Clinical trial NCT03891225: Efficacy of Amniotic Membrane Over Pancreatic Anastomosis After Pancreaticoduodenenctomy to Preventing Pancreatic Fistula
Official title: Efficacy of Amniotic Membrane Implantation Over Pancreo-jejunal Anastomosis After Pancreaticoduodenectomy in Reducing Post-operative Pancreatic Fistula POPF.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Post Operative Pancreatic Fistula
Pancreatic Resection
Biological Dressing
Lead sponsor: Casa di Cura Dott. Pederzoli
Sponsor class: OTHER
Collaborators: name: Fondazione Banca dei Tessuti di Treviso onlus
First posted: 2019-03-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: postoperative complications
timeFrame: up to 90 days after surgery
Secondary outcomes:
measure: correlation between microscopic pancreatic fibrosis and CR POPF
timeFrame: 90 days from surgery
Other outcomes:
Locations:
city: Peschiera Del Garda
country: Italy
facility: Pederzoli Hospital
state: Verona
Study officials:
affiliation: PEDERZOLI HOSPITAL
name: ISABELLA FRIGERIO
role: PRINCIPAL_INVESTIGATOR
References:
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