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EUFURO - EUS-based Follow-Up on R0-resected Patients for Esophageal, Gastric and Pancreatic Cancer


2011-04


2016-01


2016-08


182

Study Overview

EUFURO - EUS-based Follow-Up on R0-resected Patients for Esophageal, Gastric and Pancreatic Cancer

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.

N/A

  • Esophageal Cancer
  • Stomach Cancer
  • Pancreatic Cancer
  • BEHAVIORAL: standard follow-up
  • PROCEDURE: PET/CT and EUS
  • 2011-41-5702

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2011-11-28  

N/A  

2014-08-04  

2014-08-04  

N/A  

2014-08-05  

2014-08-05  

N/A  

2014-08  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic


Allocation:
Randomized


Interventional Model:
Parallel


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
ACTIVE_COMPARATOR: Standard outpatient follow-up

Outpatient clinic visits 3,6,9,12,18 and 24 mths after surgery

BEHAVIORAL: standard follow-up

  • Outpatient clinic visits
EXPERIMENTAL: Intervention PET/CT and EUS

PET/CT and EUS at 3,6,9,12,18 and 24 months after surgery

PROCEDURE: PET/CT and EUS

  • PET/CT and EUS
Primary Outcome MeasuresMeasure DescriptionTime Frame
Number of patients eligible for treatmentDoes early detection of recurrent disease translate in to more patients being eligible for oncologic treatment?2 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:

  • R0- resection for primary adenocarcinoma or squamous cell carcinoma of the esophagus, stomach or pancreas.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Odense University Hospital

  • : ,

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.
  • 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.