Efficacy of Amniotic Membrane Over Pancreatic Anastomosis After Pancreaticoduodenenctomy to Preventing Pancreatic Fistula
Condition: Post Operative Pancreatic Fistula; Pancreatic Resection; Biological Dressing
MeSH terms: Pancreatic Fistula; Fistula
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      Twenty consecutive patients candidated to PD regardless the diagnosis will be enrolled if
      presenting an high Fistula Risk Score. Enrollement will be done in O.R. after frozen section
      of the pancreas. The AM is provided by Fondazione Banca dei Tessuti di Treviso Onlus. The
      placenta is sourced from donors undergoing caesarean sections and processed shortly after
      retrieval, donors are evaluated according to Italian requirements. The AM is carefully
      detached from the chorion and rinsed with sterile saline solution, flattened on a
      nitrocellulose membrane filter (Merck Millipore), with its stromal side facing down, in
      contact with the filter. The AM is then immersed in a cocktail of antibiotics then cut into
      patches and immersed in cryopreservant solution. Cryopreservation was achieved using a
      programmable cryogenic freezer (Planer KryoSave Integra, 750-30), which triggers a controlled
      cooling rate. The AM patches were stored in vapor-phase liquid nitrogen. Thirty minutes
      before its use, the AM was defrozen and washed with saline. A 10x15cm MA patch was placed
      around the pancreatic anastomoses starting from the posterior surface. The caudal and the
      cranial flap were overlapped on the anterior surface to wrap the anastomosis. The membrane
      was than fixed with 4-0 Monocryl sutures at the jejunal surface and at the peri-pancreatic
      tissue. Then an end-to-side bilio-enteric anastomosis was carried out. The reconstruction was
      completed by an end-to-side antecolic duodenojejunostomy. At the end of the procedure, two
      drains were placed ventral and dorsal to the PJ, without friction with the AM.

      In the postoperative period will be evaluated: morbidity according to Clavien Dindo
      classification with attention to clinical relevant pancreatic fistula, bleeding, need of
      reintervention, surgical site infection, multi drug resistant infection and mortality. Costs
      and postoperative staying will be monitored as well.

      Student t test, Mann Whitney and Chi square will be used for statistical analysis.
    

Intervention name(s): Amniotic Membrane implantation
Intervention type(s): Procedure
Intervention description(s): Surgical procedure will be performed with Longemire Traverso technique. At the end of all pancreatic, biliary and duodenal anastomosis, the AM will be implanted.
Intervention model: Single Group Assignment
Intervention model description: Pilot study
Masking: None (Open Label)
Primary purpose: Prevention