Technical Strategies for Pancreatic Fistula Prevention After Pancreaticoduodenectomy in High-risk Pancreatic Remnant

Pancreatic Fistula Clinical Trial

— PREP  

Official title:

Technical Strategies for Pancreatic Fistula Prevention After Pancreaticoduodenectomy in High-risk Pancreatic Remnant: a Risk-adjusted Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212196
• Other study ID #: PREP 1041CESC
• Status: Completed
• Phase: N/A
• Start date: June 12, 2017
• Est. completion date: July 10, 2019

Study information

• Verified date: September 2019
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 10, 2019
• Est. primary completion date: June 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula

Intervention

Procedure:
• Pancreaticogastrostomy with external drain
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.
• Pancreaticojejunostomy with transanastomotic drain
Pancreatico-enteric anastomosis is provided through a double-layer, duct-to-mucosa anastomosis with a transanastomotic externalized drain.

Locations

Country	Name	City	State
Italy	Ospedale Policlinico GB Rossi	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Epub 2016 Oct 11. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	POPF severity	POPF grade B and grade C rates	30 days post-operative
Secondary	Length of Hospital Stay	calculated from the day of surgery to the day of discharge, adding up the days after a possible re-admission	1 year
Secondary	Mortality	Death related to surgical morbidity	90 days
Secondary	Post-Pancreatectomy Hemorrhage	As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates	90 days
Secondary	Delayed Gastric Emptying	As defined by ISGPS, grade A, B and C rates	90 days
Secondary	Biliary fistula	Output of bile from drains on or by POD 3, pancreaticojejunostomy leak should be ruled out	90 days
Secondary	Gastrojejunal/Duodenojejunal fistula	Fistula from gastro/duodenojejunostomy	90 days
Secondary	Abdominal abscess	Collection >5cm in size, containing gas bubbles, determining systemic signs of infection	90 days
Secondary	Acute pancreatitis	Altered serum amylase count on POD 0 or POD 1	1 day post index surgery
Secondary	Wound infection	Superficial and Deep Surgical Site Incisional Infection as defined by the Center for Disease Control and Prevention	90 days
Secondary	Blood transfusions	Need and number of packed red blood cells transfused	90 days
Secondary	Myocardial infarction	Myocardial necrosis	90 days
Secondary	Acute Kidney Failure	Abrupt change in serum creatinine >1.5 baseline value	90 days
Secondary	Pulmonary Embolism	Blood clots in the pulmonary arterial system	90 days
Secondary	Pneumonia	Bacterial infection of the lungs	90 days
Secondary	Respiratory insufficiency	Need for re-intubation	90 days
Secondary	Urinary Tract Infection	Bacterial infection of the urinary tract	90 days
Secondary	Cerebrovascular accidents	Stroke, hemorrhage, brain death	90 days
Secondary	Reoperation	Need for new surgery due to severe morbidity	90 days
Secondary	Readmission	New admission within 30-days of discharge from hospital	30 days after hospital discharge
Secondary	Time-to-adjuvant therapy	Time form index operation to the beginning of adjuvant treatment (only for malignancy)	1 year