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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Surgery--Complications; Pancreas Adenocarcinoma; Pancreas Cancer; Pancreas Disease; Pancreas; Fistula; Surgery Site Fistula
• Intervention / Treatment: Device: Hemopatch

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • Hamilton Health Sciences
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston General Hospital
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital
    • Toronto, Ontario, Canada
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5G2N2
      • University Health Network
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Clinically Significant Post-operative Pancreatic Fistula (POPF)	Incidence of clinically-significant POPF - defined as ISGPS Grade B or C POPF. Determination of Grade B or C POPF was made on the basis of confirmation of presence of pancreatic fistula (any measurable volume of drain fluid on or after postoperative day 3, with an amylase content greater than 3 times the upper normal serum value) in conjunction with a review of participants' postoperative clinical course.	Within 90 days post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Post-operative Pancreatic Fistula (POPF)	Incidence of any POPF - defined as International Study Group Pancreatic Fistula (ISGPF) all grades (A, B, C). Determination of POPF grade was made on the basis of confirmation of presence of pancreatic fistula (any measurable volume of drain fluid on or after postoperative day 3, with an amylase content greater than 3 times the upper normal serum value) in conjunction with a review of participants' postoperative clinical course.	Within 90 days post-operatively
Number of Participants Who Experienced Post-Operative Complications	Postoperative complications graded using the Clavien-Dindo system - participants experiencing a Clavien-Dindo complication of greater than or equal to 3 were counted (grade 3 or higher is typically indicated by a procedural intervention to treat the post-operative complication). This grading system was used as a measure of 90-day postoperative morbidity.	Within 90 days post-operatively
90-Day Mortality Count	Indicated by death within 90-days after surgery.	Within 90 days post-operatively
Average Length of Stay in Hospital	Number of days from date of surgery (POD0) to the date of discharge	Within 90 days post-operatively

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: University Health Network, Toronto; Baxter Healthcare Corporation; The Ottawa Hospital; Hamilton Health Sciences Corporation; Queen's University; London Health Sciences Centre; Royal University Hospital Foundation
• Investigators: Principal Investigator: Paul Karanicolas, MD, Sunnybrook Health Sciences Centre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2018
• Primary Completion (Actual): October 3, 2020
• Study Completion (Actual): October 23, 2020

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: January 19, 2018
• First Posted (Actual): January 25, 2018

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Hemopatch
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pathological Conditions, Anatomical; Digestive System Fistula; Fistula; Pancreatic Neoplasms; Pancreatic Fistula; Pancreatic Diseases
• Other Study ID Numbers: 346-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No