Gastric Outlet Obstructions Tailored Covered Stents for GOO

A Multicenter Randomized Controlled Trial of Malignant Gastric Outlet Obstruction: Tailored Partially Covered Stents (Placed Fluoroscopically) Versus Standard Uncovered Stents (Placed Endoscopically)

gastric outlet obstruction tailored versus standard stents for malignant gastric outlet obstruction treatments

Study Overview

• Status: Completed
• Conditions: Gastric Outlet Obstruction
• Intervention / Treatment: Device: Tailored stents MTN-WE-20/100-A; Device: Standard stents MTN-CG-s-20/100

Detailed Description

To determine the shape of the GOOs, stomach opacifications were performed using contrast media before stenting. In the GOO tailored group (33 cases), the distal stents were semi-spherical with a length of 20 mm and a diameter of 28 mm. The middle stent segments had diameters of 20 mm. The proximal ends of large cup-shaped stents had 53.3 ± 5.5 mm diameters and were 15 or 20 mm long, whereas the large funnel-shaped stents had 33.6 ± 3.6 mm diameters and were 25 or 30 mm long. The control group (32 cases) received standard uncovered stents (semi-spherical, with diameters of 28 mm and 20 mm long).Our hypothesis was that unresectable GOO tailored covered stents are superior to the standard uncovered ones in terms of stent re-obstruction and stent migration. In the current study the efficacy and safety of GOO tailored covered stents for the treatment of non-resectable GOOs caused by distal gastric cancer was compared with standard uncovered stents.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hangzhou, China
    • The First People's Hospital of Yuhang District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

GOO defined by symptoms resulting in decreased oral intake (nausea, vomiting and inability to eat),the obstruction was caused by primary distal stomach cancer and the site of stenosis was between the gastric body and duodenum bulb

Exclusion Criteria:

the presence of only mild symptoms in patients who could tolerate a liquid diet, clinical evidence of perforation or peritonitis, evidence of multiple small-bowel obstructions because of peritoneal seeding as well as diabetes or other diseases that affect gastric motility and use of promotility agents.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tailored stents MTN-WE-20/100-A; The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.	Device: Tailored stents MTN-WE-20/100-A; cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs.
Experimental: Standard stents MTN-CG-s-20/100; Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm	Device: Standard stents MTN-CG-s-20/100; The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficiency of Stents	number of participants considered having efficacious outcome. Efficacy is defined by Ingrowth + overgrowth in this study	up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	bleeding, abdominal pain	up to 5 years

Collaborators and Investigators

• Sponsor: The First People's Hospital of Yuhang District
• Investigators: Study Director: Ding Shi, The First People's Hospital of Yuhang District

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: November 17, 2014
• First Submitted That Met QC Criteria: November 20, 2014
• First Posted (Estimate): November 24, 2014

Study Record Updates

• Last Update Posted (Estimate): February 12, 2015
• Last Update Submitted That Met QC Criteria: February 10, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pyloric Stenosis; Gastric Outlet Obstruction
• Other Study ID Numbers: 2011ZHE008