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Carcinomas of the Esophagogastric JunctionAEG-II-EGNCT02302118

Esophagogastrectomy Versus Extended Gastrectomy in AEG II

An observational study of Carcinomas of the Esophagogastric Junction, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Comparison of the oncological outcome of patients who underwent esophagogastrectomy versus extended gastrectomy due to carcinomas of the esophagogastric junction (Siewert type II) Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Esophagogastrectomy
Type of treatment
Surgery or procedure
How many people
128 participants
Where
1 siteGermany
Study dates
Apr 2013to Nov 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with carcinomas of the esophagogastric junction

Who may be able to join

  • Carcinoma of the esophagogastric junction (AEG type II)
  • Age of Minimum 18 years

Who cannot join

  • non

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • University Hospital Hamburg Eppendorf

    Hamburg, 20246

Other trials in Germany

About this study

Official title: Survival Benefit by Esophagogastrectomy Versus Extended Gastrectomy of Patients With Carcinoma of the Esophagogastric Junction

Comparison of the oncological outcome of patients who underwent esophagogastrectomy versus extended gastrectomy due to carcinomas of the esophagogastric junction (Siewert type II)

Read the detailed description

The esophagogastric junction (EGJ) is an anatomical region where different tumour entities which should be treated with different surgical approaches. Carcinomas within this area cause discordance concerning the classification due to the topographical borderland between the esophagus and the stomach. The definition, classification and staging of adenocarcinomas of the esophagogastric junction (AEG) have been inconsistent and are challenging. Siewert provided a system for classifying the tumours into three types based on topographical-anatomical criteria with direct impact on therapeutic strategies and wide acceptance in Europe. Adenocarcinomas of the esophagogastric junction type I involve the distal esophagus and mostly arise in intestinal metaplasia of Barrett's esophagus; AEG type II originates at the anatomical cardia and AEG type III are subcardial gastric carcinomas infiltrating the esophagogastric junction and distal esophagus from below. The mix of esophageal and gastric classification systems and especially, the controversy of the cell of origin of AEG type II present significant difficulties in defining this entity. The 7th edition of the American Joint Committee on Cancer/Union Internationale Contre Cancer (AJCC/UICC) classification presented a new definition of AEG in 2009. A tumour is classified as esophageal as soon as it extends into the esophagus and its epicentre is located within 5cm of the esophagogastric junction. Thus, Tumours with an epicentre in the stomach and distance greater than 5cm from the esophagogastric junction (EGJ) or those within 5cm of the EGJ but without extension into the esophagus are staged as gastric carcinoma. Most of the cardia carcinomas which originally were staged according to the gastric cancer TNM classification are now staged according the esophageal carcinoma TNM classification. Accurate preoperative staging of Siewert type II tumours is a challenge. Apparently, AEG type II show a specific biology with a high rate of lymph node metastases in comparison to distal esophageal carcinomas. The optimal surgical approach ranges from extended gastrectomy to radical esophagogastrectomy. In our opinion, an esophagogastrectomy with colonic interposition could be suggested as an appropriate approach in AEG type II. Therefore, we analyzed the oncological outcome of patients who underwent esophagogastrectomy versus extended gastrectomy due to carcinomas of the esophagogastric junction (Siewert type II).

Being tested
Esophagogastrectomy
Keywords
esophageal carcinoma, kardia carcinoma
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EsophagogastrectomyProcedure or surgery

    Esophagogastrectomy

Study groups in NCT02302118
Study groupRoleWhat they receive
Surgical approachGroup A: Esophagogastrectomy Group B: Extended gastrectomy
Receives: Procedure: Esophagogastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2014 (estimated)
  2. Study startApr 2013
  3. Primary completionOct 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02302118
Sponsor's protocol ID
AEG-II-esophagogastrectomy
Acronym
AEG-II-EG
Status last verified
Dec 2015
First submitted
24 Nov 2014
Last updated
3 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Carcinomas of the Esophagogastric Junction, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.

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