NCT06723847

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
313

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
15.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

15.3 years

First QC Date

December 4, 2024

Last Update Submit

December 4, 2024

Conditions

Keywords

learning curverobotic pancreaticoduodenectomy

Outcome Measures

Primary Outcomes (1)

  • Post-operative complications

    90-day post-operative complications assessed by the Comprehensive Complication Index (CCI)

    90 days

Study Arms (1)

Patient underwent robotic pancreaticoduodenectomy

All patients undergoing robotic pancreaticoduodenectomy regardless of the pathology for which they underwent it

Procedure: Robotic pancreaticoduodenectomy

Interventions

All procedures are performed used a standard technique of our center for robotic pancreaticoduodenectomy

Also known as: robotic Whipple, robot-assisted pancreaticoduodenectomy, robot-assisted Whipple
Patient underwent robotic pancreaticoduodenectomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patient underwent robotic pancreaticoduodenectomy at our institution regardless for the pathology

You may qualify if:

  • All patients underwent robotic pancreaticoduodenectomy.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

pancreatic head specimen

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FEBS

Study Record Dates

First Submitted

December 4, 2024

First Posted

December 9, 2024

Study Start

June 1, 2008

Primary Completion

October 1, 2023

Study Completion

June 1, 2024

Last Updated

December 9, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

They will be shared upon request