NCT02545153

Brief Summary

Bile leak reduction from the common bile duct, as a result of glue appliance after cholangiotomy.

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
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_2

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

January 1, 2009

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2012

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

7 years

First QC Date

October 10, 2012

Last Update Submit

September 8, 2015

Conditions

Common Bile Duct Gall StonesInfectionBile Leak

Outcome Measures

Primary Outcomes (1)

  • Postoperative biliary leakage

    The amount of bile in the drain is measured daily until it is withdrawn

    From the the day of surgery until discharge and/or removal of abdominal drain, up to two weeks

Study Arms (2)

Fibrin sealant

ACTIVE COMPARATOR

Tisseel, Baxter (Aprotinin and Fibrinogen)

Drug: Tisseel, Baxter (Aprotinin and Fibrinogen)

Control

PLACEBO COMPARATOR

Suturing the incision without fibrin glue

Drug: Control

Interventions

Tisseel, Baxter (Aprotinin and Fibrinogen)DRUG

After introducton of t tube and closure of the incision with running sutures, fibrin sealant is applied on the incision.

Also known as: Closing the incision with fibrin sealant
Fibrin sealant
ControlDRUG

No fibrin sealant applied

Also known as: Closing the incision without fibrin sealant
Control

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gallbladder disease

You may not qualify if:

  • Cancer/Tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lasarettet i Enkoping

Enköping, Uppsala County, 754 25, Sweden

RECRUITING

Related Publications (1)

  • Darkahi B, Norden T, Sandblom G. Fibrin Sealant for Prevention of Bile Leakage After Laparoscopic Common Bile Duct Incision: Outcome of a Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2022 Feb;32(2):171-175. doi: 10.1089/lap.2020.0404. Epub 2021 Jun 14.

    PMID: 34129409DERIVED

MeSH Terms

Conditions

GallstonesInfections

Interventions

Fibrin Tissue AdhesiveAprotininFibrinogen

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsAcute-Phase ProteinsBlood Coagulation FactorsProtein PrecursorsBiological Factors

Study Officials

  • Gabriel Sandblom, Assoc Prof

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bahman Darkahi Darkahi, MD

CONTACT

bahman.darkahi@lul.se

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 10, 2012

First Posted

September 9, 2015

Study Start

January 1, 2009

Primary Completion

January 1, 2016

Study Completion

December 1, 2016

Last Updated

September 9, 2015

Record last verified: 2015-09

Locations

SE(1)