NCT01929538

Brief Summary

Benign biliary strictures caused by chronic pancreatitis can be endoscopically treated with covered self-expandable metal stents (cSEMS).The purpose of the prospective randomized study is to define the optimal duration of stenting and the diameter of the 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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 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

Study Start

First participant enrolled

August 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 28, 2013

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

10.3 years

First QC Date

August 14, 2013

Last Update Submit

August 15, 2022

Conditions

Biliary StrictureChronic Pancreatitis

Keywords

Chronic pancreatitisBiliary strictureEndoscopic treatmentcSEMS

Outcome Measures

Primary Outcomes (1)

  • Stricture resolution of the common bile duct in the two study groups

    Stricture resolution during stenting and follow-up period, defined by normal liver function tests and abdominal ultrasonography

    2,5 years

Secondary Outcomes (2)

  • Stent removability

    1 year

  • Occurrence of complications related to stents and procedure

    2,5 years

Other Outcomes (1)

  • Biliary stricture Chronic pancreatitis

    2,5 years

Study Arms (2)

Covered biliary metal stent, 12 mm

ACTIVE COMPARATOR

ERCP and placement of a covered self-expanding biliary metal stent, 12mm in diameter

Procedure: ERCPDevice: covered self-expanding biliary metal stent, 12mm in diameter

covered Biliary metal stent, 10 mm

ACTIVE COMPARATOR

ERCP and placement of a covered self-expanding biliary metal stent, 10 mm in diameter

Procedure: ERCPDevice: covered self-expanding biliary metal stent, 10mm in diameter

Interventions

ERCPPROCEDURE

endoscopic retrograde cholangiopancreatography

Covered biliary metal stent, 12 mmcovered Biliary metal stent, 10 mm
covered self-expanding biliary metal stent, 12mm in diameterDEVICE
Covered biliary metal stent, 12 mm
covered self-expanding biliary metal stent, 10mm in diameterDEVICE
covered Biliary metal stent, 10 mm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Benign biliary stricture caused by chronic pancreatitis

You may not qualify if:

  • Malignancy, cirrhosis, acute/chronic hepatitis or abnormal hepatic imaging. First attack of acute pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

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

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

  • Leena Kylänpää, MD, PhD

    Helsinki University Central Hospital

    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
MD

Study Record Dates

First Submitted

August 14, 2013

First Posted

August 28, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

August 17, 2022

Record last verified: 2022-08

Locations

FI(1)