Prognostic Score To Predict Major Complications After Pancreaticoduodenectomy

NCT ID: NCT01278381

Last Updated: 2011-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-01-31

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Pancreaticoduodenectomy (PD) still carries a high rate of severe postoperative complications. No score is currently available to help identify the patient's surgical risk. The purpose of this study was to develop and validate a prognostic score to predict major postoperative complications after PD.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators prospectively collected in an electronic database preoperative, intraoperative and outcome data of 700 patients undergoing PD in our Institution from 2002 to 2010. The investigators used a multivariate logistic regression analysis to create a new score to predict severe complications defined as Clavien-Dindo classification III, IV and V. The score was developed using a random two-thirds of the population (469 patients), and was then validated and calibrated in the remaining third of the patients (231).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pancreaticoduodenectomy (PD)

Patients undergoing PD from 2002 to 2010

Pancreaticoduodenectomy

Intervention Type PROCEDURE

Resection of pancreatic lesion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pancreaticoduodenectomy

Resection of pancreatic lesion

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Patients undergoing pancreaticoduodenectomy in our Institution

Exclusion Criteria

* Metastatic disease
* Patient not suitable for surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Università Vita-Salute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Università Vita-Salute San Raffaele

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marco Braga, MD

Role: PRINCIPAL_INVESTIGATOR

Università Vita-Salute San Raffaele

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

San Raffaele Hospital

Milan, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PANCREATICODUODENECTOMY_SCORE

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Bile Leak After Liver Surgery
NCT02056028 COMPLETED