Effectiveness of a newly designed antireflux valve metal stent to reduce duodenobiliary reflux in patients with unresectable distal malignant biliary obstruction: a randomized, controlled pilot study (with videos)

Lee, Yun Nah; Moon, Jong Ho; Choi, Moon Han; Lee, Tae Hoon; Cha, Sang‐Woo; Cho, Young Deok; Choi, Seo-Youn; Lee, Hae Kyung; Park, Sang‐Heum

doi:10.1016/j.gie.2015.08.084

Cited by 64 publications

(102 citation statements)

References 17 publications

Supporting

Mentioning

102

Contrasting

Order By: Relevance

“…However, this study was limited by the use of uncovered SEMS as a comparative group because tumor ingrowth was reported to be a predominant cause of RBO in this group. In a more recent randomized trial of 77 patients, ARMS was first compared with a covered SEMS in terms of patency duration . ARMS with a windsock‐shaped valve provided significantly longer patency time compared with the covered SEMS (14 vs 7 months).…”

Section: Discussionmentioning

confidence: 99%

“…An antireflux metal stent (ARMS) with a valve against duodenobiliary reflux was developed to mitigate the risk of SEMS dysfunction as a result of duodenobiliary reflux . Despite different designs of antireflux valves in prior studies, ARMS have generally been associated with lower risks of stent occlusion and non‐occlusion cholangitis compared with conventional SEMS.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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

Hamada

Isayama

Nakai

et al. 2019

Digestive Endoscopy

View full text Add to dashboard Cite

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).

show abstract

Section: Discussionmentioning

confidence: 99%

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

View full text Add to dashboard Cite

show abstract

“…In a more recent randomized trial by Lee et al . (n=77),31 an ARMS with a windsock-shaped valve provided significantly longer patency time compared with conventional covered SEMS (14 months vs 7 months, p=0.01). Of note, barium meal examination after stent placement demonstrated a significantly lower rate of the duodenobiliary reflux in the ARMS group (8% vs 100%, p<0.01).…”

Section: Discussionmentioning

confidence: 94%

Antireflux Metal Stent as a First-Line Metal Stent for Distal Malignant Biliary Obstruction: A Pilot Study

et al. 2017

View full text Add to dashboard Cite

Background/AimsIn distal malignant biliary obstruction, an antireflux metal stent (ARMS) with a funnel-shaped valve is effective as a reintervention for metal stent occlusion caused by reflux. This study sought to evaluate the feasibility of this ARMS as a first-line metal stent.MethodsPatients with nonresectable distal malignant biliary obstruction were identified between April and December 2014 at three Japanese tertiary centers. We retrospectively evaluated recurrent biliary obstruction and adverse events after ARMS placement.ResultsIn total, 20 consecutive patients were included. The most common cause of biliary obstruction was pancreatic cancer (75%). Overall, recurrent biliary obstruction was observed in seven patients (35%), with a median time to recurrent biliary obstruction of 246 days (range, 11 to 246 days). Stent occlusion occurred in five patients (25%), the causes of which were sludge and food impaction in three and two patients, respectively. Stent migration occurred in two patients (10%). The rate of adverse events associated with ARMS was 25%: pancreatitis occurred in three patients, cholecystitis in one and liver abscess in one. No patients experienced non-occlusion cholangitis.ConclusionsThe ARMS as a first-line biliary drainage procedure was feasible. Because the ARMS did not fully prevent stent dysfunction due to reflux, further investigation is warranted.

show abstract

“…Also, we tried to position the stent center just on the center of the stricture. Third, our stent reduced duodenobiliary reflux especially in patients with LDLT by locating the stent inside the common bile duct . The risk of duodenobiliary reflux is much higher in LDLT patients if the stent locates across the papilla because the stricture occurs short and isolated in this population .…”

Section: Discussionmentioning

confidence: 94%

Intraductal placement of non‐flared fully covered metallic stent for refractory anastomotic biliary strictures after living donor liver transplantation: Long‐term results of prospective multicenter trial

Yoo

Lee

et al. 2019

J of Gastro and Hepatol

Self Cite

View full text Add to dashboard Cite

Background and Aim Fully covered self‐expandable metallic stent (FCSEMS) may be an effective modality for managing anastomotic biliary stricture (ABS) after liver transplantation. However, stent migration and stent‐induced ductal injury are the main limitations. The objective of this study was to evaluate the usefulness of an unflared, intraductal FCSEMS that was designed to minimize migration and ductal injury for refractory ABS after living donor liver transplantation (LDLT). Methods A total of 32 consecutive patients with symptomatic ABS after LDLT unresolved by plastic stents with or without balloon dilation at four tertiary medical centers were prospectively enrolled. A short (3 or 5 cm) FCSEMS having long lasso (10 cm) used in this study had unflared convex ends to minimize tissue hyperplasia and smaller center portion to prevent migration. The FCSEMS was placed above the papilla and removed at 3–4 months after stenting. Results Technical and clinical success rates of intraductal placement with FCSEMS were 100% (32/32) and 81.2% (26/32), respectively. Early stent migration was observed in five (15.6%) patients. However, three patients with early stent migration had stricture resolution without needing additional intervention. Intended stent removal was successful in 27 (100%) patients (median, 101 days; range, 23–118 days). No stent‐induced ductal change was observed in all patients. Stricture recurrence was observed in 11.5% (3/26) of patients during 639 days of median duration of follow‐up (range, 366–2079 days). Conclusions Intraductal placement of an unflared short FCSEMS may be a promising option for refractory ABS after LDLT with minimal stent‐induced ductal injury and stent migration.

show abstract

Effectiveness of a newly designed antireflux valve metal stent to reduce duodenobiliary reflux in patients with unresectable distal malignant biliary obstruction: a randomized, controlled pilot study (with videos)

Cited by 64 publications

References 17 publications

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

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

Antireflux Metal Stent as a First-Line Metal Stent for Distal Malignant Biliary Obstruction: A Pilot Study

Intraductal placement of non‐flared fully covered metallic stent for refractory anastomotic biliary strictures after living donor liver transplantation: Long‐term results of prospective multicenter trial

Contact Info

Product

Resources

About