Technical Strategies for Pancreatic Fistula Prevention After Pancreaticoduodenectomy in High-risk Pancreatic Remnant
PREP
1 other identifier
interventional
72
1 country
1
Brief Summary
This trial will investigate what surgical technique between pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains is associated with the lowest rate of pancreatic fistula after pancreaticoduodenectomy in case of high-risk pancreatic remnants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2016
CompletedStudy Start
First participant enrolled
June 12, 2017
CompletedFirst Posted
Study publicly available on registry
July 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2019
CompletedSeptember 13, 2019
September 1, 2019
2 years
November 9, 2016
September 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-operative Pancreatic Fistula (POPF)
Presence of Amylase \> 3 times the upper limit of normal in surgical drains at or by post-operative day 3 (POD) determining a clinically relevant change in patient's management
30 days post-operative
Secondary Outcomes (21)
POPF severity
30 days post-operative
Length of Hospital Stay
1 year
Mortality
90 days
Post-Pancreatectomy Hemorrhage
90 days
Delayed Gastric Emptying
90 days
- +16 more secondary outcomes
Study Arms (2)
Pancreaticogastrostomy
ACTIVE COMPARATORPancreaticogastrostomy with external drain
Pancreaticojejunostomy
ACTIVE COMPARATORPancreaticojejunostomy with transanastomotic drain
Interventions
Pancreatico-enteric anastomosis is provided according to the "Bassi technique", pancreatic remnant is pushed into the gastric cavity through a posterior gastrotomy. An externalized drain is placed into the main pancreatic duct.
Pancreatico-enteric anastomosis is provided through a double-layer, duct-to-mucosa anastomosis with a transanastomotic externalized drain.
Eligibility Criteria
You may qualify if:
- All the patients undergoing pancreaticoduodenectomy (only Whipple or Traverso) for all kind of pancreatic disease (benign, malignant or premalignant).
- Patients able to give their informed consent
You may not qualify if:
- Informed consent withdrawal
- Impossibility to undergo surgery for any reason
- Use of glues or biological matrices to protect the anastomosis
- Fistula Risk Score \< 7
- Post-operative octreotide analogues administration (only prophylactic use, therapeutic use allowed)
- Wrong randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedale Policlinico GB Rossi
Verona, 37134, Italy
Related Publications (6)
McMillan MT, Ecker BL, Behrman SW, Callery MP, Christein JD, Drebin JA, Fraker DL, Kent TS, Lee MK, Roses RE, Sprys MH, Vollmer CM Jr. Externalized Stents for Pancreatoduodenectomy Provide Value Only in High-Risk Scenarios. J Gastrointest Surg. 2016 Dec;20(12):2052-2062. doi: 10.1007/s11605-016-3289-6. Epub 2016 Oct 11.
PMID: 27730401BACKGROUNDBassi C, Molinari E, Malleo G, Crippa S, Butturini G, Salvia R, Talamini G, Pederzoli P. Early versus late drain removal after standard pancreatic resections: results of a prospective randomized trial. Ann Surg. 2010 Aug;252(2):207-14. doi: 10.1097/SLA.0b013e3181e61e88.
PMID: 20622661BACKGROUNDCallery 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: 23122535BACKGROUNDHallet J, Zih FS, Deobald RG, Scheer AS, Law CH, Coburn NG, Karanicolas PJ. The impact of pancreaticojejunostomy versus pancreaticogastrostomy reconstruction on pancreatic fistula after pancreaticoduodenectomy: meta-analysis of randomized controlled trials. HPB (Oxford). 2015 Feb;17(2):113-22. doi: 10.1111/hpb.12299. Epub 2014 Jul 7.
PMID: 25040921BACKGROUNDWang SE, Chen SC, Shyr BU, Shyr YM. Comparison of Modified Blumgart pancreaticojejunostomy and pancreaticogastrostomy after pancreaticoduodenectomy. HPB (Oxford). 2016 Mar;18(3):229-35. doi: 10.1016/j.hpb.2015.09.007. Epub 2015 Nov 17.
PMID: 27017162BACKGROUNDAndrianello S, Marchegiani G, Malleo G, Masini G, Balduzzi A, Paiella S, Esposito A, Landoni L, Casetti L, Tuveri M, Salvia R, Bassi C. Pancreaticojejunostomy With Externalized Stent vs Pancreaticogastrostomy With Externalized Stent for Patients With High-Risk Pancreatic Anastomosis: A Single-Center, Phase 3, Randomized Clinical Trial. JAMA Surg. 2020 Apr 1;155(4):313-321. doi: 10.1001/jamasurg.2019.6035.
PMID: 32101272DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudio Bassi, MD
Università degli studi di Verona
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2016
First Posted
July 11, 2017
Study Start
June 12, 2017
Primary Completion
June 10, 2019
Study Completion
July 10, 2019
Last Updated
September 13, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share
Individual Participant Data will not be shared with other researchers