Early Drain Removal Versus Standard Drain Management After Distal Pancreatectomy (Early-Dist)

NACompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

October 13, 2020

Primary Completion Date

September 30, 2023

Study Completion Date

October 30, 2023

Conditions
Pancreas DiseaseComplication,PostoperativePROMsPancreatic Fistula
Interventions
PROCEDURE

Early drain removal

"Patients randomized to the experimental group, will have an early drain removal if DFA on POD1 is lower than 2000 U/L and/or the drain fluid does not appear sinister (i.e. varying from dark brown to greenish fluid to milky water to clear spring water pancreatic juice like appearance) according to the clinical team. If DFA is greater than 2000 U/L, the drain will be maintained in place. If the sample on POD1 DFA is not available (e.g. drainage fluid is viscous and amylase value cannot be evaluated) or the sample could not be analyzed DFA will be evaluated on POD2, and drain removal will be considered if DFA is lower than 2000 U/L. If DFA on POD 3 is lower than 300 U/L, that is 3-fold the upper limit of normal serum amylase value, and/or the drain fluid does not appear sinister according to the clinical team, the drain will be removed. Otherwise, the drain will be kept in place and the patient will then follow standard postoperative drain management."

PROCEDURE

Standard drain removal

"Patients randomized to this group will receive the current standard of care, thus the drain will be maintained at least until postoperative day 5. If DFA on POD 5 is lower than 3-fold the upper limit of normal serum amylase value, and/or the drain fluid does not appear sinister (i.e. varying from dark brown to greenish fluid to milky water to clear spring water pancreatic juice like appearance) according to the clinical team, the drain will be removed. If the drain is maintained in place beyond POD 5, it will be removed inhospital or after discharge when the daily amount is lower than 10 ml and there are no signs of ongoing infection"

Trial Locations (1)

20132

San Raffaele Hospital, Milan

All Listed Sponsors
lead

IRCCS San Raffaele

OTHER

NCT04609137 - Early Drain Removal Versus Standard Drain Management After Distal Pancreatectomy (Early-Dist) | Biotech Hunter | Biotech Hunter