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Impact of Highest Drain Fluid Amylase Levels on Surgical Outcomes and Postoperative Interventions in Patients Undergoing Pancreaticoduodenectomy

Significance of Drain Amylase Levels After Pancreaticoduodenectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04448795
Enrollment
600
Registered
2020-06-26
Start date
2010-10-01
Completion date
2020-05-30
Last updated
2020-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas; Fistula

Brief summary

This study investigated the impact of highest drain fluid amylase (DFA) level on postoperative pancreatic fistula (POPF) severity and outcomes of patients undergoing pancreaticoduodenectomy (PD) with POPF. Patient demographics of biochemical POPF and clinically relevant POPF (CR-POPF) were compared. Predictive factors were assessed using binary logistic regression. Receiver operating characteristic curve analysis was performed to determine the optimal cutoff value of highest DFA (beyond 3 days post-PD). The investigators compared length of hospital stay, surgical mortality rates, and need for postoperative interventions by highest DFA level.

Interventions

None listed

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum

Inclusion criteria

* underwent PD from October 2010 to September 2018 in our institution

Exclusion criteria

* younger than 20 years of age * clinical information was unavailable due to private or legal issues * receiving PD without pancreaticojejunostomy

Design outcomes

Primary

MeasureTime frameDescription
postoperative pancreatic fistulathrough study completion, an average of 2 monthfluid output of any measureable volume via an operatively placed drain with amylase activity greater than 3 times the upper normal serum value

Secondary

MeasureTime frameDescription
postoperative interventionsthrough study completion, an average of 2 monthtransarterial embolization, image-guided second drainage, and reoperation
length of hospital staythrough study completion, an average of 2 month
30-day mortality rates30 day

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026