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Comparison Between Novel Flower-type Covered Stent and Conventional Covered Stent

NCT03215108 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2017-07-12

No results posted yet for this study

Summary

The aim of this animal study is determining the technical feasibility of the novel flower-type covered self-expandable metal stent (F-CSEMS) and investigating whether the novel flower-type covered self-expandable metal stent (F-CSEMS) could prevent cholecystitis and pancreatitis, comparing with conventional covered self-expandable metal stent (C-CSEMS).

Conditions

  • Malignant Biliary Obstruction

Interventions

DEVICE

Endoscopic Retrograde CholangioPancreatography(ERCP)

This study is prospective randomized multicenter study by using Endoscopic Retrograde CholangioPancreatography(ERCP). Comparison between Novel flower-type covered stent and Conventional covered stent in malignant extrahepatic biliary obstruction will be conducted after stent insertion by using Endoscopic Retrograde CholangioPancreatography(ERCP).

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Jong Kyun Lee, MD PhD · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-12
Primary Completion
2019-06-01
Completion
2019-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03215108 on ClinicalTrials.gov