Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Recurrence After Whipple's (RAW) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04596865
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : October 27, 2021
Sponsor:
Collaborator:
University of Plymouth
Information provided by (Responsible Party):
University Hospital Plymouth NHS Trust

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
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 Procedure: Pancreaticoduodenectomy

Show Show detailed description
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official 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
Actual Study Start Date : October 12, 2020
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Pancreatic ductal adenocarcinoma
Patients who underwent pancreaticoduodenectomy for PDAC between 01/06/2010 and 31/05/2015
 Procedure: Pancreaticoduodenectomy
Date of surgery 01/06/2010 - 31/05/2015
Ampullary cancer
Patients who underwent pancreaticoduodenectomy for ampullary cancer between 01/06/2010 and 31/05/2015
 Procedure: Pancreaticoduodenectomy
Date of surgery 01/06/2010 - 31/05/2015
Distal extrahepatic cholangiocarcinoma
Patients who underwent pancreaticoduodenectomy for distal extrahepatic cholangiocarcinoma between 01/06/2010 and 31/05/2015
 Procedure: Pancreaticoduodenectomy
Date of surgery 01/06/2010 - 31/05/2015


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Patterns of disease recurrence [ Time Frame: Five years after date of surgery ]
    Local, locoregional, distant


Secondary Outcome Measures :
  1. Determine if/how morbidity, mortality, disease free survival (DFS) and overall survival (OS) following pancreaticoduodenectomy for pancreatic head malignancy correlate with the following factors: [ Time Frame: Pre-operative ]
    • 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.

  2. 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: [ Time Frame: Five years after date of surgery ]
    • 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent pancreatioduodenectomy for pancreatic head malignancy (PDAC, ampullary cancer or distal extrahepatic cholangiocarcinoma) between 01/06/2010* and 31/05/2015 inclusive in participating centres (*01/05/2006 for Plymouth sub-study).
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04596865


Contacts
Layout table for location contacts
Contact: Chris Rollinson +44-1752-432-824 plh-tr.RD-Office@nhs.net
Contact: Victoria Yates +44-1752-432-824 plh-tr.RD-Office@nhs.net

Locations
Show Show 25 study locations
Sponsors and Collaborators
University Hospital Plymouth NHS Trust
University of Plymouth
Investigators
Layout table for investigator information
Principal Investigator: Somaiah Aroori University Hospitals Plymouth NHS Trust
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital Plymouth NHS Trust
ClinicalTrials.gov Identifier: NCT04596865    
Other Study ID Numbers: 20/GAS/413
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Plymouth NHS Trust:
Pancreatic cancer
Ampullary cancer
Cholangiocarcinoma
 Pancreaticoduodenectomy
Whipple's procedure
Cancer recurrence
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Pancreatic Neoplasms
Cholangiocarcinoma
Bile Duct Neoplasms
Carcinoma, Ductal
Carcinoma, Pancreatic Ductal
Recurrence
Disease Attributes
Pathologic Processes
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Neoplasms, Ductal, Lobular, and Medullary