NCT03738787

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

October 5, 2021

Status Verified

October 1, 2021

Enrollment Period

4 years

First QC Date

November 5, 2018

Last Update Submit

October 4, 2021

Conditions

Pancreatic FistulaPancreatic NeoplasmsPostoperative Complications

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Number of participants with onset of post-surgical diabetes

    12 months

  • Percentual variation of weight after pancreatoduodenectomy

    12 months

  • Variation of Body Mass Index after pancreatoduodenectomy

    12 months

Other Outcomes (1)

  • Overall survival

    36 months

Study Arms (2)

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.

Procedure: Pancreatic duct occlusion with Neoprene

Pancreato-Jejunal anastomosi

ACTIVE COMPARATOR

Patients considered at low risk for pancreatic fistula submitted to pancreato-jejunal anastomosis.

Procedure: Pancreato-Jejunal anastomosis

Interventions

Pancreatic duct occlusion with NeoprenePROCEDURE

Pancreatic duct occlusion of the pancreatic stump with Neoprene-based glue after Pancreatoduodenectomy.

Pancreatic duct occlusion
Pancreato-Jejunal anastomosisPROCEDURE

Standardized pancreato-jejunal anastomosis after Pancreatoduodenectomy

Pancreato-Jejunal anastomosi

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • All other patients who undergo PD in which the eligibility conditions for the study group are not present, are enrolled in the Control Arm..

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Milan, 20133, Italy

Location

Related Publications (1)

  • 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.

    PMID: 31567180DERIVED

MeSH Terms

Conditions

Pancreatic FistulaPancreatic NeoplasmsPostoperative Complications

Interventions

Neoprene

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesPancreatic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsEndocrine System DiseasesPathologic Processes

Intervention Hierarchy (Ancestors)

PolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsElastomersPolymersBiomedical and Dental MaterialsRubberManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 13, 2018

Study Start

January 1, 2015

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

October 5, 2021

Record last verified: 2021-10

Locations

IT(1)