Recurrence After Whipples (RAW) study
Would you be interested in taking part in a multicentre retrospective cohort study investigating the causes and recurrence patterns of pancreatic duodenal adenocarcinoma (PDAC), ampullary adenocarcinoma and distal cholangiocarcinoma following pancreaticoduodenectomy?
- Retrospective cohort study of all patients with PDAC, ampullary adenocarcinoma or distal cholangiocarcinoma who underwent a curative-intent pancreaticoduodenectomy at your unit between 31/05/2007 and 31/05/2015. These dates were chosen as pre-2007 data is often incomplete and patients up to May 2015 will already have 5 year follow up data completed.
Purpose of the study
- Pancreatic cancer cure rates remain very low because many patients get recurrence despite surgery.
- Whilst many patients get distant metastases, around 12% of patients (range 1-28%) are found to have local only recurrence (please see recent systematic review and meta-analysis from Birmingham)
- We theorise that there may be factors that can predict which patients will get local only recurrence. If we can identify these patients before surgery, we may be able to instigate intraoperative therapies which may increase cure rates.
- If we can identify these patients based on features on their histology report, we may be able to select this cohort for adjuvant locoregional therapies to reduce local recurrence rates.
Research questions to be addressed
- What preoperative risk factors are associated with local recurrence in PDAC, ampullary cancer and distal cholangiocarcinoma?
- What perioperative risk factors (e.g. complications, surgical factors) are associated with local recurrence in PDAC, ampullary cancer and distal cholangiocarcinoma?
- What histological factors are associated with local recurrence in PDAC, ampullary cancer and distal cholangiocarcinoma?
What would be involved?
- We will provide our local R&D proposal to each participating unit for you to get local approval for the study.
- We will list each approved unit as a local site on the REC application (being filled out currently, not yet submitted).
- We will provide a data collection template (Excel spreadsheet) and data collection guide (PDF) to each unit to collect their unit’s data.
- Once data is completed, the anonymised data set is to be returned to the research team at Plymouth who will collate the data and perform statistical analysis.
- We expect to generate a number of publications from this data set, so expect a high research output from this study.
- We plan to list local PIs as named authors on publications, with a collaborative authorship model for other local collaborators who were involved in data collection.
- The full data set is large. We are performing the full analysis of all variables with our data set, but acknowledge that some units may not have all the data available. Many of you may have previously collected data for similar projects, which may simplify data collection. Whilst all data could theoretically be collected by one person, we suggest having a local team involving histology, oncology, and/or radiology colleagues. If you would like to participate in some but not all of the study, we can identify which parts of the data set are associated with particular planned analyses and will include you in any publications derived from the parts of the data set that your unit contributed to.
Interested in taking part or want further information?
- Please contact Mr Somaiah Aroori (firstname.lastname@example.org) to express interest.