NCT01457092

Brief Summary

The purpose of the study was to analyze the resolution rate of benign biliary strictures due to chronic pancreatitis after temporary insertion of unflared-ends and flared-ends fully covered self-expandable metal stents.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

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, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
Last Updated

November 9, 2015

Status Verified

November 1, 2015

Enrollment Period

2.7 years

First QC Date

October 19, 2011

Last Update Submit

November 6, 2015

Conditions

Benign Biliary StricturesChronic Pancreatitis

Keywords

benign biliary strictureschronic pancreatitis

Outcome Measures

Primary Outcomes (1)

  • Stricture dilatation

    6 months

Study Arms (1)

FC Nitinol SEMS

EXPERIMENTAL

FC Nitinol SEMS

Device: FC Nitinol SEMS (Niti-S, TaeWoong Medical Co., Korea)

Interventions

FC Nitinol SEMS (Niti-S, TaeWoong Medical Co., Korea)DEVICE

Placement of self-expandable metal stents

FC Nitinol SEMS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥18 years,
  • symptomatic (persistent cholestasis, jaundice, cholangitis) common bile duct strictures secondary to CP, that persist 3 months or more after placement of a single 10 French plastic stent and
  • patient unfit for surgery (portal cavernomatosis, comorbidities) or patient refusal of surgery.

You may not qualify if:

  • benign biliary strictures secondary to compression from a pancreatic pseudocyst;
  • patients with associated pancreatic neoplasia
  • ongoing alcohol abuse (ethanol \> 80 g/day).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 19, 2011

First Posted

October 21, 2011

Study Start

January 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

November 9, 2015

Record last verified: 2015-11