Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.

PHASE3CompletedINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

August 1, 2017

Primary Completion Date

November 1, 2020

Study Completion Date

November 1, 2020

Conditions
Unresectable Malignant Gastric Outlet Obstruction
Interventions
OTHER

Partially covered pyloro-duodenal stent

The PCDS (Niti-S COMVITM - Flare, Taewoong, Gyeonggi-do, South Korea) used in the current study is a partially covered metallic pyloro-duodenal stent. It consists of two portions (Figure 1). The stent is 2cm in diameter and the proximal 2cm of the stent is uncovered and flared. This is designed to provide anchorage of the stent to surrounding tissue and reduce the risk of migration. The remaining of the stent is covered, where a polytetrafluoroethylene (PTFE) membrane is held between two nitinol mesh to prevent the risk of tumour ingrowth into the stent. The stents come in lengths of 6, 8, 10 \& 12cm.

OTHER

Uncovered pyloro-duodenal stents

The UCDS (Niti-S pyloric-duodenal D stent, Taewoong, Gyeonggi-do, South Korea) used in the current study is an uncovered stent made of nitinol wire, with a diameter of 20mm and length of 6,8,10,12cm. This stent is an unfixed-cell braided stent with low axial force, high flexibility and good conformability.

Trial Locations (1)

Unknown

Chinese University of Hong Kong, Hong Kong

All Listed Sponsors
collaborator

National University Hospital, Singapore

OTHER

collaborator

Singapore General Hospital

OTHER

collaborator

Changi General Hospital

OTHER

collaborator

Baldota Institute of Digestive Diseases, Mumbai, India.

UNKNOWN

lead

Chinese University of Hong Kong

OTHER

NCT03223831 - Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial. | Biotech Hunter | Biotech Hunter