A Phase 2 interventional study of Hemopatch in Pancreas Cancer, Pancreas Disease and Pancreas Adenocarcinoma, sponsored by Sunnybrook Health Sciences Centre. Completed at 7 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-03.
Sponsored by Sunnybrook Health Sciences Centre · Phase 2, Interventional, and Prevention
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Among 184 studies in Pancreatic Neoplasms with a site in Canada — 37 open to participants now, 60 under way, 9 of them phase 3. Pancreatic Neoplasms · Canada.
Among the 184 studies in Pancreatic Neoplasms with a site in Canada, this one is the 116th largest by enrollment of the 161 interventional ones that give a count, is one of 6 that started in 2018, is one of 48 in phase 2, and was the 107th registered.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,006 are open to participants now.
Browse Pancreatic Neoplasms studies →37 of the 184 studies in Pancreatic Neoplasms with a site in Canada are open now. Recruiting first, the newest first:
Bristol-Myers Squibb · Sites in Canada, United States, Belgium and 10 more countries
Ages 18+
Verastem, Inc. · Sites in Canada, United States, Australia and 1 more country
Ages 18+
University Health Network, Toronto · Sites in Canada
Ages 18+
Unity Health Toronto · Sites in Canada
Ages 18+
Incyte Corporation · Sites in Canada, United States, Australia and 19 more countries
Ages 18+
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 745 Pancreatic Neoplasms studies recruiting now, 478 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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184 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 55 · Phase 2 71 · Phase 3 39 · Phase 4 1
First in 1998; this study’s year is marked. 6 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 52 is above the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Median enrollment 119 across the 161 interventional studies, 450 across the 20 observational. Of the 119 that completed or were terminated, 44 (37%) have results posted.
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107 of 184 have an industry lead sponsor. The 10 most frequent:
Sunnybrook Health Sciences Centre is the lead sponsor of 584 studies on the registry; 135 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Sunnybrook Health Sciences Centre has 2 studies filed under Pancreatic Neoplasms — fewer than ten, so there is no comparison to draw.
20 of the studies in Pancreatic Neoplasms with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05687123National Cancer Institute (NCI)Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors | 2026-12-14 |
| NCT02912949Partner Therapeutics, Inc.A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy) | 2026-12-31 |
| NCT04276857University of SaskatchewanSystemic Therapy With a Loco-regional Treatment in Patients With Locally Advanced Pancreatic Cancer | 2026-12-31 |
| NCT05941507LigaChem Biosciences, Inc.A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors | 2027-01 |
| NCT03816358National Cancer Institute (NCI)Testing the Combination of Anetumab Ravtansine With Either Nivolumab, Nivolumab and Ipilimumab, or Gemcitabine and Nivolumab in Advanced Pancreatic Cancer | 2027-01-31 |
Add all 20 to your calendar (.ics) → With an account.
Among the 184 studies in Pancreatic Neoplasms with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Application of hemopatch to the divided end of the pancreas during surgery
Device: Hemopatch
Application of hemopatch to the divided end of the pancreas during surgery.
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.
Time frame: Within 90 days post-operatively
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.
Time frame: 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.
Time frame: Within 90 days post-operatively
90-Day Mortality Count
Indicated by death within 90-days after surgery.
Time frame: Within 90 days post-operatively
Average Length of Stay in Hospital
Number of days from date of surgery (POD0) to the date of discharge
Time frame: Within 90 days post-operatively
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.
| Milestone | Hemopatch |
|---|---|
| Started | 52 |
| Completed | 52 |
| Not completed | 0 |
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.
| Participants | Hemopatch |
|---|---|
| Number of Participants With a Clinically Significant Post-operative Pancreatic Fistula (POPF) | 13 |
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.
| Participants | Hemopatch |
|---|---|
| Number of Participants With a Post-operative Pancreatic Fistula (POPF) | 25 |
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.
| Participants | Hemopatch |
|---|---|
| Number of Participants Who Experienced Post-Operative Complications | 14 |
Indicated by death within 90-days after surgery.
| Participants | Hemopatch |
|---|---|
| 90-Day Mortality Count | 2 |
Number of days from date of surgery (POD0) to the date of discharge
| days | Hemopatch |
|---|---|
| Average Length of Stay in Hospital | 6 (4 to 8) |
Collected over Adverse events were recorded up until 90 days post-operative.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hemopatch | 2/52 (3.8%) | 14/52 (26.9%) | 21/52 (40.4%) |
| Event | Hemopatch |
|---|---|
| Grade B POPFHepatobiliary disorders | 6/52 |
| BleedGeneral disorders | 3/52 |
| Colonic Anastomotic LeakGastrointestinal disorders | 2/52 |
| Atrial FibrillationCardiac disorders | 1/52 |
| Grade C POPFHepatobiliary disorders | 1/52 |
| Intra-Abdominal AbscessInfections and infestations | 1/52 |
| Respiratory DistressRespiratory, thoracic and mediastinal disorders | 1/52 |
| PancreatitisHepatobiliary disorders | 1/52 |
| Bile LeakHepatobiliary disorders | 1/52 |
| Disseminated Intravascular CoagulationBlood and lymphatic system disorders | 1/52 |
| Event | Hemopatch |
|---|---|
| Biochemical Leak (Grade A POPF)Hepatobiliary disorders | 12/52 |
| Grade B POPFHepatobiliary disorders | 6/52 |
| NeurologicalPsychiatric disorders | 4/52 |
| Deep Wound InfectionInfections and infestations | 3/52 |
| IleusGastrointestinal disorders | 3/52 |
| Age, Continuous(years) | Hemopatch |
|---|---|
| Median | 69 (59 to 74) |
| Sex: Female, Male(Participants) | Hemopatch |
|---|---|
| Female | 20 |
| Male | 32 |
| Race and Ethnicity Not Collected(Participants) | Hemopatch |
|---|
| Region of Enrollment(participants) | Hemopatch |
|---|---|
| Canada | 52 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2018 to primary completion in Oct 2020, 25 months.
Results were first posted in Aug 2021, 10 months after primary completion.
Of 324 non-industry phase 2 interventional studies under Pancreatic Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 80. This study's 25 months is below that.
Counting every sponsor, half of 393 studies reached it within 57 months; a quarter within 35 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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