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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
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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
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Secondary ID [1]
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20/GAS/413
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer
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0
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Ampullary Cancer
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Bile Duct Cancer
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Cholangiocarcinoma, Extrahepatic
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Cholangiocarcinoma Resectable
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Cholangiocarcinoma of the Extrahepatic Bile Duct
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Pancreatic Ductal Adenocarcinoma
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Pancreatic Ductal Carcinoma
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Surgery
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Survivorship
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Recurrent Cancer
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0
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Cancer Recurrent
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Cancer Recurrence
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Local Recurrence of Malignant Tumor of Pancreas
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Condition category
Condition code
Cancer
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Pancreatic
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Cancer
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Biliary tree (gall bladder and bile duct)
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Cancer
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0
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Other cancer types
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Patterns of disease recurrence
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Assessment method [1]
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Local, locoregional, distant
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Timepoint [1]
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Five years after date of surgery
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Secondary outcome [1]
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Determine if/how morbidity, mortality, disease free survival (DFS) and overall survival (OS) following pancreaticoduodenectomy for pancreatic head malignancy correlate with the following factors:
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Assessment method [1]
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* The use of pre-operative endoscopic or percutaneous biliary stenting.
* Pre-operative systemic comorbidities.
* Pre-operative diagnosis of diabetes.
* Pre-operative radiological UICC Tumour Node Metastasis (TNM) staging.
* Named vessel involvement on pre-operative imaging.
* Sarcopenia or myosteatosis present on pre-operative imaging.\*
* The use of neoadjuvant chemotherapy/radiotherapy.
* Pre-operative serum bilirubin.
* Portal Vein (PV) / Superior Mesenteric Vein (SMV) resection.
* Hepatic Artery (HA) / Superior Mesenteric (SMA) / Coeliac Artery (CA) resection
* Need for peri-operative blood transfusion.
* Type of pancreatic anastomosis \[pancreatico-gastric (PG) vs. pancreatico-jejunal (PJ)\].
* Post-operative complications.
* The use and number of post-operative drains.
* Histological factors:
* The use of adjuvant chemotherapy.
* The use of palliative chemotherapy.
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Timepoint [1]
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Pre-operative
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Secondary outcome [2]
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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:
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Assessment method [2]
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* Preoperative TNM staging.
* Named vessel involvement on preoperative imaging.
* The use of neoadjuvant chemotherapy/radiotherapy.
* PV/SMV resection.
* HA/SMA/CA resection.
* Histological factors
* The use of adjuvant chemotherapy.
* The use of palliative chemotherapy.
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Timepoint [2]
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Five years after date of surgery
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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).
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/10/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/06/2023
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Sample size
Target
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Accrual to date
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Final
1484
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Medical Centre - Clayton
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment outside Australia
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Austria
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State/province [1]
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Innsbruck
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Italy
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State/province [2]
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Sardinia
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Italy
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Rome
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Mexico
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Mexico City
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Pakistan
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State/province [5]
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Lahore
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Spain
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State/province [6]
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Barcelona
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Spain
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State/province [7]
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Zaragoza
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Sudan
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State/province [8]
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Khartoum
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Country [9]
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United Kingdom
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State/province [9]
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Devon
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United Kingdom
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State/province [10]
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Lancashire
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Country [11]
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United Kingdom
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State/province [11]
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Surrey
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United Kingdom
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State/province [12]
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Wales
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United Kingdom
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State/province [13]
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Warwickshire
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Country [14]
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United Kingdom
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State/province [14]
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West Midlands
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Country [15]
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United Kingdom
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State/province [15]
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West Yorkshire
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Country [16]
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United Kingdom
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State/province [16]
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Yorkshire
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Country [17]
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United Kingdom
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State/province [17]
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Bristol
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Country [18]
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United Kingdom
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State/province [18]
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Edinburgh
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Country [19]
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United Kingdom
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State/province [19]
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London
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Country [20]
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United Kingdom
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State/province [20]
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Newcastle Upon Tyne
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United Kingdom
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State/province [21]
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Nottingham
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United Kingdom
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State/province [22]
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Oxford
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Country [23]
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United Kingdom
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State/province [23]
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Sheffield
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Country [24]
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United Kingdom
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State/province [24]
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Southampton
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Funding & Sponsors
Primary sponsor type
Other
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Name
University Hospital Plymouth NHS Trust
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Address
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Other collaborator category [1]
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Other
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Name [1]
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University of Plymouth
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Address [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT04596865
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Somaiah Aroori
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Address
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University Hospitals Plymouth NHS Trust
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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