A double-layered (comvi) self-expandable metal stent for malignant gastroduodenal obstruction: a prospective multicenter study.
BACKGROUND
A self-expandable metal stent (SEMS) has emerged as an effective palliative treatment for malignant gastroduodenal obstruction resulting from gastric or periampullary malignancy. Despite the stent's effectiveness, tumor ingrowth and stent migration remain complications requiring reintervention. The purpose of this study was to evaluate the efficacy and safety of a double-layered SEMS (Comvi).


METHODS
We performed a prospective multicenter study in two university hospitals and two referral hospitals. In fifty consecutive patients with malignant gastroduodenal obstructions, placement of double-layered SEMS, comprising an outer uncovered stent and an inner covered stent that overlap each other, was performed. Palliation, efficacy, and incidence of complications were evaluated.


RESULTS
Technical and clinical success was achieved in 100 and 88% of patients, respectively. There were no procedure-related complications. Five patients experienced stent migration (10%). For four of five patients' stent migration occurred within two weeks of stent placement. Stent collapse occurred in five patients after one month. Reintervention for stent migration, collapse, or tumor overgrowth was required for 14 (28%) patients.


CONCLUSIONS
Endoscopic placement of a double-layered stent is a safe and effective modality for the palliation of malignant gastroduodenal obstruction. However, considering reintervention, this stent does not seem to add any clear advantage compared with preexisting uncovered stents. Migration, especially within the first two weeks, and stent collapse are still unresolved problems. The device should be fixed or the design modified to reduce these problems.
Department of Internal Medicine, Pusan National University School of Medicine and Medical Research Institute, Beomeo-ri, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do, 626-770, South Korea.
Yong Wuk
YW
Kim
Cheol Woong
CW
Choi
Dae Hwan
DH
Kang
Hyung Wook
HW
Kim
Chung Uk
CU
Chung
Dong Uk
DU
Kim
Su Bum
SB
Park
Kee Tae
KT
Park
Suk
S
Kim
Eul Jo
EJ
Jeung
Yong Mok
YM
Bae
D000368:Aged; D000369:Aged, 80 and over; D004067:Digestive System Neoplasms / Q000150:complications*; D004380:Duodenal Obstruction / Q000209:etiology / Q000601:surgery*; D004868:Equipment Failure; D005260:Female; D005548:Foreign-Body Migration / Q000517:prevention & control; D017219:Gastric Outlet Obstruction / Q000209:etiology / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011707:Pyloric Stenosis / Q000209:etiology / Q000601:surgery; D015607:Stents; D016896:Treatment Outcome
N Engl J Med. 2001 May 31;344(22):1681-7
11386268
J Gastroenterol Hepatol. 2008 Jul;23(7 Pt 1):1056-62
18086117
Endoscopy. 2004 Jun;36(6):543-50
15202052
AJR Am J Roentgenol. 2002 Apr;178(4):847-52
11906861
Gastrointest Endosc. 2007 May;65(6):782-7
17324410
Gastrointest Endosc. 2009 Apr;69(4):806-12
19136108
Am J Gastroenterol. 2002 Jan;97(1):72-8
11808972
J Clin Gastroenterol. 2005 Feb;39(2):124-8
15681907
Gastrointest Endosc. 1998 Mar;47(3):267-70
9540881
Gastrointest Endosc. 2004 Dec;60(6):1010-7
15605026
Gastrointest Endosc. 2005 Mar;61(3):421-6
15758914
Radiology. 2001 Jun;219(3):679-83
11376254
Surgery. 2004 Feb;135(2):171-7
14739852
AJR Am J Roentgenol. 2007 Jun;188(6):1495-9
17515367
Gastrointest Endosc. 2007 Aug;66(2):361-3
17643713
Gastrointest Endosc. 1992 Jan-Feb;38(1):7-11
1377148
Endoscopy. 1998 Mar;30(3):266-72
9615875
Gastrointest Endosc. 2009 May;69(6):1059-66
19152912
Endoscopy. 2003 Jan;35(1):79-85
12510232
Surg Endosc. 2006 Jul;20(7):1083-7
16703436
Dig Dis Sci. 2008 Apr;53(4):938-45
17805967
Scand J Gastroenterol. 2004 Oct;39(10):1010-4
15513343
Surg Endosc. 1991;5(4):185-8
1805395
J Vasc Interv Radiol. 2000 May;11(5):645-54
10834499
Gastrointest Endosc. 2007 Dec;66(6):1206-10
18028923
Gastrointest Endosc. 2006 Jun;63(7):920-6
16733104
J Gastroenterol. 2005 Oct;40(10):932-7
16261429
Gastrointest Endosc. 2007 Aug;66(2):355-60
17643712
Endoscopy. 2001 Oct;33(10):843-8
11571679
Radiology. 2000 Nov;217(2):551-7
11058659
Anticancer Res. 2004 Jan-Feb;24(1):269-71
15015607