• Clinical Endoscopy
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• v.57 no.3
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• pp.375-383
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• 2024

Background/Aims: Endoscopic self-expandable metal stent (SEMS) placement is currently the standard technique for treating unresectable malignant distal biliary obstructions (MDBO). Therefore, covered SEMS with longer stent patency and fewer migrations are required. This study aimed to assess the clinical performance of a novel, fully covered SEMS for unresectable MDBO. Methods: This was a multicenter single-arm prospective study. The primary outcome was a non-obstruction rate at 6 months. The secondary outcomes were overall survival (OS), recurrent biliary obstruction (RBO), time to RBO (TRBO), technical and clinical success, and adverse events. Results: A total of 73 patients were enrolled in this study. The non-obstruction rate at 6 months was 61%. The median OS and TRBO were 233 and 216 days, respectively. The technical and clinical success rates were 100% and 97%, respectively. Furthermore, the rate of occurrence of RBO and adverse events was 49% and 21%, respectively. The length of bile duct stenosis (<2.2 cm) was the only significant risk factor for stent migration. Conclusions: The non-obstruction rate of a novel fully covered SEMS for MDBO is comparable to that reported earlier but shorter than expected. Short bile duct stenosis is a significant risk factor for stent migration.

• Journal of Gastric Cancer
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• v.18 no.1
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• pp.37-47
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• 2018

Purpose: The endoscopic management of a fully covered self-expandable metal stent (SEMS) has been suggested for the primary treatment of patients with anastomotic leaks after total gastrectomy. Embedded stents due to tissue ingrowth and migration are the main obstacles in endoscopic stent management. Materials and Methods: The effectiveness and safety of endoscopic management were evaluated for anastomotic leaks when using a benign fully covered SEMS with an anchoring thread and thick silicone covering the membrane to prevent stent embedding and migration. We retrospectively reviewed the data of 14 consecutive patients with gastric cancer and anastomotic leaks after total gastrectomy treated from January 2009 to December 2016. Results: The technical success rate of endoscopic stent replacement was 100%, and the rate of complete leaks closure was 85.7% (n=12). The mean size of leaks was 13.1 mm (range, 3-30 mm). The time interval from operation to stent replacement was 10.7 days (range, 3-35 days) and the interval from stent replacement to extraction was 32.3 days (range, 18-49 days). The complication rate was 14.1%, and included a single jejunal ulcer and delayed stricture at the site of leakage. No embedded stent or migration occurred. Two patients died due to progression of pneumonia and septic shock 2 weeks after stent replacement. Conclusions: A benign fully covered SEMS with an anchoring thread and thick membrane is an effective and safe stent in patients with anastomotic leaks after total gastrectomy. The novelty of this stent is that it provides complete prevention of stent migration and embedding, compared with conventional fully covered SEMS.

• Clinical Endoscopy
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• v.57 no.1
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• pp.112-121
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• 2024

Background/Aims: Since the usefulness of neoadjuvant chemo(radiation) therapy (NAT) for pancreatic cancer has been demonstrated, recurrent biliary obstruction (RBO) in patients with pancreatic cancer with a fully covered self-expandable metal stent (FCSEMS) during NAT is expected to increase. This study investigated the impact of sarcopenia on RBO in this setting. Methods: Patients were divided into normal and low skeletal muscle index (SMI) groups and retrospectively analyzed. Patient characteristics, overall survival, time to RBO (TRBO), stent-related adverse events, and postoperative complications were compared between the two groups. A Cox proportional hazard model was used to identify the risk factors for short TRBO. Results: A few significant differences were observed in patient characteristics, overall survival, stent-related adverse events, and postoperative complications between 38 patients in the normal SMI group and 17 in the low SMI group. The median TRBO was not reached in the normal SMI group and was 112 days in the low SMI group (p=0.004). In multivariate analysis, low SMI was the only risk factor for short TRBO, with a hazard ratio of 5.707 (95% confidence interval, 1.148-28.381; p=0.033). Conclusions: Sarcopenia was identified as an independent risk factor for RBO in patients with pancreatic cancer with FCSEMS during NAT.

• Clinical Endoscopy
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• v.57 no.2
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• pp.209-216
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• 2024

Background/Aims: Endoscopic ultrasonography-guided gastrojejunostomy is a minimally invasive method for the management of gastric outlet obstruction. Conventionally, a lumen-apposing metal stent (LAMS) is used to create an anastomosis. However, LAMS is expensive and not widely available. In this report, we described a tubular fully covered self-expandable metallic stent (T-FCSEMS) for this purpose. Methods: Twenty-one patients (15 men [71.4%]; median age, 66 years; range, 40-87 years) were included in this study. A total of 19 malignant (12 pancreatic, 6 gastric, and 1 metastatic rectal cancer) and 2 benign cases were observed. The proximal jejunum was punctured with a 19 G needle. The stomach and jejunum walls were dilated with a 6 F cystotome, and a 20×80 mm polytetrafluoroethylene T-FCSEMS (Hilzo) was deployed. Oral feeding was initiated after 12 to 18 hours and solid foods after 48 hours. Results: The median procedure time was 33 minutes (range, 23-55 minutes). After two weeks, 19 patients tolerated oral feeding. In patients with malignancy, the median survival time was 118 days (range, 41-194 days). No serious complications or deaths occurred. All patients with malignancy tolerated oral food intake until they expired. Conclusions: T-FCSEMS is safe and effective. This stent should be considered as an alternative to LAMS for gastric outlet obstruction.

• Journal of Chitin and Chitosan
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• v.23 no.4
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• pp.256-261
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• 2018

Recently, the number of cardiovascular disease-related deaths worldwide has increased. Therefore, the importance of percutaneous cardiovascular intervention and drug-eluting stents (DES) has been highlighted. Despite the great clinical success of DES, the re-endothelialization at the site of stent implantation is retarded owing to the anti-proliferative effect from the coated drug, resulting in late thrombosis or very late restenosis. In order to solve this problem, studies have been actively carried out to excavate new drugs that promote rapid re-endothelialization. In this study, we introduced hydrophilic drug, tauroursodeoxycholate (TUDCA), that improves the proliferation of endothelial progenitor cells and promotes apoptosis of vascular smooth muscle cells. In addition, we utilized shellac, which is a natural resin from lac bug to coat TUDCA on the surface of the metal. When using conventional coating method including biodegradable polymers and organic solvents, phase separation between polymer and drug occurred in the coating layer that caused incomplete incorporation of drug into the polymer layer. However, when using shellac as a coating polymer, no phase separation was observed and drug was fully covered with the polymer matrix. In addition, by adjusting the composition of coating solution and modifying the hydrophilicity of the metal surface using oxygen plasma, the surface roughness decreased due to the increased affinity between coating solution and metal surface. This result provides a method of depositing a hydrophilic drug layer on the stent.

• Clinical Endoscopy
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• v.57 no.1
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• pp.122-127
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• 2024

Benign biliary stricture (BBS) is a complication of chronic pancreatitis (CP). Despite endoscopic biliary stenting, some patients do not respond to treatment, and they experience recurrent cholangitis. We report two cases of CP with refractory BBS treated using endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) fistula creation. A 50-year-old woman and a 60-year-old man both presented with obstructive jaundice secondary to BBS due to alcoholic CP. They underwent repeated placement of a fully covered self-expandable metal stent for biliary strictures. However, the strictures persisted, causing repeated episodes of cholangitis. Therefore, an EUS-CDS was performed. The stents were eventually removed and the patients became stent-free. These fistulas have remained patent without cholangitis for more than 2.5 years. Fistula creation using EUS-CDS is an effective treatment option for BBS.