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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04596865




Registration number
NCT04596865
Ethics application status
Date submitted
15/10/2020
Date registered
22/10/2020

Titles & IDs
Public title
Recurrence After Whipple's (RAW) Study
Scientific title
An International Multi-centre Retrospective Cohort Study Investigating Patterns of Cancer Recurrence Following Pancreaticoduodenectomy for Pancreatic Ductal Adenocarcinoma, Ampullary Adenocarcinoma and Distal Bile Duct Cholangiocarcinoma
Secondary ID [1] 0 0
20/GAS/413
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 0 0
Ampullary Cancer 0 0
Bile Duct Cancer 0 0
Cholangiocarcinoma, Extrahepatic 0 0
Cholangiocarcinoma Resectable 0 0
Cholangiocarcinoma of the Extrahepatic Bile Duct 0 0
Pancreatic Ductal Adenocarcinoma 0 0
Pancreatic Ductal Carcinoma 0 0
Surgery 0 0
Survivorship 0 0
Recurrent Cancer 0 0
Cancer Recurrent 0 0
Cancer Recurrence 0 0
Local Recurrence of Malignant Tumor of Pancreas 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Other cancer types
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Pancreaticoduodenectomy

Pancreatic ductal adenocarcinoma - Patients who underwent pancreaticoduodenectomy for PDAC between 01/06/2010 and 31/05/2015

Ampullary cancer - Patients who underwent pancreaticoduodenectomy for ampullary cancer between 01/06/2010 and 31/05/2015

Distal extrahepatic cholangiocarcinoma - Patients who underwent pancreaticoduodenectomy for distal extrahepatic cholangiocarcinoma between 01/06/2010 and 31/05/2015


Treatment: Surgery: Pancreaticoduodenectomy
Date of surgery 01/06/2010 - 31/05/2015
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patterns of disease recurrence
Timepoint [1] 0 0
Five years after date of surgery
Secondary outcome [1] 0 0
Determine if/how morbidity, mortality, disease free survival (DFS) and overall survival (OS) following pancreaticoduodenectomy for pancreatic head malignancy correlate with the following factors:
Timepoint [1] 0 0
Pre-operative
Secondary outcome [2] 0 0
Determine if/how specific patterns of recurrence (local only, distant only, synchronous local and distant) following pancreaticoduodenectomy for pancreatic head malignancy correlate with the following factors:
Timepoint [2] 0 0
Five years after date of surgery

Eligibility
Key inclusion criteria
* Patients who underwent pancreaticoduodenectomy for pancreatic head malignancy.
* Date of surgery from 01/06/2010* to 31/05/2015 inclusive (*01/05/2006 for Plymouth sub-study).
* Post-operative surgical histology confirmed pancreatic ductal adenocarcinoma (PDAC), ampullary adenocarcinoma (AA) or distal bile duct cholangiocarcinoma (DBCC).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Postoperative surgical histology confirmed benign pathology, non-invasive neoplasia or malignant tumours other than adenocarcinoma of pancreatic, ampullary or biliary origin.
* Patients who underwent distal pancreatectomy or total pancreatectomy as their primary procedure.
* Patients in whom five-year follow up data is not available.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2023
Sample size
Target
Accrual to date
Final
1484
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Innsbruck
Country [2] 0 0
Italy
State/province [2] 0 0
Sardinia
Country [3] 0 0
Italy
State/province [3] 0 0
Rome
Country [4] 0 0
Mexico
State/province [4] 0 0
Mexico City
Country [5] 0 0
Pakistan
State/province [5] 0 0
Lahore
Country [6] 0 0
Spain
State/province [6] 0 0
Barcelona
Country [7] 0 0
Spain
State/province [7] 0 0
Zaragoza
Country [8] 0 0
Sudan
State/province [8] 0 0
Khartoum
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Devon
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Lancashire
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Surrey
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Wales
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Warwickshire
Country [14] 0 0
United Kingdom
State/province [14] 0 0
West Midlands
Country [15] 0 0
United Kingdom
State/province [15] 0 0
West Yorkshire
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Yorkshire
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Bristol
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Edinburgh
Country [19] 0 0
United Kingdom
State/province [19] 0 0
London
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Newcastle Upon Tyne
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Nottingham
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Oxford
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Sheffield
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Other
Name
University Hospital Plymouth NHS Trust
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Plymouth
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Somaiah Aroori
Address 0 0
University Hospitals Plymouth NHS Trust
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04596865