Pancreatic FistulaNCT04783831
Biodegradable Pancreatic Stents for the Prevention of Postoperative Pancreatic Fistula After Cephalic Pancreaticoduodenectomy
An observational study of Pancreatic Fistula and Pancreas Neoplasm, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
Trial summary
Background: postoperative pancreatic fistula (POPF) remains the most important morbidity after pancreaticoduodenectomy (PD). There is no consensual technique for pancreatic reconstruction and many surgeons use a transanastomotic drain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Fistula, Pancreas Neoplasm, Stent Disintegration
- What is being tested?
- Biodegradable stent
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2018to 1 May 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cephalic pancreaticoduodenectomy (Whipple procedure).
Who may be able to join
- Patients undergoing cephalic pancreaticoduodenectomy (Whipple procedure).
Who cannot join
- Patients with soft pancreas or chronic pancreatitis.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
David Ferreras
Murcia, 30120
David Ferreras, MD, 0034968369677, david_99db@hotmail.com
About this study
Official title: Usefulness of Biodegradable Pancreatic Stents for the Prevention of Postoperative Pancreatic Fistula After Cephalic Pancreaticoduodenectomy. Prospective Non-randomized Controlled Clinical Study Comparing Biodegradable vs Non-biodegradable Stents
Background: postoperative pancreatic fistula (POPF) remains the most important morbidity after pancreaticoduodenectomy (PD). There is no consensual technique for pancreatic reconstruction and many surgeons use a transanastomotic drain. Currently, the stents used are not degradable and they can cause obstruction, stricture and pancreatitis. The use of biodegradable stents that disappear a few months after the intervention could have a role in the prevention of pancreaticojejunostomy complications.
Material and method: A single-center prospective randomized study was planned with patients undergoing PD. A duct-to-mucosa end-to-side anastomosis is performed for the pancreaticojejunal anastomosis and the stent is placed from the pancreatic duct to the jejunum.
The primary outcome of the study is the evaluation of the presence of POPF (drainage fluid amylase value of > 5000 U/L on the first day).
- Conditions
- Pancreatic Fistula, Pancreas Neoplasm, Stent Disintegration, Pancreatic Cancer, Pancreatic Anastomotic Leak
- Being tested
- Biodegradable stent
- Keywords
- pancreaticoduodenectomy, pancreaticojejunostomy, pancreatic stent, pancreatic fistula
- Medical subject headings
- Pancreatic Fistula, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodegradable stentDevice
Biodegradable stent (polymeric prostheses) is placed from the pancreatic duct to the jejunum. Duct-to-mucosa end-to-side anastomosis is performed for the pancreaticojejunal anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| Biodegradable stent | Not described Receives: Device: Biodegradable stent | |
| Non-biodegradable stent | Not described Receives: Device: Biodegradable stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
POPF
Evaluation of the presence of POPF (drainage fluid amylase value of > 5000 U/L on the first day).
Measured: 1 week
Secondary outcomes (1)
Position and degradation of biodegradable stents
Evaluation of the position and degradation time of the biodegradable stents
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Nov 2018
- Primary completion1 Dec 2018
- Study completion1 May 2021 (estimated)
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen de la Arrixaca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ferreras, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783831
- Sponsor's protocol ID
- ARQUIMEDES
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 9 Mar 2021
- 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 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Biodegradable Pancreatic Stents for the Prevention of Postoperative Pancreatic Fistula After Cephalic Pancreaticoduodenectomy. Prospective Non-randomized Controlled Clinical Study Comparing Biodegradable vs Non-biodegradable Stents
- ClinicalTrials.gov ID
- NCT04783831
- Acronym / sponsor ID
- ARQUIMEDES
- Conditions
- Pancreatic Fistula, Pancreas Neoplasm, Stent Disintegration, Pancreatic Cancer, Pancreatic Anastomotic Leak
- Keywords
- pancreaticoduodenectomy, pancreaticojejunostomy, pancreatic stent, pancreatic fistula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen de la ArrixacaUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 5 Mar 2021 (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.
Background: postoperative pancreatic fistula (POPF) remains the most important morbidity after pancreaticoduodenectomy (PD). There is no consensual technique for pancreatic reconstruction and many surgeons use a transanastomotic drain. Currently, the stents used are not degradable and they can cause obstruction, stricture and pancreatitis. The use of biodegradable stents that disappear a few months after the intervention could have a role in the prevention of pancreaticojejunostomy complications.
Material and method: A single-center prospective randomized study was planned with patients undergoing PD. A duct-to-mucosa end-to-side anastomosis is performed for the pancreaticojejunal anastomosis and the stent is placed from the pancreatic duct to the jejunum.
The primary outcome of the study is the evaluation of the presence of POPF (drainage fluid amylase value of > 5000 U/L on the first day).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biodegradable stent | – | Device: Biodegradable stent |
| Non-biodegradable stent | – | Device: Biodegradable stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cephalic pancreaticoduodenectomy (Whipple procedure).
Key inclusion criteria (1 listed)
- Patients undergoing cephalic pancreaticoduodenectomy (Whipple procedure).
Key exclusion criteria (1 listed)
- Patients with soft pancreas or chronic pancreatitis.
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 |
|---|---|---|
| Biodegradable stentBiodegradable stent (polymeric prostheses) is placed from the pancreatic duct to the jejunum. Duct-to-mucosa end-to-side anastomosis is performed for the pancreaticojejunal anastomosis. | Device | Biodegradable stent, Non-biodegradable stent |
Primary outcome
POPF
Time frame: 1 week
Evaluation of the presence of POPF (drainage fluid amylase value of > 5000 U/L on the first day).
1 secondary outcome
Position and degradation of biodegradable stents
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- 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.
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 and Pancreas Neoplasm, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
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 1 inclusion and 1 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 9 Mar 2021. 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 Spain. 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?
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?
POPF (time frame: 1 week). 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 9 Mar 2021.