A Phase 2 interventional study of Pancreatic duct occlusion with Neoprene and Pancreato-Jejunal anastomosis in Pancreatic Fistula, Pancreatic Neoplasms and Postoperative Complications, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. Completed at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-10-05.
Sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Phase 2, Interventional, and Treatment
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.
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.
9,371 studies on the registry are indexed under Neoplasms; 2,492 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 7,258 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Fondazione IRCCS Istituto Nazionale dei Tumori, Milano is the lead sponsor of 169 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
Patients considered at high risk for pancreatic fistula or oncological relapse due to introperative evaluation submitted to pancreatic duct occlusion with Neoprene-based glue.
Procedure: Pancreatic duct occlusion with Neoprene
Patients considered at low risk for pancreatic fistula submitted to pancreato-jejunal anastomosis.
Procedure: Pancreato-Jejunal anastomosis
Pancreatic duct occlusion of the pancreatic stump with Neoprene-based glue after Pancreatoduodenectomy.
Standardized pancreato-jejunal anastomosis after Pancreatoduodenectomy
Rate of postoperative complications of grade > II according to Dindo-Clavien classification
Comparison of 90-days clinically relevant postoperative morbidity rate of grade \> II according to Dindo-Clavien classification between the two arms.
Time frame: 90 days
Rate of overall postoperative complications
Comparison of 90-days overall postoperative morbidity rate of any grade according to Dindo-Clavien classification between the two arms.
Time frame: 90 days
Rate of postoperative mortality
Comparison of 90-days postoperative mortality rate between the two arms
Time frame: 90 days
Number of participants with onset of post-surgical diabetes
Comparison between arms of onset of newly diagnosed post-surgical diabetes needing tablets or insulin therapy during a follow-up period of 12 months
Time frame: 12 months
Percentual variation of weight after pancreatoduodenectomy
Comparison between arms of percentual weight variation between preoperative measure in kilograms and follow up at 1, 3, 6 and 12 months
Time frame: 12 months
Variation of Body Mass Index after pancreatoduodenectomy
Comparison between arms of Body Mass Index variation measured combining weight and height to report BMI in kg/m\^2 between preoperative evaluation and follow up at 1, 3, 6 and 12 months
Time frame: 12 months
Overall survival
Evaluation of overall survival in both arms of study
Time frame: 36 months
Plan to share: Undecided
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano