NCT03993067

Brief Summary

The aim of the study is to investigate the use of Hemopatch to prevent biliary fistula in patients submitted to surgery for malignancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

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 15, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

1.2 years

First QC Date

June 19, 2019

Last Update Submit

April 2, 2021

Conditions

Biliary FistulaSurgery

Outcome Measures

Primary Outcomes (1)

  • The rate of biliary fistula

    Use a Hemopatch to prevent biliary fistula

    12 months

Study Arms (2)

Standard Treatment

ACTIVE COMPARATOR

Fibrin glue and Tabotamp on cut surface

Procedure: Fribrin glue and Tabotamp

Hemopatch

EXPERIMENTAL

Hemopatch on cut surface

Procedure: Hemopatch

Interventions

HemopatchPROCEDURE

Hemopatch is a collagen based sealant is a hemostat agent. We want to investigate his role in the prevention of post operative biliary fistula

Also known as: Experimental
Hemopatch
Fribrin glue and TabotampPROCEDURE

Fibrin glue and Tabotampis the standard treatment

Also known as: Standard treatment
Standard Treatment

Eligibility Criteria

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

You may qualify if:

  • all patients submitted to liver surgery for malignancies.
  • \>18 years of age.

You may not qualify if:

  • biliary reconstruction
  • other associated visceral resections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan

Rozzano, Milan, 20089, Italy

Location

MeSH Terms

Conditions

Biliary Fistula

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Guido Torzilli

    Department of Biomedical Sciences Humanitas University, Milan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Department of Surgery Head of the General and Hepatobiliary surgery unit, Clinical Professor and Principal investigator

Study Record Dates

First Submitted

June 19, 2019

First Posted

June 20, 2019

Study Start

November 15, 2018

Primary Completion

January 15, 2020

Study Completion

January 15, 2020

Last Updated

April 6, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)