NCT00501176

Brief Summary

Randomized study comparing the effect of plastic stents to that of expandable metal stents as pre-operative drainage of the bile ducts prior to Whipple operation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

December 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2007

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 29, 2022

Status Verified

June 1, 2022

Enrollment Period

7.9 years

First QC Date

July 11, 2007

Last Update Submit

June 22, 2022

Conditions

Pancreas Cancer

Keywords

PancreascancerSEMSPlasticstentWhippleJaundicie

Outcome Measures

Primary Outcomes (1)

  • Intra-operative measurement of the Culture from the bile.

    Intraoperativt

Secondary Outcomes (1)

  • Intraoperative measurements of inflammatory reaction in the liver, hepatoduodenal ligament and around the bile ducts with biopsies. Stent dysfunction and cholangitis after ERCP and pre-operative bile flow relief. Postoperative analysis.

    Perioperative

Study Arms (2)

plastic stent

ACTIVE COMPARATOR

Stent insertion

Procedure: Plastic and metalic stent inserion

metalic stent

ACTIVE COMPARATOR

Stent inserttion

Procedure: Plastic and metalic stent inserion

Interventions

Plastic and metalic stent inserionPROCEDURE

Patient randomizes to metal or plastic insertion prior to Whipple procedure

Also known as: Two types of Stent prior to Whipple procedure
metalic stentplastic stent

Eligibility Criteria

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

You may not qualify if:

  • Define as failed ERCP, patients who have previously undergone bile flow drainage or radical surgery is not possible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinksa University Hospital

Stockholm, 14186, Sweden

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsNeoplasms

Interventions

Plastics

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Lars Enochsson, MD, PhD

    Karolinksa Institutet

    PRINCIPAL INVESTIGATOR

  • Urban Arnelo, M.D.

    Karolinska Institutet

    STUDY DIRECTOR

  • Lars Lundell, Professor

    Karolinska Institutet

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2007

First Posted

July 13, 2007

Study Start

December 1, 2006

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

June 29, 2022

Record last verified: 2022-06

Locations

SE(1)