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.
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
- Conditions the study is for
- Carcinomas of the Esophagogastric Junction
- 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.
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 group | Role | What they receive |
|---|---|---|
| Surgical approach | Group 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.
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.
- First posted26 Nov 2014 (estimated)
- Study startApr 2013
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinomas of the Esophagogastric JunctionStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jakob R Izbicki, MD, Study chair, Universitätsklinikum Hamburg-Eppendorf
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Benefit by Esophagogastrectomy Versus Extended Gastrectomy of Patients With Carcinoma of the Esophagogastric Junction
- ClinicalTrials.gov ID
- NCT02302118
- Acronym / sponsor ID
- AEG-II-EG / AEG-II-esophagogastrectomy
- Keywords
- esophageal carcinoma, kardia carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 26 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of the oncological outcome of patients who underwent esophagogastrectomy versus extended gastrectomy due to carcinomas of the esophagogastric junction (Siewert type II)
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical approach | – | Procedure: EsophagogastrectomyGroup A: Esophagogastrectomy Group B: Extended gastrectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with carcinomas of the esophagogastric junction
Key inclusion criteria (2 listed)
- Carcinoma of the esophagogastric junction (AEG type II)
- Age of Minimum 18 years
Key exclusion criteria (1 listed)
- non
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsophagogastrectomyEsophagogastrectomy | Procedure or surgery | Surgical approach |
Primary outcome
Overall survival
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakob R Izbicki, MD study chair
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
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.