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

Pancreas; Fistula Clinical Trial

Official title:

Significance of Drain Amylase Levels After Pancreaticoduodenectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04448795
• Other study ID #: 202000980B0
• Status: Completed
• Start date: October 1, 2010
• Est. completion date: May 30, 2020

Study information

• Verified date: June 2020
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: May 30, 2020
• Est. primary completion date: September 30, 2018
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Pancreas; Fistula
• Pancreatic Fistula

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	postoperative interventions	transarterial embolization, image-guided second drainage, and reoperation	through study completion, an average of 2 month
Secondary	length of hospital stay		through study completion, an average of 2 month
Secondary	30-day mortality rates		30 day