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NCT04662346 Clinical Trial

Evaluation of Difficulty Score for Robotic Pancreatoduodenectomy

Pancreatic Neoplasm Clinical Trial

Official title:
Difficulty Scoring System in Robotic Pancreatoduodenectomy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04662346
Other study ID # Difficulty Score RPD
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date February 28, 2021

Study information
Verified date December 2020
Source University of Pisa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 1000
Est. completion date February 28, 2021
Est. primary completion date January 20, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - pathology of the head of pancreas requiring surgery Exclusion Criteria: - pathology of the head of pancreas not requiring surgery

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Difficulty score system for robotic pancreatoduodenectomy
calculate the score for patient in you cohort

Locations
Country Name City State
Italy Division of pancreatic surgery Pisa
Italy University of Pisa Pisa

Sponsors (1)
Lead Sponsor Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary correlation to post-operative complication the score increase as complications increase 6 months
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