Pancreas; FistulaAEON-DPNCT06764134
Assessing Pancreatic Fistula Rates After Distal Pancreatectomy Using AEON Endostapler
An observational study of Pancreas; Fistula and Pancreas Cancer, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
This prospective, observational study evaluates the rate of postoperative pancreatic fistula (POPF) following distal pancreatectomy (DP) using the AEON™ Endostapler. The study involves 110 patients undergoing DP and assesses primary outcomes based on the International Study Group of Pancreatic Fistula (ISGPF)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas; Fistula, Pancreas Cancer, Pancreatic Disease
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2024to 31 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 18 years or older scheduled to undergo minimally invasive or open distal pancreatectomy (DP) for any indication, with or without splenectomy and/or left adrenalectomy. These patients will be recruited from the University of Heidelberg and screened for eligibility based on inclusion and exclusion criteria. Participants must provide informed consent and demonstrate the ability to comply with study procedures and follow-up assessments.
Who may be able to join
- Age 18 years or older.
- Ability to understand the nature and consequences of the study.
- Provision of written informed consent.
- Scheduled for minimally invasive or open distal pancreatectomy (DP) for any indication, with or without splenectomy and/or left adrenalectomy.
Who cannot join
- Inability to comply with study procedures or follow-up.
- Multivisceral resection beyond left adrenalectomy.
- History of previous pancreatic surgeries.
- Expected lack of compliance with the study protocol.
- Participation in another trial that may interfere with the intervention or outcomes of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Arianeb Mehrabi, Professor, +4962215636223, arianeb.mehrabi@med.uni-heidelberg.de
Elias khajeh, Dr., +4962215635853, elias.khajeh@med.uni-heidelberg.de
About this study
Official title: Study Protocol for an Investigator Initiated, Observational Prospective Study, Evaluating the Rate of Postoperative Pancreatic Fistula in Distal Pancreatectomy Using AEON™ Endostapler
This prospective, observational study evaluates the rate of postoperative pancreatic fistula (POPF) following distal pancreatectomy (DP) using the AEON™ Endostapler. The study involves 110 patients undergoing DP and assesses primary outcomes based on the International Study Group of Pancreatic Fistula (ISGPF) classification, alongside secondary perioperative parameters. The findings aim to optimize surgical techniques, reduce complications, and improve healthcare outcomes.
Read the detailed description
This is a prospective, observational, monocentric study designed to evaluate the incidence of postoperative pancreatic fistula (POPF) following distal pancreatectomy (DP) performed using the AEON™ Endostapler. POPF is one of the most serious complications after DP, and effective stump closure remains a critical challenge in reducing its occurrence. The study will involve 110 patients who meet the inclusion criteria and undergo DP at the University of Heidelberg.
Primary outcomes will focus on the rate of clinically relevant POPF as defined by the International Study Group of Pancreatic Fistula (ISGPF). Secondary outcomes include intraoperative and postoperative parameters, such as estimated blood loss, operation duration, ICU and hospital stay, reoperation rates, and 90-day mortality. All outcomes will be assessed following standardized protocols.
Patients will be enrolled after providing informed consent and will receive follow-up evaluations at specific time points, including postoperative days 1, 3, 14, 30, and 90. Amylase levels in drain fluid will be measured to monitor pancreatic leakage. Data collected during the study will be analyzed to assess the effectiveness and safety of the AEON™ Endostapler in reducing POPF and other complications.
The findings aim to contribute critical evidence to improve surgical practices and outcomes for DP patients, potentially shaping future guidelines and reducing healthcare costs.
- Medical subject headings
- Pancreatic Fistula, Pancreatic Neoplasms, Pancreatic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Clinically Relevant Postoperative Pancreatic Fistula (POPF)
The rate of clinically relevant POPF will be assessed based on the International Study Group of Pancreatic Fistula (ISGPF) definition, which includes drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content exceeding three times the upper limit of normal serum amylase activity, associated with a clinically relevant condition.
Measured: Up to 90 days post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Nov 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
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 University Hospital HeidelbergThe 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
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arianeb Mehrabi, MD, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764134
- Sponsor's protocol ID
- S-473/2024
- Acronym
- AEON-DP
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 8 Jan 2025
- 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 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Protocol for an Investigator Initiated, Observational Prospective Study, Evaluating the Rate of Postoperative Pancreatic Fistula in Distal Pancreatectomy Using AEON™ Endostapler
- ClinicalTrials.gov ID
- NCT06764134
- Acronym / sponsor ID
- AEON-DP / S-473/2024
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 8 Jan 2025 (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 prospective, observational study evaluates the rate of postoperative pancreatic fistula (POPF) following distal pancreatectomy (DP) using the AEON™ Endostapler. The study involves 110 patients undergoing DP and assesses primary outcomes based on the International Study Group of Pancreatic Fistula (ISGPF) classification, alongside secondary perioperative parameters. The findings aim to optimize surgical techniques, reduce complications, and improve healthcare outcomes.
Detailed description
This is a prospective, observational, monocentric study designed to evaluate the incidence of postoperative pancreatic fistula (POPF) following distal pancreatectomy (DP) performed using the AEON™ Endostapler. POPF is one of the most serious complications after DP, and effective stump closure remains a critical challenge in reducing its occurrence. The study will involve 110 patients who meet the inclusion criteria and undergo DP at the University of Heidelberg.
Primary outcomes will focus on the rate of clinically relevant POPF as defined by the International Study Group of Pancreatic Fistula (ISGPF). Secondary outcomes include intraoperative and postoperative parameters, such as estimated blood loss, operation duration, ICU and hospital stay, reoperation rates, and 90-day mortality. All outcomes will be assessed following standardized protocols.
Patients will be enrolled after providing informed consent and will receive follow-up evaluations at specific time points, including postoperative days 1, 3, 14, 30, and 90. Amylase levels in drain fluid will be measured to monitor pancreatic leakage. Data collected during the study will be analyzed to assess the effectiveness and safety of the AEON™ Endostapler in reducing POPF and other complications.
The findings aim to contribute critical evidence to improve surgical practices and outcomes for DP patients, potentially shaping future guidelines and reducing healthcare costs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 years or older scheduled to undergo minimally invasive or open distal pancreatectomy (DP) for any indication, with or without splenectomy and/or left adrenalectomy. These patients will be recruited from the University of Heidelberg and screened for eligibility based on inclusion and exclusion criteria. Participants must provide informed consent and demonstrate the ability to comply with study procedures and follow-up assessments.
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Ability to understand the nature and consequences of the study.
- Provision of written informed consent.
- Scheduled for minimally invasive or open distal pancreatectomy (DP) for any indication, with or without splenectomy and/or left adrenalectomy.
Key exclusion criteria (5 listed)
- Inability to comply with study procedures or follow-up.
- Multivisceral resection beyond left adrenalectomy.
- History of previous pancreatic surgeries.
- Expected lack of compliance with the study protocol.
- Participation in another trial that may interfere with the intervention or outcomes of this study.
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
Rate of Clinically Relevant Postoperative Pancreatic Fistula (POPF)
Time frame: Up to 90 days post-surgery.
The rate of clinically relevant POPF will be assessed based on the International Study Group of Pancreatic Fistula (ISGPF) definition, which includes drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content exceeding three times the upper limit of normal serum amylase activity, associated with a clinically relevant condition.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
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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.
University Hospital Heidelberg
Heidelberg, Germany
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 Pancreas; Fistula and Pancreas Cancer, run by University Hospital Heidelberg at 1 site in Germany.
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 5 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: looking for participants now, as of the sponsor's last update on 8 Jan 2025. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Clinically Relevant Postoperative Pancreatic Fistula (POPF) (time frame: Up to 90 days post-surgery.). 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 8 Jan 2025.