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Status unknownNCT02209415EUFUROUpdated Aug 5, 2014

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

An interventional study of standard follow-up and PET/CT and EUS in Esophageal Cancer, Stomach Cancer and Pancreatic Cancer, sponsored by Michael Bau Mortensen. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-05.

Sponsored by Michael Bau Mortensen · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Aug 2014), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
182
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Esophageal Cancer
  • Stomach Cancer
  • Pancreatic Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • R0- resection for primary adenocarcinoma or squamous cell carcinoma of the esophagus, stomach or pancreas.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
182 participants (estimated)

Study arms

  • Active comparator
    Standard outpatient follow-up

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

    Behavioral: standard follow-up

  • 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

Interventions

  • Behavioralstandard follow-up

    Outpatient clinic visits

  • ProcedurePET/CT and EUS

    PET/CT and EUS

05

What researchers measure

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?

    Time frame: 2 years

06

Study locations

1 site
  • Center for Surgical Ultrasound, Department of upper surgical gastroenterology
    Odense, Region of Southern Denmark 5000, Denmark
07

References and documents

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. PubMed 31595970 ↗
  • 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. PubMed 30036892 ↗
08

Registry details

Key details

Study ID
NCT02209415
Lead sponsor
Michael Bau Mortensen
Collaborators
Odense University Hospital
Responsible party
Michael Bau Mortensen (MD, PhD, Odense University Hospital) — Sponsor-investigator
First posted
Aug 5, 2014
Start date
Apr 2011
Primary completion
Jan 2016 (estimated)
Completion
Aug 2016 (estimated)
Last update
Aug 5, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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