Pancreatic FistulaPhase 2NCT03738787
Treatment of the Pancreatic Stump With Neoprene®-Based Glue After High-risk Pancreatoduodenectomy
A Phase 2 study testing Pancreatic duct occlusion with Neoprene and Pancreato-Jejunal anastomosis in people with Pancreatic Fistula and Pancreatic Neoplasms, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatic Fistula, Pancreatic Neoplasms, Postoperative Complications
- What is being tested?
- Pancreatic duct occlusion with Neoprene and Pancreato-Jejunal anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2015to Jan 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an alternative-Fistula Risk Score >15%.
- Patients with insulin-dependent diabetes.
- Cirrhotic patients or with histologically proven chronic liver disease.
- Age> 75 years (relative criterion, ie insufficient by itself to justify the procedure and therefore to be associated with one of the other cited criteria).
- Patients with intraoperative demonstration on histological examination of lymph node metastasis;
- Patients with R1 interventions.
- Presence of minimal extra-pancreatic tumor disease not detected pre-operatively (nodule of carcinosis, single liver metastasis) and removed with the primary tumor within the same intervention;
- Patients undergoing preoperative radiotherapy / chemotherapy for tumors reconverted to surgical operability.
Who cannot join
- All other patients who undergo PD in which the eligibility conditions for the study group are not present, are enrolled in the Control Arm..
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Exocrine Pancreatectomy With Neoprene®-Based Glue After High-risk Pancreatoduodenectomy (PD) in Patients With Pancreatic, Papilla, Duodenal, and Distal Choledochus Neoplasm
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.
Read the 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.
- Being tested
- Pancreatic duct occlusion with Neoprene, Pancreato-Jejunal anastomosis
- Medical subject headings
- Pancreatic Fistula, Pancreatic Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic duct occlusion with NeopreneProcedure or surgery
Pancreatic duct occlusion of the pancreatic stump with Neoprene-based glue after Pancreatoduodenectomy.
Pancreato-Jejunal anastomosisProcedure or surgery
Standardized pancreato-jejunal anastomosis after Pancreatoduodenectomy
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic duct occlusion | Experimental | Patients considered at high risk for pancreatic fistula or oncological relapse due to introperative evaluation submitted to pancreatic duct occlusion with Neoprene-based glue. Receives: Procedure: Pancreatic duct occlusion with Neoprene |
| Pancreato-Jejunal anastomosi | Active comparator | Patients considered at low risk for pancreatic fistula submitted to pancreato-jejunal anastomosis. Receives: Procedure: Pancreato-Jejunal anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 90 days
Rate of postoperative mortality
Comparison of 90-days postoperative mortality rate between the two arms
Measured: 90 days
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start1 Jan 2015
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Mazzaferro, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738787
- Sponsor's protocol ID
- 191/14
- Status last verified
- Oct 2021
- First submitted
- 5 Nov 2018
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mazzaferro V, Virdis M, Sposito C, Cotsoglou C, Droz Dit Busset M, Bongini M, Flores M, Prinzi N, Coppa J. Permanent Pancreatic Duct Occlusion With Neoprene-based Glue Injection After Pancreatoduodenectomy at High Risk of Pancreatic Fistula: A Prospective Clinical Study. Ann Surg. 2019 Nov;270(5):791-798. doi: 10.1097/SLA.0000000000003514.
PubMed 31567180
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Exocrine Pancreatectomy With Neoprene®-Based Glue After High-risk Pancreatoduodenectomy (PD) in Patients With Pancreatic, Papilla, Duodenal, and Distal Choledochus Neoplasm
- ClinicalTrials.gov ID
- NCT03738787
- Acronym / sponsor ID
- 191/14
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreatic duct occlusion | Experimental | Procedure: Pancreatic duct occlusion with NeoprenePatients considered at high risk for pancreatic fistula or oncological relapse due to introperative evaluation submitted to pancreatic duct occlusion with Neoprene-based glue. |
| Pancreato-Jejunal anastomosi | Active comparator | Procedure: Pancreato-Jejunal anastomosisPatients considered at low risk for pancreatic fistula submitted to pancreato-jejunal anastomosis. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with an alternative-Fistula Risk Score >15%.
- Patients with insulin-dependent diabetes.
- Cirrhotic patients or with histologically proven chronic liver disease.
- Age> 75 years (relative criterion, ie insufficient by itself to justify the procedure and therefore to be associated with one of the other cited criteria).
- Patients with intraoperative demonstration on histological examination of lymph node metastasis;
Key exclusion criteria (1 listed)
- All other patients who undergo PD in which the eligibility conditions for the study group are not present, are enrolled in the Control Arm..
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pancreatic duct occlusion with NeoprenePancreatic duct occlusion of the pancreatic stump with Neoprene-based glue after Pancreatoduodenectomy. | Procedure or surgery | Pancreatic duct occlusion |
| Pancreato-Jejunal anastomosisStandardized pancreato-jejunal anastomosis after Pancreatoduodenectomy | Procedure or surgery | Pancreato-Jejunal anastomosi |
Primary outcome
Rate of postoperative complications of grade > II according to Dindo-Clavien classification
Time frame: 90 days
Comparison of 90-days clinically relevant postoperative morbidity rate of grade > II according to Dindo-Clavien classification between the two arms.
Rate of overall postoperative complications
Time frame: 90 days
Comparison of 90-days overall postoperative morbidity rate of any grade according to Dindo-Clavien classification between the two arms.
Rate of postoperative mortality
Time frame: 90 days
Comparison of 90-days postoperative mortality rate between the two arms
3 secondary outcomes
Number of participants with onset of post-surgical diabetes
Time frame: 12 months
Percentual variation of weight after pancreatoduodenectomy
Time frame: 12 months
Variation of Body Mass Index after pancreatoduodenectomy
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Derived from this study: PubMed 31567180Mazzaferro V, Virdis M, Sposito C, Cotsoglou C, Droz Dit Busset M, Bongini M, Flores M, Prinzi N, Coppa J. Permanent Pancreatic Duct Occlusion With Neoprene-based Glue Injection After Pancreatoduodenectomy at High Risk of Pancreatic Fistula: A Prospective Clinical Study. Ann Surg. 2019 Nov;270(5):791-798. doi: 10.1097/SLA.0000000000003514.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pancreatic duct occlusion with Neoprene and Pancreato-Jejunal anastomosis in people with Pancreatic Fistula and Pancreatic Neoplasms, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of postoperative complications of grade > II according to Dindo-Clavien classification (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03738787, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.