Pancreatic FistulaNCT05014425
Risk Factors for Post Whipple Pancreatic Fistula
An observational study of Pancreatic Fistula, run by Assiut University.
Trial summary
Postoperative pancreatic fistula (POPF) following pancreaticoduodenectomy is considered a life-threatening complication. This study was designed to analyze the risk factors for development of such fistula in a tertiary care center (Al-Rajhi Liver Hospital/ Assiut University). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Fistula
- What is being tested?
- pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients underwent pancreaticoduodenectomy at Al-Rajhi liver Hospital, Assiut university from January 2017 to December 2020
Who may be able to join
- All patients underwent pancreaticoduodenectomy for pancreatic cancer
Who cannot join
- All types of pancreatic resection other than pancreaticoduodenectomy
About this study
Official title: Risk Factors Predicting Development of Pancreatic Fistula Following Pancreaticoduodenectomy
Postoperative pancreatic fistula (POPF) following pancreaticoduodenectomy is considered a life-threatening complication. This study was designed to analyze the risk factors for development of such fistula in a tertiary care center (Al-Rajhi Liver Hospital/ Assiut University).
- Conditions
- Pancreatic Fistula
- Being tested
- pancreaticoduodenectomy
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreaticoduodenectomyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of pancreatic fistula following pancreaticoduodenectomy
Analysis of risk factors for development of pancreatic fistula following pancreaticoduodenectomy
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start1 Jan 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramy A. Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014425
- Sponsor's protocol ID
- Pancreatic fistula
- Status last verified
- Aug 2021
- First submitted
- 14 Aug 2021
- Last updated
- 20 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Predicting Development of Pancreatic Fistula Following Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT05014425
- Acronym / sponsor ID
- Pancreatic fistula
- Conditions
- Pancreatic Fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 20 Aug 2021 (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.
Postoperative pancreatic fistula (POPF) following pancreaticoduodenectomy is considered a life-threatening complication. This study was designed to analyze the risk factors for development of such fistula in a tertiary care center (Al-Rajhi Liver Hospital/ Assiut University).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients underwent pancreaticoduodenectomy at Al-Rajhi liver Hospital, Assiut university from January 2017 to December 2020
Key inclusion criteria (1 listed)
- All patients underwent pancreaticoduodenectomy for pancreatic cancer
Key exclusion criteria (1 listed)
- All types of pancreatic resection other than pancreaticoduodenectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pancreaticoduodenectomy | Procedure or surgery | – |
Primary outcome
Development of pancreatic fistula following pancreaticoduodenectomy
Time frame: Baseline
Analysis of risk factors for development of pancreatic fistula following pancreaticoduodenectomy
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 20 Aug 2021.
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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 Pancreatic Fistula, run by Assiut University.
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 1 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 20 Aug 2021. 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?
Development of pancreatic fistula following pancreaticoduodenectomy (time frame: Baseline). 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 20 Aug 2021.