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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03410914
Recruitment Status : Active, not recruiting
First Posted : January 25, 2018
Last Update Posted : September 19, 2019
Sponsor:
Collaborators:
Baxter Healthcare Corporation
Hamilton Health Sciences Corporation
The Ottawa Hospital
Kingston Health Sciences Centre
Royal University Hospital Foundation
London Health Sciences Centre
University Health Network, Toronto
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE January 19, 2018
First Posted Date  ICMJE January 25, 2018
Last Update Posted Date September 19, 2019
Actual Study Start Date  ICMJE August 13, 2018
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2018)
  • 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)
  • Post-Operative Complications [ Time Frame: Within 90 days post-operatively ]
    Postoperative complications graded using the Clavien-Dindo system
  • 90-Day Mortality [ Time Frame: Within 90 days post-operatively ]
    Death within 90-days of surgery
  • Length of Stay [ Time Frame: Within 90 days post-operatively ]
    Number of days from date of surgery (POD0) to the date of discharge
  • Resource Utilization [ Time Frame: Within 90 days post-operatively ]
    Healthcare costs
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intra-operative Application of HEMOPATCH to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Pancreas Cancer
  • Pancreas Disease
  • Pancreas Adenocarcinoma
  • Pancreas; Fistula
  • Surgery
  • Surgery--Complications
  • Surgery Site Fistula
Intervention  ICMJE Device: Hemopatch
Application of hemopatch to the divided end of the pancreas during surgery.
Study Arms  ICMJE Experimental: Hemopatch
Application of hemopatch to the divided end of the pancreas during surgery
Intervention: Device: Hemopatch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 19, 2018)
52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2020
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03410914
Other Study ID Numbers  ICMJE 346-2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE
  • Baxter Healthcare Corporation
  • Hamilton Health Sciences Corporation
  • The Ottawa Hospital
  • Kingston Health Sciences Centre
  • Royal University Hospital Foundation
  • London Health Sciences Centre
  • University Health Network, Toronto
Investigators  ICMJE
Principal Investigator: Paul Karanicolas, MD Sunnybrook Health Sciences Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP