NCT00493675

Brief Summary

Endoscopic sphincterotomy and temporary stenting is a routine treatment for post cholecystectomy cystic duct leakage. The draw back is that the plastic stent need to be removed later in a second intervention. Our studies with animal models have demonstrated that biodegradable biliary stent is at least as good as conventional plastic stent to heal that kind of leakage. In this pilot study the biodegradable biliary stent is inserted endoscopically to patients with confirmed cystic duct leakage to demonstrate the efficacy in human setting.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 28, 2010

Status Verified

February 1, 2009

First QC Date

June 27, 2007

Last Update Submit

June 24, 2010

Conditions

Cyst

Keywords

Cystic duct leakage

Outcome Measures

Primary Outcomes (1)

  • Clinical healing of bile leakage

    1 month

Secondary Outcomes (1)

  • Laboratory tests for liver function, ultra sound for bile collections and bile duct diameter and abdominal plain X-ray for stent degradation

    6 months

Interventions

endoscopic bile duct stentingPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Patients with confirmed post cholecystectomy cystic duct leakage requiring endoscopic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, FIN-33521, Finland

Location

MeSH Terms

Conditions

Cysts

Condition Hierarchy (Ancestors)

NeoplasmsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Juhani A Sand, MD, PhD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 27, 2007

First Posted

June 28, 2007

Study Start

June 1, 2006

Study Completion

June 1, 2010

Last Updated

June 28, 2010

Record last verified: 2009-02

Locations

FI(1)