NCT02166840

Brief Summary

Patients with obstructive jaundice due to periampullary tumor can temporarily be relieved of their jaundice with transpapillary stenting at endoscopic retrograde cholangio-pancreatography (ERCP) prior to operation. Usually plastic stents are used. Hypothesis: Self expanding metallic stents offer a be a better alternative for preoperative stenting in patients with obstructive jaundice due to periampullary tumour obstruction.

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 phase_2

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

October 22, 2015

Status Verified

October 1, 2015

Enrollment Period

7.8 years

First QC Date

March 3, 2014

Last Update Submit

October 21, 2015

Conditions

Obstructive JaundicePeriampullary Tumour

Outcome Measures

Primary Outcomes (1)

  • Degree and amount of bile bacterial contamination at the time of resection

    Time at the operation

Secondary Outcomes (4)

  • Degree of inflammation around the bile duct.

    Time at the operative intervention

  • General complication rates

    Time from intervention until day of discharge from hospital (on an average less than 90 days).

  • Postoperative hospital stay.

    Time from intervention until day of discharge from hospital (on an average less than 90 days).

  • Bacterial culture of lymph nodes in the hepatoduodenal ligament.

    Time of operative intervention

Study Arms (2)

Self expanding metal stent

EXPERIMENTAL

Patients with self expanding metal stent inserted into bile duct.

Procedure: Self Expanding Metal Stent

Plastic stent

ACTIVE COMPARATOR

Patients with obstructive jaundice who got a plastic stent inserted into bile duct.

Procedure: Plastic stent (7-10Fr)

Interventions

Plastic stent (7-10Fr)PROCEDURE
Plastic stent
Self Expanding Metal StentPROCEDURE
Self expanding metal stent

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obstructive jaundice in periampullary tumor.

You may not qualify if:

  • Not willing to participate.
  • Not a resectable tumor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 141 86, Sweden

Location

MeSH Terms

Conditions

Jaundice, Obstructive

Condition Hierarchy (Ancestors)

JaundiceHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Lars Lundell, Professor

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 3, 2014

First Posted

June 18, 2014

Study Start

March 1, 2007

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

October 22, 2015

Record last verified: 2015-10

Locations

SE(1)