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

NCT ID: NCT02209415

Last Updated: 2014-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Esophageal Cancer Stomach Cancer Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Standard outpatient follow-up

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

Group Type ACTIVE_COMPARATOR

standard follow-up

Intervention Type BEHAVIORAL

Outpatient clinic visits

Intervention PET/CT and EUS

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

Group Type EXPERIMENTAL

PET/CT and EUS

Intervention Type PROCEDURE

PET/CT and EUS

Interventions

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standard follow-up

Outpatient clinic visits

Intervention Type BEHAVIORAL

PET/CT and EUS

PET/CT and EUS

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* R0- resection for primary adenocarcinoma or squamous cell carcinoma of the esophagus, stomach or pancreas.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role collaborator

Michael Bau Mortensen

OTHER

Sponsor Role lead

Responsible Party

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Michael Bau Mortensen

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Center for Surgical Ultrasound, Department of upper surgical gastroenterology

Odense, Region Syddanmark, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 31595970 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30036892 (View on PubMed)

Other Identifiers

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2011-41-5702

Identifier Type: -

Identifier Source: org_study_id

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