Pancreatic FistulaPhase 3NCT01068886
External Pancreatic Duct Stent After Pancreaticoduodenectomy
A Phase 3 study testing External pancreatic stent in people with Pancreatic Fistula, run by University Hospital, Angers at 1 site in France.
Trial summary
Pancreatoduodenectomy (PD) is performed in many high volume centers with a very low mortality. Reduced mortality rate is largely the result of careful patient selection, improved intraoperative management and a better postoperative care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Fistula
- What is being tested?
- External pancreatic stent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2006to Dec 2009
- Phase
- Phase 3
- 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
- All patients scheduled for elective PD,
- Confirmation of the soft pancreas or nondilated pancreatic duct during PD.
Who cannot join
- Age less than 18 year,
- Emergency surgery,
- Previous pancreatic surgery,
- Previous susmesocolic radiotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Pancreatic Duct Stent After Pancreaticoduodenectomy: a Prospective Randomized Multicenter Trial
Pancreatoduodenectomy (PD) is performed in many high volume centers with a very low mortality. Reduced mortality rate is largely the result of careful patient selection, improved intraoperative management and a better postoperative care. Unfortunately, there is not a similar reduction in morbidity rates which remains about 40%. Persistent morbidity is predominantly due to pancreatic fistula (PF). Abdominal abscess and hemorrhage are common sequelae of PF which have been associated with a high mortality rate. While many different risk factors have been reported, a soft pancreatic texture and a nondilated pancreatic duct have been most consistently linked to high rates of PF. A number of methods for reducing the incidence of PF have been proposed and analysed. Many of these involve technical features of the anastomosis, including site of reconstruction, anastomotic technique, use of biologic glue, and prophylactic use of somatostatin analogue. The placement of a stent through the pancreatic anastomosis is an attractive strategy to reduce the PF rate. This multicenter prospective randomized trial was designed to compare the outcome after PD with external drainage stent versus no stent in patients with high risk of PF (with soft pancreas and a diameter of wirsung <3mm).
Analysis:The primary objective of the study was to compare the incidence PF in patients with or without external pancreatic stent. With an anticipated PF rate of 30%, based on literature experience, it was calculated that a reduction to 10% of PF rate would require the inclusion of 75 patients in each group (statistical significance P < 0.05 and power 80 per cent with a two-tailed test of proportions). We'll enroll 158 patients to take into account the possibility of 5% being lost to follow-up.
Read the detailed description
Analysis: The primary objective of the study was to compare the incidence PF in patients with or without external pancreatic stent. With an anticipated PF rate of 30%, based on literature experience, it was calculated that a reduction to 10% of PF rate would require the inclusion of 75 patients in each group (statistical significance P < 0.05 and power 80 per cent with a two-tailed test of proportions). We'll enroll 158 patients to take into account the possibility of 5% being lost to follow-up.
PF was defined, according to the International Study Group of Pancreatic Fistula, as amylase rich fluid (amylase concentration more than three times serum concentration) collected from the drainage placed intraoperatively from day 3 or by needle aspiration of an intraabdominal collection. PF were graded according to the clinical impact on the patient's hospital course (grades A,B,C).
- Conditions
- Pancreatic Fistula
- Being tested
- External pancreatic stent
- Keywords
- 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.
External pancreatic stentProcedure or surgery
Also called pancreatic stent
stent through pancreatic anastomosis
| Study group | Role | What they receive |
|---|---|---|
| no stent | No intervention | no stent through pancreatic anastomosis |
| stent | Experimental | stent through pancreatic anastomosis Receives: Procedure: External pancreatic stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
pancreatic fistula
Measured: on postoperative day 30
Secondary outcomes (1)
overall morbidity
Measured: postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2010 (estimated)
- Study startJan 2006
- Primary completionApr 2009
- Study completionDec 2009
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 FistulaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Investigators
- arnaud - jean-pierre, professor, Principal investigator, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068886
- Sponsor's protocol ID
- PHRC 04-04
- Status last verified
- Feb 2010
- First submitted
- 14 Sep 2005
- Last updated
- 15 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pessaux P, Sauvanet A, Mariette C, Paye F, Muscari F, Cunha AS, Sastre B, Arnaud JP; Federation de Recherche en Chirurgie (French). External pancreatic duct stent decreases pancreatic fistula rate after pancreaticoduodenectomy: prospective multicenter randomized trial. Ann Surg. 2011 May;253(5):879-85. doi: 10.1097/SLA.0b013e31821219af.
PubMed 21368658
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Pancreatic Duct Stent After Pancreaticoduodenectomy: a Prospective Randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT01068886
- Acronym / sponsor ID
- PHRC 04-04
- Conditions
- Pancreatic Fistula
- Keywords
- Pancreaticoduodenectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jan 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 15 Feb 2010 (estimated)
- 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.
Pancreatoduodenectomy (PD) is performed in many high volume centers with a very low mortality. Reduced mortality rate is largely the result of careful patient selection, improved intraoperative management and a better postoperative care. Unfortunately, there is not a similar reduction in morbidity rates which remains about 40%. Persistent morbidity is predominantly due to pancreatic fistula (PF). Abdominal abscess and hemorrhage are common sequelae of PF which have been associated with a high mortality rate. While many different risk factors have been reported, a soft pancreatic texture and a nondilated pancreatic duct have been most consistently linked to high rates of PF. A number of methods for reducing the incidence of PF have been proposed and analysed. Many of these involve technical features of the anastomosis, including site of reconstruction, anastomotic technique, use of biologic glue, and prophylactic use of somatostatin analogue. The placement of a stent through the pancreatic anastomosis is an attractive strategy to reduce the PF rate. This multicenter prospective randomized trial was designed to compare the outcome after PD with external drainage stent versus no stent in patients with high risk of PF (with soft pancreas and a diameter of wirsung <3mm).
Analysis:The primary objective of the study was to compare the incidence PF in patients with or without external pancreatic stent. With an anticipated PF rate of 30%, based on literature experience, it was calculated that a reduction to 10% of PF rate would require the inclusion of 75 patients in each group (statistical significance P < 0.05 and power 80 per cent with a two-tailed test of proportions). We'll enroll 158 patients to take into account the possibility of 5% being lost to follow-up.
Detailed description
Analysis: The primary objective of the study was to compare the incidence PF in patients with or without external pancreatic stent. With an anticipated PF rate of 30%, based on literature experience, it was calculated that a reduction to 10% of PF rate would require the inclusion of 75 patients in each group (statistical significance P < 0.05 and power 80 per cent with a two-tailed test of proportions). We'll enroll 158 patients to take into account the possibility of 5% being lost to follow-up.
PF was defined, according to the International Study Group of Pancreatic Fistula, as amylase rich fluid (amylase concentration more than three times serum concentration) collected from the drainage placed intraoperatively from day 3 or by needle aspiration of an intraabdominal collection. PF were graded according to the clinical impact on the patient's hospital course (grades A,B,C).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no stent | No intervention | –no stent through pancreatic anastomosis |
| stent | Experimental | Procedure: External pancreatic stentstent through pancreatic anastomosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients scheduled for elective PD,
- Confirmation of the soft pancreas or nondilated pancreatic duct during PD.
Key exclusion criteria (4 listed)
- Age less than 18 year,
- Emergency surgery,
- Previous pancreatic surgery,
- Previous susmesocolic radiotherapy.
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 |
|---|---|---|
| External pancreatic stentAlso: pancreatic stentstent through pancreatic anastomosis | Procedure or surgery | stent |
Primary outcome
pancreatic fistula
Time frame: on postoperative day 30
1 secondary outcome
overall morbidity
Time frame: postoperative day 30
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 15 Feb 2010.
- Derived from this study: PubMed 21368658Pessaux P, Sauvanet A, Mariette C, Paye F, Muscari F, Cunha AS, Sastre B, Arnaud JP; Federation de Recherche en Chirurgie (French). External pancreatic duct stent decreases pancreatic fistula rate after pancreaticoduodenectomy: prospective multicenter randomized trial. Ann Surg. 2011 May;253(5):879-85. doi: 10.1097/SLA.0b013e31821219af.
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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.
arnaud - jean-pierre, professor principal investigator
University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing External pancreatic stent in people with Pancreatic Fistula, run by University Hospital, Angers at 1 site in France.
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 2 inclusion and 4 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 15 Feb 2010. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
pancreatic fistula (time frame: on postoperative day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01068886, 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 15 Feb 2010.