Pancreas; FistulaNCT04448795
Impact of Highest Drain Fluid Amylase Levels on Surgical Outcomes and Postoperative Interventions in Patients Undergoing Pancreaticoduodenectomy
An observational study of Pancreas; Fistula, run by Chang Gung Memorial Hospital.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pancreas; Fistula
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2010to 30 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Adult, Older adult
Study population: underwent PD in Chang Gung Memorial Hospital at Linkou
Who may be able to join
- underwent PD from October 2010 to September 2018 in our institution
Who cannot join
- younger than 20 years of age
- clinical information was unavailable due to private or legal issues
- receiving PD without pancreaticojejunostomy
About this study
Official title: 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.
- Conditions
- Pancreas; Fistula
- Medical subject headings
- Pancreatic Fistula
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 2 month
Secondary outcomes (3)
postoperative interventions
transarterial embolization, image-guided second drainage, and reoperation
Measured: through study completion, an average of 2 month
length of hospital stay
Measured: through study completion, an average of 2 month
30-day mortality rates
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start1 Oct 2010
- Primary completion30 Sep 2018
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas; FistulaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448795
- Sponsor's protocol ID
- 202000980B0
- Status last verified
- Jun 2020
- First submitted
- 22 Jun 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significance of Drain Amylase Levels After Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT04448795
- Acronym / sponsor ID
- 202000980B0
- Conditions
- Pancreas; Fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2010 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 26 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- underwent PD in Chang Gung Memorial Hospital at Linkou
Key inclusion criteria (1 listed)
- underwent PD from October 2010 to September 2018 in our institution
Key exclusion criteria (3 listed)
- younger than 20 years of age
- clinical information was unavailable due to private or legal issues
- receiving PD without pancreaticojejunostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
postoperative interventions
Time frame: through study completion, an average of 2 month
length of hospital stay
Time frame: through study completion, an average of 2 month
30-day mortality rates
Time frame: 30 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas; Fistula, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pancreatic fistula (time frame: through study completion, an average of 2 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2020.