A Prospective Multicenter Study of a Fully Covered Metal Stent in Patients with Distal Malignant Biliary Obstruction: WATCH-2 Study

Kogure, Hirofumi; Ryozawa, Shomei; Maetani, Iruru; Nakai, Yousuke; Kawakami, Hiroshi; Yasuda, Ichiro; Mochizuki, Hitoshi; Iwano, Hirotoshi; Maguchi, Hiroyuki; Kida, Mitsuhiro; Kubota, Kensuke; Mukai, Tsuyoshi; Hasebe, Osamu; Igarashi, Yoshinori; Hanada, Keiji; Irisawa, Atsushi; Ito, Kei; Itoi, Takao; Isayama, Hiroyuki

doi:10.1007/s10620-017-4875-5

Cited by 33 publications

(39 citation statements)

References 38 publications

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“…SEMS are usually placed across the duodenal papilla in patients with unresectable distal MBO, but the optimal choice of SEMS has not been established. In a meta-analysis of endoscopic transpapillary SEMS placement for distal MBO, no significant difference was found between covered and uncovered SEMS regarding stent patency or between fully-covered vs. partially-covered SEMS [19,20]. Therefore, a new strategy to extend the time to RBO is required for patients with distal MBO.…”

Section: Discussionmentioning

confidence: 99%

Self-expandable metallic stent placement above the papilla without endoscopic sphincterotomy in patients with distal malignant biliary obstruction

et al. 2020

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Background and study aims The best method for endoscopic placement of self-expandable metallic stents (SEMS) for distal malignant biliary obstruction (MBO) has not yet been determined. The aim of this study was to evaluate how SEMS placement above the papilla and without endoscopic sphincterotomy (EST) impacts the time to recurrent biliary obstruction (RBO) in patients with distal MBO. Patients and methods We retrospectively reviewed data for 73 consecutive patients with unresectable distal MBO who underwent endoscopic SEMS placement for the first time at our institution between April 2014 and March 2016. We compared time to RBO of SEMS placement above the papilla (intraductal placement) with SEMS placement across the papilla (transpapillary placement). In the intraductal placement group, we also compared time to RBO of placement without EST with placement with EST. Results Endoscopic SEMS placement was performed in 30 patients with intraductal placement and in 43 patients with transpapillary placement. The median time to RBO was significantly longer with intraductal placement (307 days) than with transpapillary placement (161 days) (P = 0.022). Complication rates did not differ between the two groups. In both univariate and multivariate analysis, intraductal placement was an independent factor contributing to prolonged time to RBO. In intraductal placement, time to RBO was significantly longer in SEMS placement without EST than with EST (363 days vs. 227 days, respectively; P = 0.026). Conclusions Intraductal SEMS placement, especially without EST for distal MBO contributed to longer time to RBO.

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Section: Discussionmentioning

confidence: 99%

Self-expandable metallic stent placement above the papilla without endoscopic sphincterotomy in patients with distal malignant biliary obstruction

et al. 2020

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“…Endoscopic placement of a self‐expandable metal stent (SEMS) has been first‐line palliative treatment of nonresectable distal malignant biliary obstruction (MBO) because of longer duration of patency compared to plastic stents . Covered SEMS have emerged as an alternative to uncovered SEMS with the expectation of further prolonged patency through preventing tumor tissue and reactive epithelial hyperplasia from invading through the mesh wall . Furthermore, improvements in conformability of SEMS in the bile duct have reduced the risk of recurrent biliary obstruction (RBO) as a result of stent migration .…”

Section: Introductionmentioning

confidence: 99%

“…[1][2][3][4][5] Covered SEMS have emerged as an alternative to uncovered SEMS with the expectation of further prolonged patency through preventing tumor tissue and reactive epithelial hyperplasia from invading through the mesh wall. [6][7][8][9][10][11] Furthermore, improvements in conformability of SEMS in the bile duct have reduced the risk of recurrent biliary obstruction (RBO) as a result of stent migration. 10 In this setting, biliary sludge and food impaction serve as major causes of covered SEMS occlusion.…”

Section: Introductionmentioning

confidence: 99%

Antireflux covered metal stent for nonresectable distal malignant biliary obstruction: Multicenter randomized controlled trial

Hamada

Isayama

Nakai

et al. 2019

Digestive Endoscopy

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Background and Aim An antireflux metal stent (ARMS) for nonresectable distal malignant biliary obstruction (MBO) may prevent recurrent biliary obstruction (RBO) as a result of duodenobiliary reflux and prolong time to RBO (TRBO). Superiority of ARMS over conventional covered self‐expandable metal stents (SEMS) has not been fully examined. Methods We conducted a multicenter randomized controlled trial to examine whether TRBO of an ARMS with a funnel‐shaped valve was longer than that of a covered SEMS in SEMS‐naïve patients. We enrolled 104 patients (52 patients per arm) at 11 hospitals in Japan. Secondary outcomes included causes of RBO, adverse events, and patient survival. Results TRBO did not differ significantly between the ARMS and covered SEMS groups (median, 251 vs 351 days, respectively; P = 0.11). RBO as a result of biliary sludge or food impaction was observed in 13% and 9.8% of patients who received an ARMS and covered SEMS, respectively (P = 0.83). ARMS was associated with a higher rate of stent migration compared with the covered SEMS (31% vs 12%, P = 0.038). Overall rates of adverse events were 20% and 18% in the ARMS and covered SEMS groups, respectively (P = 0.97). No significant between‐group difference in patient survival was observed (P = 0.26). Conclusions The current ARMS was not associated with longer TRBO compared with the covered SEMS. Modifications including addition of an anti‐migration system are required to use the current ARMS as first‐line palliative treatment of distal MBO (UMIN‐CTR clinical trial registration number: UMIN000014784).

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“…To investigate the potential non-inferiority of an 8-mm diameter FCSEMS to a 10-mm diameter FCSEMS with regard to TRBO and the frequency of adverse events, we designed a multicenter prospective controlled study using a WallFlex Biliary RX Fully Covered Stent, which has flare to prevent migration and is reported to have a relatively weak axial force. 14,15,20 The primary end-point of the study was the TRBO of the 10-versus 8-mm diameter FCSEMS. The secondary endpoints were overall survival time, frequency and type of adverse events, and non-RBO rate at the time of death.…”

Section: Introduction E Ndoscopic Stent Placement In Patients Withmentioning

confidence: 99%

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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A Prospective Multicenter Study of a Fully Covered Metal Stent in Patients with Distal Malignant Biliary Obstruction: WATCH-2 Study

Abstract: UMIN000007131.

Cited by 33 publications

References 38 publications

Self-expandable metallic stent placement above the papilla without endoscopic sphincterotomy in patients with distal malignant biliary obstruction

Self-expandable metallic stent placement above the papilla without endoscopic sphincterotomy in patients with distal malignant biliary obstruction

Antireflux covered metal stent for nonresectable distal malignant biliary obstruction: Multicenter randomized controlled trial

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

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