Back to resultsEUFURO - EUS-based Follow-Up on R0-resected Patients for Esophageal, Gastric and Pancreatic Cancer (EUFURO)
Primary Purpose
Esophageal Cancer, Stomach Cancer, Pancreatic Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
standard follow-up
PET/CT and EUS
Sponsored by
About this trial
This is an interventional diagnostic trial for Esophageal Cancer
Eligibility Criteria
Inclusion Criteria:
- R0- resection for primary adenocarcinoma or squamous cell carcinoma of the esophagus, stomach or pancreas.
Sites / Locations
- Center for Surgical Ultrasound, Department of upper surgical gastroenterology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard outpatient follow-up
Intervention PET/CT and EUS
Arm Description
Outpatient clinic visits 3,6,9,12,18 and 24 mths after surgery
PET/CT and EUS at 3,6,9,12,18 and 24 months after surgery
Outcomes
Primary Outcome Measures
Number of patients eligible for treatment
Does early detection of recurrent disease translate in to more patients being eligible for oncologic treatment?
Secondary Outcome Measures
Full Information
NCT ID
NCT02209415
First Posted
November 28, 2011
Last Updated
August 4, 2014
Sponsor
Michael Bau Mortensen
Collaborators
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02209415
Brief Title
EUFURO - EUS-based Follow-Up on R0-resected Patients for Esophageal, Gastric and Pancreatic Cancer
Acronym
EUFURO
Official Title
Endoscopic Ultrasound (EUS) and PET-CT Based Follow-up of Patients Radically Resected for Cancer of the Oesophagus, Stomach or Pancreas.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Bau Mortensen
Collaborators
Odense University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Follow-up after successful operative treatment of cancer in the esophagus, stomach or pancreas in order to detect recurrent disease is a controversial topic.
This is because the methods and the consequence of following these patients is unknown.
Therefore the investigators will randomize these patients in to two groups:
One group of patients will be offered visits with a specialist surgeon in a outpatient setting for a clinical evaluation every 3,6,9,12,18 and 24 months after surgery, as is the current standard at our department.
The other group will be offered Endoscopic UltraSound, EUS, and PET/CT with the same intervals as the first group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Stomach Cancer, Pancreatic Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard outpatient follow-up
Arm Type
Active Comparator
Arm Description
Outpatient clinic visits 3,6,9,12,18 and 24 mths after surgery
Arm Title
Intervention PET/CT and EUS
Arm Type
Experimental
Arm Description
PET/CT and EUS at 3,6,9,12,18 and 24 months after surgery
Intervention Type
Behavioral
Intervention Name(s)
standard follow-up
Intervention Description
Outpatient clinic visits
Intervention Type
Procedure
Intervention Name(s)
PET/CT and EUS
Intervention Description
PET/CT and EUS
Primary Outcome Measure Information:
Title
Number of patients eligible for treatment
Description
Does early detection of recurrent disease translate in to more patients being eligible for oncologic treatment?
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
R0- resection for primary adenocarcinoma or squamous cell carcinoma of the esophagus, stomach or pancreas.
Facility Information:
Facility Name
Center for Surgical Ultrasound, Department of upper surgical gastroenterology
City
Odense
State/Province
Region of Southern Denmark
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
31595970
Citation
Bjerring OS, Fristrup CW, Pfeiffer P, Lundell L, Mortensen MB. Phase II randomized clinical trial of endosonography and PET/CT versus clinical assessment only for follow-up after surgery for upper gastrointestinal cancer (EUFURO study). Br J Surg. 2019 Dec;106(13):1761-1768. doi: 10.1002/bjs.11290. Epub 2019 Oct 9.
Results Reference
derived
PubMed Identifier
30036892
Citation
Bjerring OS, Hess S, Fristrup CW, Hoilund-Carlsen PF, Mortensen MB. The impact of endoscopic ultrasound-guided fine-needle aspiration of lymph nodes on subsequent positron emission tomography/computed tomography imaging: a prospective study. Endoscopy. 2019 Feb;51(2):165-168. doi: 10.1055/a-0647-6824. Epub 2018 Jul 23.
Results Reference
derived
Learn more about this trial
EUFURO - EUS-based Follow-Up on R0-resected Patients for Esophageal, Gastric and Pancreatic Cancer
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