PancreaticoduodenectomyNCT00931554
Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections
A study testing Postoperative drain removal in people with Pancreaticoduodenectomy and Distal Pancreatectomy, run by Universita di Verona at 1 site in Italy.
Trial summary
Despite a substantial decrease in postoperative mortality, morbidity after pancreatic resections is still high, even at high-volume centers. It has been recently suggested that early removal of postoperative drainages is associated to a decreased rate of intra-abdominal complications, with particular regard to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreaticoduodenectomy, Distal Pancreatectomy, Pancreatic Fistula
- What is being tested?
- Postoperative drain removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2007to Apr 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergone either pancreaticoduodenectomy (reconstruction by pancreaticojejunostomy) or distal pancreatectomy with an amylase value in drains on postoperative day 1 less than 5000 IU/L
Who cannot join
- Pancreaticoduodenectomy reconstructed with pancreaticogastrostomy
- Clinical suspect of postoperative haemorrhage within 72hours after the operation
- Clinical suspect of biliary fistula
- Fluid collection greater than 3cm at an ultrasound carried out on postoperative day 3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Versus Standard Drainage Removal After Pancreatic Resections: Results of a Prospective Randomized Clinical Trial
Despite a substantial decrease in postoperative mortality, morbidity after pancreatic resections is still high, even at high-volume centers. It has been recently suggested that early removal of postoperative drainages is associated to a decreased rate of intra-abdominal complications, with particular regard to pancreatic fistula. Furthermore, our research group demonstrated that measuring amylase value in drainages (AVD) on postoperative day 1 plays a cardinal role in predicting the developement of abdominal complications, including pancreatic fistula. In particular, patients with an AVD lower than 5000 IU/L in postoperative day 1 were considered at low risk of fistula. Therefore, the investigators designed a randomized prospective trial on early (postoperative day 3) versus standard (postoperative day 5) drainages removal after pancreatic resections in patients at low risk of developing pancreatic fistula (AVD < 5000 IU/L in postoperative day 1) to test whether drainages "per se" influence postoperative complication rates and to eventually validate a fast-track policy in pancreatic resections.
- Being tested
- Postoperative drain removal
- Medical subject headings
- Pancreatic Fistula, Abdominal Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative drain removalProcedure or surgery
removal of postoperative drainages at different time points (postoperative day 3 versus postoperative day 5)
| Study group | Role | What they receive |
|---|---|---|
| Early drain removal | Active comparator | Drain removal in postoperative day 3 Receives: Procedure: Postoperative drain removal |
| Standard drain removal | Active comparator | Drain removal on postoperative day 5 Receives: Procedure: Postoperative drain removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Complications
Measured: 1 month
Secondary outcomes (3)
In-hospital stay
Measured: 1 month
Pulmonary complications
Measured: 1 month
Hospital readmission
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startMar 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931554
- Sponsor's protocol ID
- DREN-01
- Status last verified
- Jul 2009
- First submitted
- 28 May 2009
- Last updated
- 2 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Molinari E, Bassi C, Salvia R, Butturini G, Crippa S, Talamini G, Falconi M, Pederzoli P. Amylase value in drains after pancreatic resection as predictive factor of postoperative pancreatic fistula: results of a prospective study in 137 patients. Ann Surg. 2007 Aug;246(2):281-7. doi: 10.1097/SLA.0b013e3180caa42f.
PubMed 17667507Kawai M, Tani M, Terasawa H, Ina S, Hirono S, Nishioka R, Miyazawa M, Uchiyama K, Yamaue H. Early removal of prophylactic drains reduces the risk of intra-abdominal infections in patients with pancreatic head resection: prospective study for 104 consecutive patients. Ann Surg. 2006 Jul;244(1):1-7. doi: 10.1097/01.sla.0000218077.14035.a6.
PubMed 16794381Bassi C, Molinari E, Malleo G, Crippa S, Butturini G, Salvia R, Talamini G, Pederzoli P. Early versus late drain removal after standard pancreatic resections: results of a prospective randomized trial. Ann Surg. 2010 Aug;252(2):207-14. doi: 10.1097/SLA.0b013e3181e61e88.
PubMed 20622661
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Standard Drainage Removal After Pancreatic Resections: Results of a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00931554
- Acronym / sponsor ID
- DREN-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- Mar 2007
- Study completion
- Apr 2008 (actual)
- First posted
- 2 Jul 2009 (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.
Despite a substantial decrease in postoperative mortality, morbidity after pancreatic resections is still high, even at high-volume centers. It has been recently suggested that early removal of postoperative drainages is associated to a decreased rate of intra-abdominal complications, with particular regard to pancreatic fistula. Furthermore, our research group demonstrated that measuring amylase value in drainages (AVD) on postoperative day 1 plays a cardinal role in predicting the developement of abdominal complications, including pancreatic fistula. In particular, patients with an AVD lower than 5000 IU/L in postoperative day 1 were considered at low risk of fistula. Therefore, the investigators designed a randomized prospective trial on early (postoperative day 3) versus standard (postoperative day 5) drainages removal after pancreatic resections in patients at low risk of developing pancreatic fistula (AVD < 5000 IU/L in postoperative day 1) to test whether drainages "per se" influence postoperative complication rates and to eventually validate a fast-track policy in pancreatic resections.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early drain removal | Active comparator | Procedure: Postoperative drain removalDrain removal in postoperative day 3 |
| Standard drain removal | Active comparator | Procedure: Postoperative drain removalDrain removal on postoperative day 5 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergone either pancreaticoduodenectomy (reconstruction by pancreaticojejunostomy) or distal pancreatectomy with an amylase value in drains on postoperative day 1 less than 5000 IU/L
Key exclusion criteria (4 listed)
- Pancreaticoduodenectomy reconstructed with pancreaticogastrostomy
- Clinical suspect of postoperative haemorrhage within 72hours after the operation
- Clinical suspect of biliary fistula
- Fluid collection greater than 3cm at an ultrasound carried out on postoperative day 3
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 |
|---|---|---|
| Postoperative drain removalremoval of postoperative drainages at different time points (postoperative day 3 versus postoperative day 5) | Procedure or surgery | Early drain removal, Standard drain removal |
Primary outcome
Abdominal Complications
Time frame: 1 month
3 secondary outcomes
In-hospital stay
Time frame: 1 month
Pulmonary complications
Time frame: 1 month
Hospital readmission
Time frame: 1 month
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 2 Jul 2009.
- Background: PubMed 17667507Molinari E, Bassi C, Salvia R, Butturini G, Crippa S, Talamini G, Falconi M, Pederzoli P. Amylase value in drains after pancreatic resection as predictive factor of postoperative pancreatic fistula: results of a prospective study in 137 patients. Ann Surg. 2007 Aug;246(2):281-7. doi: 10.1097/SLA.0b013e3180caa42f.
- Background: PubMed 16794381Kawai M, Tani M, Terasawa H, Ina S, Hirono S, Nishioka R, Miyazawa M, Uchiyama K, Yamaue H. Early removal of prophylactic drains reduces the risk of intra-abdominal infections in patients with pancreatic head resection: prospective study for 104 consecutive patients. Ann Surg. 2006 Jul;244(1):1-7. doi: 10.1097/01.sla.0000218077.14035.a6.
- Derived from this study: PubMed 20622661Bassi C, Molinari E, Malleo G, Crippa S, Butturini G, Salvia R, Talamini G, Pederzoli P. Early versus late drain removal after standard pancreatic resections: results of a prospective randomized trial. Ann Surg. 2010 Aug;252(2):207-14. doi: 10.1097/SLA.0b013e3181e61e88.
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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 Postoperative drain removal in people with Pancreaticoduodenectomy and Distal Pancreatectomy, run by Universita di Verona at 1 site in Italy.
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 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 2 Jul 2009. 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 Italy. 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?
Abdominal Complications (time frame: 1 month). 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 NCT00931554, which also lists 3 linked publications.
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 2 Jul 2009.