NCT01278381

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2002

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 17, 2011

Completed
Last Updated

January 17, 2011

Status Verified

November 1, 2010

Enrollment Period

8.8 years

First QC Date

January 14, 2011

Last Update Submit

January 14, 2011

Conditions

Pancreatic Neoplasm

Keywords

pancreas, pancreaticoduodenectomy, major complications

Outcome Measures

Primary Outcomes (1)

  • Major Complication rate

    Clavien-Dindo grade III to V complications considered as major

    Postoperative. Until 30 days after discharge

Study Arms (1)

Pancreaticoduodenectomy (PD)

Patients undergoing PD from 2002 to 2010

Procedure: Pancreaticoduodenectomy

Interventions

PancreaticoduodenectomyPROCEDURE

Resection of pancreatic lesion

Pancreaticoduodenectomy (PD)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

700 patients undergoing pancreaticoduodenectomy in our Institution from 2002 to 2010

You may qualify if:

  • \- Patients undergoing pancreaticoduodenectomy in our Institution

You may not qualify if:

  • Metastatic disease
  • Patient not suitable for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Raffaele Hospital

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Marco Braga, MD

    Università Vita-Salute San Raffaele

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 14, 2011

First Posted

January 17, 2011

Study Start

January 1, 2002

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

January 17, 2011

Record last verified: 2010-11

Locations

IT(1)