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

Phase 2

Completed

• Conditions: Pancreas Cancer; Surgery; Surgery--Complications; Surgery Site Fistula; Pancreas; Fistula; Pancreas Adenocarcinoma; Pancreas Disease
• Interventions: Device: Hemopatch

• Registration Number: NCT03410914
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-01-19
• Study First Posted: 2018-01-25
• Study Start: 2018-08-13
• Primary Completion: 2020-10-03
• Study Completion: 2020-10-23
• Results First Submitted: 2021-07-16
• Results First Submitted QC: 2021-07-16
• Results First Posted: 2021-08-09
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-29
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hemopatch	Hemopatch	Application of hemopatch to the divided end of the pancreas during surgery

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Clinically Significant Post-operative Pancreatic Fistula (POPF)	Within 90 days post-operatively	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.

Secondary Outcome Measures

Name	Time	Method
Average Length of Stay in Hospital	Within 90 days post-operatively	Number of days from date of surgery (POD0) to the date of discharge
Number of Participants Who Experienced Post-Operative Complications	Within 90 days post-operatively	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.
90-Day Mortality Count	Within 90 days post-operatively	Indicated by death within 90-days after surgery.
Number of Participants With a Post-operative Pancreatic Fistula (POPF)	Within 90 days post-operatively	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.

Trial Locations

Locations (7)

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada