Ospedale Policlinico GB Rossi
Verona, 37134, Italy
NCT Number: NCT03212196
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Verona, 37134, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 30 days post-operative
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
Time frame: 30 days post-operative
POPF grade B and grade C rates
Time frame: 1 year
calculated from the day of surgery to the day of discharge, adding up the days after a possible re-admission
Time frame: 90 days
Death related to surgical morbidity
Time frame: 90 days
As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates
Time frame: 90 days
As defined by ISGPS, grade A, B and C rates
Time frame: 90 days
Output of bile from drains on or by POD 3, pancreaticojejunostomy leak should be ruled out
Time frame: 90 days
Fistula from gastro/duodenojejunostomy
Time frame: 90 days
Collection >5cm in size, containing gas bubbles, determining systemic signs of infection
Time frame: 1 day post index surgery
Altered serum amylase count on POD 0 or POD 1
Time frame: 90 days
Superficial and Deep Surgical Site Incisional Infection as defined by the Center for Disease Control and Prevention
Time frame: 90 days
Need and number of packed red blood cells transfused
Time frame: 90 days
Myocardial necrosis
Time frame: 90 days
Abrupt change in serum creatinine >1.5 baseline value
Time frame: 90 days
Blood clots in the pulmonary arterial system
Time frame: 90 days
Bacterial infection of the lungs
Time frame: 90 days
Need for re-intubation
Time frame: 90 days
Bacterial infection of the urinary tract
Time frame: 90 days
Stroke, hemorrhage, brain death
Time frame: 90 days
Need for new surgery due to severe morbidity
Time frame: 30 days after hospital discharge
New admission within 30-days of discharge from hospital
Time frame: 1 year
Time form index operation to the beginning of adjuvant treatment (only for malignancy)
Azienda Ospedaliera Universitaria Integrata Verona
Other
Technical Strategies for Pancreatic Fistula Prevention After Pancreaticoduodenectomy in High-risk Pancreatic Remnant: a Risk-adjusted Randomized Controlled Trial
Acronym: PREP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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