Pancreas NeoplasmNCT05711433
Risk Factors for Postoperative Pancreatic Fistula Following Non-traumatic Pancreatic Surgery. Retrospective Observational Study.
An observational study of Pancreas Neoplasm, run by Zagazig University.
Trial summary
Postoperative pancreatic fistula is a potentially fatal sequela with substantial morbidity and mortality. A retrospective observational study was conducted in the surgical unit of Zagazig university hospital . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Neoplasm
- What is being tested?
- pancreatic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 347 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2014to 1 Sep 2022
- How long will I take part?
- 42 Months
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: A retrospective observational study was conducted in the surgical unit of Zagazig university hospital from July 2014 to July 2019. Three hundred forty-seven patients were admitted with a clinical diagnosis of pancreatic fistula following both open and laparoscopic approaches for pancreatic benign and malignant tumors.
Who may be able to join
- > 18 years,
- both sexes,
- respectablee pancreaticoduodenal tumors, or chronic pancreatitis
Who cannot join
- <18 years,
- Patients who underwent total pancreatectomies,
- Patients discovered intraoperatively to be fixed to portal vein or superior mesenteric artery, traumatic pancreatic surgeries, postoperative associated gastric or biliary leak, pancreaticoduodenal cancers infiltrating the colon, stomach or liver.
About this study
Postoperative pancreatic fistula is a potentially fatal sequela with substantial morbidity and mortality. A retrospective observational study was conducted in the surgical unit of Zagazig university hospital . Three hundred forty-seven patients were admitted with a clinical diagnosis of pancreatic fistula following both open and laparoscopic approaches for pancreatic benign and malignant tumors.
Read the detailed description
Postoperative pancreatic fistula is a potentially fatal sequela with substantial morbidity and mortality. POPF incidence and risk factors vary.
A retrospective observational study was conducted in the surgical unit of Zagazig university hospital . Three hundred forty-seven patients were admitted with a clinical diagnosis of pancreatic fistula following both open and laparoscopic approaches for pancreatic benign and malignant tumors.
- Conditions
- Pancreas Neoplasm
- Being tested
- pancreatic surgery
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreatic surgeryProcedure or surgery
pancreaticoduodenectomy and distal pancreatectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative pancreatic fistula
an amylase level in the fluid collected from the drain on the third postoperative day (POD) that was > three times the serum amylase level
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Jul 2014
- Primary completion1 Jul 2019
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas NeoplasmStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Other
- Enrolment
- 347 participants (actual)
- Target duration
- 42 Months
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer.A.A.M.Habeeb, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711433
- Sponsor's protocol ID
- zagazig 16
- Status last verified
- Feb 2023
- First submitted
- 21 Oct 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- 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 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Postoperative Pancreatic Fistula Following Non-traumatic Pancreatic Surgery. Retrospective Observational Study.
- ClinicalTrials.gov ID
- NCT05711433
- Acronym / sponsor ID
- zagazig 16
- Conditions
- Pancreas Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 3 Feb 2023 (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 is a potentially fatal sequela with substantial morbidity and mortality. A retrospective observational study was conducted in the surgical unit of Zagazig university hospital . Three hundred forty-seven patients were admitted with a clinical diagnosis of pancreatic fistula following both open and laparoscopic approaches for pancreatic benign and malignant tumors.
Detailed description
Postoperative pancreatic fistula is a potentially fatal sequela with substantial morbidity and mortality. POPF incidence and risk factors vary.
A retrospective observational study was conducted in the surgical unit of Zagazig university hospital . Three hundred forty-seven patients were admitted with a clinical diagnosis of pancreatic fistula following both open and laparoscopic approaches for pancreatic benign and malignant tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 42 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A retrospective observational study was conducted in the surgical unit of Zagazig university hospital from July 2014 to July 2019. Three hundred forty-seven patients were admitted with a clinical diagnosis of pancreatic fistula following both open and laparoscopic approaches for pancreatic benign and malignant tumors.
Key inclusion criteria (3 listed)
- > 18 years,
- both sexes,
- respectablee pancreaticoduodenal tumors, or chronic pancreatitis
Key exclusion criteria (3 listed)
- <18 years,
- Patients who underwent total pancreatectomies,
- Patients discovered intraoperatively to be fixed to portal vein or superior mesenteric artery, traumatic pancreatic surgeries, postoperative associated gastric or biliary leak, pancreaticoduodenal cancers infiltrating the colon, stomach or liver.
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 |
|---|---|---|
| pancreatic surgerypancreaticoduodenectomy and distal pancreatectomy | Procedure or surgery | – |
Primary outcome
incidence of postoperative pancreatic fistula
Time frame: 3.5 years
an amylase level in the fluid collected from the drain on the third postoperative day (POD) that was > three times the serum amylase level
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 3 Feb 2023.
- 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 Neoplasm, run by Zagazig 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 3 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 3 Feb 2023. 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?
incidence of postoperative pancreatic fistula (time frame: 3.5 years). 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 3 Feb 2023.