NCT03419676

Brief Summary

The objective of this study is to determine the effect of the sealant patch Hemopatch, compared to current practice without any sealant, on the decrease of the postoperative pancreatic fistula on patients undergoing pancreatoduodenectomy for benign or malignant tumors or other benign process.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2018

Typical duration for phase_3

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

First Submitted

Initial submission to the registry

December 10, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
Last Updated

February 11, 2022

Status Verified

February 1, 2022

Enrollment Period

2.2 years

First QC Date

December 10, 2017

Last Update Submit

February 9, 2022

Conditions

Pancreatic Fistula

Keywords

PancreatoduodenectomyPostoperative pancreatic fistulaSealantHemopatch

Outcome Measures

Primary Outcomes (1)

  • Postoperative type B and C pancreatic fistula

    Postoperative type B and C pancreatic fistula rate defined according to the International Study Group of Pancreatic Fistula criteria, measured by amylases and/or lipases levels in the perianastomotic drainage

    Up to 3 months

Secondary Outcomes (10)

  • Hospital stay

    Up to 3 months

  • Stay in intensive care unit

    Up to 3 months

  • Total postoperative fistula (including type A, B, and C)

    Up to 3 months

  • Reoperations including interventional radiology

    Up to 3 months

  • Delayed gastric emptying

    Up to 3 months

  • +5 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

No reinforcement.

Hemopatch

EXPERIMENTAL

Reinforcement with Hemopatch.

Device: Hemopatch

Interventions

HemopatchDEVICE

Collagen patch derived from bovine dermis, coated with NHS-PEG, applied covering the pancreaticojejunostomy after pancreatoduodenectomy once the anastomosis is completed.

Hemopatch

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for pancreatoduodenectomy by open approach, depending on the diagnosis/nature of the tumor.
  • ASA score \< 4.
  • Male and female patients ≥ 18 and ≤ 80 years of age.
  • With the consent form signed.

You may not qualify if:

  • Patients scheduled for pancreatoduodenectomy by open approach, depending on the diagnosis/nature of the tumor.
  • ASA score \< 4.
  • Male and female patients ≥ 18 and ≤ 80 years of age.
  • With the consent form signed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mario Serradilla Martín

Zaragoza, 50008, Spain

Location

Related Publications (1)

  • Serradilla-Martin M, Paterna-Lopez S, Palomares-Cano A, Cantalejo-Diaz M, Abadia-Forcen T, Gutierrez-Diez ML, Artigas-Marco C, Serrablo-Requejo A. Polyethylene glycol-coated haemostatic patch for prevention of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy: randomized clinical trial. BJS Open. 2023 Mar 7;7(2):zrad028. doi: 10.1093/bjsopen/zrad028.

    PMID: 37021546DERIVED

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mario Serradilla

    Hospital Miguel Servet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: All patient data are anonymous. Each patient who meets the selection criteria and has signed the informed consent will be entered into a database and identified by a number (from 1 to 64). The list of patient identification numbers will be in the hands of the principal investigator. After carrying out the surgery, the patient number is entered into an online computerized randomization tool ("Randomizer for clinical trials"), https://www.meduniwien.ac.at/randomizer. It is a tool of the University of Vienna in Austria, where it is registered in a study, which allows, once the patient number is entered, the randomization of the same, obtaining one of the two methods to compare (32 patients in each study group): 1. Basic treatment: duct-to-mucosa pancreaticojejunostomy WITHOUT Hemopatch reinforcement. 2. The same, but reinforced WITH Hemopatch. Once the treatment to be performed is obtained, surgery will be carried out according to the treatment obtained in the randomization.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Attending Surgeon

Study Record Dates

First Submitted

December 10, 2017

First Posted

February 5, 2018

Study Start

May 1, 2018

Primary Completion

June 30, 2020

Study Completion

February 10, 2022

Last Updated

February 11, 2022

Record last verified: 2022-02

Locations

ES(1)