The Results of Pancreatic Operations After the Implementa... | NCT04237441

Studies
The Results of Pancreatic Operations After the Implementation of Multidisciplinary Team Conference (MDT):

NCT04237441

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Nov 30, 2023Actual

Enrollment

7,294Actual

Phase

Not provided

Conditions

Pancreatic Neoplasms

Interventions

number of participants with surgical complications

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2010Actual

Primary Completion Date

Dec 31, 2016Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Jan 15, 2020

First Submission Date that Met QC Criteria

Jan 17, 2020

First Posted Date

Jan 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2023

Last Update Posted Date

Nov 30, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Background: Centralization has improved the outcome of complex operations including cancer surgery. Moreover, the implementation of multidisciplinary team conferences (MDT) has ameliorated the decision making, but the impact on patient outcome is controversial. The aim of the study was to investigate the outcome of pancreatic surgery in the setting of centralization and upfront multidisciplinary decision making.

Detailed Description

Study is a retrospective register study from a prospective database over MDT conferences and patient outcome. End points are quality evaluation regarding postoperative complications and mortality and long-term survival of patients radically operated for pancreatic cancer.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

7,294Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MDT conference		participants evaluated at MDT conference	Other: number of participants with surgical complications
no MDT conference		participants not evaluated at MDT conference	Other: number of participants with surgical complications

Interventions

Name	Type	Description	Arm Group Labels	Other Names
number of participants with surgical complications	Other	observation before and after multidisplinary team conference (MDT) was implemented	MDT conference no MDT conference

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
complications following pancreatic surgery	study from clinical database	14 years
survival following pancreatic surgery	study from clinical database	14 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria: all gender seen at multidisciplinary team conference (MDT) Exclusion criteria: all gender not seen at MDT -

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

86 Years

Standard Ages

AdultOlder Adult

Study Population

all gender referred to MDT all gender not referred to MDT

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
carsten hansen, DMSc	Rigshospitalet, Denmark	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided