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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
50
Fast Degradable, Biodegradable ARCHEMEDES stent. Placed in the pancreaticojejunostomy.
Rigshospitalet
Copenhagen, Capitol, Denmark
POPF
Number of participants with a Postoperative pancreatic fistula
Time frame: 30 days
Number of participants with a Biliary fistula
Postoperative biliary fistula
Time frame: 30 days
Complications to stent placement
Incidence of complications to placement of the biodegradable stent, including displacement.
Time frame: 30 days
Postoperative complications
Overall incidence of complications following PD classified according to Clavien-Dindo
Time frame: 30 days postoperative
Mortality
Participant Mortality at 30 and 90 days
Time frame: 30 days and 90 days
LOS
Participant Length of hospital stay (LOS).
Time frame: Length in days, from surgery until discharge ( up to 200 days from surgery)
Quality of Life according to VR12 Quality of Life Score
Patient reported quality of life according to VR12 Quality of Life Score (activity level, pain episodes, pain levels, patient mood)
Time frame: 30 days post surgery
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