Safety and Performance of a Synthetic Tissue Sealant in Reducing Fluid Leakage in Hepatobiliary and Pancreatic Surgery (SHIELDS)
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|ClinicalTrials.gov Identifier: NCT04024956|
Recruitment Status : Not yet recruiting
First Posted : July 18, 2019
Last Update Posted : March 5, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatectomy Hepatic Resection||Device: Sealing Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-label, single-arm, multicenter study|
|Masking:||None (Open Label)|
|Official 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|
|Estimated Study Start Date :||June 2020|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||October 2021|
Experimental: Sealing Device
Sealing Device applied in hepatic resection or distal pancreatectomy
Device: Sealing 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.
- 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
- 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
- Bleeding [ Time Frame: Day 1 ]Intra-operative control bleeding
- Leak-associated comorbidities [ Time Frame: 16 months ]Incidence of leak-associated comorbidities
- re-intervention [ Time Frame: 16 months ]Incidence of re-intervention
- Ease of Use [ Time Frame: Day 1 ]Ease of Use of the device as measured by questionnaire
- Post-operative bile leakage [ Time Frame: 90 and 180 days ]Incidence of post-operative bile leakage (liver only)
- Post-hepatectomy haemorrhage (PHH) [ Time Frame: 30 days ]Incidence of post-operative bleeding (liver only)
- Post-operative pancreatic juice leakage [ Time Frame: 90 and 180 days ]Incidence of post-operative pancreatic juice leakage (pancreas only)
- Post-pancreatectomy haemorrhage (PPH) [ Time Frame: 30 days ]Incidence of post-operative bleeding (pancreas only)
- (Serious) Adverse Device Effects [ Time Frame: 16 months ]Incidence of (Serious) Adverse Device Effects
- Incidence of transfusion [ Time Frame: 16 months ]Incidence of transfusion
- Length of hospital stay [ Time Frame: 30 days ]Length of hospital stay
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04024956
|Contact: Hilde Geraedts, PhD||+31 50 588 firstname.lastname@example.org|
|Contact: Ester Maas-Soer, MSc||+31 50 588 email@example.com|