NCT01789502

Brief Summary

This study is a prospective, randomized study to compare of outcome of fully covered metal stents with that of plastic stents for preoperative biliary drainage in distal common bile duct cancer, pancreas head cancer or ampullary cancer with respect to the incidence of stent-related adverse events, the re-intervention rate, the effectiveness of biliary drainage, surgical outcomes and hospital stays.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Study Start

First participant enrolled

January 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

August 4, 2015

Status Verified

August 1, 2015

Enrollment Period

2.9 years

First QC Date

February 5, 2013

Last Update Submit

August 2, 2015

Conditions

Periampullary CancerComplications of Surgical Procedures or Medical CareDisorder of Bile Duct Stent

Keywords

self-expandable metal stent; plastic stent

Outcome Measures

Primary Outcomes (1)

  • Adverse events related to the stent insertion

    Primary outcome parameter is adverse events related to the stent insertion includes post-ERCP pancreatitis, cholecystitis, cholangitis, bowel perforation or hemorrhage.

    up to 4weeks

Secondary Outcomes (3)

  • Re-intervention rate

    up to 4weeks

  • Hospital stay

    up to 1months

  • Surgical outcomes

    up to 1months

Study Arms (2)

Plastic stents

ACTIVE COMPARATOR

Plastic stents are inserted by ERCP

Device: Plastic stents

Fully covered metal stents

EXPERIMENTAL

Fully covered metal stents are inserted by ERCP

Device: Fully covered metal stents

Interventions

Fully covered metal stentsDEVICE

Fully covered metal stents were inserted by ERCP

Also known as: BONASTENT, Standard Sci Tech, Seoul, Korea
Fully covered metal stents
Plastic stentsDEVICE

Plastic stents were inserted by ERCP

Also known as: Biliary stents, Cook Endoscopy, Winston-Salem, NC
Plastic stents

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 20 years old of age
  • Obstructive jaundice due to common bile duct cancer and pancreas head cancer, or ampullary cancer
  • No evidence of distant metastases or locally advanced tumor

You may not qualify if:

  • Unresectable stage of cancer
  • Preoperative gastric operation that preclude ERCP (total gastrectomy and subtotal gastrectomy with B-II anastomosis)
  • Severe gastric outlet obstruction or duodenal obstruction
  • Severe comorbidity (Karnofsky\<50%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Daejun Eulji University Hospital

Daejun, Daejun, 302-799, South Korea

Location

Inje University Ilsan Paik Hospital

Koyang, Gyeonggi-do, 411-706, South Korea

Location

Asan Medical Center

Seoul, Seoul, 138-736, South Korea

Location

Related Publications (1)

  • Song TJ, Lee JH, Lee SS, Jang JW, Kim JW, Ok TJ, Oh DW, Park DH, Seo DW, Lee SK, Kim MH, Kim SC, Kim CN, Yun SC. Metal versus plastic stents for drainage of malignant biliary obstruction before primary surgical resection. Gastrointest Endosc. 2016 Nov;84(5):814-821. doi: 10.1016/j.gie.2016.04.018. Epub 2016 Apr 22.

    PMID: 27109456DERIVED

Study Officials

  • Tae Jun Song, MD, PhD

    Department of Internal Medicine, Inje University Ilsan Paik Hospital, Koyang, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 12, 2013

Study Start

January 1, 2012

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

August 4, 2015

Record last verified: 2015-08

Locations

KR(3)