Treatment of the Pancreatic Stump With Neoprene®-Based Glue After High-risk Pancreatoduodenectomy
Condition: Pancreatic Fistula; Pancreatic Neoplasms; Postoperative Complications
MeSH terms: Neoplasms; Pancreatic Neoplasms; Pancreatic Fistula; Fistula; Postoperative Complications
Study type: Interventional
Phase: Phase 2

Summary: 
      The study evaluates the safety and efficacy of Neoprene-based glue in the management of
      pancreatic stump after pancreatoduodenectomy (PD) in patients at high risk for pancreatic
      fistula and early neoplastic recurrence, compared with a population of patients at
      conventional risk.
    

Detailed description: 
      Although improved in many aspects, the PD intervention is still burdened by a significant
      morbidity, related above all to the delicate phase following the removal of the tumor which
      involves the reconstruction of the gastro-enteric, biliary and especially pancreatic pathway.
      Among the many variants of the reconstructive phase, that of pancreato-jejunal anastomosis is
      the one burdened by the highest complication rate (quantified around 40%, with a percentage
      of pancreatic fistula between 5% and 35%).

      In cases at risk of pancreatic fistula it is possible not to perform a conventional
      pancreato-jejunal anastomosis, but to decide to inject into the pancreatic stump the
      solidifying glues with the aim of inducing a chemical pancreatectomy of the exocrine
      component of the pancreas.

      Neoprene® (Polychloroprene) has the property of polymerizing and solidifying in an
      environment with a pH lower than its own (pH <12).

      After a systematic review of the sporadic experiences of chemical pancreatectomy published
      until today, due to the increased complexity of the surgical cases of patients undergoing PD,
      the investigators have undertaken a formal, single-center prospective study, aimed at
      clarifying the safety and efficacy data of a Neoprene®-based glue in patients selected
      through objective criteria (such as the high risk of pancreatic fistula and early tumor
      recovery after pancreatoduodenectomy).

      In this study is expected the prospective collection of a cohort of patients with tumor of
      the head of the pancreas, papilla, duodenum and distal choledochus to undergo
      pancreatoduodenectomy (PD) at high risk of pancreatic fistula and / or local recurrence
      ("Study Arm").

      At the same time a second cohort of patients with the same type of neoplasia will be
      collected, subjected to PD intervention in which however it will be possible to proceed with
      pancreato-jejunal anastomosis. This group will be defined as "Control Arm".

      The first cohort will be the group of patients in which to detect the safety and efficacy of
      the treatment with Neoprene®-based glue.

      The second cohort will be the comparative control group against which patients treated with
      Neoprene®-based glue can be compared in the hypothesis that peri-operative
      morbidity,mortality and short and long-term side effects of the intervention are equivalent.
    

Intervention name(s): Pancreatic duct occlusion with Neoprene; Pancreato-Jejunal anastomosis
Intervention type(s): Procedure; Procedure
Intervention description(s): Pancreatic duct occlusion of the pancreatic stump with Neoprene-based glue after Pancreatoduodenectomy.; Standardized pancreato-jejunal anastomosis after Pancreatoduodenectomy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment