Pilot study of a novel, large‐bore, fully covered self‐expandable metallic stent for unresectable distal biliary malignancies

Mukai, Tsuyoshi; Yasuda, Ichiro; Isayama, Hiroyuki; Iwashita, Takuji; Itoi, Takao; Kawakami, Hiroshi; Kogure, Hirofumi; Nakai, Yousuke

doi:10.1111/den.12643

Cited by 24 publications

(28 citation statements)

References 27 publications

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“…Fully covered SEMS, a stent with a larger inner diameter, tends to be selected. Many previous studies comparing types of SEMS used 10‐mm diameter SEMS, and the utility of a 12‐mm diameter FCSEMS has also been reported . Certainly, in the present study, there was no difference in the insertion success rate between 10‐ and 8‐mm diameter FCSEMS and the thickness of the delivery shaft was also the same.…”

Section: Discussionsupporting

confidence: 60%

“…Many previous studies comparing types of SEMS used 10-mm diameter SEMS, and the utility of a 12-mm diameter FCSEMS has also been reported. 25 Certainly, in the present study, there was no difference in the insertion success rate between 10-and 8-mm diameter FCSEMS and the thickness of the delivery shaft was also the same. The thinner 8-mm FCSEMS felt easier to insert in actual clinical practice.…”

Section: Discussioncontrasting

confidence: 39%

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Comparison of 8‐ and 10‐mm diameter fully covered self‐expandable metal stents: A multicenter prospective study in patients with distal malignant biliary obstruction

Kawashima

Hashimoto

Ohno

et al. 2019

Digestive Endoscopy

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Objectives The time to recurrent biliary obstruction (TRBO) of unresectable distal malignant biliary obstruction is generally thought to be longer when a self‐expandable metal stent (SEMS) with a thicker inner diameter is used for drainage, but the dependence on the inner diameter using a fully covered SEMS (FCSEMS) is uncertain. The objective of this multicenter prospective study was to compare TRBO and adverse events, such as cholecystitis and pancreatitis, in treatment of patients with unresectable malignant biliary obstruction using 8‐ and 10‐mm diameter FCSEMS. Methods Eighteen tertiary‐care centers participated in the study. Patients were allocated to the 8‐ and 10‐mm diameter groups. TRBO, non‐inferiority of the 8‐mm FCSEMS, overall survival time, frequency and type of adverse events, and non‐recurrent biliary obstruction (RBO) rate at the time of death were compared between the two groups. Results Median TRBO did not differ significantly between the 8‐mm (n = 102) and 10‐mm (n = 100) groups (275 vs 293 days, P = 0.971). The hazard ratio of the 8‐ to 10‐mm groups was 0.90 (80% confidence interval, 0.77–1.04; upper limit lower than the acceptable hazard ratio [1.33] of the null hypothesis). Based on these findings, the 8‐mm diameter stent was determined to be non‐inferior to the 10‐mm diameter stent. Survival time, incidence of adverse events and non‐RBO rate at the time of death did not differ significantly between the two groups. Conclusions Time to RBO with an 8‐mm diameter FCSEMS was non‐inferior to that with a 10‐mm diameter FCSEMS. This finding is important for development of future SEMS.

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Section: Discussionsupporting

confidence: 60%

Section: Discussioncontrasting

confidence: 39%

Comparison of 8‐ and 10‐mm diameter fully covered self‐expandable metal stents: A multicenter prospective study in patients with distal malignant biliary obstruction

Kawashima

Hashimoto

Ohno

et al. 2019

Digestive Endoscopy

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“…The newly M‐FCSEMS has a diameter of 12 mm, which may increase radial force that greater influence on the prevention of early migration . In a recent pilot study, a 12‐mm diameter FCSEMS with flared ends had a migration rate of 7.9% (3/38) at a median of 177 days . Our 12‐mm diameter M‐FCSEMS also showed a comparable rate of migration but had non‐flared margins to minimize ductal inflammation and ischemia.…”

Section: Discussionmentioning

confidence: 51%

“…In a multicenter study, a stent with anchoring flaps was superior to one with flared ends in terms of the frequency of migration in patients with benign biliary strictures (0% vs 33%, P = 0.004) . A study in Japan reported that stents with larger diameters have a reduced risk of migration …”

Section: Discussionmentioning

confidence: 99%

“…15 A study in Japan reported that stents with larger diameters have a reduced risk of migration. 16 Although many studies have been performed in evaluating the anti-migration effect of various FCSEMS, it remains controversial as to which stent is effective because they have several limitations. Removal of stents with anchoring fins at both ends can cause ulceration and bleeding of the mucosa.…”

Section: Discussionmentioning

confidence: 99%

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Usefulness of newly modified fully covered metallic stent of 12 mm in diameter and anti‐migration feature for periampullary malignant biliary strictures: Comparison with conventional standard metal stent

Lee

Moon

Lee

et al. 2019

J of Gastro and Hepatol

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Backgrounds Fully covered self‐expandable metal stent (FCSEMS) are preferred for distal malignant biliary stricture (MBS). However, stent migration is a major adverse event of FCSEMS, especially for far distal MBS. We evaluated the usefulness of newly modified FCSEMS (M‐FCSEMS) having 12 mm in diameter and anti‐migration feature to minimize stent migration compared with the conventional FCSEMS (C‐FCSEMS). Methods Total 102 patients were enrolled between January 2015 and September 2017 in this prospective comparative study; 50 were allocated to the M‐FCSEMS group and 52 to the C‐FCSEMS group. The primary outcome was stent migration, and the secondary outcomes were other adverse events, stent occlusion rate, and stent patency during the follow‐up period. Results The baseline characteristics of the two groups did not significantly differ. Endoscopic stent placement was technically successful in all patients. Stent migration occurred in 8.0% (4/50) of the patients in the M‐FCSEMS group and 23.1% (12/52) of those in the C‐FCSEMS group (P = 0.036). The other adverse events, including stent‐related pancreatitis and cholecystitis did not significantly differ between the two groups (P = 0.415). Stent occlusion occurred in 23.9% (11/46) of the patients in the M‐FCSEMS group and 37.5% (15/40) in the C‐FCSEMS group (P = 0.171). Stent patency was significantly longer in the M‐FCSEMS group than in the C‐FCSEMS group (228 vs 157 days, P = 0.048). Conclusions Modified FCSEMS with 12‐mm diameter and anti‐migration feature significantly decreased the risk of stent migration and had longer patency compared with C‐FCSEMS in patients with periampullary MBS.

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Re‐intervention with 10‐mm vs 12‐mm covered self‐expandable metallic stent for recurrent unresectable distal biliary obstruction in patients with previous stent implantation

Chikugo

Hayashi

Tanaka

et al. 2022

J Hepato Biliary Pancreat

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Background: Treatment for unresectable distal malignant biliary obstruction (DMBO) involves placing a 10-mm covered self-expandable metallic stent (CSEMS). In recurrent biliary obstruction (RBO), replacement of the CSEMS is recommended; however, the appropriate stent type remains unknown. We speculated that large-bore CSEMSs would provide longer patency. We compared the efficacy of 10-mm and 12-mm CSEMS in patients with RBO. Methods:We retrospectively retrieved data on patients who underwent CSEMS replacement from the endoscopic database. We investigated the time to RBO (TRBO) after CSEMS replacement. The hazard ratio (HR) for the the second TRBO was estimated using the Cox proportional hazard model. The estimated median second TRBO was determined using the Kaplan-Meier method.Results: Among the 493 patients with DMBOs treated with 10-mm CSEMS, 48 and 29 patients underwent re-intervention with 10-mm and 12-mm CSEMS, respectively. The use of 12-mm CSEMS was inversely associated with second TRBO (multivariable-adjusted HR, 0.62; 95% CI, 0.39-0.98; P = .042). The estimated median second TRBO was greater with the 12 mm CSEMS than with the 10 mm variety (562 days vs 207 days; P = .019). Conclusion:The second intervention with 12-mm CSEMS was associated with a longer TRBO.

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Pilot study of a novel, large‐bore, fully covered self‐expandable metallic stent for unresectable distal biliary malignancies

Abstract: Our novel FCSEMS may be safe and effective for managing malignant distal obstruction with an acceptable incidence of adverse events.

Cited by 24 publications

References 27 publications

Comparison of 8‐ and 10‐mm diameter fully covered self‐expandable metal stents: A multicenter prospective study in patients with distal malignant biliary obstruction

Comparison of 8‐ and 10‐mm diameter fully covered self‐expandable metal stents: A multicenter prospective study in patients with distal malignant biliary obstruction

Usefulness of newly modified fully covered metallic stent of 12 mm in diameter and anti‐migration feature for periampullary malignant biliary strictures: Comparison with conventional standard metal stent

Re‐intervention with 10‐mm vs 12‐mm covered self‐expandable metallic stent for recurrent unresectable distal biliary obstruction in patients with previous stent implantation

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