NCT03215108

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
256

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

July 12, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 12, 2017

Status Verified

May 1, 2017

Enrollment Period

1.9 years

First QC Date

May 26, 2017

Last Update Submit

July 9, 2017

Conditions

Malignant Biliary Obstruction

Outcome Measures

Primary Outcomes (2)

  • Pancreatitis, Cholecystitis - Occurrence rate : %

    The incidence of pancreatitis is calculated using percentiles.

    3 months after procedure

  • Pancreatitis, Cholecystitis - Severity

    The extent of each side effect is described in the Adverse Reactions Report according to the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE) Rating System version 4.0.

    3 months after procedure

Secondary Outcomes (2)

  • Stent-related adverse events

    6 months after procedure

  • Stent patency

    6 months after procedure

Study Arms (2)

Flower-CSEMS

EXPERIMENTAL

EGIS Flower Biliary Full Covered Stent(Flower-CSEMS), Bile Duct Stent, (S \& G Biotech Co., Ltd.) will be inserted by using Endoscopic Retrograde CholangioPancreatography(ERCP).

Device: Endoscopic Retrograde CholangioPancreatography(ERCP)

Conventional-CSEMS

EXPERIMENTAL

Conventional-CSEMS (S \& G Biotech Co., Ltd.) will be inserted by using Endoscopic Retrograde CholangioPancreatography(ERCP).

Device: Endoscopic Retrograde CholangioPancreatography(ERCP)

Interventions

Endoscopic Retrograde CholangioPancreatography(ERCP)DEVICE

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).

Conventional-CSEMSFlower-CSEMS

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults from 19 to 85 years of age who have voluntarily agreed to the clinical trial and signed a written agreement
  • Patients with malignant extrahepatic bile duct obstruction without surgery

You may not qualify if:

  • Patients who had already undergone surgical biliary drainage
  • Patients who previously underwent percutaneous spinal cholecystectomy (PTGBD)
  • Patients who underwent conventional metal-on-metal self-expandable metal stents (C-CSEMS)
  • Patients who underwent biliary plastic stent implantation for more than 15 days
  • Patients with malignant stricture of the intrahepatic bile duct and patients with stenosis within 2 cm of the liver
  • Patients whose expected life expectancy is less than 3 months
  • Pregnant patient
  • Patients who can not undergo endoscopic procedures based on the judgment of the researcher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SamsungMC

Seoul, KS013, South Korea

RECRUITING

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

CholangiographyRadiography, AbdominalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Digestive SystemEndoscopy, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Jong Kyun Lee, MD PhD

    Samsung Medical Center

    STUDY CHAIR

Central Study Contacts

Jong Kyun Lee, MD PhD

CONTACT

+82-2-3410-3409jongk.lee@samsung.com

Jae Keun Park, MD

CONTACT

+82-2-3410-3409jaekeunjaekeun.park@samsung.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Flower-CSEMS vs. Conventional-CSEMS
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2017

First Posted

July 12, 2017

Study Start

July 12, 2017

Primary Completion

June 1, 2019

Study Completion

December 31, 2019

Last Updated

July 12, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)