Pancreatic NeoplasmNCT04662346
Evaluation of Difficulty Score for Robotic Pancreatoduodenectomy
A study testing Difficulty score system for robotic pancreatoduodenectomy in people with Pancreatic Neoplasm, run by University of Pisa at 2 sites in Italy.
Trial summary
Robotic pancreatoduodenectomy is the most complex surgery for a general surgeon and consequently a pancreatic surgeon can aspire to. Due to the close proximity of the pancreas to the large vessels, great skill and experience in the field of pancreatic surgery, robotic surgery and also vascular surgery is essential. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Neoplasm
- What is being tested?
- Difficulty score system for robotic pancreatoduodenectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Dec 2020to 28 Feb 2021
- 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
- pathology of the head of pancreas requiring surgery
Who cannot join
- pathology of the head of pancreas not requiring surgery
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Division of pancreatic surgery
Pisa, 56125
University of Pisa
Pisa, 56125
About this study
Official title: Difficulty Scoring System in Robotic Pancreatoduodenectomy
Robotic pancreatoduodenectomy is the most complex surgery for a general surgeon and consequently a pancreatic surgeon can aspire to. Due to the close proximity of the pancreas to the large vessels, great skill and experience in the field of pancreatic surgery, robotic surgery and also vascular surgery is essential. The ability to predict the depth of robotic pancreatoduodenectomy in each individual patient would be extremely important, for patient selection and for the implementation of the learning curve. This study aims to provide a difficulty score (DS) for robotic pancreatoduodenectomy to be used to select cases based on the experience and expertise of the surgeon.
Read the detailed description
Our Robot DIFFICULT Score was developed starting from factors evaluated by surgeons with experience in performing robotic pancreatoduodenectomy in high-volume centers. Based on the univariate and multivariate analysis, the elevated BMI, ASA 3, the need for venous resection and vascular variations in arterial liver supply were considered significant in increasing the degree of "difficulty" in the robotic pancreatoduodenectomy. The Robot ADDICT Score will be calculated in all cases of the International Consortium on Minimally Invasive Pancreatic Surgery (I-MIPS; www.i-mips.com).
- Conditions
- Pancreatic Neoplasm
- Being tested
- Difficulty score system for robotic pancreatoduodenectomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Difficulty score system for robotic pancreatoduodenectomyOther
calculate the score for patient in you cohort
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing robotic pancreatoduodenectomy | Other | patients have pancreatic neoplasm and undergoing robotic pancreatoduodenectomy Receives: Other: Difficulty score system for robotic pancreatoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation to post-operative complication
the score increase as complications increase
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start1 Dec 2020
- Primary completion20 Jan 2021 (estimated)
- Study completion28 Feb 2021 (estimated)
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Concetta Cacace, University of Pisa
- Investigators
- ugo boggi, Study chair, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662346
- Sponsor's protocol ID
- Difficulty Score RPD
- Status last verified
- Dec 2020
- First submitted
- 30 Nov 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: creation of the formula, validation
Publications
Napoli N, Cacace C, Kauffmann EF, Jones L, Ginesini M, Gianfaldoni C, Salamone A, Asta F, Ripolli A, Di Dato A, Busch OR, Cappelle ML, Chao YJ, de Wilde RF, Hackert T, Jang JY, Koerkamp BG, Kwon W, Lips D, Luyer MDP, Nickel F, Saint-Marc O, Shan YS, Shen B, Vistoli F, Besselink MG, Hilal MA, Boggi U; International Consortium on Minimally Invasive Pancreatic Surgery (I-MIPS). The PD-ROBOSCORE: A difficulty score for robotic pancreatoduodenectomy. Surgery. 2023 Jun;173(6):1438-1446. doi: 10.1016/j.surg.2023.02.020. Epub 2023 Mar 25.
PubMed 36973127
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difficulty Scoring System in Robotic Pancreatoduodenectomy
- ClinicalTrials.gov ID
- NCT04662346
- Acronym / sponsor ID
- Difficulty Score RPD
- Conditions
- Pancreatic Neoplasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 20 Jan 2021 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 10 Dec 2020 (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.
Robotic pancreatoduodenectomy is the most complex surgery for a general surgeon and consequently a pancreatic surgeon can aspire to. Due to the close proximity of the pancreas to the large vessels, great skill and experience in the field of pancreatic surgery, robotic surgery and also vascular surgery is essential. The ability to predict the depth of robotic pancreatoduodenectomy in each individual patient would be extremely important, for patient selection and for the implementation of the learning curve. This study aims to provide a difficulty score (DS) for robotic pancreatoduodenectomy to be used to select cases based on the experience and expertise of the surgeon.
Detailed description
Our Robot DIFFICULT Score was developed starting from factors evaluated by surgeons with experience in performing robotic pancreatoduodenectomy in high-volume centers. Based on the univariate and multivariate analysis, the elevated BMI, ASA 3, the need for venous resection and vascular variations in arterial liver supply were considered significant in increasing the degree of "difficulty" in the robotic pancreatoduodenectomy. The Robot ADDICT Score will be calculated in all cases of the International Consortium on Minimally Invasive Pancreatic Surgery (I-MIPS; www.i-mips.com).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing robotic pancreatoduodenectomy | Other | Other: Difficulty score system for robotic pancreatoduodenectomypatients have pancreatic neoplasm and undergoing robotic pancreatoduodenectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- pathology of the head of pancreas requiring surgery
Key exclusion criteria (1 listed)
- pathology of the head of pancreas not requiring 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 |
|---|---|---|
| Difficulty score system for robotic pancreatoduodenectomycalculate the score for patient in you cohort | Other | patients undergoing robotic pancreatoduodenectomy |
Primary outcome
correlation to post-operative complication
Time frame: 6 months
the score increase as complications increase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Derived from this study: PubMed 36973127Napoli N, Cacace C, Kauffmann EF, Jones L, Ginesini M, Gianfaldoni C, Salamone A, Asta F, Ripolli A, Di Dato A, Busch OR, Cappelle ML, Chao YJ, de Wilde RF, Hackert T, Jang JY, Koerkamp BG, Kwon W, Lips D, Luyer MDP, Nickel F, Saint-Marc O, Shan YS, Shen B, Vistoli F, Besselink MG, Hilal MA, Boggi U; International Consortium on Minimally Invasive Pancreatic Surgery (I-MIPS). The PD-ROBOSCORE: A difficulty score for robotic pancreatoduodenectomy. Surgery. 2023 Jun;173(6):1438-1446. doi: 10.1016/j.surg.2023.02.020. Epub 2023 Mar 25.
- Individual participant dataSharing planned: Yes. creation of the formula, validation
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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.
ugo boggi study chair
University of Pisa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Difficulty score system for robotic pancreatoduodenectomy in people with Pancreatic Neoplasm, run by University of Pisa at 2 sites 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: status not confirmed, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
correlation to post-operative complication (time frame: 6 months). 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 NCT04662346, 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 10 Dec 2020.