PATCH-DP: Intra-operative Application of HEMOPATCH to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy

• Sponsor: Sunnybrook Health Sciences Centre (Other)
• Overall Status: Completed
• CT.gov ID: NCT03410914
• Collaborator: Baxter Healthcare Corporation (Industry), Hamilton Health Sciences Corporation (Other), The Ottawa Hospital (Other), Kingston Health Sciences Centre (Other), Royal University Hospital Foundation (Other), London Health Sciences Centre (Other), University Health Network, Toronto (Other)
• Enrollment: 52
• Locations: 7
• Arm: 1
• Actual Duration (Months): 26.3
• Patients Per Site: 7.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Cancer; Pancreas Disease; Pancreas Adenocarcinoma; Pancreas; Fistula; Surgery; Surgery--Complications; Surgery Site Fistula	Device: Hemopatch	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Aug 13, 2018
• Actual Primary Completion Date: Oct 3, 2020
• Actual Study Completion Date: Oct 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hemopatch 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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With a Clinically Significant Post-operative Pancreatic Fistula (POPF) [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.

Secondary Outcome Measures

1. Number of Participants With a Post-operative Pancreatic Fistula (POPF) [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.

2. Number of Participants Who Experienced Post-Operative Complications [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.

3. 90-Day Mortality Count [Within 90 days post-operatively]

   Indicated by death within 90-days after surgery.

4. Average Length of Stay in Hospital [Within 90 days post-operatively]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamilton Health Sciences	Hamilton	Ontario	Canada
2	Kingston General Hospital	Kingston	Ontario	Canada	K7L 2V7
3	London Health Sciences Centre	London	Ontario	Canada	N6A 5W9
4	The Ottawa Hospital	Ottawa	Ontario	Canada	K1H 8L6
5	University Health Network	Toronto	Ontario	Canada	M5G2N2
6	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada
7	Royal University Hospital	Saskatoon	Saskatchewan	Canada	S7N 0W8

Sponsors and Collaborators

• Sunnybrook Health Sciences Centre
• 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

Investigators

• Principal Investigator: Paul Karanicolas, MD, Sunnybrook Health Sciences Centre

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 18, 2018

More Information

Publications

None provided.

• Responsible Party: Sunnybrook Health Sciences Centre
• ClinicalTrials.gov Identifier: NCT03410914
• Other Study ID Numbers: 346-2017
• First Posted: Jan 25, 2018
• Last Update Posted: Nov 3, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sunnybrook Health Sciences Centre: Hemopatch
• Additional relevant MeSH terms: Pancreatic Neoplasms; Pancreatic Fistula; Pancreatic Diseases; Fistula

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Hemopatch
Arm/Group Description	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.
Period Title: Overall Study
STARTED	52
COMPLETED	52
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Hemopatch
Arm/Group Description	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 Participants	52
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	69
Sex: Female, Male (Count of Participants)
Female	20 38.5%
Male	32 61.5%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Canada	52 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Clinically Significant Post-operative Pancreatic Fistula (POPF)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hemopatch
Arm/Group Description	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.
Measure Participants	52
Count of Participants [Participants]	13 25%

2. Secondary Outcome

Title	Number of Participants With a Post-operative Pancreatic Fistula (POPF)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hemopatch
Arm/Group Description	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.
Measure Participants	52
Count of Participants [Participants]	25 48.1%

3. Secondary Outcome

Title	Number of Participants Who Experienced Post-Operative Complications
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hemopatch
Arm/Group Description	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.
Measure Participants	52
Count of Participants [Participants]	14 26.9%

4. Secondary Outcome

Title	90-Day Mortality Count
Description	Indicated by death within 90-days after surgery.
Time Frame	Within 90 days post-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hemopatch
Arm/Group Description	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.
Measure Participants	52
Count of Participants [Participants]	2 3.8%

5. Secondary Outcome

Title	Average Length of Stay in Hospital
Description	Number of days from date of surgery (POD0) to the date of discharge
Time Frame	Within 90 days post-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hemopatch
Arm/Group Description	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.
Measure Participants	52
Median (Inter-Quartile Range) [days]	6

Adverse Events

Time Frame	Adverse events were recorded up until 90 days post-operative.
Arm/Group Title	Hemopatch
Arm/Group Description	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.
All Cause Mortality
	Hemopatch
	Affected / at Risk (%)	# Events
Total	2/52 (3.8%)
Serious Adverse Events
	Hemopatch
	Affected / at Risk (%)	# Events
Total	14/52 (26.9%)
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation	1/52 (1.9%)	1
Cardiac disorders
Atrial Fibrillation	1/52 (1.9%)	1
Acute Coronary Syndrome/NSTEMI	1/52 (1.9%)	1
Gastrointestinal disorders
Colonic Anastomotic Leak	2/52 (3.8%)	2
General disorders
Bleed	3/52 (5.8%)	3
Hepatobiliary disorders
Grade B POPF	6/52 (11.5%)	6
Grade C POPF	1/52 (1.9%)	1
Pancreatitis	1/52 (1.9%)	1
Bile Leak	1/52 (1.9%)	1
Infections and infestations
Intra-Abdominal Abscess	1/52 (1.9%)	1
Renal and urinary disorders
Urinary Retention	1/52 (1.9%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory Distress	1/52 (1.9%)	1
Other (Not Including Serious) Adverse Events
	Hemopatch
	Affected / at Risk (%)	# Events
Total	21/52 (40.4%)
Gastrointestinal disorders
Ileus	3/52 (5.8%)	3
Hepatobiliary disorders
Grade B POPF	6/52 (11.5%)	6
Biochemical Leak (Grade A POPF)	12/52 (23.1%)	12
Infections and infestations
Deep Wound Infection	3/52 (5.8%)	3
Psychiatric disorders
Neurological	4/52 (7.7%)	4

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.