Hepatic Resection, Pancreatectomy
Conditions
Keywords
Hepatic resection, Distal pancreatectomy, Sealant
Brief summary
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.
Interventions
DEVICESealing 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.
Sponsors
Genae
Polyganics BV
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, single-arm, multicenter study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bile leakage | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Post-operative bile leakage | 90 and 180 days | Incidence of post-operative bile leakage (liver only) |
| Post-hepatectomy haemorrhage (PHH) | 30 days | Incidence of post-operative bleeding (liver only) |
| (Serious) Adverse Device Effects | 16 months | Incidence of (Serious) Adverse Device Effects |
| Incidence of transfusion | 16 months | Incidence of transfusion |
| re-intervention | 16 months | Incidence of re-intervention |
| Post-operative pancreatic juice leakage | 90 and 180 days | Incidence of post-operative pancreatic juice leakage (pancreas only) |
| Post-pancreatectomy haemorrhage (PPH) | 30 days | Incidence of post-operative bleeding (pancreas only) |
| Bleeding | Day 1 | Intra-operative control bleeding |
| Leak-associated comorbidities | 16 months | Incidence of leak-associated comorbidities |
| Length of hospital stay | 30 days | Length of hospital stay |
| Ease of Use | Day 1 | Ease of Use of the device as measured by questionnaire |
Countries
Germany
Outcome results
None listed