SPIRIT 2013 statement: defining standard protocol items for clinical trials.
An-Wen Chan, Jennifer M Tetzlaff, Douglas G Altman...
https://pubmed.ncbi.nlm.nih.gov/23295957Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05668260
Internal Biodegradable Stent Versus No Stent in Patients at High Risk of Fistula After Pancreatoduodenectomy A Randomized Controlled Study
Led by Ospedale San Raffaele · Updated on 2025-03-14
122
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
O
Ospedale San Raffaele
Lead Sponsor
A
amg International
Collaborating Sponsor
AI-Summary
What this Trial Is About
Clinically relevant postoperative pancreatic fistula (CR-POPF) is a serious complication after pancreatoduodenectomy (PD), often leading to significant health risks including high mortality. Researchers are evaluating whether placing a biodegradable internal pancreatic stent can better prevent CR-POPF compared to no stenting in patients undergoing PD, focusing on those at high risk of developing this complication. This randomized controlled study is conducted at a single center to assess the potential benefits of this new device. Participants will be randomly assigned to one of two groups. One group will receive a biodegradable internal pancreatic stent (ARCHIMEDES™) placed at the site of the pancreatic anastomosis during surgery, designed to reduce stent displacement. The other group will undergo PD without any stent placement. The device is shaped to fit the jejunal loop to minimize movement. The study compares the occurrence of CR-POPF between these two approaches. Throughout the study, participants will be monitored from three days after surgery up to three months to track the development and severity of CR-POPF as well as other outcomes like postoperative complications, length of hospital stay, time to functional recovery, quality of life, and cost-effectiveness. Stent displacement will also be assessed 10 days after surgery. The total follow-up period is three months, with careful evaluation of health status and recovery progress during this time.
CONDITIONS
Brief Title
Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patients undergoing pancreatoduodenectomy (PD)
- Able to provide informed consent
You will not qualify if you...
- Previous distal pancreatectomy
- Patients with low, intermediate, or moderate risk of postoperative pancreatic fistula (fistula risk score less than 7)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery
Participants undergo pancreatoduodenectomy surgery during which they are randomized to receive either an internal biodegradable pancreatic stent or no stent at the pancreatic anastomosis.
1 visit (in-person)
Post-operative Follow-up
Duration - Up to 3 months after surgery
Participants are monitored for clinically relevant postoperative pancreatic fistula (CR-POPF), postoperative morbidity, stent displacement (if applicable), and recovery outcomes including length of hospital stay and quality of life.
Approximately weekly visits for up to 3 months
Trial Site Locations
Total: 1 location
1
IRCCS Ospedale San Raffaele
Milan, Milan, Italy, 20132
Actively Recruiting
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Research Team
M
Massimo Falconi, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After.
Claudio Bassi, Giovanni Marchegiani, Christos Dervenis...
https://pubmed.ncbi.nlm.nih.gov/28040257Current Definition of and Controversial Issues Regarding Postoperative Pancreatic Fistulas.
Giovanni Marchegiani, Stefano Andrianello, Roberto Salvia...
https://pubmed.ncbi.nlm.nih.gov/30419630The role of acinar content at pancreatic resection margin in the development of postoperative pancreatic fistula and acute pancreatitis after pancreaticoduodenectomy.
Stefano Partelli, Valentina Andreasi, Marco Schiavo Lena...
https://pubmed.ncbi.nlm.nih.gov/33933282Early recognition of clinically relevant postoperative pancreatic fistula: a systematic review.
F Jasmijn Smits, I Quintus Molenaar, Marc G Besselink...
https://pubmed.ncbi.nlm.nih.gov/31445782Pancreatic anastomosis after pancreatoduodenectomy: A position statement by the International Study Group of Pancreatic Surgery (ISGPS).
Shailesh V Shrikhande, Masillamany Sivasanker, Charles M Vollmer...
https://pubmed.ncbi.nlm.nih.gov/28027816Postoperative pancreatic fistula: a review of traditional and emerging concepts.
Christopher B Nahm, Saxon J Connor, Jaswinder S Samra...
https://pubmed.ncbi.nlm.nih.gov/29588609Systematic review and meta-analysis of outcomes after intraoperative pancreatic duct stent placement during pancreaticoduodenectomy.
J J Xiong, K Altaf, R Mukherjee...
https://pubmed.ncbi.nlm.nih.gov/22622664Stents for the prevention of pancreatic fistula following pancreaticoduodenectomy.
Zhiyong Dong, Jing Xu, Zhen Wang...
https://pubmed.ncbi.nlm.nih.gov/27153248External pancreatic duct stent decreases pancreatic fistula rate after pancreaticoduodenectomy: prospective multicenter randomized trial.
Patrick Pessaux, Alain Sauvanet, Christophe Mariette...
https://pubmed.ncbi.nlm.nih.gov/21368658