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

Surgery Clinical Trial

— PATCH-DP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03410914
• Other study ID #: 346-2017
• Status: Completed
• Phase: Phase 2
• Start date: August 13, 2018
• Est. completion date: October 23, 2020

Study information

• Verified date: October 2021
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 23, 2020
• Est. primary completion date: October 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fistula
• Pancreas Adenocarcinoma
• Pancreas Cancer
• Pancreas Disease
• Pancreas; Fistula
• Pancreatic Diseases
• Pancreatic Fistula
• Pancreatic Neoplasms
• Surgery
• Surgery Site Fistula
• Surgery--Complications

Intervention

Device:
• Hemopatch
Application of hemopatch to the divided end of the pancreas during surgery.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (8)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Baxter Healthcare Corporation, Hamilton Health Sciences Corporation, Kingston Health Sciences Centre, London Health Sciences Centre, Royal University Hospital Foundation, The Ottawa Hospital, University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	90-Day Mortality Count	Indicated by death within 90-days after surgery.	Within 90 days post-operatively
Secondary	Average Length of Stay in Hospital	Number of days from date of surgery (POD0) to the date of discharge	Within 90 days post-operatively