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OpenTrials
Completed

NCT Number: NCT04448795

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

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. postoperative interventions

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

    transarterial embolization, image-guided second drainage, and reoperation

  2. length of hospital stay

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

  3. 30-day mortality rates

    Time frame: 30 day

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Significance of Drain Amylase Levels After Pancreaticoduodenectomy

Important dates

Study start
2010
Primary completion
2018
Study completion
2020
First posted
Jun 26, 2020
Registry last updated
Jun 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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