Antireflux Versus Conventional Plastic Stent in Malignant Biliary Obstruction: A Prospective Randomized Study

Vihervaara, Hanna; Grönroos, Juha; Hurme, Saija; Gullichsen, Risto

doi:10.1089/lap.2016.0178

Cited by 13 publications

(10 citation statements)

References 16 publications

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“…In all patients enrolled in this study, the median patency of this new ARPS was 285 d, which was significantly longer than 130 d observed for the TPS. Moreover, the median patency was also better than previously reported median ARPS patency times[1,11,12]. There were no side holes in either ARPS or TPS; this avoided the possibility of duodenal contents entering the bile duct to bypass the valve.…”

Section: Discussionmentioning

confidence: 59%

“…This provided further evidence that duodenobiliary reflux may play another important role in stent occlusion. To our knowledge, only three studies[1,11,12] in the published English literature have focused on changing the design of PSs to eliminate retrograde flow from the duodenum, prolonging the duration of stent patency. Dua et al[11] in 2007 initially reported an ARPS with a 4 cm windsock-shaped tubular valve made of expanded polytetrafluoroethylene material attached to the duodenal end.…”

Section: Discussionmentioning

confidence: 99%

“…However, the clinical relevance of an increase in median stent patency of 44 d could be questioned[24]. Vihervaara et al[12] also conducted a clinical study using the same ARPS; however, their study was prematurely terminated owing to early stent occlusion in the ARPS group. An unplanned interim analysis was performed and showed that the median stent patency in the ARPS group was 34 d, which was significantly shorter than that in the TPS group (167 d).…”

Section: Discussionmentioning

confidence: 99%

“…In recent years, the design of PS with an antireflux valve at the duodenal end has been an attractive idea to eliminate retrograde flow from the duodenum, thereby prolonging stent patency. Some investigators have reported the effectiveness of these modified PSs[1,11,12], but no excellent results have been reported; thus, modified PSs have not been widely used in clinical practice. We developed a new antireflux PS (ARPS) with a “duckbilled” valve attached to the duodenal end of the stent (Figure 1).…”

Section: Introductionmentioning

confidence: 99%

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New antireflux plastic stent for patients with distal malignant biliary obstruction

Yuan

Wei

et al. 2019

WJG

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BACKGROUND Endoscopic biliary stenting is a well-established palliative treatment for patients with unresectable distal malignant biliary obstruction (MBO). However, the main problem with stent placement is the relatively short duration of stent patency. Although self-expanding metal stents (SEMSs) have a longer patency period than plastic stents (PSs), the higher costs limit the wide use of SEMSs. A PS with an antireflux valve is an attractive idea to prolong stent patency, but no ideal design for an antireflux PS (ARPS) has been proposed. We developed a new ARPS with a “duckbilled” valve attached to the duodenal end of the stent. AIM To compare the patency of ARPSs with that of traditional PSs (TPSs) in patients with unresectable distal MBO. METHODS We conducted a single-center, prospective, randomized, controlled, double-blind study. This study was conducted at the West China Hospital of Sichuan University. Consecutive patients with extrahepatic MBO were enrolled prospectively. Eligible patients were randomly assigned to receive either an ARPS or a TPS. Patients were followed by clinic visits or telephone interviews every 1-2 mo until stent exchange, death, or the final study follow-up in October 2018. The primary outcome was the duration of stent patency. Secondary outcomes included the rate of technical success, the rate of clinical success, adverse events, and patient survival. RESULTS Between February 2016 and December 2017, 38 patients were randomly assigned to two groups, with 19 patients in each group, to receive ARPSs or TPSs. Stent insertion was technically successful in all patients. There were no significant differences between the two groups in the rates of clinical success or the rates of early or late adverse events ( P = 0.660, 1.000, and 1.000, respectively). The median duration of stent patency in the ARPS group was 285 d [interquartile range (IQR), 170], which was significantly longer than that in the TPS group (median, 130 d; IQR, 90, P = 0.005). No significant difference in patient survival was noted between the two groups ( P = 0.900). CONCLUSION The new ARPS is safe and effective for the palliation of unresectable distal MBO, and has a significantly longer stent patency than a TPS.

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Section: Discussionmentioning

confidence: 59%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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New antireflux plastic stent for patients with distal malignant biliary obstruction

Yuan

Wei

et al. 2019

WJG

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“…In fact, 1 study suggested that anti-reflux stents had a shorter median patency of only 34 (8–49) days compared to a conventional stent patency of 167 (38–214) days. [29] The search for materials that inhibit microbial colonization, which likely contributes to stent obstruction, is ongoing, and experimental stents have been developed. [30,31] However, these innovative stents cannot yet be considered as definitive substitutes for conventional stents.…”

Section: Discussionmentioning

confidence: 99%

Suspended over length biliary stents versus conventional plastic biliary stents for the treatment of biliary stricture

Yan

Huang²,

Chang³

et al. 2018

Medicine

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To compare patency between suspended over length biliary stents (SOBSs; made from nasobiliary tube) and conventional plastic biliary stents (CPBSs). We retrospectively analyzed 61 patients with extrahepatic biliary stricture who underwent SOBS placement (intrahepatic bile duct) and 74 patients who underwent CPBS placement. Stent patency and complications were compared. The SOBS group was slightly older and contained more females than the CPBS group but other baseline characteristics were similar. Malignant biliary obstruction accounted for 57.4% (SOBS group) and 45.9% (CPBS group) of cases. Technical success rate, hospital stay and post-procedure complications were similar between groups. Median patency in the CPBS and SOBS group was 116 (2–360) days and 175 (3–480) days, respectively ( P <.001). The SOBS group had lower stent occlusion rates than the CPBS group at 3 months (9.8% vs 36.5%), 4 months (22.0% vs 55.4%), 5 months (35.6% vs 67.6%), and 6 months (39.3% vs 77.0%) (all P <.01). In Cox regression analysis, stent type (SOBS vs CPBS) was the only factor associated with patency (hazard ratio [HR]: 3.449; 95% CI: 1.973-6.028; P <.001). SOBS may have better medium-term patency than CPBS for benign/malignant biliary stricture.

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Scientific surgery

2017

British Journal of Surgery

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et al. Effect of a scalp cooling device on alopecia in women undergoing chemotherapy for breast cancer. The SCALP randomized clinical trial. JAMA 2017; 317: 596-605. The trial was stopped early after 142 women had been randomized. The trial endpoint (< 50 per cent hair loss, not needing a wig) was reached by 50⋅5 per cent of cooled women, compared with none in the control group, P = 0⋅0061. Kowalski TJ, Kothari SN, Mathiason MA, Borgert AJ. Impact of hair removal on surgical site infection rates: a prospective randomized noninferiority trial. J Am Coll Surg 2016; 223: 704-711.

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Antireflux Versus Conventional Plastic Stent in Malignant Biliary Obstruction: A Prospective Randomized Study

Abstract: According to these results, the use of this ARS is not recommended.

Cited by 13 publications

References 16 publications

New antireflux plastic stent for patients with distal malignant biliary obstruction

New antireflux plastic stent for patients with distal malignant biliary obstruction

Suspended over length biliary stents versus conventional plastic biliary stents for the treatment of biliary stricture

Scientific surgery

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