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

NCT03410914 | Completed Phase 2 Results

• 1 other identifier: 346-2017
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 7

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.

Conditions

Pancreas Cancer; Pancreas Disease; Pancreas Adenocarcinoma; Pancreas; Fistula; Surgery; Surgery--Complications; Surgery Site Fistula

Keywords

Hemopatch

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants With a Post-operative Pancreatic Fistula (POPF)

  Within 90 days post-operatively

• Number of Participants Who Experienced Post-Operative Complications

  Within 90 days post-operatively

• 90-Day Mortality Count

  Within 90 days post-operatively

• Average Length of Stay in Hospital

  Within 90 days post-operatively

Study Arms (1)

Hemopatch

EXPERIMENTAL

Application of hemopatch to the divided end of the pancreas during surgery

Device: Hemopatch

Interventions

Hemopatch DEVICE

Application of hemopatch to the divided end of the pancreas during surgery.

Hemopatch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Baxter Healthcare Corporation: collaborator
• Hamilton Health Sciences Corporation: collaborator
• The Ottawa Hospital: collaborator
• Kingston Health Sciences Centre: collaborator
• Royal University Hospital Foundation: collaborator
• London Health Sciences Centre: collaborator
• University Health Network, Toronto: collaborator

Study Sites (7)

Hamilton Health Sciences

Hamilton, Ontario, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

University Health Network

Toronto, Ontario, M5G2N2, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (1)

• 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.

  PMID: 34176743 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic Diseases; Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Endocrine System Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Broad inclusion criteria does not permit specific evaluation of patient subgroups given overall small sample size. Small sample size also introduces the potential for oversampling of high-risk cases, such as those requiring multivisceral resection.

Results Point of Contact

• Title: Dr. Paul Karanicolas
• Organization: Sunnybrook Health Sciences Centre

paul.karanicolas@sunnybrook.ca

4164806100

Study Officials

• Paul Karanicolas, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: January 25, 2018
• Study Start: August 13, 2018
• Primary Completion: October 3, 2020
• Study Completion: October 23, 2020
• Last Updated: November 3, 2021
• Results First Posted: August 9, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)