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Efficacy of Amniotic Membrane Over Pancreatic Anastomosis After Pancreaticoduodenenctomy to Preventing Pancreatic Fistula

NCT03891225 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-01-06

No results posted yet for this study

Summary

Post-operative pancreatic fistula (POPF) after pancreatic resection is a potentially life-threatening complication occuring in up to 27% of patients undergoing a pancreatic resection. Despite several strategies have been proposed further improvements are needed. Many studies suggest that amniotic membrane(AM) implantation is effective in tissue regeneration and prevention of fluid leakage at many surgical sites. However,the implantation of AM has never been used in pancreatic surgery.

After having completed the first case of implantation of AM we proceed with this pilot study to determine in 20 consecutive patients undergone to pancreaticoduodenectomy (PD) with high risk of POPF, the efficacy of AM in reducing this event and the related morbidity.

Conditions

  • Post Operative Pancreatic Fistula
  • Pancreatic Resection
  • Biological Dressing

Interventions

PROCEDURE

Amniotic Membrane implantation

Surgical procedure will be performed with Longemire Traverso technique. At the end of all pancreatic, biliary and duodenal anastomosis, the AM will be implanted.

Sponsors & Collaborators

  • Fondazione Banca dei Tessuti di Treviso onlus

    collaborator UNKNOWN

  • Casa di Cura Dott. Pederzoli

    lead OTHER

Principal Investigators

  • ISABELLA FRIGERIO · PEDERZOLI HOSPITAL

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-25
Primary Completion
2020-09-30
Completion
2020-12-20

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03891225 on ClinicalTrials.gov