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Completed

NCT Number: NCT04024956

Safety and Performance of a Synthetic Tissue Sealant in Reducing Fluid Leakage in 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.

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Key information

Conditions

Pancreatectomy Hepatic Resection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitats Klinikum Hamburg-Eppendorf, Hamburg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Preoperative inclusion criteria:

Subjects will be eligible according the following criteria:

  • Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
  • Subjects who are ≥ 18 years old.
  • Subjects who are able to comply with the follow-up or other requirements.
  • 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:

  • 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:

  • Female subjects who are pregnant and/or breastfeeding.
  • 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)).
  • Subject with bleeding disorders requiring anti-coagulation medication (except acetylsalicylic acid).
  • Subjects who receive double-coagulation.
  • Subjects who receive peritoneal dialysis.
  • Subjects who previously required liver transplantation.
  • Subjects with a presence of systemic infection.
  • Subject who previously participated in this study, or in any investigational drug- or device study within 30 days of screening.
  • 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:

  • Subjects with multivisceral resections, except resection of spleen.
  • Not able to apply the patch(es) according to the Instructions For Use.
  • 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:

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

Additional for pancreas group:

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

Treatment and study plan

Sealing Device

Device

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Bleeding

    Time frame: Day 1

    Intra-operative control bleeding

  2. Leak-associated comorbidities

    Time frame: 16 months

    Incidence of leak-associated comorbidities

  3. re-intervention

    Time frame: 16 months

    Incidence of re-intervention

  4. Ease of Use

    Time frame: Day 1

    Ease of Use of the device as measured by questionnaire

  5. Post-operative bile leakage

    Time frame: 90 and 180 days

    Incidence of post-operative bile leakage (liver only)

  6. Post-hepatectomy haemorrhage (PHH)

    Time frame: 30 days

    Incidence of post-operative bleeding (liver only)

  7. Post-operative pancreatic juice leakage

    Time frame: 90 and 180 days

    Incidence of post-operative pancreatic juice leakage (pancreas only)

  8. Post-pancreatectomy haemorrhage (PPH)

    Time frame: 30 days

    Incidence of post-operative bleeding (pancreas only)

  9. (Serious) Adverse Device Effects

    Time frame: 16 months

    Incidence of (Serious) Adverse Device Effects

  10. Incidence of transfusion

    Time frame: 16 months

    Incidence of transfusion

  11. Length of hospital stay

    Time frame: 30 days

    Length of hospital stay

Sponsors and collaborators

Lead sponsor

Polyganics BV

Industry

Collaborators

  • Genae

Registry information

Official study title

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

Acronym: SHIELDS

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Jul 18, 2019
Registry last updated
Jul 3, 2023

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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