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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
| Hamilton Health Sciences Corporation | OTHER |
| The Ottawa Hospital | OTHER |
| Kingston Health Sciences Centre |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemopatch | Experimental | Application of hemopatch to the divided end of the pancreas during surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemopatch | Device | Application of hemopatch to the divided end of the pancreas during surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Karanicolas, MD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences | Hamilton | Ontario | Canada | |||
| Kingston General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34176743 | Derived | 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. |
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78 patients were assessed for eligibility at 7 hepatopancreaticobiliary centres in Canada. Of these, 52 patients met the inclusion criteria and consented to trial participation. These 52 participants were enrolled and allocated to the investigational Hemopatch intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hemopatch | Application of hemopatch to the divided end of the pancreas during surgery Hemopatch: Application of hemopatch to the divided end of the pancreas during surgery. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2018 |
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| OTHER |
| Royal University Hospital Foundation | OTHER |
| London Health Sciences Centre | OTHER |
| University Health Network, Toronto | OTHER |
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| 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. | Within 90 days post-operatively |
| 90-Day Mortality Count | Indicated by death within 90-days after surgery. | Within 90 days post-operatively |
| Average Length of Stay in Hospital | Number of days from date of surgery (POD0) to the date of discharge | Within 90 days post-operatively |
| Kingston |
| Ontario |
| K7L 2V7 |
| Canada |
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| University Health Network | Toronto | Ontario | M5G2N2 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hemopatch | Application of hemopatch to the divided end of the pancreas during surgery Hemopatch: Application of hemopatch to the divided end of the pancreas during surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | Within 90 days post-operatively |
|
| ||||||||||||||||||||||||||||
| Secondary | 90-Day Mortality Count | Indicated by death within 90-days after surgery. | Posted | Count of Participants | Participants | 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 | Posted | Median | Inter-Quartile Range | days | Within 90 days post-operatively |
|
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Adverse events were recorded up until 90 days post-operative.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hemopatch | Application of hemopatch to the divided end of the pancreas during surgery Hemopatch: Application of hemopatch to the divided end of the pancreas during surgery. | 2 | 52 | 14 | 52 | 21 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Grade B POPF | Hepatobiliary disorders | Systematic Assessment |
| ||
| Grade C POPF | Hepatobiliary disorders | Systematic Assessment |
| ||
| Intra-Abdominal Abscess | Infections and infestations | Systematic Assessment |
| ||
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bleed | General disorders | Systematic Assessment |
| ||
| Colonic Anastomotic Leak | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pancreatitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Bile Leak | Hepatobiliary disorders | Systematic Assessment |
| ||
| Disseminated Intravascular Coagulation | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute Coronary Syndrome/NSTEMI | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Wound Infection | Infections and infestations | Systematic Assessment |
| ||
| Grade B POPF | Hepatobiliary disorders | Systematic Assessment |
| ||
| Biochemical Leak (Grade A POPF) | Hepatobiliary disorders | Systematic Assessment |
| ||
| Neurological | Psychiatric disorders | Systematic Assessment |
| ||
| Ileus | Gastrointestinal disorders | Systematic Assessment |
|
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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Karanicolas | Sunnybrook Health Sciences Centre | 4164806100 | 4774 | paul.karanicolas@sunnybrook.ca |
| Jul 9, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D010182 | Pancreatic Diseases |
| D010185 | Pancreatic Fistula |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D004700 | Endocrine System Diseases |
| D016154 | Digestive System Fistula |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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