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

January 4, 2021 updated by: Isabella Frigerio, Casa di Cura Dott. Pederzoli

Efficacy of Amniotic Membrane Implantation Over Pancreo-jejunal Anastomosis After Pancreaticoduodenectomy in Reducing Post-operative Pancreatic Fistula POPF.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Twenty consecutive patients candidated to PD regardless the diagnosis will be enrolled if presenting an high Fistula Risk Score. Enrollement will be done in O.R. after frozen section of the pancreas. The AM is provided by Fondazione Banca dei Tessuti di Treviso Onlus. The placenta is sourced from donors undergoing caesarean sections and processed shortly after retrieval, donors are evaluated according to Italian requirements. The AM is carefully detached from the chorion and rinsed with sterile saline solution, flattened on a nitrocellulose membrane filter (Merck Millipore), with its stromal side facing down, in contact with the filter. The AM is then immersed in a cocktail of antibiotics then cut into patches and immersed in cryopreservant solution. Cryopreservation was achieved using a programmable cryogenic freezer (Planer KryoSave Integra, 750-30), which triggers a controlled cooling rate. The AM patches were stored in vapor-phase liquid nitrogen. Thirty minutes before its use, the AM was defrozen and washed with saline. A 10x15cm MA patch was placed around the pancreatic anastomoses starting from the posterior surface. The caudal and the cranial flap were overlapped on the anterior surface to wrap the anastomosis. The membrane was than fixed with 4-0 Monocryl sutures at the jejunal surface and at the peri-pancreatic tissue. Then an end-to-side bilio-enteric anastomosis was carried out. The reconstruction was completed by an end-to-side antecolic duodenojejunostomy. At the end of the procedure, two drains were placed ventral and dorsal to the PJ, without friction with the AM.

In the postoperative period will be evaluated: morbidity according to Clavien Dindo classification with attention to clinical relevant pancreatic fistula, bleeding, need of reintervention, surgical site infection, multi drug resistant infection and mortality. Costs and postoperative staying will be monitored as well.

Student t test, Mann Whitney and Chi square will be used for statistical analysis.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Verona
      • Peschiera Del Garda, Verona, Italy, 37019
        • Pederzoli Hospital

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 and 85 years
  • Undergone to Pancreatico-duodenectomy with high FRS (>=5)
  • Adeguate consent

Exclusion Criteria:

  • Total pancreatectomy
  • Pancreatic anastomosis different from pancreo-jejunal anastomosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amniotic Membrane implantation Arm
All consecutive patients undergone pancreaticoduodenectomy with high FRS will be treated with implantation of AM, by overlapping it over the pancreo-jejunal anastomosis.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative complications
Time Frame: up to 90 days after surgery
clinical relevant pancreatic fistula, intra-abdominal collection, acute pancreatitis, SSI, need for reintervention, mortality
up to 90 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between microscopic pancreatic fibrosis and CR POPF
Time Frame: 90 days from surgery
the absence of microscopic fibrosis in a macroscopically soft pancreas may be related to higher risk of CR POPF and therefore may suggest implementation of anastomotic protecion (ie. the AM)
90 days from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Casa di Cura Dott. Pederzoli

Collaborators

Fondazione Banca dei Tessuti di Treviso onlus

Investigators

  • Principal Investigator: ISABELLA FRIGERIO, Pederzoli Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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 Major Dates

Study Start (Actual)

March 25, 2019

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

December 20, 2020

Study Registration Dates

First Submitted

March 25, 2019

First Submitted That Met QC Criteria

March 25, 2019

First Posted (Actual)

March 26, 2019

Study Record Updates

Last Update Posted (Actual)

January 6, 2021

Last Update Submitted That Met QC Criteria

January 4, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2039CESC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

UPON REQUEST

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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