Covered Metallic Stents With an Anti-Migration Design vs. Uncovered Stents for the Palliation of Malignant Gastric Outlet Obstruction: A Multicenter, Randomized Trial

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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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Most cited references 30

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Endoscopic palliation of malignant gastric outlet obstruction using self-expanding metal stents: experience in 36 patients.

Todd Baron, Sharon G. Adler (2001)

Malignant gastric outlet obstruction is seen in the setting of a variety of cancers, most commonly pancreatic. Self-expanding metal stents can be used to palliate these patients and restore the ability to eat. We reviewed the Mayo Clinic experience in the endoscopic treatment of malignant gastric outlet obstruction. Thirty-six patients (26 male, 10 female) were treated between October, 1998 and January, 2001. Data were collected from charts, endoscopy reports, x-rays, and telephone calls. A scoring system was created to grade the ability to eat. All procedures were successful. Thirty-one of 36 patients (86%) required one stent at initial endoscopy, and 5/36 patients (14%) required two or more stents. Pretreatment, 19/36 patients (53%) were nil per os, 15/36 (42%) drank liquids, and 2/36 were able to eat soft solids. After stent placement, only 1/36 (3%) was still nil per os, 13/36 (36%) drank liquids, 13/36 (36%) ate soft solids, and 9/36 (25%) ate a full diet. The improvement in ability to eat using the scoring system was statistically significant (p < 0.0001). Nine of 36 patients (25%) required reintervention for recurrent symptoms. Sixteen of 36 patients (44%) had concomitant or subsequent development of biliary obstruction, of which 15 were successfully decompressed. Self-expanding metal stents are a safe and efficacious method for palliating malignant gastric outlet obstruction. The majority of patients do not require reintervention, and those that do can usually be managed nonoperatively.

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Modified intention to treat reporting in randomised controlled trials: systematic review

Iosief Abraha, ALESSANDRO MONTEDORI (2010)

Objectives To determine the incidence and characteristics of randomised controlled trials that report using the modified intention to treat approach, and how the approach is described. Design Systematic review. Data sources PubMed, Embase, Cochrane central register of controlled trials, ISI Web of Knowledge, Ovid, HighWire Press, Science-Direct, Ingenta, Medscape, BioMed Central, Springer, and Wiley, from inception to December 2006. Main outcome measures Incidence of trials in which use of modified intention to treat was reported, and how the approach was described (classified according to the type and number of deviations from the intention to treat approach). Results 475 randomised controlled trials reported use of a modified intention to treat analysis. Of these, 76 (16%) were published in five highly cited general medical journals. The incidence of all trials that reported use of modified intention to treat published in journals indexed in Medline increased from 0.006% in 1982-6 to 0.5% in 2002-6 (P<0.001 for linear trend). When the description of the modified intention to treat was examined in each trial, 192 (40%) reported one type of deviation from the intention to treat approach, 261 (55%) reported two or more types, and 22 (5%) did not describe any type. In 266 (56%) of the trials the deviation was related to the treatment received, in 196 (41%) to a post baseline assessment, in 118 (25%) to a baseline assessment, in 108 (23%) to a target condition, and in 23 (5%) to follow-up. Post-randomisation exclusions occurred in 380 (80%) trials. The results reported by 270 of the 352 (77%) superiority trials favoured the drug under investigation. All of the 123 trials using equivalence or non-inferiority methods to investigate interventions reported results that favoured their assumptions. Conclusions Randomised controlled trials that report using a modified intention to treat are increasingly being published in the medical literature. The descriptions of such an approach were ambiguous, and may cover any type of descriptions for exclusion, such as missing data and deviation from protocol. Explicit statements about post-randomisation exclusions should replace the ambiguous terminology of modified intention to treat.

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Self-expanding metal stents for gastroduodenal malignancies: systematic review of their clinical effectiveness.

A Dormann, S Meisner, N Verin … (2004)

The current standard approach to the management of malignant gastric outlet obstruction mainly involves bypass surgery, which is associated with significant rates of mortality and morbidity. Recently, metal stents have emerged as a new therapeutic option. The aim of the present study was to review the currently published evidence on the effectiveness and safety of this form of endoscopic treatment. A systematic review of the published data was carried out by searching medline, embase, and abstracts from the major gastroenterological conferences from January 1992 to September 2003. A total of 136 relevant publications were identified (case series, single case reports, letters and editorials, or reviews). The systematic review included 32 case series from a total of 46 publications identified as reporting primary clinical data. Abstracts and single case reports were not taken into account. Analysis of these 32 case series included data on technical success (successful stent placement and deployment), clinical success (relief of symptoms such as nausea and vomiting, and/or improvement of food intake), and complications. Pooled results were calculated from the 32 studies (10 of which were prospective). Stent insertion was attempted in 606 patients with malignant symptomatic gastroduodenal obstruction; 94 % of the patients were unable to take food orally or were mainly ingesting liquids. Stent placement and deployment were successful in 589 of the patients (97 %). Clinical success was achieved in 526 patients in the group in which technical success was reported (89 %; 87 % of the entire group undergoing stenting). Disease-related factors accounted for the majority of clinical failures. Oral intake became possible in all of the patients in whom a successful procedure was carried out, with 87 % taking soft solids or a full diet, with final resolution of symptoms occurring after a mean of 4 days. There was no procedure-related mortality. Severe complications (bleeding and perforation) were observed in seven patients (1.2 %). Stent migration was reported in 31 patients (5 %). Stent obstruction occurred in 104 cases (18 %), mainly due to tumor infiltration. The mean survival period was 12.1 weeks. Published evidence from case series suggests that gastroduodenal stenting offers good palliation and is a safe and effective treatment option in patients with a short remaining lifespan. However, patient selection for this intervention continues to be an issue requiring thorough consideration, and studies comparing the method with surgery are needed.

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Author and article information

Journal

Journal ID (nlm-ta): Am J Gastroenterol

Journal ID (iso-abbrev): Am. J. Gastroenterol

Title: The American Journal of Gastroenterology

Publisher: Nature Publishing Group

ISSN (Print): 0002-9270

ISSN (Electronic): 1572-0241

Publication date (Print): October 2015

Publication date (Electronic): 15 September 2015

Volume: 110

Issue: 10

Pages: 1440-1449

Affiliations

[1 ]Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine , Seoul, Republic of Korea

[2 ]Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center , Seoul, Republic of Korea

[3 ]Department of Internal Medicine, Seoul National University Bundang Hospital , Seongnam, Republic of Korea

[4 ]Division of Gastroenterology, Department of Internal Medicine, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences , Seoul, Republic of Korea

[5 ]Department of Internal Medicine, Yonsei University College of Medicine , Seoul, Republic of Korea

[6 ]Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine , Seoul, Republic of Korea

Author notes

[* ]Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine , 101, Daehak-ro, Jongno-gu, Seoul 110-744, Republic of Korea. E-mail: gidoctor@ 123456snuh.org

[7]

The first two authors contributed equally to this work

Article

Publisher Item ID: ajg2015286

DOI: 10.1038/ajg.2015.286

PMC ID: 4697131

PubMed ID: 26372507

SO-VID: 121ab985-e0cb-4b0c-a17e-419d388eb9b3

License:

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. The images or other third party material in this article are included in the article's Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/4.0/

History

Date received : 09 April 2015

Date revision received : 01 June 2015

Date accepted : 03 June 2015

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Covered Metallic Stents With an Anti-Migration Design vs. Uncovered Stents for the Palliation of Malignant Gastric Outlet Obstruction: A Multicenter, Randomized Trial

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Abstract

OBJECTIVES:

METHODS:

RESULTS:

CONCLUSIONS:

Related collections

Karger: Gastroenterology

Most cited references 30

Endoscopic palliation of malignant gastric outlet obstruction using self-expanding metal stents: experience in 36 patients.

Modified intention to treat reporting in randomised controlled trials: systematic review

Self-expanding metal stents for gastroduodenal malignancies: systematic review of their clinical effectiveness.

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