Safety and Performance of a Synthetic Tissue Sealant in Reducing Fluid Leakage in Hepatobiliary and Pancreatic Surgery (SHIELDS)

June 29, 2023 updated by: Polyganics BV

Prospective, Multicenter Study to Evaluate the Safety and Performance of a syntHetic Tissue Sealant in Reducing fluId lEakage Following Elective hepatobiLiary anD Pancreatic Surgery

Polyganics BV (Groningen, The Netherlands), in close collaboration with University Hospital-Eppendorf (UKE) Hamburg, has developed the Sealing Device for use in hepato-pancreato-bilary (HPB) surgery to reduce leakage of fluids from the site of surgery into the abdominal cavity and as an adjunctive hemostatic device to control minimal to moderate bleeding at the surgical site. The Sealing Device has been challenged in pre-clinical testing (laboratory and in-vivo work), but has not been evaluated for safety and performance in humans.

This investigation will be conducted to clinically assess the safety and performance of Sealing Device as a means to reduce bile and pancreatic juice leakage in hepato-pancreato-bilary (HPB) surgery. Secondarily, the control of minimal to moderate bleeding will be assessed. To achieve adequate representation of the primary objective, the study will contain two separate surgical patient groups: Liver and Pancreas.

The primary objective of the study is to demonstrate safety and performance in reducing intra- and post-operative leakage (bile and pancreatic juices) by using the Sealing Device in patients undergoing elective hepatic resection or distal pancreatectomy.

The study will be conducted as an open-label, single-arm, multicenter study with a 16 months follow up. Up to 80 patients (40 liver and 40 pancreas patients) will be enrolled at up to 7 sites in Europe.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hamburg, Germany
        • Universitats Klinikum Hamburg-Eppendorf
      • Oldenburg, Germany
        • University Hospital Oldenburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Preoperative inclusion criteria:

Subjects will be eligible according the following criteria:

  1. Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
  2. Subjects who are ≥ 18 years old.
  3. Subjects who are able to comply with the follow-up or other requirements.
  4. Subjects who are planned for an elective hepatic resection or distal pancreatectomy.

During the surgery, the patients also need to comply with the intraoperative criteria.

Intraoperative inclusion criteria:

Subjects will be eligible according the following criteria:

1. Patch is applied manually (during open procedure, conversion procedure, or laparoscopic assisted procedure).

Exclusion Criteria:

Preoperative exclusion criteria

Subjects who meet any of the following criteria will be excluded from participation:

  1. Female subjects who are pregnant and/or breastfeeding.
  2. Subjects with a known allergy to any of the components of the Sealing Device (Polyurethane (SDPU), 8-ArmPEG40k-SC (SDA), Disodium Hydrogen Phosphate (Na2HPO4) (BS) and DC-Green #6 (SDD)).
  3. Subject with bleeding disorders requiring anti-coagulation medication (except acetylsalicylic acid).
  4. Subjects who receive double-coagulation.
  5. Subjects who receive peritoneal dialysis.
  6. Subjects who previously required liver transplantation.
  7. Subjects with a presence of systemic infection.
  8. Subject who previously participated in this study, or in any investigational drug- or device study within 30 days of screening.
  9. Subjects undergoing a procedure requiring an anastomosis (e.g. Klatskin tumours or Whipple).

Intraoperative exclusion criteria:

Subjects who meet any of the following criteria will be excluded from participation:

  1. Subjects with multivisceral resections, except resection of spleen.
  2. Not able to apply the patch(es) according to the Instructions For Use.
  3. Total surgery requiring > 3 HPB Sealing Devices of 10 x 5 cm (which equals a resection surface of more than 88cm2).

    Additional for liver group:

  4. Subjects with a Grade 3 or 4 of bleeding after primary closure after liver transection (Lewis 2016).
  5. Subjects with liver cirrhosis Grade C on the Child-Turcotte-Pugh score.

    Additional for pancreas group:

  6. Subjects with a margin of < 1 cm between the defect and the portal vein.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sealing Device
Sealing Device applied in hepatic resection or distal pancreatectomy
The Sealing Device is indicated for use in hepato-pancreato-biliary (HPB) surgery to reduce leakage of fluids from the site of surgery into the abdominal cavity and as an adjunctive hemostatic device to control minimal to moderate bleeding at the surgical site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bile leakage
Time Frame: 30 days
Incidence of post-operative bile leakage (International Study Group of Liver Surgery Bile leakage Grading Scale); categories in order of ascending severity: biochemical leak, Grade B or Grade C
30 days
Pancreatic leakage
Time Frame: 30 days
Incidence of post-operative pancreatic juice leakage (International Study Group of Pancreas Surgery Grading Scale); categories in order of ascending severity: biochemical leak, Grade B or Grade C
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: 30 days
Length of hospital stay
30 days
Bleeding
Time Frame: Day 1
Intra-operative control bleeding
Day 1
Leak-associated comorbidities
Time Frame: 16 months
Incidence of leak-associated comorbidities
16 months
re-intervention
Time Frame: 16 months
Incidence of re-intervention
16 months
Ease of Use
Time Frame: Day 1
Ease of Use of the device as measured by questionnaire
Day 1
Post-operative bile leakage
Time Frame: 90 and 180 days
Incidence of post-operative bile leakage (liver only)
90 and 180 days
Post-hepatectomy haemorrhage (PHH)
Time Frame: 30 days
Incidence of post-operative bleeding (liver only)
30 days
Post-operative pancreatic juice leakage
Time Frame: 90 and 180 days
Incidence of post-operative pancreatic juice leakage (pancreas only)
90 and 180 days
Post-pancreatectomy haemorrhage (PPH)
Time Frame: 30 days
Incidence of post-operative bleeding (pancreas only)
30 days
(Serious) Adverse Device Effects
Time Frame: 16 months
Incidence of (Serious) Adverse Device Effects
16 months
Incidence of transfusion
Time Frame: 16 months
Incidence of transfusion
16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2020

Primary Completion (Actual)

November 19, 2021

Study Completion (Actual)

May 26, 2023

Study Registration Dates

First Submitted

July 16, 2019

First Submitted That Met QC Criteria

July 17, 2019

First Posted (Actual)

July 18, 2019

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 29, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CIP-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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