Evaluation of Difficulty Score for Robotic Pancreatoduodenectomy

• Sponsor: University of Pisa (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04662346
• Collaborator: (none)
• Enrollment: 1,000
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 2.9
• Patients Per Site: 500
• Patients Per Site Per Month: 171

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Neoplasm	Other: Difficulty score system for robotic pancreatoduodenectomy	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 1000 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Difficulty Scoring System in Robotic Pancreatoduodenectomy
• Actual Study Start Date: Dec 1, 2020
• Anticipated Primary Completion Date: Jan 20, 2021
• Anticipated Study Completion Date: Feb 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: patients undergoing robotic pancreatoduodenectomy patients have pancreatic neoplasm and undergoing robotic pancreatoduodenectomy	Other: Difficulty score system for robotic pancreatoduodenectomy; calculate the score for patient in you cohort

Outcome Measures

Primary Outcome Measures

1. correlation to post-operative complication [6 months]

   the score increase as complications increase

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• pathology of the head of pancreas requiring surgery

Exclusion Criteria:

• pathology of the head of pancreas not requiring surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of pancreatic surgery	Pisa		Italy	56125
2	University of Pisa	Pisa		Italy	56125

Sponsors and Collaborators

• University of Pisa

Investigators

• Study Chair: ugo boggi, University of Pisa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Concetta Cacace, principal investigator, University of Pisa
• ClinicalTrials.gov Identifier: NCT04662346
• Other Study ID Numbers: Difficulty Score RPD
• First Posted: Dec 10, 2020
• Last Update Posted: Dec 10, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pancreatic Neoplasms

Study Results

No Results Posted as of Dec 10, 2020