At a glance
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Efficacy of Amniotic Membrane Implantation Over Pancreo-jejunal Anastomosis After Pancreaticoduodenectomy in Reducing Post-operative Pancreatic Fistula POPF.
In Brief
A Phase 1 clinical trial evaluating Amniotic Membrane implantation for Post Operative Pancreatic Fistula and 2 related conditions. Completed, enrolled 20 participants across 1 site.
Detailed Summary
Post-operative pancreatic fistula (POPF) after pancreatic resection is a potentially life-threatening complication occuring in up to 27% of patients undergoing a pancreatic resection. Despite several strategies have been proposed further improvements are needed. Many studies suggest that amniotic membrane(AM) implantation is effective in tissue regeneration and prevention of fluid leakage at many surgical sites. However,the implantation of AM has never been used in pancreatic surgery. After having completed the first case of implantation of AM we proceed with this pilot study to determine in 20 consecutive patients undergone to pancreaticoduodenectomy (PD) with high risk of POPF, the efficacy of AM in reducing this event and the related morbidity.
Study Details
Timeline
Interventions
Surgical procedure will be performed with Longemire Traverso technique. At the end of all pancreatic, biliary and duodenal anastomosis, the AM will be implanted.