MedDataX Logo

Intra-operative Application of HEMOPATCH to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy

NCT ID: NCT03410914

Last Updated: 2021-11-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-13

Study Completion Date

2020-10-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Despite improvements and advances in pancreas surgery, about 30-35% of patients who have pancreas surgery develop a type of complication called a pancreatic fistula. A pancreatic fistula occurs when fluid produced by the pancreas leaks into the abdomen after pancreas surgery. Patients who develop a pancreatic fistula can have poor short-term and long-term consequences.We are studying the effect of a medical device named HEMOPATCH on the development and seriousness of pancreatic fistulas. HEMOPATCH is a thin, flexible bovine protein-based pad that may improve tissue sealing where it is applied during surgery. Some small studies called case studies of between 2 and 7 patients, and two clinical trials have shown that HEMOPATCH is effective at stopping bleeding and reducing drain output after some types of surgery. However, there have been no completed clinical trials using HEMOPATCH to prevent or reduce pancreatic fistulas in patients having pancreas surgery, so we don't know if it works in this setting. Health Canada has approved the use of HEMOPATCH as a device to stop bleeding or seal other bodily fluids for procedures in which the control of bleeding or leakage of other body fluids or air by standard surgical techniques are either ineffective or impractical.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreas Cancer Pancreas Disease Pancreas Adenocarcinoma Pancreas; Fistula Surgery Surgery--Complications Surgery Site Fistula

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Hemopatch

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hemopatch

Application of hemopatch to the divided end of the pancreas during surgery

Group Type EXPERIMENTAL

Hemopatch

Intervention Type DEVICE

Application of hemopatch to the divided end of the pancreas during surgery.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hemopatch

Application of hemopatch to the divided end of the pancreas during surgery.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Scheduled to undergo distal pancreatectomy surgery that is open or laparoscopic, with or without splenectomy
* Age ≥ 18 years
* Able and willing to comply with study procedures and follow-up examinations contained within the written consent form

Exclusion Criteria

* Contraindication to placement of HEMOPATCH tissue sealant including: 1) Known hypersensitivity to bovine proteins; 2) Known hypersensitivity to brilliant blue \[FD\&C Blue No.1 (Blue 1)\]; 3) Presence of an active infection; and 4) Known pregnancy or lactation (a negative urine pregnancy test must be obtained for women of child bearing potential during the pretreatment evaluation)
* Participating in another interventional trial that may result in co-intervention or contamination (to be determined by sponsor)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role collaborator

The Ottawa Hospital

OTHER

Sponsor Role collaborator

Kingston Health Sciences Centre

OTHER

Sponsor Role collaborator

Royal University Hospital Foundation

OTHER

Sponsor Role collaborator

London Health Sciences Centre

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Paul Karanicolas, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

Kingston General Hospital

Kingston, Ontario, Canada

Site Status

London Health Sciences Centre

London, Ontario, Canada

Site Status

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

University Health Network

Toronto, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

Bubis LD, Behman R, Roke R, Serrano PE, Khalil JA, Coburn NG, Law CH, Bertens K, Martel G, Hallet J, Marcaccio M, Balaa F, Quan D, Gallinger S, Nanji S, Leslie K, Tandan V, Luo Y, Beck G, Skaro A, Dath D, Moser M, Karanicolas PJ; HPB CONCEPT team. PATCH-DP: a single-arm phase II trial of intra-operative application of HEMOPATCH to the pancreatic stump to prevent post-operative pancreatic fistula following distal pancreatectomy. HPB (Oxford). 2022 Jan;24(1):72-78. doi: 10.1016/j.hpb.2021.05.007. Epub 2021 Jun 9.

Reference Type DERIVED
PMID: 34176743 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

346-2017

Identifier Type: -

Identifier Source: org_study_id