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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03410914

Acronym

PATCH-DP

Enrollment

Registered

2018-01-25

Start date

2018-08-13

Completion date

2020-10-23

Last updated

2021-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas Cancer, Pancreas Disease, Pancreas Adenocarcinoma, Pancreas; Fistula, Surgery, Surgery--Complications, Surgery Site Fistula

Keywords

Hemopatch

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.

Interventions

DEVICEHemopatch

Application of hemopatch to the divided end of the pancreas during surgery.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
90-Day Mortality Count	Within 90 days post-operatively	Indicated by death within 90-days after surgery.
Average Length of Stay in Hospital	Within 90 days post-operatively	Number of days from date of surgery (POD0) to the date of discharge

Countries

Canada

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.

Participants by arm

Arm	Count
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.	52
Total	52

Baseline characteristics

Characteristic	Hemopatch	—
Age, Continuous	69 years	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Canada	52 participants	—
Sex: Female, Male Female	20 Participants	—
Sex: Female, Male Male	32 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	2 / 52
other Total, other adverse events	21 / 52
serious Total, serious adverse events	14 / 52

Outcome results

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.