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

Completed
Conditions
Pancreas; Fistula
Registration Number
NCT04448795
Lead Sponsor
Chang Gung Memorial Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
600
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
postoperative pancreatic fistulathrough study completion, an average of 2 month

fluid output of any measureable volume via an operatively placed drain with amylase activity greater than 3 times the upper normal serum value

Secondary Outcome Measures
NameTimeMethod
length of hospital staythrough study completion, an average of 2 month
30-day mortality rates30 day
postoperative interventionsthrough study completion, an average of 2 month

transarterial embolization, image-guided second drainage, and reoperation

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