Recurrence After Whipple's (RAW) Study

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.

Conditions

• Pancreatic Cancer
• Ampullary Cancer
• Bile Duct Cancer
• Cholangiocarcinoma, Extrahepatic
• Cholangiocarcinoma Resectable
• Cholangiocarcinoma of the Extrahepatic Bile Duct
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Ductal Carcinoma
• Surgery
• Survivorship
• Recurrent Cancer
• Cancer Recurrent
• Cancer Recurrence
• Local Recurrence of Malignant Tumor of Pancreas

Interventions

PROCEDURE

Pancreaticoduodenectomy

Date of surgery 01/06/2010 - 31/05/2015

Sponsors & Collaborators

• University of Plymouth

  collaborator OTHER

• University Hospital Plymouth NHS Trust

  lead OTHER

Principal Investigators

• Somaiah Aroori · University Hospitals Plymouth NHS Trust

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-12

Primary Completion

2022-03-31

Completion

2023-06-30

Countries

• Australia
• Austria
• Italy
• Mexico
• Pakistan
• Spain
• Sudan
• United Kingdom

Study Locations