self-expanding metal stent placement in malignant colorectal obstruction according to stent type and manufacturer

Background

Self-expandable metallic stents (SEMS) of varying designs and materials have been developed to reduce complications, but few comparative data are available with regard to the type of stent and the stent manufacturer. We analyzed the success rates and complication rates, according to stent type (uncovered vs. covered stent) and individual stent manufacturer, in malignant colorectal obstruction.

Methods

From November 2001 to August 2008, 103 patients were retrospectively included in this study: four types of uncovered stents in 73 patients and two types of covered stents in 30 patients. The SEMS was inserted into the obstructive site by using the through-the-scope method.

Results

Technical and clinical success rates were not different between stent type or among stent manufacturers: 100 and 100% (p?=?ns) and 100 and 96.6% (p?>?0.05), respectively, in uncovered and covered stents. Stent occlusion and migration rates were 12.3 and 3.3% (p?=?0.274) and 13.7 and 16.7% (p?=?0.761), respectively, in uncovered and covered stents, and 11.1, 5, and 9% (p?=?0.761) and 25.9, 15, and 0% (p?=?0.037) in Wallstent, Niti-S, and Bonastent uncovered stents, respectively.

Conclusions

The placement of SEMS is an effective and safe treatment for patients with malignant colorectal obstruction. Although minor differences in outcome were detected according to the type and the manufacturer of the stents, no statistically significant difference was observed, except in stent migration among the stent manufacturer.     

Endoscopic stenting for benign upper gastrointestinal strictures and leaks

Background

Self-expandable metal stents (SEMS) and self-expandable plastic stents (SEPS) maybe used for the treatment of benign upper gastrointestinal (GI) leaks and strictures. This study reviewed our experience with stent insertions in patients with benign upper GI conditions.

Methods

Patients who underwent stent placement for benign upper GI strictures and leaks between March 2007 and April 2011 at a tertiary referral academic center were studied using an endoscopic database and electronic patient records. The technical success, complications, and clinical improvement after stent removal were compared according to type of stent. The outcomes measured were clinical response, adverse events, and predictors of stent migration.

Results

Thirty-eight patients (50 % male, mean age = 54 years, range = 12–82) underwent 121 endoscopic procedures. Twenty patients had stents placed for strictures, and 18 had stents placed for leaks. Stent placement was technically successful in all patients. The average duration of stent placement was 54 days (range = 18–118). Clinical improvement immediately after stent placement was seen in 29 of the 38 patients (76.3 %). Immediate post-procedure adverse events occurred in 8 patients. Late adverse events were seen in 18 patients. Evidence of stent migration occurred in 16 patients and was seen in 42 of the 118 successfully placed stents (35.5 %). Migration was more frequent with fully covered SEMS (p = 0.002). After stent removal, 27 patients were evaluable for long-term success (median follow-up time of 283 days, IQR 38–762). Resolution of strictures or leaks was seen in 11 patients (40.7 %). Predictors for long-term success included increasing age and if the stent did not cross the GE junction.

Conclusions

Placement of SEPS and SEMS for benign refractory strictures and fistulas has modest long-term clinical efficacy and is limited by a significant migration rate. Stent migration is common and frequent with fully covered SEMS compared to other types of stents, regardless of indication or location.     

Clinical outcomes following secondary self-expandable metal stent (SEMS) insertion due to previous stent migration in malignant colorectal obstruction

Background

There has been no research on the clinical outcomes of secondary self-expandable metal stent (SEMS) placement after initial stent migration. Therefore, this study aimed to assess the clinical outcomes of secondary SEMS placement after initial stent migration compared to the outcomes of secondary SEMS placement done for reasons other than migration and identify factors predictive of long-term outcomes.

Methods

Between January 2005 and February 2011, a total of 422 patients underwent SEMS insertion for malignant colorectal obstruction at Severance Hospital. Of these, there were 98 cases of secondary SEMS placement, 38 of which were due to previous stent migration. We compared the clinical outcomes of secondary SEMS between stent migration and nonmigration groups. We also sought to identify risk factors for long-term outcomes of secondary SEMS after initial stent migration.

Results

The baseline clinical characteristics were similar between the two groups. The technical and clinical success rates of secondary SEMS insertion in the migration and nonmigration groups were 94.7 % and 83.3 % (p = 0.09) and 73.7 % and 53.3 % (p = 0.122), respectively. In the migration group, sustained clinical success after secondary SEMS was associated with the absence of complications after insertion of the first stent (p < 0.001) and a longer time interval (more than 100 days) between the first and second stent insertion (p = 0.011).

Conclusions

Our data showed that secondary colorectal SEMS after stent migration is safe and effective. Moreover, the sustained clinical success of the secondary stent following migration was dependent on the outcomes of the first stent.     

Risk factors for pancreatitis following transpapillary self-expandable metal stent placement

Background

Pancreatitis is one of complications after self-expandable metal stent (SEMS) placement. The purpose of this study was to evaluate risk factors for pancreatitis after endoscopic SEMS placement for malignant biliary obstruction (MBO).

Methods

We retrospectively reviewed 370 consecutive patients who underwent initial transpapillary SEMS placement for biliary decompression. The characteristics of inserted SEMSs were classified according to axial and radial force.

Results

Pancreatitis following SEMS insertion was observed in 22 patients (6%). All of them were mild according to consensus criteria. Univariate analysis indicated that injections of contrast into the pancreatic duct (frequency of pancreatitis, 10.3%), the placement of an SEMS with high axial force (8.3%), and nonpancreatic cancer (16.1%) significantly contributed to the development of pancreatitis, whereas female gender, a younger age, a covered SEMS, and a SEMS with high radial force or without a biliary sphincterotomy did not. In a multivariate risk model, SEMSs with high axial force (odds ratio [OR], 3.69; p?=?0.022) and nonpancreatic cancer (OR, 5.52; p?Conclusions SEMSs with high axial force and an etiology of MBO other than pancreatic cancer were strongly associated with a high incidence of pancreatitis following transpapillary SEMS placement in patients with distal MBO.     

Newly designed large cell Niti-S stent for malignant hilar biliary obstruction: a pilot study

Background

Whether uni- or bilateral drainage should be performed for malignant hilar biliary obstruction remains a matter of debate. Moreover, endoscopic placement of bilateral metallic stents has been considered difficult and complicated. Although the Y-stent with a central wide-open mesh facilitates bilateral stent placement, it has limitations. This study evaluated the feasibility and efficacy of the Niti-S large cell D-type biliary stent (LCD) with a uniform large cell for both uni- and bilateral drainage of malignant hilar biliary obstruction.

Methods

From April 2008 to March 2009, a total of 12 consecutive patients with unresectable malignant hilar biliary obstruction of Bismuth type 2 or greater underwent placement of LCD. Before LCD placement, all the patients underwent endoscopic unilateral biliary drainage using a plastic stent or a nasobiliary drainage tube. If jaundice improved after the procedure, the plastic stent or nasobiliary drainage tube was replaced with the unilateral LCD. If jaundice did not resolve or contralateral cholangitis occurred, bilateral LCD placement was performed.

Results

Seven patients had unilateral and five patients had bilateral LCD placement. Technical success was achieved for all 12 patients. An early complication occurred for one patient (8%), and stent occlusion occurred for six patients (50%) because of tumor ingrowth (n?=?4) or sludge (n?=?2). These patients were managed by insertion of plastic stents (n?=?4) or percutaneous transhepatic biliary drainage (n?=?2). The median stent patency period was 202?days.

Conclusions

The newly designed endoscopic metallic stent may be feasible and effective for malignant hilar biliary obstruction, and endoscopic reintervention is relatively simple.     

Partially covered self-expanding metal stent for unresectable malignant extrahepatic biliary obstruction: results of a large prospective series

Background

Endoscopic biliary stenting is a well-established palliative treatment in patients with unresectable malignant biliary strictures. Obstruction of uncovered self-expanding metal stent (SEMS) due to tumor ingrowth is the most frequent complication. Partially covered SEMS might increase stent patency but could favor complications related to stent covering, such as pancreatitis, cholecystitis, and migration. The aim of this study was to evaluate the efficacy and safety of partially covered SEMS in patients with an unresectable malignant biliary stricture.

Methods

Patients with malignant extrahepatic biliary obstruction treated endoscopically with partially covered SEMS were included in this multicenter, prospective, nonrandomized study.

Results

One hundred ninety-nine patients were endoscopically treated with partially covered SEMS in 32 Spanish hospitals. Clinical success after deep cannulation was 96%. Early complications occurred in 4% (3 pancreatitis, 2 cholangitis, 1 hemorrhage, 1 perforation, and 1 cholecystitis). Late complications occurred in 19.5% (18 obstructions, 10 migrations, 6 cholangitis without obstruction, 3 acute cholecystitis, and 2 pancreatitis), with no tumor ingrowth in any case. Median stent patency was 138.9 ± 112.6?days. One-year actuarial probability of stent patency was 70% and that of nonmigration was 86%. Multivariate analysis showed adjuvant radio- or chemotherapy as the only independent predictive factor of stent patency and previous insertion of a biliary stent was the only predictive factor of migration.

Conclusions

The partially covered SEMS was easily inserted, had a high clinical success rate, and prevented tumor ingrowth. The incidence of possible complications related to stent coverage, namely, migration, pancreatitis, and cholecystitis, was lower than in previously published series.     

Factors associated with 30-day readmission and long-term efficacy of enteral stent placement for malignancy

Background

Readmissions to the hospital within 30 days of discharge (30-day readmission rate) may impact stent use in palliative treatment of cancer.

Objective

Our objective was to investigate the incidence of readmission and factors predicting readmissions and long-term outcomes in patients with self-expanding metal stents (SEMS) placed for malignant obstruction.

Methods

Retrospective analysis of all patients who underwent placement of SEMS from 2007 to 2012 for malignant esophageal, gastroduodenal, and colonic obstruction. Incidence and variables associated with 30-day readmission and long-term outcomes were determined.

Results

A total of 191 patients underwent stent placement. The 30-day readmission rate was 17.3 % (N = 33). Readmissions were for stent-related complications in 7.3 % (N = 14) and non-stent-related complications in 9.9 % (N = 19). Stent placement was technically successful in 185 of 191 (96.9 %) and clinically successful in 170 of 191 (89.0 %) patients. On long-term follow-up, 32 (16.8 %) patients needed re-intervention. The mean stent patency was 142 days. Readmission within 30 days was independently associated with development of early complications (<7 days) following stent placement (odds ratio [OR] 5.90; 95 % confidence interval [CI] 2.04–17.1), while the stent location did not impact readmission risk. On Cox regression analysis, American Society of Anesthesiologists physical classification (OR 1.36; 95 % CI 1.02–1.87) and stent location in the esophagus (OR 1.82; 95 % CI 1.10–3.02) were independently associated with long-term mortality.

Conclusions

Early complications following stent placement increase the risk of 30-day readmission. SEMS is efficacious long-term for palliation of malignant gastrointestinal obstruction.     

Comparison of uncovered and covered stents for the treatment of malignant duodenal obstruction caused by pancreaticobiliary cancer

Background

Few clinical studies to date have compared different types of self-expandable metallic stents (SEMS) and their outcomes in patients with pure duodenal obstruction caused by pancreaticobiliary cancer. The aim of this study was to compare the clinical effectiveness and side effects of uncovered and covered SEMS for the palliation of duodenal obstruction caused by pancreaticobiliary cancer.

Methods

We retrospectively analyzed all patients with pancreaticobiliary cancer who underwent upper endoscopy with SEMS placement for malignant duodenal obstruction at the National Cancer Center of Korea between April 2003 and December 2010. The technical and clinical success rates of the procedure, complications, and durations of stent patency and overall survival were evaluated.

Results

We identified 70 patients with a mean age of 51.2 years (range = 39–81 years); of these, 46 (65.7 %) had pancreatic cancer, 9 (12.9 %) had bile duct cancer, 11 (15.7 %) had gallbladder cancer, and 4 (5.7 %) had cancer of the ampulla of Vater. Twenty-four patients (34.3 %) received covered SEMSs and 46 (65.7 %) received uncovered SEMSs. Technical and clinical success rates were similar for the covered and uncovered stent groups. The complication rate was higher in the covered than in the uncovered group (62.5 vs. 34.8 %, P = 0.025), due primarily to a significantly higher stent migration rate (20.8 vs. 0 %, P = 0.004). Perforation as a late complication occurred in four patients, two in each group (8.3 vs. 4.3 %, P = 0.425). Stent patency tended to be shorter for covered than for uncovered duodenal stents (13.7 ± 8.6 weeks vs. not reached, P = 0.069).

Conclusions

The use of uncovered stents may be a preferred option for duodenal obstruction secondary to pancreaticobiliary malignancies, since they were effective in preventing stent migration and tended to have longer patency than covered stents. Careful attention should be paid to signs and symptoms of perforation during follow-up.     

Partially versus fully covered self-expanding metal stents for benign and malignant esophageal conditions: a single center experience

Background

Fully covered self-expanding metal stents (FCSEMS), unlike partially covered SEMS (PCSEMS), have been used to treat benign as well as malignant conditions. We aimed to evaluate the outcome of PCSEMS and FCSEMS in patients with both benign and malignant esophageal diseases.

Methods

Data were reviewed of all patients who underwent SEMS placement for malignant or benign conditions between January 1995 and January 2012. Patients with cancer were followed for at least 3 months, until death or surgery. Patients with benign conditions had stents removed between 4 and 12 weeks. Patient demographics, location and type of lesion, stent placement and removal, clinical success, and adverse events were analyzed.

Results

A total of 252 patients (mean ± standard deviation age 68.5 ± 14 years; 171 male) received 321 SEMS (209 PCSEMS, 112 FCSEMS) for malignant (78 %) and benign (22 %) conditions. Stent placement and removal was successful in 97.6 and 95.6 % procedures. Successful relief of malignant dysphagia was noted in 140 of 167 patients (83.8 %) and control of benign fistulas, leaks, and perforations was noted in 21 of 25 patients (84 %), but only 8 of 15 patients (53 %) with recalcitrant benign strictures had effective treatment. Fifty-six patients (22.2 %) experienced at least one stent-related adverse events. Migration was frequent, occurring in 61 of 321 stent placements (19 %), and more frequently with FCSEMS than PCSEMS (37.5 vs. 9.1 %, p < 0.001). FCSEMS, benign conditions, and distal location were the variables independently associated with migration (p < 0.001, p = 0.022, and p = 0.008). Patients with PCSEMS were more likely to have tissue in- or overgrowth than FCSEMS (53.4 vs. 29.1 %, p = 0.004).

Conclusions

Both PCSEMS and FCSEMS can be used in benign and malignant conditions; they are both effective for relieving malignant dysphagia and for closing leaks and perforations, but they seem less effective for relieving benign recalcitrant strictures. Stent migration is more common with FCSEMS, which may limit its use for the palliation of malignant dysphagia.     

Randomized controlled trial to investigate the effect of metal clips on early migration during stent implantation for malignant esophageal stricture

Background

The rate of stent migration, especially in the short term after implantation, is high in the treatment process. We sought to explore an effective method for preventing early migration after stent implantation for malignant esophageal stricture and to provide the basis for clinical treatment.

Methods

We conducted a prospective, open-label, parallel-assignment randomized controlled trial with patients undergoing stent implantation for malignant esophageal stricture. The proximal segments of stents in the treatment group were fixed with 2 metal clips during the perioperative period of esophageal stent implantation, while no treatment was used in the control group. All patients underwent radiography at 3 and 7 days and 1 and 3 months after placement to assess the stent migration.

Results

There were 83 patients in our study. Demographic characteristics were similar between the groups. There was no stent migration observed in the treatment group within 2 weeks of the operation, while stent migration was observed in 6 of 41 (14.6%) cases in the control group, occurring at 3 and 7 days after placement. There were no perioperative complications.

Conclusion

Perioperative fixation of the proximal segments of stents with metal clips is effective in preventing early stent migration.     

Comparison of treatment outcomes of endoscopic stenting for colonic and extracolonic malignant obstruction

Background

Self-expandable metal stents (SEMS) have been used as a bridging or palliative treatment for malignant colorectal obstruction. Colonic obstruction also may arise from advanced extracolonic malignancy, but the clinical outcomes of stent placement for extracolonic malignancy are unclear. This study compared the clinical outcomes of SEMS between patients with colorectal cancer and those with extracolonic malignancy.

Methods

Patients who underwent endoscopic SEMS placement for a malignant colorectal obstruction were enrolled at Seoul National University Hospital from April 2005 and August 2011. Their medical records were retrospectively reviewed in terms of success rate, complications, and duration of stent patency.

Results

Endoscopic SEMS placements were performed for colorectal cancer in 149 patients and for extracolonic malignancy in 60 patients. The causes of obstruction in extracolonic malignancy were advanced gastric cancer in 39 patients (65 %), pancreatic cancer in nine patients (15 %), ovarian cancer in three patients (5 %) and other causes in nine patients (15 %). The clinical success rates were similar between the two groups (92.6 vs 86.7 %; p = 0.688), and multivariate analysis showed no significant risk factor for unsuccessful endoscopic SEMS placement. Reobstruction in palliative endoscopic SEMS placement occurred for 16 patients with colorectal cancer (21.9 %) and 18 patients with extracolonic malignancy (30 %) during a median follow-up period of 90 days (p = 0.288). The rates did not differ significantly between the two groups (4.1 vs 8.3 %; p = 0.467). The median duration of stent patency was 193 ± 42 days for the patients with colorectal cancer and 186 ± 31 days for the patients with extracolonic malignancy (p = 0.253). The duration of stent patency was not affected by underlying malignancy, previous surgery, or palliative chemotherapy.

Conclusions

Endoscopic SEMS placement is highly effective and comparable for palliation of obstruction in extracolonic malignancy and colorectal cancer in terms of clinical success, complications, and duration of patency.     

Use of a specially designed partially covered self-expandable metal stent (PSEMS) with a 40-mm diameter for the treatment of upper gastrointestinal suture or staple line leaks in 11 cases

Introduction

The use of self-expandable stents to treat postoperative leaks and fistula in the upper gastrointestinal (GI) tract is an established treatment for leaks of the upper GI tract. However, lumen-to-stent size discrepancies (i.e., after sleeve gastrectomy or esophageal resection) may lead to insufficient sealing of the leaks requiring further surgical intervention. This is mainly due to the relatively small diameter (≤30 mm) of commonly used commercial stents. To overcome this problem, we developed a novel partially covered stent with a shaft diameter of 36 mm and a flare diameter of 40 mm.

Methods

From September 2008 to September 2010, 11 consecutive patients with postoperative leaks were treated with the novel large diameter stent (gastrectomy, n = 5; sleeve gastrectomy, n = 2; fundoplication after esophageal perforation, n = 2; Roux-en-Y gastric bypass, n = 1; esophageal resection, n = 1). Treatment with commercially available stents (shaft/flare: 23/28 mm and 24/30 mm) had been unsuccessful in three patients before treatment with the large diameter stent. Due to dislocation, the large diameter stent was anchored in four patients (2× intraoperatively with transmural sutures, 2× endoscopically with transnasally externalized threads).

Results

Treatment was successful in 11 of 11 patients. Stent placement and removal was easy and safe. The median residence time of the stent was 24 (range, 18–41) days. Stent dislocation occurred in four cases (36 %). It was treated by anchoring the stent. Mean follow-up was 25 (range, 14–40) months. No severe complication occurred during or after intervention and no patient was dysphagic.

Conclusions

Using the novel large diameter, partially covered stent to seal leaks in the upper GI tract is safe and effective. The large diameter of the stent does not seem to injure the wall of the upper GI tract. However, stent dislocation sometimes requires anchoring of the stent with sutures or transnasally externalized threads.     

Covered self-expandable metal stents are more associated with complications in the management of malignant colorectal obstruction

Background

The use of self-expandable metal stents (SEMS) for the treatment of malignant colorectal obstruction is increasing. However, results of risk factors for its complications are inconsistent. This study aimed to examine the clinical effectiveness of the procedure as well as the complications and risk factors associated with the complications.

Methods

Medical records of patients with malignant colorectal obstruction who underwent endoscopic placement of covered or uncovered SEMS were reviewed retrospectively. The procedure was performed by two endoscopists with experience in pancreatobiliary endoscopy.

Results

A total of 152 patients were included (102 men; mean age, 70 ± 12.5 years). The procedure was performed for palliative management in 83 patients and performed as a bridge to surgery in 69 patients. There were 111 uncovered stents and 41 covered stents. The technical success rate was 100 % and the clinical success rate 94.1 %. Overall complications were observed in 49 patients (32.2 %) during the follow-up period (median, 98 days; interquartile range, 19–302 days). Obstruction (17.1 %), migration (7.9 %), perforation (5.2 %), bleeding (1.3 %), and tenesmus (0.7 %) were the causes of the complications. Stage IV disease, carcinomatosis peritonei, complete obstruction of the colon, palliative intention, and covered stents increased the complications based on the univariate analysis. Multivariate analysis revealed that complete obstruction of the colon and covered stents were significantly independent risk factors for complications. In the palliative group, Kaplan–Meier analysis showed significantly shorter median duration to the onset of complications in the covered stent group than in the uncovered stent group.

Conclusions

Although SEMS in patients with malignant colorectal obstruction is effective both as palliative therapy and as a bridge to surgery, one-third of patients experienced complications. Severity of obstruction and stent type can influence outcomes.     

The use of retrievable fully covered self-expanding metal stent in refractory postoperative restenosis of benign esophageal stricture in children

Purpose

This study analyzes the efficacy and safety of a retrievable, fully covered self-expanding metal stent (cSEMS) in the treatment of refractory benign esophageal restenosis in children.

Methods

This is a retrospective analysis of the application of a newly designed cSEMS in treating refractory benign postoperative restenosis in five children with ages ranging from 16 months to 8 years. Efficacy and safety were evaluated during the follow-up period.

Results

cSEMS with or without an antireflux valve at the distal end were successfully placed and removed in five children. These five patients were followed up for 4–12 months after stent removal. Among the five patients, ulcerative stricture was observed in two patients because of reflux esophagitis, while three patients showed no signs of stricture recurrence. Stent migration was observed in three patients, two of which required the stent to be reset. The narrow esophagus was successfully expended to a diameter of 12–13 mm. Besides the observation of mild granulation tissue growth in one case, no severe complications were observed during surgery and after stent placement.

Conclusion

Our study suggests that a retrievable, fully covered SEMS is safe and partially effective for treating refractory benign postoperative esophageal restenosis in children during short-term observation.     

Duodenal metal stent placement is a risk factor for biliary metal stent dysfunction: an analysis using a time-dependent covariate

Background

Although the combination of biliary and duodenal self-expandable metal stents (SEMS) is useful, the exacerbating effect of duodenal SEMS placement on biliary SEMS has not been documented. We conducted a multicenter retrospective study to evaluate the effect of duodenal SEMS placement on biliary SEMS.

Methods

Patients who underwent first-time biliary SEMS placement for a distal malignant biliary obstruction between September 1994 and November 2010 were included. Time to dysfunction of biliary SEMS was analyzed to identify risk factors for biliary SEMS dysfunction. Duodenal SEMS placement was analyzed as a time-dependent covariate.

Results

In total, 410 eligible patients were identified. Duodenal SEMS were placed in 33 patients (8 %). The median time to dysfunction of biliary SEMS was 170 days. Male gender (hazard ratio 1.37, 95 % confidence interval 1.03–1.83, P = 0.029) and duodenal SEMS placement (hazard ratio 2.00, 95 % confidence interval 1.16–3.45, P = 0.013) were risk factors in the multivariate Cox model. In patients undergoing duodenal SEMS, biliary SEMS dysfunction was observed in 17 (52 %) with a median time to dysfunction of 64 days after duodenal SEMS placement. As many as 60 % of the patients with biliary SEMS dysfunction after duodenal SEMS placement needed permanent percutaneous transhepatic biliary external drainage.

Conclusions

Duodenal SEMS placement is a risk factor for biliary SEMS dysfunction. Alternative methods for biliary drainage should be considered for better biliary drainage in patients with a gastric outlet obstruction.     

Outcome and safety of self-expandable metallic stents for malignant colon obstruction: a Korean multicenter randomized prospective study

Background

Newly developed uncovered stents are designed to have varied radial force and high conformability to improve clinical outcome and safety. This study aimed to determine and compare the clinical outcome and safety of the Taewoong D-type uncovered stent and the Boston Scientific Wallfex stent.

Methods

Patients with acute malignant colonic obstruction were treated with a colonic stent. For the purpose of palliation, patients were randomly allocated. For the purpose of bridging, the type of stent was determined by the discretion of the individual doctors. Technical and clinical success and complication occurrence were measured as primary outcomes.

Results

From 12 university hospitals, 123 patients with malignant colonic obstruction were enrolled. Of these 123 patients, 58 were treated with colonic stents for palliative purposes. The technical and clinical success rate was 100?% for both stents in the palliative group. Perforation occurred for one patient (3.6?%) in the Wallflex stent group (n?=?28) on day 5 and for no patients in the D-type stent group (n?=?30). Two cases of migration occurred: one with the Wallflex stent and one with the D-type stent. Stent restenosis occurred for one patient with the Wallflex stent. Preoperative bridging stents were placed in 65 patients. The median time to surgery was 10?days. The technical success rate was 93.4?%, and clinical success was achieved for 86.2?% of the patients. Perforation occurred for five patients: four with the Wallflex stent and one with the D-type stent. The efficacy and safety of the two stents did not differ statistically.

Conclusions

The D-type colonic uncovered stent and the Wallflex colonic uncovered stent are effective and safe for both palliative and preoperative bridging therapy used to treat acute malignant colonic obstruction.