Comparison trial of uncovered D-type stent and covered ComVi stent in patients with unresectable malignant gastric outlet obstruction

Comparison trial of uncovered D-type stent and covered ComVi stent in patients with unresectable malignant gastric outlet obstruction. (Randomized controlled single blind multi-center trial)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000853

Enrollment

114

Registered

2013-09-26

Start date

2009-03-13

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device, Procedure/Surgery : Eligible patients were assigned to undergo covered or uncovered SEMS placement according to a computer-generated randomization number. All procedures were performed

Olympus, Tokyo, Japan) reached the obstruction, a water-soluble contrast medium was injected through a 5-F biliary catheter to measure the length of the obstruction. The length of the SEMS was determi

Boston Scientific, Natick, MA, USA) was inserted through the working channel of the endoscope and passed through the obstruction. The delivery system for the SEMS was advanced through the obstruction

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. patients with the obstructive symptoms due to unresectable malignant gastric outlet obstruction 2. a Karnofsky performance score of more than 30

Exclusion criteria

Exclusion criteria: 1) a history of previous SEMS placement 2) gastrointestinal tract obstruction other than at the gastric outlet 3) severe comorbidities precluding the endoscopic procedure (such as cardiopulmonary disease, sepsis, or a bleeding disorder) 4) a life expectancy of less than 1 month 5) a history of gastric surgery.

Design outcomes

Primary

Measure	Time frame
the rate of reintervention	—

Secondary

Measure	Time frame
the rates of different types of stent malfunction (stent migration or stent occlusion due to tumor ingrowth/overgrowth);the stent patency time from the time of placement to the time of restenosis due to stent malfunction, or death;the relationships between chemotherapy and stent malfunction;overall survival time	—

Countries

Korea, Republic of

Contacts

Public ContactSun Gyo Lim

Ajou University Hospital

Outcome results