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

June 24, 2020 updated by: Chang Gung Memorial Hospital

Significance of Drain Amylase Levels After Pancreaticoduodenectomy

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

underwent PD in Chang Gung Memorial Hospital at Linkou

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pancreatic fistula
Time Frame: through 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
through study completion, an average of 2 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative interventions
Time Frame: through study completion, an average of 2 month
transarterial embolization, image-guided second drainage, and reoperation
through study completion, an average of 2 month
length of hospital stay
Time Frame: through study completion, an average of 2 month
through study completion, an average of 2 month
30-day mortality rates
Time Frame: 30 day
30 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2010

Primary Completion (ACTUAL)

September 30, 2018

Study Completion (ACTUAL)

May 30, 2020

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

June 24, 2020

First Posted (ACTUAL)

June 26, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 26, 2020

Last Update Submitted That Met QC Criteria

June 24, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202000980B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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