A Multicenter Prospective Study of the Short-Term Outcome of a Newly Developed Partially Covered Self-Expandable Metallic Biliary Stent (WallFlex®)

Tsuchiya, Takayoshi; Itoi, Takao; Gotoda, Takuji; Kuraoka, Kensuke; Itokawa, Fumihide; Kurihara, Toshio; Ishii, Kentaro; Tsuji, Shujiro; Ikeuchi, Nobuhito; Tanaka, Reina; Umeda, Junko

doi:10.1007/s10620-011-1581-6

Cited by 12 publications

(10 citation statements)

References 24 publications

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“…19,20 The rates of perforation and bleeding in the ES group were only 0% and 1%, respectively, and were comparable with previously reported rates for covered SEMS (0%-0.7% and 0%-2%, respectively). 4,5,[7][8][9][11][12][13][14][15] These rates are relatively low compared with those for ES for extraction of bile duct stones, and this may be attributable to the wrapping and tamponade effect of covered SEMS because the covering membrane may seal tiny perforations and other minor vessel injuries that occur during ES.…”

Section: Discussionmentioning

confidence: 99%

“…6 However, the combined rate of bleeding and perforation in the ES group was 24.3%, 6 which was exceedingly high relative to other reports of SEMS placement with ES (0%-1%). [2][3][4][5][7][8][9][10][11] Furthermore, post-SEMS placement pancreatitis was not observed in either the non-ES or ES groups. 6 This is in contrast to several previous studies that have reported that pancreatitis is the most frequent early post-SEMS placement AE (0%-8.8%).…”

mentioning

confidence: 83%

“…The previously reported rates of early SEMS placement-related AEs varied widely (0%-25%). [2][3][4][5][6][7][8][9][10][11][12][13][14][15] However, during the planning of the study protocol (August 2009), only 2 prospective studies concerning covered SEMS placement for the treatment of distal malignant biliary stricture were available. 4,12 In these studies, the rates of AEs specifically related to the presence or absence of ES ranged from 4% to 8.8% (mean, 6.4%).…”

Section: Outcome Measures and Statistical Analysismentioning

confidence: 99%

“…6 This is in contrast to several previous studies that have reported that pancreatitis is the most frequent early post-SEMS placement AE (0%-8.8%). [2][3][4][5][7][8][9][10][11][12][13][14][15] Because these results do not reflect the typical clinical practice experience and impaired pancreatic outflow is considered a major cause of pancreatitis, the majority of endoscopists continue to perform ES routinely before SEMS placement to minimize the influence of the strong expansive force of the SEMS on the pancreatic duct orifice. In Japan, some endoscopists believe ES before SEMS placement is useless, especially in pancreatic cancer patients in whom exocrine function already has ceased because of a main pancreatic duct obstruction.…”

mentioning

confidence: 98%

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No Benefit of Endoscopic Sphincterotomy Before Biliary Placement of Self-Expandable Metal Stents for Unresectable Pancreatic Cancer

Hayashi

Kawakami

Osanai

et al. 2015

Clinical Gastroenterology and Hepatology

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 83%

Section: Outcome Measures and Statistical Analysismentioning

confidence: 99%

mentioning

confidence: 98%

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No Benefit of Endoscopic Sphincterotomy Before Biliary Placement of Self-Expandable Metal Stents for Unresectable Pancreatic Cancer

Hayashi

Kawakami

Osanai

et al. 2015

Clinical Gastroenterology and Hepatology

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“…8,9 Endoscopically placed biliary and duodenal metal stents exhibit a geometric progress of evolution because of substantial improvements in manufacturing technology and materials. 10 The fourthgeneration metal stents used now in everyday practice are made of nitinol alloy and may be covered (partially or fully) with materials that improve patency rates. 11 In addition, biliary and duodenal stents may be used easily in combination for palliation of the same patient, without significant technical problems.…”

mentioning

confidence: 99%

Palliation With Endoscopic Metal Stents May Be Preferable to Surgical Intervention for Patients With Obstructive Pancreatic Head Adenocarcinoma

Kofokotsios¹,

Papazisis²,

Andronikidis³

et al. 2015

International Surgery

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The aim of this study was to evaluate the efficacy of endoscopically placed metal stents in comparison with operative procedures, in patients with obstructive pancreatic head cancer. Endoscopic stenting techniques and materials for gastrointestinal malignancies are constantly improving. Despite this evolution, many still consider operative procedures to be the gold standard for palliation in patients with unresectable obstructive pancreatic head cancer. This is a retrospective study of 52 patients who were diagnosed with obstructive (biliary, duodenal, or both) adenocarcinoma of the pancreatic head. Twenty-nine patients (endoscopy group) underwent endoscopic stenting. Eleven patients (bypass group) underwent biliodigestive bypass. Twelve patients (Whipple group) underwent Whipple operation with curative intent; however, histopathology revealed R1 resection (palliative Whipple). T4 disease was identified in 13 (44.8%), 7 (63.6%), and 3 (25%) patients in the endoscopy, bypass, and Whipple groups, respectively. Metastatic disease was present only in the endoscopy group (n = 12; 41.3%). There was no intervention-related mortality. Median survival was 280 days [95% confidence interval (95% CI), 103, 456 days], 157 days (95% CI, 0, 411 days), and 647 days (95% CI, 300, 993 days) for the endoscopy, bypass, and Whipple groups, respectively (P = 0.111). In patients with obstructive pancreatic head cancer, endoscopic stenting may offer equally good palliation compared with surgical double bypass. The numerically (not statistically) better survival after palliative Whipple might be explained by the smaller tumor burden in this subgroup of patients and not by the superior efficacy of this operation.

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Usefulness of half‐covered metallic stent placement in preventing acute cholecystitis complication in pancreatic cancer‐induced distal biliary stricture

et al. 2020

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Background and Aim A self‐expandable metallic stent (SEMS) is commonly used for biliary stricture caused by pancreatic cancer. Covered SEMS may obstruct the cystic duct, causing acute cholecystitis. This study aimed to determine the outcomes of using a half‐covered SEMS with an offset covered portion for preventing cystic duct obstruction. Methods Among 80 patients with half‐covered SEMS placement for the treatment of pancreatic cancer‐induced distal biliary stricture, 74 were followed up. The half‐covered SEMS has a total length of 6 or 7 cm, and the offset covered part was 0.5–4.5 or 0.5–5.5 cm, respectively. Intraductal ultrasonography (IDUS) and endoscopic nasobiliary drainage (ENBD) were performed during the initial endoscopic retrograde cholangiopancreatography (ERCP). IDUS findings and ENBD tube cholangiogram confirmed the cystic duct confluence. SEMS placement was performed on the second ERCP or several weeks after the initial tube stent placement. Results Half‐covered SEMS placement was successful in all patients. However, four (5.4%) patients exhibited early complications, including acute cholecystitis in one patient and stent displacement in another. Over 30 days, cholangitis, tumor growth, and stent displacement occurred in nine (11.3%), five (6.3%), and two (2.5%) patients, respectively. The median stent patency was 71.1 weeks, and the median overall survival in patients with and without chemotherapy was 31.8 and 12.2 weeks, respectively. Conclusions With confirmation of the cystic duct confluence, half‐covered SEMS placement may become a treatment option for distal biliary stricture caused by pancreatic cancer to prevent acute cholecystitis. Half‐covered SEMS patency was comparable with that of covered SEMS.

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A Multicenter Prospective Study of the Short-Term Outcome of a Newly Developed Partially Covered Self-Expandable Metallic Biliary Stent (WallFlex®)

Abstract: The present results revealed that the new WallFlex(®) Biliary RX Partially Covered SEMSs were useful for the short-term relief of biliary obstruction due to unresectable distal biliary malignancies.

Cited by 12 publications

References 24 publications

No Benefit of Endoscopic Sphincterotomy Before Biliary Placement of Self-Expandable Metal Stents for Unresectable Pancreatic Cancer

No Benefit of Endoscopic Sphincterotomy Before Biliary Placement of Self-Expandable Metal Stents for Unresectable Pancreatic Cancer

Palliation With Endoscopic Metal Stents May Be Preferable to Surgical Intervention for Patients With Obstructive Pancreatic Head Adenocarcinoma

Usefulness of half‐covered metallic stent placement in preventing acute cholecystitis complication in pancreatic cancer‐induced distal biliary stricture

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