Pancreatic CancerNCT01059097
Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy
A study testing Pancreaticoduodenectomy in people with Pancreatic Cancer and Pancreatic Surgery, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
The independent impact of surgeon volume on outcome of patients undergoing pancreaticoduodenectomy in a high-volume Institution was assessed. A significant reduction of pancreatic fistula rate was found in the high-volume surgeon group in comparison with low-volume surgeon group. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Surgery
- What is being tested?
- Pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2001to Jan 2010
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent pancreaticoduodenectomy between August 2001 and August 2009
Who cannot join
- Other type of surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy in a High Volume Hospital.
The independent impact of surgeon volume on outcome of patients undergoing pancreaticoduodenectomy in a high-volume Institution was assessed. A significant reduction of pancreatic fistula rate was found in the high-volume surgeon group in comparison with low-volume surgeon group. However, no difference between groups was found in mortality, major complications, and hospital stay.
Read the detailed description
Objectives: To define the independent impact of surgeon volume on outcome after pancreaticoduodenectomy (PD) in a single high-volume institution.
Summary Background Data: The impact of surgeon volume on PD outcome is still controversial. So far, data available are from retrospective multi-institutional reviews, considering in-hospital mortality as the only outcome variable.
Methods: Prospectively collected data on 610 patients who underwent PD from August 2001 to August 2009 were analyzed. Cut-off value to categorize high and low-volume surgeons (HVS and LVS, respectively) was 18 PD/year. Primary endpoint was operative mortality (death within 30-day post-discharge). Secondary endpoints were morbidity, pancreatic fistula (PF) and length of stay. Demographic, clinical, and surgical variables were recorded.
- Conditions
- Pancreatic Cancer, Pancreatic Surgery
- Being tested
- Pancreaticoduodenectomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PancreaticoduodenectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| High volume surgeons | Active comparator | high volume surgeons performed at least 18 PD/year. Receives: Procedure: Pancreaticoduodenectomy |
| Low volume surgeons | Active comparator | low volume surgeons performed less than 18 PD/year. Receives: Procedure: Pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative mortality after pancreaticoduodenectomy within 30 days of discharge
Measured: 30 days after discharge
Secondary outcomes (2)
Postoperative morbidity rate measuring the following complications: pancreatic fistula, biliary fistula, delayed gastric emptying, infectious complications, bleeding, cardiovascular complications, respiratory complications.
Measured: 30 days post-discharge
Postoperative hospital stay. Measuring the length of hospital stay.
Measured: At day of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startAug 2001
- Primary completionAug 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 610 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Investigators
- Marco Braga, MD, Principal investigator, San Raffaele University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059097
- Sponsor's protocol ID
- PANCREAS2010
- Status last verified
- Jan 2010
- First submitted
- 25 Jan 2010
- Last updated
- 29 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Balzano G, Zerbi A, Braga M, Rocchetti S, Beneduce AA, Di Carlo V. Fast-track recovery programme after pancreatico- duodenectomy reduces delayed gastric emptying. Br J Surg. 2008 Nov;95(11):1387-93. doi: 10.1002/bjs.6324.
PubMed 18844251Balzano G, Zerbi A, Capretti G, Rocchetti S, Capitanio V, Di Carlo V. Effect of hospital volume on outcome of pancreaticoduodenectomy in Italy. Br J Surg. 2008 Mar;95(3):357-62. doi: 10.1002/bjs.5982.
PubMed 17933001
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy in a High Volume Hospital.
- ClinicalTrials.gov ID
- NCT01059097
- Acronym / sponsor ID
- PANCREAS2010
- Conditions
- Pancreatic Cancer, Pancreatic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- Aug 2001
- Primary completion
- Aug 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 29 Jan 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.
The independent impact of surgeon volume on outcome of patients undergoing pancreaticoduodenectomy in a high-volume Institution was assessed. A significant reduction of pancreatic fistula rate was found in the high-volume surgeon group in comparison with low-volume surgeon group. However, no difference between groups was found in mortality, major complications, and hospital stay.
Detailed description
Objectives: To define the independent impact of surgeon volume on outcome after pancreaticoduodenectomy (PD) in a single high-volume institution.
Summary Background Data: The impact of surgeon volume on PD outcome is still controversial. So far, data available are from retrospective multi-institutional reviews, considering in-hospital mortality as the only outcome variable.
Methods: Prospectively collected data on 610 patients who underwent PD from August 2001 to August 2009 were analyzed. Cut-off value to categorize high and low-volume surgeons (HVS and LVS, respectively) was 18 PD/year. Primary endpoint was operative mortality (death within 30-day post-discharge). Secondary endpoints were morbidity, pancreatic fistula (PF) and length of stay. Demographic, clinical, and surgical variables were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High volume surgeons | Active comparator | Procedure: Pancreaticoduodenectomyhigh volume surgeons performed at least 18 PD/year. |
| Low volume surgeons | Active comparator | Procedure: Pancreaticoduodenectomylow volume surgeons performed less than 18 PD/year. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who underwent pancreaticoduodenectomy between August 2001 and August 2009
Key exclusion criteria (1 listed)
- Other type of surgery
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 |
|---|---|---|
| Pancreaticoduodenectomy | Procedure or surgery | High volume surgeons, Low volume surgeons |
Primary outcome
Postoperative mortality after pancreaticoduodenectomy within 30 days of discharge
Time frame: 30 days after discharge
2 secondary outcomes
Postoperative morbidity rate measuring the following complications: pancreatic fistula, biliary fistula, delayed gastric emptying, infectious complications, bleeding, cardiovascular complications, respiratory complications.
Time frame: 30 days post-discharge
Postoperative hospital stay. Measuring the length of hospital stay.
Time frame: At day of discharge
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 29 Jan 2010.
- Background: PubMed 18844251Balzano G, Zerbi A, Braga M, Rocchetti S, Beneduce AA, Di Carlo V. Fast-track recovery programme after pancreatico- duodenectomy reduces delayed gastric emptying. Br J Surg. 2008 Nov;95(11):1387-93. doi: 10.1002/bjs.6324.
- Background: PubMed 17933001Balzano G, Zerbi A, Capretti G, Rocchetti S, Capitanio V, Di Carlo V. Effect of hospital volume on outcome of pancreaticoduodenectomy in Italy. Br J Surg. 2008 Mar;95(3):357-62. doi: 10.1002/bjs.5982.
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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.
Marco Braga, MD principal investigator
San Raffaele University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pancreaticoduodenectomy in people with Pancreatic Cancer and Pancreatic Surgery, run by Università Vita-Salute San Raffaele 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 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: finished, as of the sponsor's last update on 29 Jan 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 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?
Postoperative mortality after pancreaticoduodenectomy within 30 days of discharge (time frame: 30 days after discharge). 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 NCT01059097, which also lists 2 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 29 Jan 2010.