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

NCT03891225 | Completed Phase 1

• 1 other identifier: 2039CESC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pancreatic Fistula; Pancreatic Resection; Biological Dressing

Outcome Measures

Primary Outcomes (1)

• postoperative complications

  clinical relevant pancreatic fistula, intra-abdominal collection, acute pancreatitis, SSI, need for reintervention, mortality

  up to 90 days after surgery

Secondary Outcomes (1)

• correlation between microscopic pancreatic fibrosis and CR POPF

  90 days from surgery

Study Arms (1)

Amniotic Membrane implantation Arm

EXPERIMENTAL

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

Interventions

Amniotic Membrane implantation PROCEDURE

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

Amniotic Membrane implantation Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Casa di Cura Dott. Pederzoli: lead
• Fondazione Banca dei Tessuti di Treviso onlus: collaborator

Study Sites (1)

Pederzoli Hospital

Peschiera del Garda, Verona, 37019, Italy

Location

Related Publications (8)

• Pulvirenti A, Marchegiani G, Pea A, Allegrini V, Esposito A, Casetti L, Landoni L, Malleo G, Salvia R, Bassi C. Clinical Implications of the 2016 International Study Group on Pancreatic Surgery Definition and Grading of Postoperative Pancreatic Fistula on 775 Consecutive Pancreatic Resections. Ann Surg. 2018 Dec;268(6):1069-1075. doi: 10.1097/SLA.0000000000002362.

  PMID: 28678062 BACKGROUND

• McMillan MT, Vollmer CM Jr, Asbun HJ, Ball CG, Bassi C, Beane JD, Berger AC, Bloomston M, Callery MP, Christein JD, Dixon E, Drebin JA, Castillo CF, Fisher WE, Fong ZV, Haverick E, House MG, Hughes SJ, Kent TS, Kunstman JW, Malleo G, McElhany AL, Salem RR, Soares K, Sprys MH, Valero V 3rd, Watkins AA, Wolfgang CL, Behrman SW. The Characterization and Prediction of ISGPF Grade C Fistulas Following Pancreatoduodenectomy. J Gastrointest Surg. 2016 Feb;20(2):262-76. doi: 10.1007/s11605-015-2884-2. Epub 2015 Jul 11.

  PMID: 26162925 BACKGROUND

• Patel K, Teta A, Sukharamwala P, Thoens J, Szuchmacher M, DeVito P. External pancreatic duct stent reduces pancreatic fistula: a meta-analysis and systematic review. Int J Surg. 2014;12(8):827-32. doi: 10.1016/j.ijsu.2014.06.008. Epub 2014 Jul 6.

  PMID: 25003575 BACKGROUND

• Callery MP, Pratt WB, Kent TS, Chaikof EL, Vollmer CM Jr. A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy. J Am Coll Surg. 2013 Jan;216(1):1-14. doi: 10.1016/j.jamcollsurg.2012.09.002. Epub 2012 Nov 2.

  PMID: 23122535 BACKGROUND

• Lin SD, Lai CS, Hou MF, Yang CC. Amnion overlay meshed skin autograft. Burns Incl Therm Inj. 1985 Jun;11(5):374-8. doi: 10.1016/0305-4179(85)90102-0.

  PMID: 3896420 BACKGROUND

• Talmi YP, Sigler L, Inge E, Finkelstein Y, Zohar Y. Antibacterial properties of human amniotic membranes. Placenta. 1991 May-Jun;12(3):285-8. doi: 10.1016/0143-4004(91)90010-d.

  PMID: 1754577 BACKGROUND

• Barski D, Gerullis H, Ecke T, Varga G, Boros M, Pintelon I, Timmermans JP, Winter A, Bagner JW, Otto T. Repair of a vesico-vaginal fistula with amniotic membrane - Step 1 of the IDEAL recommendations of surgical innovation. Cent European J Urol. 2015;68(4):459-61. doi: 10.5173/ceju.2015.683. Epub 2015 Nov 13.

  PMID: 26855802 BACKGROUND

• Knight BC, Kausar A, Manu M, Ammori BA, Sherlock DJ, O'Reilly DA. Evaluation of surgical outcome scores according to ISGPS definitions in patients undergoing pancreatic resection. Dig Surg. 2010;27(5):367-74. doi: 10.1159/000313693. Epub 2010 Oct 13.

  PMID: 20938180 BACKGROUND

Study Officials

• ISABELLA FRIGERIO

  PEDERZOLI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Principal Investigator

Model Details: Pilot study

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 26, 2019
• Study Start: March 25, 2019
• Primary Completion: September 30, 2020
• Study Completion: December 20, 2020
• Last Updated: January 6, 2021

Record last verified: 2021-01

Locations

IT (1)