Fistula PancreaticNCT06205693
Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy
A study testing Fast Degradable, Biodegradable ARCHEMEDES stent in people with Fistula Pancreatic, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The aim of this prospective, randomized, blinded clinical superiority trial is to establish intraoperative placement of biodegradable stents in the pancreatojejunostomy as a safe, effective, and feasible preventive measure against pancreatic fistula following pancreatoduodenectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fistula Pancreatic
- What is being tested?
- Fast Degradable, Biodegradable ARCHEMEDES stent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2023to 1 May 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing a pancreatoduodenectomy
- Patients aged 18 or above
- Patients who have given an informed consent
Who cannot join
- Patients who do not or cannot give an informed consent.
- Patients with at a high risk or with previous history of multiple thrombo-embolic diseases or bleeding disorders.
- Patients undergoing active immunosuppressive therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy - Protocol and Statistical Analysis Plan for Randomized, Clinical Trial
The aim of this prospective, randomized, blinded clinical superiority trial is to establish intraoperative placement of biodegradable stents in the pancreatojejunostomy as a safe, effective, and feasible preventive measure against pancreatic fistula following pancreatoduodenectomy.
The investigators hypothesize that intraoperative placement of biodegradable stents in the pancreatojejunostomy is safe and can reduce the risk of pancreatic leakage following pancreatoduodenectomy in patients who have not undergone PBD.
- Conditions
- Fistula Pancreatic
- Being tested
- Fast Degradable, Biodegradable ARCHEMEDES stent
- Keywords
- Fistula, postoperative pancreatic fistula, pancreatoduodenectomy
- Medical subject headings
- Pancreatic Fistula, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast Degradable, Biodegradable ARCHEMEDES stentProcedure or surgery
Fast Degradable, Biodegradable ARCHEMEDES stent. Placed in the pancreaticojejunostomy.
| Study group | Role | What they receive |
|---|---|---|
| Stent | Active comparator | Placement of biodegradable stent intraoperatively. Receives: Procedure: Fast Degradable, Biodegradable ARCHEMEDES stent |
| No stent | No intervention | Control group. No placement of stent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
POPF
Number of participants with a Postoperative pancreatic fistula
Measured: 30 days
Number of participants with a Biliary fistula
Postoperative biliary fistula
Measured: 30 days
Secondary outcomes (5)
Complications to stent placement
Incidence of complications to placement of the biodegradable stent, including displacement.
Measured: 30 days
Postoperative complications
Overall incidence of complications following PD classified according to Clavien-Dindo
Measured: 30 days postoperative
Mortality
Participant Mortality at 30 and 90 days
Measured: 30 days and 90 days
LOS
Participant Length of hospital stay (LOS).
Measured: Length in days, from surgery until discharge ( up to 200 days from surgery)
Quality of Life according to VR12 Quality of Life Score
Patient reported quality of life according to VR12 Quality of Life Score (activity level, pain episodes, pain levels, patient mood)
Measured: 30 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 posted16 Jan 2024
- Study start1 Oct 2023
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fistula PancreaticStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, blinded clinical superiority trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waqas Farooqui, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205693
- Sponsor's protocol ID
- Stent-trial
- Status last verified
- Jun 2025
- First submitted
- 14 Dec 2023
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy - Protocol and Statistical Analysis Plan for Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT06205693
- Acronym / sponsor ID
- Stent-trial
- Conditions
- Fistula Pancreatic
- Keywords
- Fistula, postoperative pancreatic fistula, pancreatoduodenectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 16 Jan 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.
The aim of this prospective, randomized, blinded clinical superiority trial is to establish intraoperative placement of biodegradable stents in the pancreatojejunostomy as a safe, effective, and feasible preventive measure against pancreatic fistula following pancreatoduodenectomy.
The investigators hypothesize that intraoperative placement of biodegradable stents in the pancreatojejunostomy is safe and can reduce the risk of pancreatic leakage following pancreatoduodenectomy in patients who have not undergone PBD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized, blinded clinical superiority trial
| Arm | Type | Receives |
|---|---|---|
| Stent | Active comparator | Procedure: Fast Degradable, Biodegradable ARCHEMEDES stentPlacement of biodegradable stent intraoperatively. |
| No stent | No intervention | –Control group. No placement of stent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing a pancreatoduodenectomy
- Patients aged 18 or above
- Patients who have given an informed consent
Key exclusion criteria (3 listed)
- Patients who do not or cannot give an informed consent.
- Patients with at a high risk or with previous history of multiple thrombo-embolic diseases or bleeding disorders.
- Patients undergoing active immunosuppressive therapy.
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 |
|---|---|---|
| Fast Degradable, Biodegradable ARCHEMEDES stentFast Degradable, Biodegradable ARCHEMEDES stent. Placed in the pancreaticojejunostomy. | Procedure or surgery | Stent |
Primary outcome
POPF
Time frame: 30 days
Number of participants with a Postoperative pancreatic fistula
Number of participants with a Biliary fistula
Time frame: 30 days
Postoperative biliary fistula
5 secondary outcomes
Complications to stent placement
Time frame: 30 days
Postoperative complications
Time frame: 30 days postoperative
Mortality
Time frame: 30 days and 90 days
LOS
Time frame: Length in days, from surgery until discharge ( up to 200 days from surgery)
Quality of Life according to VR12 Quality of Life Score
Time frame: 30 days post surgery
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 8 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast Degradable, Biodegradable ARCHEMEDES stent in people with Fistula Pancreatic, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 8 Jun 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 Denmark. 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?
POPF (time frame: 30 days). The study lists 2 primary outcomes in all. 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 Jun 2025.