Pancreatic FistulaNCT05687825
Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula
An observational study of Pancreatic Fistula, run by South Valley University at 1 site in Egypt.
Trial summary
For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pancreatic Fistula
- What is being tested?
- pancreaticoduodenectomy procedure
- Type of treatment
- Surgery or procedure
- How many people
- 107 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2017to 30 Jul 2022
- How long will I take part?
- 1 Month
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all consecutive patients who were treated with a pancreaticoduodenectomy
Who may be able to join
- Patients with resectable distal CBD carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas.
- American Society of Anesthesiologists (ASA) scores I \& II.
- Patients aged > 20 years.
- Agreement to complete the study.
Who cannot join
- Patients with benign disease, trauma, and receive neoadjuvant therapy.
- double primary cancers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Operative Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula After Pancreaticoduodenectomy: A Prospective Multicenter Cohort Study
For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. The most significant and life-threatening complication of PD is postoperative pancreatic fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this study.
Read the detailed description
For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. The most significant and life-threatening complication of PD is postoperative pancreatic fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this study.
- Conditions
- Pancreatic Fistula
- Being tested
- pancreaticoduodenectomy procedure
- Keywords
- risk factors,, clinically relevant pancreatic fistula,, 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.
pancreaticoduodenectomy procedureProcedure or surgery
Pancreaticoduodenectomy operation
| Study group | Role | What they receive |
|---|---|---|
| Clinically relevant postoperative pancreatic fistula | patients who developed clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy Receives: Procedure: pancreaticoduodenectomy procedure | |
| No clinically relevant postoperative pancreatic fistula | patients who did not develop clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy Receives: Procedure: pancreaticoduodenectomy procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinically relevant post operative pancreatic fistula
A drainage fluid of any measurable volume with an amylase level more than three times the upper normal serum level on or after the 3rd postoperative day
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Aug 2017
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
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.
- 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
- Prospective
- Enrolment
- 107 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ahmed Omar, MD, South Valley University
- Investigators
- Mohammed A Omar, M.D., Principal investigator, General Surgery Department, Faculty of Medicine, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687825
- Sponsor's protocol ID
- SVU/MED/SUR011/4/23/4/612
- Status last verified
- Jul 2023
- First submitted
- 8 Jan 2023
- Last updated
- 27 Jul 2023
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operative Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula After Pancreaticoduodenectomy: A Prospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT05687825
- Acronym / sponsor ID
- SVU/MED/SUR011/4/23/4/612
- Conditions
- Pancreatic Fistula
- Keywords
- risk factors,, clinically relevant pancreatic fistula,, pancreaticoduodenectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 18 Jan 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.
For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. The most significant and life-threatening complication of PD is postoperative pancreatic fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this study.
Detailed description
For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. The most significant and life-threatening complication of PD is postoperative pancreatic fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinically relevant postoperative pancreatic fistula | – | Procedure: pancreaticoduodenectomy procedurepatients who developed clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy |
| No clinically relevant postoperative pancreatic fistula | – | Procedure: pancreaticoduodenectomy procedurepatients who did not develop clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all consecutive patients who were treated with a pancreaticoduodenectomy
Key inclusion criteria (4 listed)
- Patients with resectable distal CBD carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas.
- American Society of Anesthesiologists (ASA) scores I \& II.
- Patients aged > 20 years.
- Agreement to complete the study.
Key exclusion criteria (2 listed)
- Patients with benign disease, trauma, and receive neoadjuvant therapy.
- double primary cancers.
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 procedurePancreaticoduodenectomy operation | Procedure or surgery | Clinically relevant postoperative pancreatic fistula, No clinically relevant postoperative pancreatic fistula |
Primary outcome
clinically relevant post operative pancreatic fistula
Time frame: 10 days
A drainage fluid of any measurable volume with an amylase level more than three times the upper normal serum level on or after the 3rd postoperative 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 27 Jul 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.
Mohammed A Omar, M.D. principal investigator
General Surgery Department, Faculty of Medicine, South Valley University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Fistula, run by South Valley University at 1 site in Egypt.
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 4 inclusion and 2 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
clinically relevant post operative pancreatic fistula (time frame: 10 days). 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 27 Jul 2023.