Pancreatic NeoplasmNCT01278381
Prognostic Score To Predict Major Complications After Pancreaticoduodenectomy
An observational study of Pancreatic Neoplasm, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
Pancreaticoduodenectomy (PD) still carries a high rate of severe postoperative complications. No score is currently available to help identify the patient's surgical risk. The purpose of this study was to develop and validate a prognostic score to predict major postoperative complications after PD. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatic Neoplasm
- What is being tested?
- Pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2002to Oct 2010
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 700 patients undergoing pancreaticoduodenectomy in our Institution from 2002 to 2010
Who may be able to join
- Patients undergoing pancreaticoduodenectomy in our Institution
Who cannot join
- Metastatic disease
- Patient not suitable for surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A PROGNOSTIC SCORE TO PREDICT MAJOR COMPLICATIONS AFTER PANCREATICODUODENECTOMY.
Pancreaticoduodenectomy (PD) still carries a high rate of severe postoperative complications. No score is currently available to help identify the patient's surgical risk. The purpose of this study was to develop and validate a prognostic score to predict major postoperative complications after PD.
Read the detailed description
The investigators prospectively collected in an electronic database preoperative, intraoperative and outcome data of 700 patients undergoing PD in our Institution from 2002 to 2010. The investigators used a multivariate logistic regression analysis to create a new score to predict severe complications defined as Clavien-Dindo classification III, IV and V. The score was developed using a random two-thirds of the population (469 patients), and was then validated and calibrated in the remaining third of the patients (231).
- Conditions
- Pancreatic Neoplasm
- Being tested
- Pancreaticoduodenectomy
- Keywords
- pancreas, pancreaticoduodenectomy, major complications
- 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
Resection of pancreatic lesion
| Study group | Role | What they receive |
|---|---|---|
| Pancreaticoduodenectomy (PD) | Patients undergoing PD from 2002 to 2010 Receives: Procedure: Pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Complication rate
Clavien-Dindo grade III to V complications considered as major
Measured: Postoperative. Until 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startJan 2002
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Investigators
- Marco Braga, MD, Principal investigator, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278381
- Sponsor's protocol ID
- PANCREATICODUODENECTOMY_SCORE
- Status last verified
- Nov 2010
- First submitted
- 14 Jan 2011
- Last updated
- 17 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PROGNOSTIC SCORE TO PREDICT MAJOR COMPLICATIONS AFTER PANCREATICODUODENECTOMY.
- ClinicalTrials.gov ID
- NCT01278381
- Acronym / sponsor ID
- PANCREATICODUODENECTOMY_SCORE
- Conditions
- Pancreatic Neoplasm
- Keywords
- pancreas, pancreaticoduodenectomy, major complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 17 Jan 2011 (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.
Pancreaticoduodenectomy (PD) still carries a high rate of severe postoperative complications. No score is currently available to help identify the patient's surgical risk. The purpose of this study was to develop and validate a prognostic score to predict major postoperative complications after PD.
Detailed description
The investigators prospectively collected in an electronic database preoperative, intraoperative and outcome data of 700 patients undergoing PD in our Institution from 2002 to 2010. The investigators used a multivariate logistic regression analysis to create a new score to predict severe complications defined as Clavien-Dindo classification III, IV and V. The score was developed using a random two-thirds of the population (469 patients), and was then validated and calibrated in the remaining third of the patients (231).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreaticoduodenectomy (PD) | – | Procedure: PancreaticoduodenectomyPatients undergoing PD from 2002 to 2010 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 700 patients undergoing pancreaticoduodenectomy in our Institution from 2002 to 2010
Key inclusion criteria (1 listed)
- Patients undergoing pancreaticoduodenectomy in our Institution
Key exclusion criteria (2 listed)
- Metastatic disease
- Patient not suitable for 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 |
|---|---|---|
| PancreaticoduodenectomyResection of pancreatic lesion | Procedure or surgery | Pancreaticoduodenectomy (PD) |
Primary outcome
Major Complication rate
Time frame: Postoperative. Until 30 days after discharge
Clavien-Dindo grade III to V complications considered as major
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 17 Jan 2011.
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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
Università Vita-Salute San Raffaele
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 Neoplasm, 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 2 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 17 Jan 2011. 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?
Major Complication rate (time frame: Postoperative. Until 30 days after discharge). 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 17 Jan 2011.