Clinical trial NCT03212196: Technical Strategies for Pancreatic Fistula Prevention After Pancreaticoduodenectomy in High-risk Pancreatic Remnant
Official title: Technical Strategies for Pancreatic Fistula Prevention After Pancreaticoduodenectomy in High-risk Pancreatic Remnant: a Risk-adjusted Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Fistula
Keywords: Pancreaticoduodenectomy
Pancreaticogastrostomy
Pancreaticojejunostomy
Stent
Transanastomotic drain
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Pancreatic fistula is the major determinant of outcome after pancreaticoduodenectomy. Several strategies to reduce the burden of this complication have been proposed in the last decade. A definite answer about what is the best technique to approach a high-risk pancreatic stump is still needed. Both pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains have been proposed in this setting, but often studies do not provide a reliable risk stratification and result are extremely variable.

The aim of this trial is to evaluate what surgical technique, between pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains, is associated with the lowest rate of pancreatic fistula in case of high-risk pancreatic remnants. Risk stratification will be provided through the Fistula Risk Score, a clinical risk score that has been extensively validated.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion criteria

* 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

Primary outcomes:
measure: Post-operative Pancreatic Fistula (POPF)
timeFrame: 30 days post-operative
Secondary outcomes:
measure: POPF severity
timeFrame: 30 days post-operative
measure: Length of Hospital Stay
timeFrame: 1 year
measure: Mortality
timeFrame: 90 days
measure: Post-Pancreatectomy Hemorrhage
timeFrame: 90 days
measure: Delayed Gastric Emptying
timeFrame: 90 days
measure: Biliary fistula
timeFrame: 90 days
measure: Gastrojejunal/Duodenojejunal fistula
timeFrame: 90 days
measure: Abdominal abscess
timeFrame: 90 days
measure: Acute pancreatitis
timeFrame: 1 day post index surgery
measure: Wound infection
timeFrame: 90 days
measure: Blood transfusions
timeFrame: 90 days
measure: Myocardial infarction
timeFrame: 90 days
measure: Acute Kidney Failure
timeFrame: 90 days
measure: Pulmonary Embolism
timeFrame: 90 days
measure: Pneumonia
timeFrame: 90 days
measure: Respiratory insufficiency
timeFrame: 90 days
measure: Urinary Tract Infection
timeFrame: 90 days
measure: Cerebrovascular accidents
timeFrame: 90 days
measure: Reoperation
timeFrame: 90 days
measure: Readmission
timeFrame: 30 days after hospital discharge
measure: Time-to-adjuvant therapy
timeFrame: 1 year
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Ospedale Policlinico GB Rossi
Study officials:
affiliation: Università degli studi di Verona
name: Claudio Bassi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bassi 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.
citation: 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.
citation: Hallet 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.
citation: Wang 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.
citation: Andrianello 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.