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Completed

NCT Number: NCT03410914

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.

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Key information

Conditions

Pancreas Cancer Digestive System Diseases Digestive System Fistula Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Fistula Neoplasms Neoplasms by Site Pancreas Adenocarcinoma Pancreas Disease Pancreas; Fistula Pancreatic Diseases Pancreatic Fistula Pancreatic Neoplasms Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Surgery Surgery Site Fistula Surgery--Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hamilton Health Sciences, Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

HEMOPATCH

Device

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

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: Within 90 days post-operatively

    Indicated by death within 90-days after surgery.

  4. Average Length of Stay in Hospital

    Time frame: Within 90 days post-operatively

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

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Baxter Healthcare Corporation
  • Hamilton Health Sciences Corporation
  • Kingston Health Sciences Centre
  • London Health Sciences Centre
  • Royal University Hospital Foundation
  • The Ottawa Hospital
  • University Health Network, Toronto

Registry information

Official study 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

Acronym: PATCH-DP

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 25, 2018
Registry last updated
Nov 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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