K86
Conditions
Interventions
Group 1: Intervention group:
After partial pancreatectomy application of the SmartPAN® indicator to visualize any pancreatic leakage and upon surgeon’s decision subsequent targeted closure of pancreat
Sponsors
Magle Chemoswed AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Planned partial pancreatectomy for any indication including minimally invasive and open distal pancreatectomy and partial pancreatoduodenectomy 2. Age = 18 years 3. Ability of subject to understand character and individual consequences of the clinical trial. 4. Willing and able to give written informed consent for participation in the investigation
Exclusion criteria
Exclusion criteria: 1. American Society of Anesthesiologists (ASA) Score > 3 2. Pregnancy or lactation 3. Allergy or known intolerability to bromothymol blue or potato starch 4. Participation in another interventional trial with interference of intervention or outcome of this study 5. Any condition which could result in an undue risk for the patient in the opinion of the investigator 6. Expected lack of compliance or language problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this post market clinical follow-up trial is to confirm the usability as well as the safety of the indicator application in the clinical environment of elective pancreatic resection when used according to the instructions for use. | — |
Secondary
| Measure | Time frame |
|---|---|
| Usability endpoints: 1. Adherence to protocol of study product application 2. Usability evaluation by surgeon’s usability score (six dimensions: experience, ease of use, usefulness, ease of learning, intention to use, safety) Safety endpoints: 3. Frequencies of serious intraoperative complications and major postoperative complications (Clavien-Dindo grade III to V) within 30 days after the index operation including information on potential relation to usage of the trial device. 4. Duration of surgery (in minutes) 5. Intraoperative blood loss (in ml) 6. Rate of postoperative biochemical leak and grade B and C pancreatic fistula within 30 days after the index operation as defined by updated 2016 ISGPF consensus guidelines 7. Rate of non-surgical re-interventions within 30 days from index operation 8. Rate of re-operations within 30 days from index operation 9. 30-days mortality 10. 30-days health-related quality of life (HRQol) 11. Analysis of concentration of bromothymol blue (degradation product of pancreatic leakage indicator) in central venous blood 15 minutes after application of indicator and on postoperative day 2 and in abdominal drainage fluid at the end of surgery and on postoperative day 2. | — |
Countries
Germany
Contacts
Public ContactThilo Hackert
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Outcome results
None listed