Pancreatic Fistula After PancreaticoduodenectomypopfNCT06300801
Postoperative Pancreatic Fistula in Patients Undergoing Pancreaticoduodenectomy
A study testing Is the preoperative c-reactive protein/albumin ratio successful in predicting postoperative pancreatic fistula in patients undergoing pancreatoduodenectomy? in people with Pancreatic Fistula After Pancreaticoduodenectomy and C-Reactive Protein, run by Erol Olcok Corum Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Fistula After Pancreaticoduodenectomy, C-Reactive Protein, Albumin
- What is being tested?
- Is the preoperative c-reactive protein/albumin ratio successful in predicting postoperative pancreatic fistula in patients undergoing pancreatoduodenectomy?
- How many people
- Not given
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 80 years
- Diagnosed with pancreatic cancer
- Patients without recurrence
Who cannot join
- Patients who underwent total pancreatectomy
- Data were not available
- Patients outside the specified age range
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Hitit University Erol olçok Traning and research Hospital
Çorum, Merkez, 19000
Hitit University Erol olçok Traning and resourge Hospital
Çorum, Merkez, 19000
About this study
Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. In this study, the investigators aim to predict pancreatic fistula using the C-reactive protein-albumin ratio (CAR). The total number of participants expected to be included in this research comprises patients who underwent PD between 2017 and 2023 and developed pancreatic fistula. The participants invitation is based on the detection of a pancreatic fistula. This study is conducted for research purposes and participation is voluntary. No interventions will be performed on the participants as part of this study; however, we have prepared this form to obtain participant permission to gather certain information. If the participants consent to the use of information for scientific purposes with the guarantee of confidentiality, they will be asked to sign a consent form.
Read the detailed description
Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality rates. Despite dramatic advancements in surgical techniques and perioperative management, reported morbidity and mortality rates following PD are 41.56% and 2.88%, respectively, which remain unsatisfactory. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. Therefore, accurate and timely prediction of POPF after PD is necessary to reduce secondary mortality from serious complications and optimize individual patient treatment decisions. The C-reactive protein-albumin ratio (CAR) is an inflammatory marker calculated by dividing serum CRP levels by albumin levels and has been associated with poor prognosis in sepsis patients. This study aimed to investigate the predictive significance of CAR for POPF.
- Being tested
- Is the preoperative c-reactive protein/albumin ratio successful in predicting postoperative pancreatic fistula in patients undergoing pancreatoduodenectomy?
- Keywords
- albumin, pancreatic fistula, c- reactive protein
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Is the preoperative c-reactive protein/albumin ratio successful in predicting postoperative pancreatic fistula in patients undergoing pancreatoduodenectomy?Diagnostic test
In this study, predicting pancreatic fistula before surgery will reduce postoperative complications and mortality.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Fistula After PancreaticoduodenectomyStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Erol Olcok Corum Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahadır Kartal, Erol Olcok Corum Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300801
- Sponsor's protocol ID
- 2023-48
- Other IDs
- hitit
- Acronym
- popf
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
Publications
Sakamoto T, Yagyu Y, Uchinaka EI, Morimoto M, Hanaki T, Tokuyasu N, Honjo S, Fujiwara Y. Predictive Significance of C-reactive Protein-to-albumin Ratio for Postoperative Pancreatic Fistula After Pancreaticoduodenectomy. Anticancer Res. 2019 Nov;39(11):6283-6290. doi: 10.21873/anticanres.13838.
PubMed 31704858
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pancreatic Fistula in Patients Undergoing Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT06300801
- Acronym / sponsor ID
- popf / 2023-48
- Keywords
- albumin, pancreatic fistula, c- reactive protein
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Erol Olcok Corum Training and Research HospitalUniversity, hospital or other
- First posted
- 8 Mar 2024 (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.
Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. In this study, the investigators aim to predict pancreatic fistula using the C-reactive protein-albumin ratio (CAR). The total number of participants expected to be included in this research comprises patients who underwent PD between 2017 and 2023 and developed pancreatic fistula. The participants invitation is based on the detection of a pancreatic fistula. This study is conducted for research purposes and participation is voluntary. No interventions will be performed on the participants as part of this study; however, we have prepared this form to obtain participant permission to gather certain information. If the participants consent to the use of information for scientific purposes with the guarantee of confidentiality, they will be asked to sign a consent form.
Detailed description
Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality rates. Despite dramatic advancements in surgical techniques and perioperative management, reported morbidity and mortality rates following PD are 41.56% and 2.88%, respectively, which remain unsatisfactory. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. Therefore, accurate and timely prediction of POPF after PD is necessary to reduce secondary mortality from serious complications and optimize individual patient treatment decisions. The C-reactive protein-albumin ratio (CAR) is an inflammatory marker calculated by dividing serum CRP levels by albumin levels and has been associated with poor prognosis in sepsis patients. This study aimed to investigate the predictive significance of CAR for POPF.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 18 and 80 years
- Diagnosed with pancreatic cancer
- Patients without recurrence
Key exclusion criteria (3 listed)
- Patients who underwent total pancreatectomy
- Data were not available
- Patients outside the specified age range
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 |
|---|---|---|
| Is the preoperative c-reactive protein/albumin ratio successful in predicting postoperative pancreatic fistula in patients undergoing pancreatoduodenectomy?In this study, predicting pancreatic fistula before surgery will reduce postoperative complications and mortality. | Diagnostic test | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Results publication: PubMed 31704858Sakamoto T, Yagyu Y, Uchinaka EI, Morimoto M, Hanaki T, Tokuyasu N, Honjo S, Fujiwara Y. Predictive Significance of C-reactive Protein-to-albumin Ratio for Postoperative Pancreatic Fistula After Pancreaticoduodenectomy. Anticancer Res. 2019 Nov;39(11):6283-6290. doi: 10.21873/anticanres.13838.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Is the preoperative c-reactive protein/albumin ratio successful in predicting postoperative pancreatic fistula in patients undergoing pancreatoduodenectomy? in people with Pancreatic Fistula After Pancreaticoduodenectomy and C-Reactive Protein, run by Erol Olcok Corum Training and Research Hospital at 2 sites in Turkey (Türkiye).
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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06300801, which also lists 1 linked publication.
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 8 Mar 2024.