Clinical trial NCT03410914: Intra-operative Application of HEMOPATCH to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreas Cancer
Pancreas Disease
Pancreas Adenocarcinoma
Pancreas; Fistula
Surgery
Surgery--Complications
Surgery Site Fistula
Keywords: Hemopatch
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
name: Hamilton Health Sciences Corporation
name: The Ottawa Hospital
name: Kingston Health Sciences Centre
name: Royal University Hospital Foundation
name: London Health Sciences Centre
name: University Health Network, Toronto
First posted: 2018-01-25
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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)

Primary outcomes:
measure: Number of Participants With a Clinically Significant Post-operative Pancreatic Fistula (POPF)
timeFrame: Within 90 days post-operatively
Secondary outcomes:
measure: Number of Participants With a Post-operative Pancreatic Fistula (POPF)
timeFrame: Within 90 days post-operatively
measure: Number of Participants Who Experienced Post-Operative Complications
timeFrame: Within 90 days post-operatively
measure: 90-Day Mortality Count
timeFrame: Within 90 days post-operatively
measure: Average Length of Stay in Hospital
timeFrame: Within 90 days post-operatively
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Paul Karanicolas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.