- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2018-08-13
2020-10-03
2020-10-23
52
NCT03410914
Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
INTERVENTIONAL
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-01-19 | 2021-07-16 | 2021-10-29 |
2018-01-19 | 2021-07-16 | 2021-11-03 |
2018-01-25 | 2021-08-09 | 2021-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Prevention
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Hemopatch Application of hemopatch to the divided end of the pancreas during surgery | DEVICE: Hemopatch
|
| Primary Outcome Measures | 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 |
| Secondary Outcome Measures | 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. | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
