Clinical trial · Interventional
Treatment of the Pancreatic Stump With Neoprene®-Based Glue After High-risk Pancreatoduodenectomy
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
NCT03738787CI-TRIAL-00054274completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Fistula | — | UNRESOLVED | — |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Postoperative Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pancreatic duct occlusion with Neoprene | Procedure | — | UNRESOLVED |
| Pancreato-Jejunal anastomosis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pancreatic duct occlusion
- description
- Patients considered at high risk for pancreatic fistula or oncological relapse due to introperative evaluation submitted to pancreatic duct occlusion with Neoprene-based glue.
- interventionNames
- Procedure: Pancreatic duct occlusion with Neoprene
- type
- ACTIVE_COMPARATOR
- label
- Pancreato-Jejunal anastomosi
- description
- Patients considered at low risk for pancreatic fistula submitted to pancreato-jejunal anastomosis.
- interventionNames
- Procedure: Pancreato-Jejunal anastomosis
Primary outcomes (3)
- measure
- Rate of postoperative complications of grade > II according to Dindo-Clavien classification
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * All other patients who undergo PD in which the eligibility conditions for the study group are not present, are enrolled in the Control Arm..
References
Publications (1)
- DERIVEDMazzaferro 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. PMID 31567180