EUFURO - EUS-based Follow-Up on R0-resected Patients for Esophageal, Gastric and Pancreatic Cancer
EUFURO
Endoscopic Ultrasound (EUS) and PET-CT Based Follow-up of Patients Radically Resected for Cancer of the Oesophagus, Stomach or Pancreas.
1 other identifier
interventional
182
1 country
1
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:
- 1.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.
- 2.The other group will be offered Endoscopic UltraSound, EUS, and PET/CT with the same intervals as the first group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 28, 2011
CompletedFirst Posted
Study publicly available on registry
August 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedAugust 5, 2014
August 1, 2014
4.8 years
November 28, 2011
August 4, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients eligible for treatment
Does early detection of recurrent disease translate in to more patients being eligible for oncologic treatment?
2 years
Study Arms (2)
Standard outpatient follow-up
ACTIVE COMPARATOROutpatient clinic visits 3,6,9,12,18 and 24 mths after surgery
Intervention PET/CT and EUS
EXPERIMENTALPET/CT and EUS at 3,6,9,12,18 and 24 months after surgery
Interventions
Eligibility Criteria
You may qualify if:
- R0- resection for primary adenocarcinoma or squamous cell carcinoma of the esophagus, stomach or pancreas.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michael Bau Mortensenlead
- Odense University Hospitalcollaborator
Study Sites (1)
Center for Surgical Ultrasound, Department of upper surgical gastroenterology
Odense, Region Syddanmark, 5000, Denmark
Related Publications (2)
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.
PMID: 31595970DERIVEDBjerring 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.
PMID: 30036892DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
November 28, 2011
First Posted
August 5, 2014
Study Start
April 1, 2011
Primary Completion
January 1, 2016
Study Completion
August 1, 2016
Last Updated
August 5, 2014
Record last verified: 2014-08