Robotic PancreaticoduodenectomyLC-RPDNCT06723847
Navigating the Learning Curve of Robotic Pancreatoduodenectomy: Feasibility, Proficiency, and Mastery in a First-generation Surgeon
An observational study of Robotic Pancreaticoduodenectomy, run by University of Pisa.
Trial summary
This study delineates the learning curve of robotic pancreatoduodenectomy (RPD) for first-generation surgeons, using the Comprehensive Complication Index (CCI) to assess patient outcomes and the PD-ROBOSCORE to stratify patients for their risk to develop post-operative complications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Robotic Pancreaticoduodenectomy
- What is being tested?
- Robotic pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 313 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2008to 1 Jun 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patient underwent robotic pancreaticoduodenectomy at our institution regardless for the pathology
Who may be able to join
- All patients underwent robotic pancreaticoduodenectomy.
Who cannot join
- None.
About this study
This study delineates the learning curve of robotic pancreatoduodenectomy (RPD) for first-generation surgeons, using the Comprehensive Complication Index (CCI) to assess patient outcomes and the PD-ROBOSCORE to stratify patients for their risk to develop post-operative complications.
Read the detailed description
This study aims to define the learning curve of a first-generation surgeon who implemented robotic pancreatoduodenectomy. When compared to previous studies on the same issue, the current study has several distinctive features. Firstly, the learning curve was defined using the cumulative sum method, with the comprehensive complication index as the main outcome metric. The comprehensive complication index provides a holistic view of the burden of postoperative complications in each individual patient, correlating with key outcome measures such as length of hospital stay, use of hospital resources, and ultimately mortality. Secondly, outcomes were adjusted by procedure complexity based on the newly described PD-ROBOSCORE (Surgery. 2023;173:1438-1446). This is the first study assessing the learning curve of robotic pancreatoduodenectomy while incorporating difficulty levels.
- Conditions
- Robotic Pancreaticoduodenectomy
- Being tested
- Robotic pancreaticoduodenectomy
- Keywords
- learning curve, robotic pancreaticoduodenectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic pancreaticoduodenectomyProcedure or surgery
Also called robotic Whipple, robot-assisted pancreaticoduodenectomy, robot-assisted Whipple
All procedures are performed used a standard technique of our center for robotic pancreaticoduodenectomy
| Study group | Role | What they receive |
|---|---|---|
| Patient underwent robotic pancreaticoduodenectomy | All patients undergoing robotic pancreaticoduodenectomy regardless of the pathology for which they underwent it Receives: Procedure: Robotic pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative complications
90-day post-operative complications assessed by the Comprehensive Complication Index (CCI)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Jun 2008
- Primary completion1 Oct 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niccolò Napoli, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723847
- Sponsor's protocol ID
- LC-RPD-Boggi
- Acronym
- LC-RPD
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: They will be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigating the Learning Curve of Robotic Pancreatoduodenectomy: Feasibility, Proficiency, and Mastery in a First-generation Surgeon
- ClinicalTrials.gov ID
- NCT06723847
- Acronym / sponsor ID
- LC-RPD / LC-RPD-Boggi
- Conditions
- Robotic Pancreaticoduodenectomy
- Keywords
- learning curve, robotic pancreaticoduodenectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 1 Jun 2008 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 9 Dec 2024 (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.
This study delineates the learning curve of robotic pancreatoduodenectomy (RPD) for first-generation surgeons, using the Comprehensive Complication Index (CCI) to assess patient outcomes and the PD-ROBOSCORE to stratify patients for their risk to develop post-operative complications.
Detailed description
This study aims to define the learning curve of a first-generation surgeon who implemented robotic pancreatoduodenectomy. When compared to previous studies on the same issue, the current study has several distinctive features. Firstly, the learning curve was defined using the cumulative sum method, with the comprehensive complication index as the main outcome metric. The comprehensive complication index provides a holistic view of the burden of postoperative complications in each individual patient, correlating with key outcome measures such as length of hospital stay, use of hospital resources, and ultimately mortality. Secondly, outcomes were adjusted by procedure complexity based on the newly described PD-ROBOSCORE (Surgery. 2023;173:1438-1446). This is the first study assessing the learning curve of robotic pancreatoduodenectomy while incorporating difficulty levels.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient underwent robotic pancreaticoduodenectomy | – | Procedure: Robotic pancreaticoduodenectomyAll patients undergoing robotic pancreaticoduodenectomy regardless of the pathology for which they underwent it |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patient underwent robotic pancreaticoduodenectomy at our institution regardless for the pathology
Key inclusion criteria (1 listed)
- All patients underwent robotic pancreaticoduodenectomy.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Robotic pancreaticoduodenectomyAlso: robotic Whipple, robot-assisted pancreaticoduodenectomy, robot-assisted WhippleAll procedures are performed used a standard technique of our center for robotic pancreaticoduodenectomy | Procedure or surgery | Patient underwent robotic pancreaticoduodenectomy |
Primary outcome
Post-operative complications
Time frame: 90 days
90-day post-operative complications assessed by the Comprehensive Complication Index (CCI)
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 9 Dec 2024.
- Individual participant dataSharing planned: No. They will be shared upon request
Related trials for Robotic Pancreaticoduodenectomy
Recruiting
Robotic vs Open Pancreatoduodenectomy
Pancreas Neoplasms
Not yet recruitingObservational study
Intra-abdominal Hypertension and Abdominal Compartment Syndrome in Patients After Pancreatic Procedures.
Intra Abdominal Pressure, Abdominal Compartment Syndrome
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Robotic Pancreaticoduodenectomy, run by University of Pisa.
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 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Post-operative complications (time frame: 90 days). 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 Dec 2024.