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

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ClinicalTrials.gov Identifier: NCT03410914
Recruitment Status : Recruiting
First Posted : January 25, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborators:
Baxter Healthcare Corporation
Hamilton Health Sciences Corporation
The Ottawa Hospital
St. Joseph's Health Centre Toronto
Jewish General Hospital
Foothills Medical Centre
Royal University Hospital Foundation
London Health Sciences Centre
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreas Cancer Pancreas Disease Pancreas Adenocarcinoma Pancreas; Fistula Surgery Surgery--Complications Surgery Site Fistula Device: Hemopatch Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : August 13, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: Hemopatch
Application of hemopatch to the divided end of the pancreas during surgery
Device: Hemopatch
Application of hemopatch to the divided end of the pancreas during surgery.




Primary Outcome Measures :
  1. Post-operative pancreatic fistula (POPF) [ Time Frame: Within 90 days post-operatively ]
    Incidence of clinically-significant POPF - defined as ISGPF Grade B or C POPF.


Secondary Outcome Measures :
  1. Post-operative pancreatic fistula (POPF) [ Time Frame: Within 90 days post-operatively ]
    Incidence of any POPF - defined as International Study Group Pancreatic Fistula (ISGPF) all grades (A, B, C)

  2. Post-Operative Complications [ Time Frame: Within 90 days post-operatively ]
    Postoperative complications graded using the Clavien-Dindo system

  3. 90-Day Mortality [ Time Frame: Within 90 days post-operatively ]
    Death within 90-days of surgery

  4. Length of Stay [ Time Frame: Within 90 days post-operatively ]
    Number of days from date of surgery (POD0) to the date of discharge

  5. Resource Utilization [ Time Frame: Within 90 days post-operatively ]
    Healthcare costs



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410914


Contacts
Contact: Rachel Roke, BSc, CCRP 416-480-6100 ext 85391 rachel.roke@sunnybrook.ca

Locations
Canada, Ontario
Hamilton Health Sciences Not yet recruiting
Hamilton, Ontario, Canada
Contact: Marlie Valencia    905-521-2100 ext 43921    valencmg@mcmaster.ca   
Principal Investigator: Pablo Serrano, MD         
Sub-Investigator: Leyo Ruo, MD         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada
Contact: Rachel Roke, BSc, CCRP    416-480-6100 ext 85391    rachel.roke@sunnybrook.ca   
Principal Investigator: Paul Karanicolas, MD         
Sub-Investigator: Natalie Coburn, MD         
Sub-Investigator: Julie Hendrick-Hallet, MD         
Sub-Investigator: Calvin Law, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Baxter Healthcare Corporation
Hamilton Health Sciences Corporation
The Ottawa Hospital
St. Joseph's Health Centre Toronto
Jewish General Hospital
Foothills Medical Centre
Royal University Hospital Foundation
London Health Sciences Centre
Investigators
Principal Investigator: Paul Karanicolas, MD Sunnybrook Health Sciences Centre

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03410914     History of Changes
Other Study ID Numbers: 346-2017
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sunnybrook Health Sciences Centre:
Hemopatch

Additional relevant MeSH terms:
Pancreatic Diseases
Adenocarcinoma
Fistula
Pancreatic Neoplasms
Pancreatic Fistula
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathological Conditions, Anatomical
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Digestive System Fistula