Recurrence After Whipple's (RAW) Study
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
1 other identifier
observational
1,484
7 countries
28
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Typical duration for all trials
28 active sites
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
October 12, 2020
CompletedFirst Submitted
Initial submission to the registry
October 15, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedNovember 18, 2023
November 1, 2023
1.5 years
October 15, 2020
November 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patterns of disease recurrence
Local, locoregional, distant
Five years after date of surgery
Secondary Outcomes (2)
Determine if/how morbidity, mortality, disease free survival (DFS) and overall survival (OS) following pancreaticoduodenectomy for pancreatic head malignancy correlate with the following factors:
Pre-operative
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:
Five years after date of surgery
Study Arms (3)
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
Interventions
Date of surgery 01/06/2010 - 31/05/2015
Eligibility Criteria
Patients who underwent pancreatioduodenectomy for pancreatic head malignancy (PDAC, ampullary cancer or distal extrahepatic cholangiocarcinoma) between 01/06/2010\* and 31/05/2015 inclusive in participating centres (\*01/05/2006 for Plymouth sub-study).
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Plymouth NHS Trustlead
- University of Plymouthcollaborator
Study Sites (29)
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Medical University Innsbruck, Anichstr. 35 A
Innsbruck, 6020, Austria
Azienda Ospedaliero - Universitaria Di Sassari
Sassari, Sardinia, 07100, Italy
Azienda Ospedaliero - Universitaria Policlinico Umberto I
Rome, 00161, Italy
Salvador Zubirán National Institute of Health Sciences and Nutrition
Tlalpan, Mexico City, 14080, Mexico
Shaukat Khanum Memorial Cancer Hospital
Lahore, Pakistan
Hospital Clinic de Barcelona
Barcelona, 50009, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Ibn Sena Specialized Hospital
Khartoum, Sudan
Derriford Hospital
Plymouth, Devon, PL6 8DH, United Kingdom
Royal Blackburn Teaching Hospital
Blackburn, Lancashire, BB2 3HH, United Kingdom
Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX, United Kingdom
Singleton Hospital
Swansea, Wales, SA2 8QA, United Kingdom
University Hospital Coventry
Coventry, Warwickshire, CV2 2DX, United Kingdom
Queen Elizabeth Hospital
Birmingham, West Midlands, B15 2TH, United Kingdom
St. James's University Hospital
Leeds, West Yorkshire, LS9 7TF, United Kingdom
Hull Royal Infirmary
Hull, Yorkshire, HU3 2JZ, United Kingdom
Bristol Royal Infirmary
Bristol, BS2 8HW, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
Hammersmith Hospital
London, W12 0HS, United Kingdom
The Royal Marsden NHS Foundation Trust
London, United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom
Queens Medical Centre
Nottingham, NG7 2UH, United Kingdom
Churchill Hospital
Oxford, OX3 7LE, United Kingdom
Northern General Hospital
Sheffield, S5 7AU, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Somaiah Aroori
University Hospitals Plymouth NHS Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2020
First Posted
October 22, 2020
Study Start
October 12, 2020
Primary Completion
March 31, 2022
Study Completion
June 30, 2023
Last Updated
November 18, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share