Endoscopic self-expandable metal stent versus endoscopy vacuum therapy for traumatic esophageal perforations: a retrospective cohort study.

BACKGROUND: Traumatic esophageal perforations (TEP) are a grave medical condition and require immediate intervention. Techniques such as Esophageal Self-Expandable Metal Stent (E-SEMS) and Endoscopic Vacuum Therapy (EVT) show promise in reducing tissue damage and controlling esophageal leakage. The present study aims to compare the application of EVT to E-SEMS placement in TEP. METHODS: Retrospective cohort study valuated 30 patients with TEP. The E-SEMS and EVT groups were assessed for time of hospitalization, treatment duration, costs, and clinical outcome. RESULTS: Patients treated with EVT (24.4 ± 13.2) demonstrated significantly shorter treatment duration (p < 0.005) compared to the group treated with E-SEMS (45.8 ± 12.9) and patients submitted to E-SEMS demonstrated a significant reduction (p = 0.02) in the time of hospitalization compared to the EVT (34 ± 2 vs 82 ± 5 days). Both groups demonstrated a satisfactory discharge rate (E-SEMS 93.7% vs EVT 71.4%) but did not show statistically significant difference (p = 0.3155). E-SEMS treatment had a lower mean cost than EVT (p < 0.05). Descriptive statistics were utilized, arranged in table form, where frequencies, percentages, mean, median, and standard deviation of the study variables were calculated and counted. The Fisher's Exact Test was used to evaluate the relationship between two categorical variables. To evaluate differences between means and central points, the parametric t-test was utilized. Comparisons with p value up to 0.05 were considered significant. CONCLUSION: E-SEMS showed a shorter time of hospitalization, but a longer duration of treatment compared to EVT. The placement of E-SEMS and EVT had the same clinical outcome. Treatment with E-SEMS had a lower cost compared with EVT.

Self-expandable metallic stents may be more efficient than balloon dilatation alone for esophageal stricture after circumferential endoscopic submucosal dissection: a retrospective cohort study in China.

INTRODUCTION: Self-expandable metallic stents (SEMSs) can be used to treat esophageal stricture after circumferential endoscopic submucosal dissection (ESD), but its efficacy and placement timing remain to be determined. In this study, the treatment time and number of dilatations were compared between the SEMS placement group and the balloon dilatation (BD) group to clarify the efficacy and placement time of SEMSs in the treatment of esophageal stricture after circumferential esophageal ESD. METHODS: This was a retrospective cohort study. Patients with esophageal stricture after circumferential ESD between January 2015 and January 2020 were included. Data on the patients' demographic characteristics, esophageal lesion-related factors, esophageal stricture occurrence, and measures taken to treat the stricture were collected. The primary outcome was the treatment time, and the secondary outcome was the number of dilatations. RESULTS: The total number of dilatations was 30 in the SEMS group and 106 in the BD group. The average number of dilatations in the SEMS group (1.76 ± 1.64) was significantly lower than that in the BD group (4.42 ± 5.32) (P = 0.016). Among the patients who underwent SEMS placement first had a shorter treatment time (average 119 days) than those who underwent BD first (average 245 days) (P = 0.041), and the average number of dilatations inpatients who underwent SEMS placement first (0.71 ± 1.07) was significantly lower than that in the patients who underwent BD first (2.5 ± 1.54). CONCLUSION: SEMSs were more efficient in the treatment of esophageal stricture in a cohort of patients after circumferential esophageal ESD.

Efficacy and Safety Analysis of Emergency Endoscopic Self-Expanding Metal Stent Placement Without Fluoroscopic Assistance for Right-Sided Colonic Cancer Obstruction.

BACKGROUND: Traditionally, surgical treatment is recommended for right-sided colonic cancer obstruction (RCCO); however, the literature comparing surgical or non-surgical procedures is lacking. METHODS: Patients included in this study were divided into two groups: one group received elective surgery after self-expanding metal stent (SEMS) placement, i.e., the bridge to surgery (BTS) group, and one group received emergency surgery (ES). RESULTS: Thirty-five patients were included in the BTS group and 60 patients underwent ES. The technical and clinical success rates for SEMS placement were 100% and 88.6%, respectively, while the short-term complication rates were 51.4% and 33.3% for the BTS and ES groups, respectively (p = 0.082). Overall, 2.9% and 3.3% of postoperative deaths occurred in the BTS and ES groups (p = 1.000). The 1-year overall survival (OS) rates were 91.4% and 88.3% (p = 0.840), 3-year OS rates were 85.7% and 81.7% (p = 0.860), and 5-year OS rates were 82.9% and 76.7% (p = 0.620) in the BTS and ES groups, respectively. No tumor recurrence was found in the BTS group but seven recurrences were found in the ES group (11.7%) [p = 0.091]. Laparoscopic surgery was chosen by 42.9% of patients in the BTS group and 26.7% of patients in the ES group (p = 0.104); however, the length of hospital stay (p = 0.001) was longer in the BTS group. CONCLUSIONS: In the two groups, no differences were found in terms of postoperative complications and mortality as well as OS. The BTS group preferred to perform laparoscopic surgery and the technical success rate of stenting was high, therefore SEMS for RCCO was considered safe and feasible.

Localized Photodynamic Therapy Using a Chlorin e6-Embedded Silicone-Covered Self-Expandable Metallic Stent as a Palliative Treatment for Malignant Esophageal Strictures.

Localized photodynamic therapy (PDT) uses a polymeric-photosensitizer (PS)-embedded, covered self-expandable metallic stent (SEMS). PDT is minimally invasive and a noteworthy potential alternative for treating esophageal strictures, where surgery is not a viable option. However, preclinical evidence is insufficient, and optimized irradiation energy dose ranges for localized PDT are unclear. Herein, we validated the irradiation energy doses of the SEMS (embedded in a PS using chlorin e6 [Ce6] and covered in silicone) and PDT-induced tissue changes in a rat esophagus. Cytotoxicity and phototoxicity in the Ce6-embedded SEMS piece with laser irradiation were significantly higher than that of the silicone-covered SEMS with or without laser and the Ce6-embedded silicone-covered SEMS without laser groups (all p < 0.001). Moreover, surface morphology, atomic changes, and homogeneous coverage of the Ce6-embedded silicone-covered membrane were confirmed. The ablation range of the porcine liver was proportionally increased with the irradiation dose (all p < 0.001). The ablation region was identified at different irradiation energy doses of 50, 100, 200, and 400 J/cm2. The in vivo study in the rat esophagus comprised a control group and 100, 200, and 400 J/cm2 energy-dose groups. Finally, histology and immunohistochemistry (TUNEL and Ki67) confirmed that the optimized Ce6-embedded silicone-covered SEMS with selected irradiation energy doses (200 and 400 J/cm2) effectively damaged the esophageal tissue without ductal perforation. The polymeric PS-embedded silicone-covered SEMS can be easily placed via a minimally invasive approach and represents a promising new approach for the palliative treatment of malignant esophageal strictures.

Anchoring fins of fully covered self-expandable metal stents affect pull-out force and stent migration.

BACKGROUND AND AIMS: Stent migration and subsequent adverse events are frequently observed in the use of fully covered self-expandable metal stents (FCSEMSs) for distal biliary stenosis. In this study, we identified predictors for stent migration based on biomechanical stent characteristics and associated these findings with clinical outcomes. METHODS: The migration resistance of FCSEMSs was quantified by measuring the pull-out force. We analyzed a single-center retrospective cohort of 178 FCSEMSs for treatment success and adverse events occurring during 180 days of follow-up. RESULTS: Biomechanical measurements revealed a 4-fold higher migration resistance of FCSEMSs with anchoring fins (AF-FCSEMSs; Fmax = 14.2 ± .1 N) compared with FCSEMSs with flared ends (FE-FCSEMSs; Fmax = 3.8 ± 1.0 N; P < .0001). Clinically, AF-FCSEMSs showed lower rates of migration compared with FE-FCSEMSs (5% vs 34%, P < .0001). Unscheduled ERCP procedures because of stent dysfunction were less frequent in the AF group compared with the FE group (15% vs 29%, P = .046). Cholangitis because of stent dysfunction was observed in 5% of the AF group compared with 19% in the FE group (P = .02). Stent patency rates at 1, 3, and 6 months were higher in the AF group (96%, 90%, and 80%, respectively) compared with the FE group (90%, 74%, and 66%; log-rank test: P = .03). CONCLUSIONS: The pull-out force as a biomechanical stent property predicts the migration resistance of FCSEMSs in distal biliary stenosis and may thus be used to classify stents for this application. AF-FCSEMSs showed a significantly lower rate of migration and adverse events compared with FE-FCSEMSs.

Efficacy of multi-hole self-expandable metal stent compared to fully covered and uncovered self-expandable metal stents in patients with unresectable malignant distal biliary obstruction: a propensity analysis.

BACKGROUND AND AIMS: Self-expandable metal stent (SEMS) insertion is the standard palliative treatment for unresectable malignant extrahepatic biliary obstruction (MBO). Drawbacks of conventional fully covered SEMS (FCSEMS) and uncovered SEMS (USEMS) include stent migration and tumor ingrowth, respectively. This study aimed to compare stent patency in MBO with the newly design multi-hole SEMS (MHSEMS), which has multiple small side holes in the stent membrane, with conventional FCSEMS and UCSEMS. PATIENTS AND METHODS: This retrospective study using a propensity score matching design and stent patency times of 40 patients with MHSEMS was compared to 40 and 34 patients with FCSEMS and UCSEMS during the same period, respectively. Secondary outcomes were procedure-related adverse events, clinical success rate, time to recurrent biliary obstruction (RBO), and etiology of RBO. RBO was compared using Kaplan-Meier analysis. RESULTS: Baseline characteristics after matching were comparable among the 3 groups. RBO rates were 21%, 37%, and 55% for MHSEMS, FCSEMS, and UCSEMS, respectively (p = 0.014), at a mean time of 479, 353, and 306 days, respectively (MHSEMS vs UCSEMS, p = 0.002). Rate of tumor ingrowth was highest in the UCSEMS group (42.4% vs 13.2% in MHSEMS; p = 0.005 and vs 0% in FCSEMS; p < 0.001). Stent migration rate was highest in the FCSEMS group at 15.8% vs 2.6% in MHSEMS (p = 0.047) and 0% in UCSEMS (p = 0.005). CONCLUSION: MHSEMS provided the longest stent patency time with lowest RBO rate compared to conventional SEMS by showing a lower stent migration rate than FCSEMS and a lower tumor ingrowth rate than UCSEMS.

Fully covered versus partially covered self-expandable metal stents for palliation of distal malignant biliary obstruction: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Self-expandable metal stents (SEMSs) are standardly used for distal malignant biliary obstruction (dMBO). Although data suggest that covered versus uncovered SEMSs increase the time to recurrent biliary obstruction (TRBO), no data are available for fully covered (FC) versus partially covered (PC) designs. METHODS: PubMed, Scopus, and Cochrane databases were screened up to January 2023 for studies concerning dMBO treated by an FC- or PC-SEMS and describing adverse events (AEs), recurrences, or TRBO for specific design subpopulations. Pooled proportions or means were calculated using a random-effects model. Several subanalyses were preplanned, including a subanalysis restricted to prospective studies and unresectable diseases. Heterogeneity and publication bias were explored. Standardized differences (d-values) were calculated between groups. RESULTS: From 1290 records, 62 studies (3327 using FC-SEMSs and 2322 using PC-SEMSs) were included. FC- versus PC-SEMSs showed negligible differences in the rate of total AEs (12% vs 9.9%) and all specific AEs, including cholecystitis (2.5% vs 2.6%). In a subanalysis restricted to prospective studies and unresectable diseases, the rate of RBO was comparable between FC-SEMSs (27.3% [95% confidence interval {CI}, 23.7-31.2], I2 = 35.34%) and PC-SEMSs (25.3% [95% CI, 20.2-30.7], I2 = 85.09%), despite small differences (d-values between .186 and .216) in the rate of ingrowth (.5% vs 2.9%) favoring FC-SEMSs and migration (9.8% vs 4.3%) favoring PC-SEMSs. TRBO was shorter for FC-SEMSs (238 days [95% CI, 191-286], I2 = 63.1%) versus PC-SEMSs (369 days [95% CI, 290-449], I2 = 71.9%; d-value = .116). CONCLUSIONS: Despite considerable heterogeneity and small standardized differences, PC-SEMSs consistently exhibited longer TRBO than FC-SEMSs across analyses, without any other differences in AE rates, potentially proposing PC-SEMSs as the standard comparator and TRBO as the primary outcome for future randomized studies on dMBO. (Clinical trial registration number: CRD42023393965.).

Adverse events of self-expandable metal stent placement for malignant distal biliary obstruction: a large multicenter study.

BACKGROUND AND AIMS: Endoscopic placement of self-expandable metal stents (SEMSs) for malignant distal biliary obstruction (MDBO) may be accompanied by several types of adverse events. The present study analyzed the adverse events occurring after SEMS placement for MDBO. METHODS: The present study retrospectively investigated the incidence and types of adverse events in patients who underwent SEMS placement for MDBO between April 2018 and March 2021 at 26 hospitals. Risk factors for acute pancreatitis, cholecystitis, and recurrent biliary obstruction (RBO) were evaluated by univariate and multivariate analyses. RESULTS: Of the 1425 patients implanted with SEMSs for MDBO, 228 (16.0%) and 393 (27.6%) experienced early adverse events and RBO, respectively. Pancreatic duct without tumor involvement (P = .023), intact papilla (P = .025), and SEMS placement across the papilla (P = .037) were independent risk factors for acute pancreatitis. Tumor involvement in the orifice of the cystic duct was an independent risk factor for cholecystitis (P < .001). Use of fully and partially covered SEMSs was an independent risk factor for food impaction and/or sludge. Use of fully covered SEMSs was an independent risk factor for stent migration. Use of uncovered SEMSs and laser-cut SEMSs was an independent risk factor for tumor ingrowth. CONCLUSIONS: Pancreatic duct without tumor involvement, intact papilla, and SEMS placement across the papilla were independent risk factors for acute pancreatitis, and tumor involvement in the orifice of the cystic duct was an independent risk factor for cholecystitis. The risk factors for food impaction and/or sludge, stent migration, and tumor ingrowth differed among types of SEMSs.

Study protocol for a prospective, multicentre, phase II trial on endoscopic treatment using two fully covered self-expandable metallic stents for benign strictures after hepaticojejunostomy.

INTRODUCTION: The current endoscopic treatment for postoperative benign hepaticojejunostomy anastomotic stricture (HJAS) has a high technical success rate and is highly effective in the short term. However, long-term results have shown a high rate of stenosis recurrence, which indicates an insufficient response to treatment. Three prospective studies on fully covered self-expandable metallic stent (FC-SEMS) treatment for benign HJAS used the stenosis resolution rate as the primary endpoint, and no study has yet used the long-term non-stenosis rate (at 12 months) as the primary endpoint. METHODS AND ANALYSIS: We launched the 'saddle-cross study', which will be conducted as a multicentre, prospective intervention of endoscopic treatment using two modified FC-SEMSs (BONASTENT️ M-Intraductal) that have been improved for benign stenosis in patients with benign HJAS, with the long-term non-restenosis rate (at 12 months) as the primary endpoint. This study aims to evaluate the long-term non-restenosis rate (at 12 months) and safety of the saddle-cross technique for benign HJAS. We plan to enrol 50 participants. ETHICS AND DISSEMINATION: This study has been approved by the Certified Review Board of the National Cancer Center, Japan (CRB3180009). The results will be reported at various conferences and published in international peer-reviewed journals.

Endoscopic retrieval of a proximally migrated fully covered self-expandable metal stent using biopsy forceps with a guiding sheath cannula.

Transpapillary endoscopic biliary drainage is the gold standard for resolving malignant biliary obstruction. Stent migration occasionally occurs and is troublesome to retrieve. Yamamoto and colleagues report with accompanying video on the successful retrieval of a proximally migrated stent using biopsy forceps through a guiding sheath cannula.

Prevention of Migration of Esophageal Self-Expandable Metallic Stents Using Endoscopic Clips.

Background and Objectives: Esophageal stenting with self-expandable metallic stents (SEMS), for both benign and malignant reasons, has been widely practiced for decades, but migration still remains the most common complication of the procedure. In this report we aim to review our experience and results in stent fixation with clips. Materials and Methods: We present 18 patients who underwent esophageal stenting for both benign and malignant reasons. The SEMSs used were partially covered and were fixated with two to four through the scope hemostatic clips in the proximal end of the prothesis. The procedure was performed only on patients with a high risk of migration of the stent. Results: Migration occurred in only one of the above-mentioned patients and was treated with stent repositioning. The other adverse events that occurred were related to tumor growth in patients with malignant diseases. Conclusions: Clip fixation of an esophageal self-expandable metallic stent in cases considered high-risk for migration is a safe procedure. It reduces the migration rate significantly for both benign and malignant indications.

Factors associated with patency of self-expandable metal stents in malignant biliary obstruction.

INTRODUCTION: Endoscopic self-expandable metal stent (SEMS) placement is the key endoscopic treatment for unresectable malignant biliary obstruction. The benefit of covered SEMS over uncovered SEMS remains unknown as are risk factors for SEMS dysfunction. This study aimed to determine the factors associated with patency of SEMS. METHODS: Patients with unresectable malignant biliary obstruction who underwent endoscopic SEMS placement at Ramathibodi Hospital, during January 2012 to March 2021 were included. Patient characteristics, clinical outcomes and patency of SEMS were collected. The primary outcome were stent patency and factors associated with patency of SEMS. The factors were analyzed by univariate and multivariate analyses. Median days of stent patency, median time of patient survival, rate of reintervention and complications after SEMS placement were collected. RESULTS: One hundred and fourteen patients were included. SEMS dysfunction was found in 37 patients (32.5%). Size of cancer (Hazard ratio (HR), 1.20, (95% CI 1.02, 1.40), p 0.025), presence of stones or sludge during SEMS placement (Hazard ratio (HR), 3.91, (95% CI 1.74, 8.75), p 0.001), length of SEMS, 8 cm (HR 2.96, (95% CI 1.06, 8.3), p 0.039), and total bilirubin level above 2 mg/dL at one month after SEMS placement (HR 1.14, (95% CI 1.06, 1.22), p < 0.001) were associated with SEMS dysfunction. The median stent patency was 97 days. The median patient survival was 133 days, (95% CI 75-165). The rate of reintervention was 86% in patients with SEMS dysfunction. CONCLUSION: The size of cancer, presence of stones or sludge during SEMS placement, the length of SEMS, and total bilirubin level above 2 mg/dL at 1 month after SEMS placement were associated with SEMS dysfunction. The median time of stent patency were not statistically different in each type of stent, covered stent, partially covered stent and uncovered stent. Median survival time of patients did not associate with SEMS patency or dysfunction.

Short- and long-term outcomes of transanal decompression tube and self-expandable metallic stent for obstructive colorectal cancer based on a multicenter database (KYCC2110).

AIM: There are well-known methods for decompressing the colorectal tract before surgery, including transanal decompression tubes (TDT) and self-expanding metallic stents (SEMS). This study aimed to compare the short and long-term results in patients with malignant large bowel obstruction in whom TDT or SEMS were placed before surgery. METHODS: This retrospective observational study enrolled 225 patients with malignant large bowel obstruction in whom TDT or SEMS were placed preoperatively and underwent R0 resection between 2008 and 2020. One-to-two propensity score matching was performed according to patient characteristics. Short- and long-term outcomes were compared. The primary endpoint was relapse-free survival (RFS). The secondary endpoints were the overall survival (OS) and postoperative complication rate. RESULTS: Fifty-seven patients in the TDT group and 114 in the SEMS group were matched. The 3-year RFS rates were 66.7% in the TDT group and 69.9% in the SEMS group (p = 0.54), and the 3-year OS rates were 90.5% in the TDT group and 87.1% in the SEMS group (p = 0.52). No significant differences in the long-term results were observed between the two groups. Regarding short-term results, the SEMS group had significantly fewer stoma construction (p = 0.007) and shorter postoperative hospitalization (p < 0.001). The incidence of postoperative complications (grade ≥ 2) was significantly lower in the SEMS group (p = 0.04). CONCLUSION: No significant differences in the long-term results were observed between the TDT and SEMS group. The SEMS showed significant usefulness in terms of improving short-term outcomes.

The evaluation of bilateral stenting using braided or laser-cut self-expandable metallic stent for malignant hilar biliary obstruction.

OBJECTIVES: Bilateral self-expandable metallic stent (SEMS) placement for unresectable malignant hilar biliary obstruction (UMHBO) is an effective option for biliary drainage with long-term stent patency. Laser-cut and braided SEMS can be used for bilateral SEMS placement. This study aimed to clarify any differences in the clinical features and proper use of the laser-cut and braided SEMS placement using the stent-in-stent method for UMHBO. METHODS: In this study, 78 patients who underwent bilateral stent-in-stent SEMS placement for UMHBO were included. The patients were divided into the laser-cut (n = 33) and braided groups (n = 45). Both groups were compared for technical and clinical success, adverse events (AEs), time to recurrent biliary obstruction (TRBO), overall survival, and endoscopic reintervention (ERI). RESULTS: There were no significant differences in technical and clinical success rates (laser-cut vs. braided group, 97% vs. 95.6%, P = 1.0), AEs (21.2% vs. 15.6%. P = 0.56), median TRBO (242 days vs. 140 days, P = 0.36), and median overall survival (654 days vs. 675 days, P = 0.58). ERI was required in 15 patients in the laser-cut group and in 20 patients in the braided group. The technical and clinical success rates of ERI (60% vs. 85%) were not significantly different (P = 0.13); however, the median ERI procedure time was significantly longer in the laser-cut group (38 min) than in the braided group (22 min; P = 0.02). CONCLUSION: No significant difference in initial SEMS placement was noted between the laser-cut and braided groups; however, the laser-cut group required a longer ERI procedure time than that required by the braided group. The use of braided SEMS may be a convenient option for ERI.

Risk factors for early and late cholecystitis after covered metal stent placement for distal biliary obstruction.

BACKGROUND: Cholecystitis is a major adverse event after self-expandable metallic stent placement for distal biliary obstruction (DBO). Covered self-expandable metallic stent (CSEMS) is being increasingly used, but few studies have investigated risk factors for cholecystitis limited to CSEMS. The present study aimed to identify risk factors for cholecystitis after CSEMS. METHODS: Patients who underwent initial CSEMS placement for DBO between November 2014 and September 2021 were enrolled and followed-up until death, recurrent biliary obstruction, cholecystitis, or until March 2022. Cholecystitis within 30 days of CSEMS was defined as early cholecystitis and after 30 days as late cholecystitis. RESULTS: Cholecystitis occurred in 51 of 339 patients (15%) after CSEMS. Forty-one patients (80.4%) had early cholecystitis, and 10 (19.6%) had late cholecystitis. Multivariate logistic regression analysis revealed that the maximum diameter of the common bile duct (CBD) (per 1 mm increase) (odds ratio [OR]: 0.87; 95% confidence interval [CI]: 0.76-1.00; p = .044), gallbladder stones (OR: 3.63; 95% CI: 1.62-8.10; p = .002), and tumor involvement in the cystic duct (CD) (OR: 4.87; 95% CI: 2.16-11.00; p < .001) were significant independent risk factors associated with early cholecystitis. No significant risk factors were identified for late cholecystitis. CONCLUSIONS: A smaller CBD diameter, gallbladder stones, and tumor involvement in the CD were identified as risk factors for early cholecystitis development after CSEMS.