Fistula Pancreatic
Conditions
Keywords
Fistula, postoperative pancreatic fistula, pancreatoduodenectomy
Brief summary
The aim of this prospective, randomized, blinded clinical superiority trial is to establish intraoperative placement of biodegradable stents in the pancreatojejunostomy as a safe, effective, and feasible preventive measure against pancreatic fistula following pancreatoduodenectomy. The investigators hypothesize that intraoperative placement of biodegradable stents in the pancreatojejunostomy is safe and can reduce the risk of pancreatic leakage following pancreatoduodenectomy in patients who have not undergone PBD.
Interventions
PROCEDUREFast Degradable, Biodegradable ARCHEMEDES stent
Fast Degradable, Biodegradable ARCHEMEDES stent. Placed in the pancreaticojejunostomy.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The investigators will mask the allocation for the outcome assessors and trial statistician who will conduct the analyses, and the author group while writing the abstract for the trial report with the two intervention groups coded as 0 and 1. Due to the nature of the intervention and control, the trial will not be blinded for the surgeons performing the interventions
Intervention model description
prospective, randomized, blinded clinical superiority trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing a pancreatoduodenectomy 2. Patients aged 18 or above 3. Patients who have given an informed consent
Exclusion criteria
1. Patients who do not or cannot give an informed consent. 2. Patients with at a high risk or with previous history of multiple thrombo-embolic diseases or bleeding disorders. 3. Patients undergoing active immunosuppressive therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| POPF | 30 days | Number of participants with a Postoperative pancreatic fistula |
| Number of participants with a Biliary fistula | 30 days | Postoperative biliary fistula |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 30 days and 90 days | Participant Mortality at 30 and 90 days |
| Complications to stent placement | 30 days | Incidence of complications to placement of the biodegradable stent, including displacement. |
| Quality of Life according to VR12 Quality of Life Score | 30 days post surgery | Patient reported quality of life according to VR12 Quality of Life Score (activity level, pain episodes, pain levels, patient mood) |
| LOS | Length in days, from surgery until discharge ( up to 200 days from surgery) | Participant Length of hospital stay (LOS). |
| Postoperative complications | 30 days postoperative | Overall incidence of complications following PD classified according to Clavien-Dindo |
Countries
Denmark
Outcome results
None listed