Trial Outcomes & Findings for Intra-operative Application of HEMOPATCH to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy (NCT NCT03410914)

NCT ID: NCT03410914

Last Updated: 2021-11-03

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 52 participants
• Primary outcome timeframe: Within 90 days post-operatively
• Results posted on: 2021-11-03

Participant Flow

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.

Participant milestones

Measure	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.
Overall Study STARTED	52
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Hemopatch n=52 Participants 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.
Age, Continuous	69 years n=52 Participants
Sex: Female, Male Female	20 Participants n=52 Participants
Sex: Female, Male Male	32 Participants n=52 Participants
Region of Enrollment Canada	52 participants n=52 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Hemopatch n=52 Participants 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.
Number of Participants With a Clinically Significant Post-operative Pancreatic Fistula (POPF)	13 Participants

SECONDARY outcome

Timeframe: Within 90 days post-operatively

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.

Outcome measures

Measure	Hemopatch n=52 Participants 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.
Number of Participants With a Post-operative Pancreatic Fistula (POPF)	25 Participants

SECONDARY outcome

Timeframe: Within 90 days post-operatively

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.

Outcome measures

Measure	Hemopatch n=52 Participants 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.
Number of Participants Who Experienced Post-Operative Complications	14 Participants

SECONDARY outcome

Timeframe: Within 90 days post-operatively

Indicated by death within 90-days after surgery.

Outcome measures

Measure	Hemopatch n=52 Participants 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.
90-Day Mortality Count	2 Participants

SECONDARY outcome

Timeframe: Within 90 days post-operatively

Number of days from date of surgery (POD0) to the date of discharge

Outcome measures

Measure	Hemopatch n=52 Participants 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.
Average Length of Stay in Hospital	6 days Interval 4.0 to 8.0

Adverse Events

Hemopatch

Serious events: 14 serious events

Other events: 21 other events

Deaths: 2 deaths

Serious adverse events

Measure	Hemopatch n=52 participants at risk 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.
Hepatobiliary disorders Grade C POPF	1.9% 1/52 • Number of events 1 • Adverse events were recorded up until 90 days post-operative.
Infections and infestations Intra-Abdominal Abscess	1.9% 1/52 • Number of events 1 • Adverse events were recorded up until 90 days post-operative.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	1.9% 1/52 • Number of events 1 • Adverse events were recorded up until 90 days post-operative.
Cardiac disorders Atrial Fibrillation	1.9% 1/52 • Number of events 1 • Adverse events were recorded up until 90 days post-operative.
Hepatobiliary disorders Grade B POPF	11.5% 6/52 • Number of events 6 • Adverse events were recorded up until 90 days post-operative.
General disorders Bleed	5.8% 3/52 • Number of events 3 • Adverse events were recorded up until 90 days post-operative.
Gastrointestinal disorders Colonic Anastomotic Leak	3.8% 2/52 • Number of events 2 • Adverse events were recorded up until 90 days post-operative.
Hepatobiliary disorders Pancreatitis	1.9% 1/52 • Number of events 1 • Adverse events were recorded up until 90 days post-operative.
Hepatobiliary disorders Bile Leak	1.9% 1/52 • Number of events 1 • Adverse events were recorded up until 90 days post-operative.
Blood and lymphatic system disorders Disseminated Intravascular Coagulation	1.9% 1/52 • Number of events 1 • Adverse events were recorded up until 90 days post-operative.
Renal and urinary disorders Urinary Retention	1.9% 1/52 • Number of events 1 • Adverse events were recorded up until 90 days post-operative.
Cardiac disorders Acute Coronary Syndrome/NSTEMI	1.9% 1/52 • Number of events 1 • Adverse events were recorded up until 90 days post-operative.

Other adverse events

Measure	Hemopatch n=52 participants at risk 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.
Infections and infestations Deep Wound Infection	5.8% 3/52 • Number of events 3 • Adverse events were recorded up until 90 days post-operative.
Hepatobiliary disorders Grade B POPF	11.5% 6/52 • Number of events 6 • Adverse events were recorded up until 90 days post-operative.
Hepatobiliary disorders Biochemical Leak (Grade A POPF)	23.1% 12/52 • Number of events 12 • Adverse events were recorded up until 90 days post-operative.
Psychiatric disorders Neurological	7.7% 4/52 • Number of events 4 • Adverse events were recorded up until 90 days post-operative.
Gastrointestinal disorders Ileus	5.8% 3/52 • Number of events 3 • Adverse events were recorded up until 90 days post-operative.

Additional Information

Dr. Paul Karanicolas

Sunnybrook Health Sciences Centre

Phone: 4164806100

Email: paul.karanicolas@sunnybrook.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place