Covered Versus Uncovered Self-expandable Metallic Stents for Malignant Gastric Outlet Obstruction

PHASE3CompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Gastric Outlet Obstruction Due to Gastric Adenocarcinoma
Interventions
DEVICE

Covered stent (Bona stent pyloric/duodenal covered) insertion

self-expandable metallic stent placement was performed with a therapeutic endoscope (working channel ≥ 3.7 mm) using a through-the-scope method. All patients underwent procedures under conscious sedation with midazolam and pethidine. The length of the stricture was assessed either endoscopically or fluoroscopically; the length of the stent had to exceed that of the stricture by at least 3 cm. After the required stent length was determined, the stent was advanced through the endoscope over a guidewire until it passed across the distal end of the stricture. Then, the stent was deployed under continuous fluoroscopic control. For the Wave covered stent group, the stent was repositioned after deployment using the lasso under fluoroscopic guidance (if necessary), aligning the central portion of the stricture with the central portion of the stent which had reduced radial force and indentation. Stent positioning was confirmed endoscopically and fluoroscopically.

DEVICE

Uncovered stent (Bona stent, pyloric/duodenal) insertion

Self-expandable metallic stent placement was performed with a therapeutic endoscope (working channel ≥ 3.7 mm) using a through-the-scope method. All patients underwent procedures under conscious sedation with midazolam and pethidine. The length of the stricture was assessed either endoscopically or fluoroscopically; the length of the stent had to exceed that of the stricture by at least 3 cm. After the required stent length was determined, the stent was advanced through the endoscope over a guidewire until it passed across the distal end of the stricture. Then, the stent was deployed under continuous fluoroscopic control. For the Wave covered stent group, the stent was repositioned after deployment using the lasso under fluoroscopic guidance (if necessary), aligning the central portion of the stricture with the central portion of the stent which had reduced radial force and indentation. Stent positioning was confirmed endoscopically and fluoroscopically.

Trial Locations (1)

Unknown

Samsung Medical Center, Seoul

All Listed Sponsors
lead

Samsung Medical Center

OTHER

NCT01646476 - Covered Versus Uncovered Self-expandable Metallic Stents for Malignant Gastric Outlet Obstruction | Biotech Hunter | Biotech Hunter