Pancreas CancerPhase 2PATCH-DPNCT03410914
Intra-operative Application of HEMOPATCH to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy
A Phase 2 study testing Hemopatch in people with Pancreas Cancer and Pancreas Disease, run by Sunnybrook Health Sciences Centre at 7 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Pancreas Disease, Pancreas Adenocarcinoma
- What is being tested?
- Hemopatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 7 sitesCanada
- Study dates
- 13 Aug 2018to 23 Oct 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Hamilton Health Sciences
Hamilton, Ontario
Kingston General Hospital
Kingston, Ontario, K7L 2V7
London Health Sciences Centre
London, Ontario, N6A 5W9
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
University Health Network
Toronto, Ontario, M5G2N2
Sunnybrook Health Sciences Centre
Toronto, Ontario
About this study
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
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
- Being tested
- Hemopatch
- Keywords
- Hemopatch
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Diseases, Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemopatchDevice
Application of hemopatch to the divided end of the pancreas during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Hemopatch | Experimental | Application of hemopatch to the divided end of the pancreas during surgery Receives: Device: Hemopatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 90 days post-operatively
Secondary outcomes (4)
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.
Measured: 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.
Measured: Within 90 days post-operatively
90-Day Mortality Count
Indicated by death within 90-days after surgery.
Measured: Within 90 days post-operatively
Average Length of Stay in Hospital
Number of days from date of surgery (POD0) to the date of discharge
Measured: Within 90 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start13 Aug 2018
- Primary completion3 Oct 2020
- Study completion23 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation, Hamilton Health Sciences Corporation, The Ottawa Hospital, Kingston Health Sciences Centre, Royal University Hospital Foundation, London Health Sciences Centre, University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- Paul Karanicolas, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410914
- Sponsor's protocol ID
- 346-2017
- Acronym
- PATCH-DP
- Status last verified
- Oct 2021
- First submitted
- 19 Jan 2018
- Last updated
- 3 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34176743
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03410914
- Acronym / sponsor ID
- PATCH-DP / 346-2017
- Conditions
- Pancreas Cancer, Pancreas Disease, Pancreas Adenocarcinoma, Pancreas; Fistula, Surgery, Surgery--Complications
- Keywords
- Hemopatch
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation, Hamilton Health Sciences Corporation, The Ottawa Hospital, Kingston Health Sciences Centre, Royal University Hospital Foundation, London Health Sciences Centre, University Health Network, Toronto
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 3 Oct 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 25 Jan 2018 (actual)
- Results
- Posted 9 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemopatch | Experimental | Device: HemopatchApplication of hemopatch to the divided end of the pancreas during surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemopatchApplication of hemopatch to the divided end of the pancreas during surgery. | Device | Hemopatch |
Primary outcome
Number of Participants With a Clinically Significant Post-operative Pancreatic Fistula (POPF)
Time frame: 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.
4 secondary outcomes
Number of Participants With a Post-operative Pancreatic Fistula (POPF)
Time frame: Within 90 days post-operatively
Number of Participants Who Experienced Post-Operative Complications
Time frame: Within 90 days post-operatively
90-Day Mortality Count
Time frame: Within 90 days post-operatively
Average Length of Stay in Hospital
Time frame: Within 90 days post-operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34176743Bubis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Karanicolas, MD principal investigator
Sunnybrook Health Sciences Centre
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hemopatch in people with Pancreas Cancer and Pancreas Disease, run by Sunnybrook Health Sciences Centre at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Clinically Significant Post-operative Pancreatic Fistula (POPF) (time frame: Within 90 days post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03410914, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.