NCT01960712

Brief Summary

Bile leakage after liver transection is treated by external drainage. The question addressed is whether downstream control by transpapillary stent insertion into distal bile duct can enhance healing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2008

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, 2008

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

8.3 years

First QC Date

September 9, 2013

Last Update Submit

October 2, 2020

Conditions

Bile Leakage

Outcome Measures

Primary Outcomes (1)

  • Number of days of bile leakage from the abdominal cavity

    From intervention until day discharge from hospital

Secondary Outcomes (1)

  • General complications rates. Postoperative hospital stay

    From intervention until day of discharge from hospital

Study Arms (2)

Continued external drainage

NO INTERVENTION

Continued external drainage alone.

Continued external drainage + transpapillary stent

ACTIVE COMPARATOR

External drainage + transpapillary plastic stent (7-10 Fr).

Device: Transpapillary plastic stent (7-10 Fr)

Interventions

Transpapillary plastic stent (7-10 Fr)DEVICE

Duodenoscopy plus transpapillary bile cannulation plus stent insertion.

Continued external drainage + transpapillary stent

Eligibility Criteria

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

You may qualify if:

  • Liver resection including at least two liver segments.

You may not qualify if:

  • Hepatobiliary digestive anastomosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 14186, Sweden

Location

Study Officials

  • Lars Lundell, Professor

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2013

First Posted

October 11, 2013

Study Start

November 1, 2008

Primary Completion

March 1, 2017

Study Completion

May 1, 2017

Last Updated

October 6, 2020

Record last verified: 2020-10

Locations

SE(1)