Covered Metallic Stents with an Anti-migration Design Vs. Uncovered Stents for the Palliation of Malignant Gastric Outlet Obstruction: a Multicenter, Randomized Trial

Overview

Journal Am J Gastroenterol

Specialty Gastroenterology

Date 2015 Sep 16

PMID 26372507

Citations 27

Authors

Hyuk Lee

Byung-Hoon Min

Jeong Hoon Lee

Cheol Min Shin

Younjoo Kim

Hyunsoo Chung

Sang Hyub Lee

Affiliations

Soon will be listed here.

Abstract

Objectives: Previous studies reported comparable stent patency between covered self-expandable metallic stents (SEMS) and uncovered SEMS (UCS) for palliation of malignant gastric outlet obstruction (GOO). The aim of this study was to evaluate the efficacy and safety of the newly developed WAVE-covered SEMS (WCS), which has an anti-migration design, compared with UCS in gastric cancer patients with symptomatic GOO.

Methods: A total of 102 inoperable gastric cancer patients with symptomatic GOO were prospectively enrolled from five referral centers and randomized to undergo UCS or WCS placement. Stent patency and recurrence of obstructive symptoms were assessed at 8 weeks and 16 weeks after stent placement.

Results: At the 8-week follow-up, both stent patency rates (72.5% vs. 62.7%) and re-intervention rates (19.6% vs. 19.6%) were comparable between the WCS and the UCS groups. Both stent stenosis (2.4% vs. 8.1%) and migration rates (9.5% vs. 5.4%) were comparable between WCS and UCS groups. At the 16-week follow-up, however, the WCS group had a significantly higher stent patency rate than the UCS group (68.6% vs. 41.2%). Re-intervention rates in the WCS and UCS groups were 23.5% and 39.2%, respectively. Compared with the UCS group, the WCS group had a significantly lower stent restenosis rate (7.1% vs. 37.8%) and a comparable migration rate (9.5% vs. 5.4%). Overall stent patency was significantly longer in the WCS group than in the UCS group. No stent-associated significant adverse events occurred in either the WCS or UCS groups. In the multivariate analysis, WCS placement and chemotherapy were identified as independent predictors of 16-week stent patency.

Conclusions: WCS group showed comparable migration rate and significantly more durable long-term stent patency compared with UCS group for the palliation of GOO in patients with inoperable gastric cancer.

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References

Jeurnink S, Steyerberg E, van Hooft J, van Eijck C, Schwartz M, Vleggaar F . Surgical gastrojejunostomy or endoscopic stent placement for the palliation of malignant gastric outlet obstruction (SUSTENT study): a multicenter randomized trial. Gastrointest Endosc. 2009; 71(3):490-9. DOI: 10.1016/j.gie.2009.09.042. View

Maetani I, Ukita T, Nambu T, Shigoka H, Omuta S, Endo T . Comparison of ultraflex and niti-s stents for palliation of unresectable malignant gastroduodenal obstruction. Dig Endosc. 2010; 22(2):83-9. DOI: 10.1111/j.1443-1661.2010.00942.x. View

Abraha I, Montedori A . Modified intention to treat reporting in randomised controlled trials: systematic review. BMJ. 2010; 340:c2697. PMC: 2885592. DOI: 10.1136/bmj.c2697. View

Kim C, Choi I, Lee J, Cho S, Park S, Lee J . Covered versus uncovered self-expandable metallic stents for palliation of malignant pyloric obstruction in gastric cancer patients: a randomized, prospective study. Gastrointest Endosc. 2010; 72(1):25-32. DOI: 10.1016/j.gie.2010.01.039. View

Kim Y, Choi C, Kang D, Kim H, Chung C, Kim D . A double-layered (comvi) self-expandable metal stent for malignant gastroduodenal obstruction: a prospective multicenter study. Dig Dis Sci. 2011; 56(7):2030-6. DOI: 10.1007/s10620-011-1566-5. View

Brimhall B, Adler D . Enteral stents for malignant gastric outlet obstruction. Gastrointest Endosc Clin N Am. 2011; 21(3):389-403, vii-viii. DOI: 10.1016/j.giec.2011.04.002. View

van Hooft J, van Montfoort M, Jeurnink S, Bruno M, Dijkgraaf M, Siersema P . Safety and efficacy of a new non-foreshortening nitinol stent in malignant gastric outlet obstruction (DUONITI study): a prospective, multicenter study. Endoscopy. 2011; 43(8):671-5. DOI: 10.1055/s-0030-1256383. View

Isayama H, Sasaki T, Nakai Y, Togawa O, Kogure H, Sasahira N . Management of malignant gastric outlet obstruction with a modified triple-layer covered metal stent. Gastrointest Endosc. 2012; 75(4):757-63. DOI: 10.1016/j.gie.2011.11.035. View

Kim C, Park S, Choi I, Lee J, Cho S, Park Y . Effect of chemotherapy on the outcome of self-expandable metallic stents in gastric cancer patients with malignant outlet obstruction. Endoscopy. 2012; 44(9):807-12. DOI: 10.1055/s-0032-1309893. View

10.

Sasaki T, Isayama H, Maetani I, Nakai Y, Kogure H, Kawakubo K . Japanese multicenter estimation of WallFlex duodenal stent for unresectable malignant gastric outlet obstruction. Dig Endosc. 2013; 25(1):1-6. DOI: 10.1111/j.1443-1661.2012.01319.x. View

11.

van den Berg M, Haijtink S, Fockens P, Vleggaar F, Dijkgraaf M, Siersema P . First data on the Evolution duodenal stent for palliation of malignant gastric outlet obstruction (DUOLUTION study): a prospective multicenter study. Endoscopy. 2013; 45(3):174-81. DOI: 10.1055/s-0032-1326077. View

12.

van den Berg M, Walter D, Vleggaar F, Siersema P, Fockens P, van Hooft J . High proximal migration rate of a partially covered "big cup" duodenal stent in patients with malignant gastric outlet obstruction. Endoscopy. 2013; 46(2):158-61. DOI: 10.1055/s-0033-1359023. View

13.

Maetani I, Mizumoto Y, Shigoka H, Omuta S, Saito M, Tokuhisa J . Placement of a triple-layered covered versus uncovered metallic stent for palliation of malignant gastric outlet obstruction: a multicenter randomized trial. Dig Endosc. 2013; 26(2):192-9. DOI: 10.1111/den.12117. View

14.

Lim S, Kim J, Lee K, Shin S, Kim C, Kim K . Conformable covered versus uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction: a randomized prospective study. Dig Liver Dis. 2014; 46(7):603-8. DOI: 10.1016/j.dld.2014.02.024. View

15.

Pan Y, Pan J, Guo L, Qiu M, Zhang J . Covered versus uncovered self-expandable metallic stents for palliation of malignant gastric outlet obstruction: a systematic review and meta-analysis. BMC Gastroenterol. 2014; 14:170. PMC: 4190394. DOI: 10.1186/1471-230X-14-170. View

16.

Sato T, Hara K, Mizuno N, Hijioka S, Imaoka H, Niwa Y . Gastroduodenal stenting with Niti-S stent: long-term benefits and additional stent intervention. Dig Endosc. 2014; 27(1):121-9. DOI: 10.1111/den.12300. View

17.

Abraha I, Cherubini A, Cozzolino F, De Florio R, Luchetta M, Rimland J . Deviation from intention to treat analysis in randomised trials and treatment effect estimates: meta-epidemiological study. BMJ. 2015; 350:h2445. PMC: 4445790. DOI: 10.1136/bmj.h2445. View

18.

Cho Y, Kim S, Hur W, Nam K, Chang J, Park J . Clinical outcomes of self-expandable metal stent and prognostic factors for stent patency in gastric outlet obstruction caused by gastric cancer. Dig Dis Sci. 2009; 55(3):668-74. DOI: 10.1007/s10620-009-0787-3. View

19.

Jung G, Song H, Kang S, Huh J, Park S, Koo J . Malignant gastroduodenal obstructions: treatment by means of a covered expandable metallic stent-initial experience. Radiology. 2000; 216(3):758-63. DOI: 10.1148/radiology.216.3.r00au05758. View

20.

Yim H, Jacobson B, Saltzman J, Johannes R, Bounds B, Lee J . Clinical outcome of the use of enteral stents for palliation of patients with malignant upper GI obstruction. Gastrointest Endosc. 2001; 53(3):329-32. DOI: 10.1016/s0016-5107(01)70407-5. View