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CompletedNCT04448795Updated Jun 26, 2020

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

An observational study in Pancreas; Fistula, sponsored by Chang Gung Memorial Hospital. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-06-26.

Sponsored by Chang Gung Memorial Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
600
Ages
20 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Pancreas; Fistula
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In context

Pancreatic Fistula

125 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.

This study's enrollment of 600 is above the median of 173 across 49 observational studies indexed under Pancreatic Fistula.

Browse Pancreatic Fistula studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

underwent PD in Chang Gung Memorial Hospital at Linkou

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
600 participants (actual)
Patient registry
No
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What researchers measure

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

    Time frame: through study completion, an average of 2 month

Secondary outcomes

  1. postoperative interventions

    transarterial embolization, image-guided second drainage, and reoperation

    Time frame: through study completion, an average of 2 month

  2. length of hospital stay

    Time frame: through study completion, an average of 2 month

  3. 30-day mortality rates

    Time frame: 30 day

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04448795
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Jun 26, 2020
Start date
Oct 1, 2010
Primary completion
Sep 30, 2018
Completion
May 30, 2020
Last update
Jun 26, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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