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2015-01-01
2019-01
2019-01
40
NCT03738787
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
INTERVENTIONAL
Treatment of the Pancreatic Stump With Neoprene®-Based Glue After High-risk Pancreatoduodenectomy
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 Ȭontrol 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-11-05 | N/A | 2021-10-04 |
2018-11-08 | N/A | 2021-10-05 |
2018-11-13 | N/A | 2021-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Pancreatic duct occlusion 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
|
| ACTIVE_COMPARATOR: Pancreato-Jejunal anastomosi Patients considered at low risk for pancreatic fistula submitted to pancreato-jejunal anastomosis. | PROCEDURE: Pancreato-Jejunal anastomosis
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | 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. | 90 days |
| Rate of postoperative mortality | Comparison of 90-days postoperative mortality rate between the two arms | 90 days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 12 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
