Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ampullary Cancer | Ampulla of Vater Carcinoma | ALIAS | 0.90 |
| Bile Duct Cancer | Malignant Bile Duct Neoplasm | CURATED_BROADER | 0.80 |
| Cancer Recurrence | — | UNRESOLVED | — |
| Cancer Recurrent | — | UNRESOLVED | — |
| Cholangiocarcinoma, Extrahepatic | Extrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Cholangiocarcinoma of the Extrahepatic Bile Duct | — | UNRESOLVED | — |
| Cholangiocarcinoma Resectable | — | UNRESOLVED | — |
| Local Recurrence of Malignant Tumor of Pancreas | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pancreaticoduodenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Pancreatic ductal adenocarcinoma
- description
- Patients who underwent pancreaticoduodenectomy for PDAC between 01/06/2010 and 31/05/2015
- interventionNames
- Procedure: Pancreaticoduodenectomy
- label
- Ampullary cancer
- description
- Patients who underwent pancreaticoduodenectomy for ampullary cancer between 01/06/2010 and 31/05/2015
- interventionNames
- Procedure: Pancreaticoduodenectomy
- label
- Distal extrahepatic cholangiocarcinoma
- description
- Patients who underwent pancreaticoduodenectomy for distal extrahepatic cholangiocarcinoma between 01/06/2010 and 31/05/2015
- interventionNames
- Procedure: Pancreaticoduodenectomy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLabib PL, Russell TB, Denson JL, Puckett MA, Ausania F, Pando E, Roberts KJ, Kausar A, Mavroeidis VK, Bhogal RH, Marangoni G, Thomasset SC, Frampton AE, Spalding DR, Lykoudis P, Bellotti R, Alhaboob N, Srinivasan P, Bari H, Smith A, Dominguez-Rosado I, Croagh D, Thakkar RG, Gomez D, Silva MA, Lapolla P, Mingoli A, Davidson BR, Porcu A, Shah NS, Hamady ZZ, Al-Sarireh BA, Serrablo A; RAW study collaborators; Aroori S. Patterns, timing and predictors of recurrence following pancreaticoduodenectomy for distal cholangiocarcinoma: An international multicentre retrospective cohort study. Eur J Surg Oncol. 2024 Jun;50(6):108353. doi: 10.1016/j.ejso.2024.108353. Epub 2024 Apr 22. PMID 38701690