Multicenter Trial Evaluating the Use of Covered Self-expanding Metal Stents in Benign Biliary Strictures

Kahaleh, Michel; Brijbassie, Alan; Sethi, Amrita; Degaetani, Marisa; Poneros, John M.; Loren, David E.; Kowalski, Thomas E.; Sejpal, Divyesh V.; Patel, Sandeep; Rosenkranz, Laura; Mcnamara, Kevin N.; Raijman, Isaac; Talreja, Jayant P.; Gaidhane, Monica; Sauer, Bryan G.; Stevens, Peter D.

doi:10.1097/mcg.0b013e31827fd311

Cited by 79 publications

(29 citation statements)

References 33 publications

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confidence: 80%

“…The data support the common hypothesis that FCSEMS are non-inferior to MPS for the first-line treatment of BBS. The resolution rates and complications are comparable to previous reports (1,4,8,10).A direct translation of the results on FCSEMS, other than in this study investigated, is not possible. FCSEMS, although showing high similarities, present with distinct characteristics such as radial expansion force, material of cover, outer surface and many more that may influence clinical outcomes with special respect to dislocation rate and dilatation of a stenosis.…”

supporting

confidence: 73%

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The freedom of choice

Weigt

Obst

Malfertheiner

2017

Hepatobiliary Surg. Nutr.

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Endoscopic stent placement is the current standard treatment for benign biliary strictures (BBS). There are two main treatment options: either the implantation of multiple plastic stents (MPS) or the implantation of selfexpandable metal stents (SEMS) (1,2). Which of the two stent implantation strategies is the better choice remains a matter of interest. Other therapies such as balloon dilatation and bouginage that are still frequently used in clinical practice provide a modest additional benefit. The most common causes of BBS include stenosis due to chronic pancreatitis (CP) or postoperative after orthotopic liver transplantation (OLT) or cholecystectomy (CCY) (3). The combination of endoscopic dilatation with sequential placement of MPS over a 1-year period shows high efficacy in resolving BBS after OLT (80-90%) as well as in patients with CP (44-92%) (1,4). However, the procedure is demanding and an average number of 4-5 endoscopic retrograde cholangiopancreatography (ERCP) is needed and causes an increased rate of complications (5). Recent studies moved the use of fully covered self-expandable metal stents (FCSEMS) into focus. FCSEMS have a low occlusion rate and a larger diameter compared to PS, which may turn out to be beneficial in the long-term treatment of BBS (6,7). However, comparative studies demonstrating a longer patency of SEMS compared to MPS are not available. In a prospective nonrandomized clinical trial the effectiveness and safety of FCSEMS for the treatment of BBS has been shown (8). Randomized clinical studies comparing FCSEMS with MPS in BBS have not been conducted before. Coté et al. present an open-label, multi-centre, randomized clinical trial comparing FCSEMS with MPS in BBS (9). The study was conducted to reveal a non-inferiority of FCSEMS versus MPS.One hundred and twelve patients (73 OLT patients, 35 CP patients, 4 CCY patients) with a symptomatic stricture of the common bile duct, located at least 2 cm below the hepatic confluence were randomized either to receive FCSEMS or MPS. Strictures had to be-in contrast to previous studies-less than 75% of the diameter of the unaffected bile duct with a minimum size of 6 mm and a maximum length of 8 mm. Diameter of FCSEMS was in addition adapted to the size of the surrounding bile duct to lower the migration rate. Successful stricture resolution was determined after a 12-month stent therapy and defined as a residual diameter of the stricture more than 75% of the duct above and below the stricture. With a resolution rate of 92.6% in the FCSEMS group against 85.4% in the MPS group (rate difference 7.2%; 95% CI, −3.0% to ∞; P<0.001), the noninferiority was proven. Furthermore, the number of ERCPs (2.14 vs. 3.24; P<0.001) and the time to resolve the stricture (181 vs. 225 days; P=0.006) was significant lower in the FCSEMS group compared to MPS group. Subgroup analysis confirmed these observations in patients after OLT and with CP without reaching statistical significance. However, the study was not adequately powered for this subgroup analys...

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supporting

confidence: 80%

supporting

confidence: 73%

The freedom of choice

Weigt

Obst

Malfertheiner

2017

Hepatobiliary Surg. Nutr.

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“…Endoscopic management of chronic pancreatitis includes ERCP with transpapillary plastic stent placement, PD balloon dilation, and ESWL for PD stones. FCSEMS placement has been reported as a treatment for refractory PD strictures in patients in whom other therapeutic modalities have failed [2]. However, in the patient described here, a conventional transpapillary ERCP approach for placement of the FCSEMS was not successful, and we used an EUS-guided technique to place an FCSEMS, and we then used this access for laser lithotripsy [3].…”

mentioning

confidence: 89%

Endoscopic management of chronic pancreatitis with a fully covered self-expanding metal stent and laser lithotripsy

Novikov¹,

Xu²,

Tyberg³

et al. 2017

Endoscopy

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“…On the other hand, another systematic review identified a higher complication rate associated with the use of self-expanding metal stents (40 %) compared to either single (36 %) or multiple plastic stents (20 %) [6]. Another relatively recent prospective multicenter study of 133 patients reported that stent duration of [90 days increased stricture resolution rate by 4.3-fold [7]. The benefit of self-expanding metal stents, however, has not been reported for all aetiologies of benign strictures; hence, further research is needed in this expanding field.…”

mentioning

confidence: 93%

Metallic Stents for Benign Extrahepatic Biliary Stricture: In Praise of Self-Expansion?

Leong

2015

Dig Dis Sci

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Benign biliary strictures are often safely and successfully treated with removable indwelling biliary stents with stricture resolution in 75-90 % of all cases. There is no consensus on the optimal time to remove the stent, and this typically varies from 3 to 12 months [1,2], depending upon the pathology of the stricture and the clinical setting. For example, shorter dwell times are recommended for post-orthotropic liver transplant (OLT) strictures in the setting of immunosuppression. Resolution of the stricture must be balanced against the complications of stent migration and of cholangitis.In this issue of Digestive Diseases and Sciences, Saxena et al. [3] collected retrospective data from the endoscopic databases of five US tertiary referral centers, identifying patients with benign biliary strictures treated with covered self-expandable metal stents. Stricture etiologies included biliary calculi, chronic pancreatitis, post-OLT, primary sclerosing cholangitis, and other benign indications. The authors evaluated pre-and post-procedural characteristics to identify predictive factors associated with stricture resolution and adverse events. On analysis of 123 patients, the stricture resolution rate was 81 % after a mean stent dwell time of 6.1 months with a corresponding cholangitis rate of 4.1 %. Stricture resolution was associated with longer stent dwell times (24.4 vs 13 weeks, P = 0.02), but stricture etiology, prior plastic stenting, duration of stricture prior to stenting, stricture length, stricture dilatation, and brand of stent (Wallflex Ò vs Viabil Ò ) did not predict stricture resolution [3]. The data may have been biased by its retrospective design and the use of mean rather than the preferred nonparametric median to describe dwell time. Nevertheless, a stent dwell time of *6 months appeared to be near optimal, allowing adequate time to ensure scar remodeling with a relatively low complication rate, including cholangitis. Liver function testing was advocated at 3-month intervals to provide an early indication of stent obstruction and migration. A previously published prospective multicenter study by Devière et al.[1] reported a stricture resolution rate of 75 % and cholangitis rate of 13.9 % after a median stent dwell time of 11.3 months. Saxena's study adds to the data from prior case series, supporting the assumption that temporary stenting is safe and effective for treating benign strictures of various aetiologies (Table 1), even though one death occurred from cholangitis. Other stenting-related complications in this and other case series include post-sphincterotomy hemorrhage, pain, and stent migration [3,4].Potential flaws of the study include its retrospective nature with variable lengths of follow-up, heterogeneity of stricture etiology, and the tertiary hospital case mix, all factors that may reduce generalizability. The strength of the study is that it suggests that a 6-month stent dwell time may be optimal.Self-expanding metal stents have been increasingly used in preference to plastic stents....

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Multicenter Trial Evaluating the Use of Covered Self-expanding Metal Stents in Benign Biliary Strictures

Cited by 79 publications

References 33 publications

The freedom of choice

The freedom of choice

Endoscopic management of chronic pancreatitis with a fully covered self-expanding metal stent and laser lithotripsy

Metallic Stents for Benign Extrahepatic Biliary Stricture: In Praise of Self-Expansion?

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