Clinical Trial Details

Recurrence After Whipple's (RAW) Study

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Trial Information

Broad Health Condition 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

Specific Health Condition














Trial Focus

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC,

Trial 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.
Eligibility

Key inclusion criteria

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).

  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.

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: University Hospital Plymouth NHS Trust

Trial websitehttps://clinicaltrials.gov/show/NCT04596865

Trial IDNCT04596865