Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
18/11/2023

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
Pancreatic head malignancies are aggressive cancers that are often inoperable when they are diagnosed. In the \~20% of patients who are diagnosed when the disease is still operable, surgery is the only treatment that can provide a chance of cure. Unfortunately, up to 75% of patients undergoing surgery will have the cancer come back (recur). One of the reasons for this is the challenge of removing the whole tumour with some surrounding non-cancerous tissue to ensure that every tumour cell has been removed. This is difficult because there are many structures very close to the pancreas (such as the blood vessels that supply the intestines) that cannot be removed. A recent review study of \>1700 patients who had a Whipple's operation (the cancer operation that is performed to remove the head of pancreas) and found that whilst the majority of patients had cancer recurrence in distant sites (like the liver) that would not be affected by how the operation was performed, 12% of patients had the cancer recur just at the site of where the operation had been; this is known as 'local' recurrence. This suggests that a small amount of cancer was not removed at the time of surgery in these patients. Very few studies have looked at the relationship between the Computerised Tomography (CT) scan before surgery and the histology results (information about the tumour after it has been examined under the microscope) and whether this can predict exactly where the tumour recurs. If investigators can find factors that predict which patients get local only recurrence, investigators may be able to offer improved surgical techniques or other therapies during or immediately after the operation to these patients, hopefully leading to improved cure rates.

This retrospective international study will look at these factors in patients who underwent a Whipple's operation for pancreatic cancer, bile duct cancer or ampullary cancer over a three year period between 2012 and 2015. Participating centres will provide data on pre-operative scans, complications around the time of surgery, any therapies (e.g. chemotherapy) that the patients had and if and where the cancer recurred. With this information, investigators hope to find ways to predict which patients will get local-only recurrence, so researchers can select them for future studies to see if additional treatments can improve the chance of cure from surgery for these patients.
Trial website
https://clinicaltrials.gov/study/NCT04596865
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04596865