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

Significance of Drain Amylase Levels After Pancreaticoduodenectomy

Sponsors

Lead Sponsor: Chang Gung Memorial Hospital

Source 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.

Overall Status Completed
Start Date October 1, 2010
Completion Date May 30, 2020
Primary Completion Date September 30, 2018
Study Type Observational
Primary Outcome
Measure Time Frame
postoperative pancreatic fistula through study completion, an average of 2 month
Secondary Outcome
Measure Time Frame
postoperative interventions through study completion, an average of 2 month
length of hospital stay through study completion, an average of 2 month
30-day mortality rates 30 day
Enrollment 600
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum Age: 20 Years

Maximum Age: N/A

Verification Date

June 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

Source: ClinicalTrials.gov