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

Phase 1

Completed

• Conditions: Post Operative Pancreatic Fistula; Pancreatic Resection; Biological Dressing
• Interventions: Procedure: Amniotic Membrane implantation

• Registration Number: NCT03891225
• Lead Sponsor: Casa di Cura Dott. Pederzoli

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.

Study Timeline

• Study Start: 2019-03-25
• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-26
• Primary Completion: 2020-09-30
• Study Completion: 2020-12-20
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-04
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
postoperative complications	up to 90 days after surgery	clinical relevant pancreatic fistula, intra-abdominal collection, acute pancreatitis, SSI, need for reintervention, mortality

Secondary Outcome Measures

Name	Time	Method
correlation between microscopic pancreatic fibrosis and CR POPF	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)

Trial Locations

Locations (1)

Pederzoli Hospital; 🇮🇹 Peschiera Del Garda, Verona, Italy