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

NCT04448795 | Completed

• 1 other identifier: 202000980B0
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreas; Fistula

Outcome Measures

Primary Outcomes (1)

• postoperative pancreatic fistula

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

  through study completion, an average of 2 month

Secondary Outcomes (3)

• 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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

underwent PD in Chang Gung Memorial Hospital at Linkou

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 26, 2020
• Study Start: October 1, 2010
• Primary Completion: September 30, 2018
• Study Completion: May 30, 2020
• Last Updated: June 26, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share