NCT02769754

Brief Summary

This prospective randomized study aims to determine the influence of the use of local hemostatic on the incidence of local complications derived from the edge of transection: biliary fistula or bleeding, after scheduled hepatic resection.

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
250

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2016

Typical duration for phase_3

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

May 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

February 15, 2018

Status Verified

May 1, 2016

Enrollment Period

2.8 years

First QC Date

May 6, 2016

Last Update Submit

February 14, 2018

Conditions

Liver DamageSurgery

Keywords

LIVERRESECTIONSURGERY

Outcome Measures

Primary Outcomes (2)

  • Bleeding

    Bleeding is defined as the fall of \> 3 g/dl of hemoglobin in the postoperative as compared to the baseline value after the operation (the hemoglobin level immediately after surgery) and/or any postoperative transfusion of red blood cells packages because of hemoglobin drop and/or the need for reoperation to stop the bleeding (e.g., embolization or re- laparotomy).

    Day 0 to day 30 (+-10 days)

  • Presence of Biliary Fistula

    Biliary fistula is defined as the presence of high bilirubin levels (Bilirubin\> 3x in serum level measured at the same time) in the abdominal drainage, being included the need for interventional radiology due to biliary collection or a re-laparotomy due to biliary fistula (Brooke-Smith et al HPB 2015).

    Day 0 to day 30 (+-10 days)

Secondary Outcomes (27)

  • Age

    Preoperative

  • Body Mass Index (BMI)

    Preoperative

  • Gender

    Preoperative

  • Medical history (heart disease, lung disease, cirrhosis)

    Preoperative

  • Hypertension

    Preoperative

  • +22 more secondary outcomes

Study Arms (2)

Control

PLACEBO COMPARATOR

In the control group (group A) no additional treatment will be applied after performing the usual surgical hemostasis.

Other: Control

Hemopatch

EXPERIMENTAL

Hemopatch will be apply in the treatment group (group B), once the standard surgical hemostasis is achieved

Device: Hemopatch

Interventions

HemopatchDEVICE

Hemopatch will be apply once the standard surgical hemostasis is achieved.

Hemopatch
ControlOTHER

No additional treatment will be applied after performing the usual surgical hemostasis.

Control

Eligibility Criteria

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

You may qualify if:

  • Scheduled major or minor liver resection surgery by laparotomy approach.
  • Age\>18
  • They have given their written consent voluntarily after having offered the possibility of their participation in the study.

You may not qualify if:

  • Pregnancy and lactation
  • Patients with urgent surgery
  • Concomitant surgery of another organ
  • Gallbladder or biliary-enteric anastomosis associated.
  • ALPPS surgery (stands for Associating Liver Partition and Portal vein Ligation for Staged hepatectomy).
  • Patients with liver transplantation history.
  • Patients with previous liver trauma.
  • Patients with congenital haematological disease involving clotting factors alteration.
  • Patients with known hypersensitivity to bovine proteins and brilliant blue colorante (FD\&C Nº1).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

RECRUITING

Related Publications (1)

  • Robledo AB, Montalva Oron EM, Seller AN, Ibanez JM, Sanz AH, Mizrahi DC, Orbis Castellanos FJ, Andujar RL. Clinical evidence on the use of Hemopatch(R) in reducing bleeding and biliary fistula after liver resection: Prospective randomized study in planned surgery. Cir Esp (Engl Ed). 2025 Dec 17:800270. doi: 10.1016/j.cireng.2025.800270. Online ahead of print.

    PMID: 41418882DERIVED

Study Officials

  • Rafael López-Andújar

    Instituto de Investigación Sanitaria La Fe

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena García

CONTACT

0034961246611investigacion_clinica@iislafe.es

Laura Segura

CONTACT

0034961246611monitor1@iislafe.es

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2016

First Posted

May 12, 2016

Study Start

May 1, 2016

Primary Completion

February 1, 2019

Study Completion

May 1, 2019

Last Updated

February 15, 2018

Record last verified: 2016-05

Locations

ES(1)