NCT00500968

Brief Summary

Randomized study assessing the effect of transpapillary pancreas duct stent in resection of the pancreatic tail.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 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

November 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

April 7, 2011

Status Verified

September 1, 2007

Enrollment Period

4.4 years

First QC Date

July 12, 2007

Last Update Submit

April 6, 2011

Conditions

Pancreas CancerFistula

Keywords

PancreasLeakageFistulatail

Outcome Measures

Primary Outcomes (1)

  • Drain fluid content analyses

    Post-operative daily measurement of X-Amylase,as long as the patient has the external drain and for at least 5 postopertaive days.

    At least 5 postoperative days

Secondary Outcomes (1)

  • Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization and cost. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent

    At least 5 postoperative days

Study Arms (2)

Stent

ACTIVE COMPARATOR
Procedure: stent

conventional distal pancreatectomy

ACTIVE COMPARATOR
Procedure: Distal pancreatectomy

Interventions

stentPROCEDURE

ERCP guided stent insertion before transection of the gland

Also known as: ERCP
Stent
Distal pancreatectomyPROCEDURE

conventional distal pancreatectomy

Also known as: surgery
conventional distal pancreatectomy

Eligibility Criteria

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

You may not qualify if:

  • The Patients who, at the time of exploration, judged to have a tumour, which is un-resectable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinksa university hospital

Stockholm, 14186, Sweden

Location

Related Publications (1)

  • Frozanpor F, Lundell L, Segersvard R, Arnelo U. The effect of prophylactic transpapillary pancreatic stent insertion on clinically significant leak rate following distal pancreatectomy: results of a prospective controlled clinical trial. Ann Surg. 2012 Jun;255(6):1032-6. doi: 10.1097/SLA.0b013e318251610f.

    PMID: 22584629DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsFistula

Interventions

StentsCholangiopancreatography, Endoscopic RetrogradeSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and SuppliesCholangiographyRadiography, AbdominalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Digestive SystemEndoscopy, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresMinimally Invasive Surgical Procedures

Study Officials

  • Urban Arnelo

    Karolinksa university hospital

    STUDY DIRECTOR

  • Farshad Frozanpor

    Karolinksa university hospital

    PRINCIPAL INVESTIGATOR

  • Lars Lundell, Professor

    Karolinska Institutet

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 12, 2007

First Posted

July 13, 2007

Study Start

November 1, 2006

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 7, 2011

Record last verified: 2007-09

Locations

SE(1)