Esophageal CarcinomaNCT01766986
Staging and Outcome Depending on Surgical Treatment in Adenocarcinomas of the Oesophagogastric Junction
An observational study of Esophageal Carcinoma, run by Universitätsklinikum Hamburg-Eppendorf.
Trial summary
Background: Owing to controversial staging and classification of adenocarcinoma of the oesophagogastric junction (AOG) before surgery, the choice of appropriate surgical approach remains problematic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Carcinoma
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jan 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: One-hundred and thirty patients with Siewert types I and II AOG who did not have neoadjuvant treatment were included in the study
Who may be able to join
- One-hundred and thirty patients with Siewert types I and II AOG who did not have neoadjuvant treatment were included in the study
Who cannot join
- AOG type III
- no surgical resection
About this study
Background: Owing to controversial staging and classification of adenocarcinoma of the oesophagogastric junction (AOG) before surgery, the choice of appropriate surgical approach remains problematic.
In a retrospective study, preoperative staging of AOG and the impact of preoperative misclassification on outcome were analysed. Methods: Data from patients with AOG were analysed from a prospectively collected database with regard to surgical treatment, preoperative and postoperative staging, and outcome.
Read the detailed description
A prospective database of all patients with surgically resectable esophageal, cardia and gastric carcinomas was established in 1992 at the Department for General, Visceral and Thoracic Surgery at the University Hospital Hamburg-Eppendorf, Germany. Only patients without neoadjuvant therapy and histologically proven AEG type I and II were included into this study. The demographic, clinical, operative and postoperative courses of each patient were collected. Informed consent was obtained from all patients before including them in the prospective database which was approved by the Medical Ethical Committee of the chamber of physicians of Hamburg.
Preoperative examinations of patients included physical examination, routine blood tests, plain chest radiography, abdominal ultrasonography, endoscopy, endosonography (EUS), computed tomography (CT) of the chest and abdomen as well as positron emission tomography (PET)-CT after January 2006 and studies of tumor markers (CEA, CA 19-9), in selected patients. Tumour localization was defined according the Siewert classification (3) based upon endoscopy, endosonography and intraoperative assessment of the respective surgeon.
All patients undergoing a thoracoabdominal esophagectomy (TA) were operated with a right-sided thoracotomy, and a median inverse T-shaped laparotomy. Peritumoral resection included an en bloc subtotal esophageal resection with dissection of the right-sided paratracheal, aortopulmonary window, subcarinal and mediastinal lymph nodes (LN) and the azygos vein and a collar or high intrathoracically anastomosis. An extensive lymphadenectomy of the upper abdominal compartment (D-II lymphadenectomy, including the paracardial, the left gastric artery nodes along with the LN of the lesser and greater curvature of the stomach, the prepyloric LN, the celiac trunk, the common hepatic artery, the LN in the hepathoduodenal ligament and the LN at the splenic artery) was conducted.
The transhiatal esophagectomy (TH) consisted of an inversed T-shaped laparotomy, a wide peritumoral dissection of the distal esophagus, DII lymphadenectomy and a dissection of the LN of the posterior mediastinum extending as far as the carina of the trachea.
Extended gastrectomy (EG) consisted of an inversed T-shaped laparotomy, a gastrectomy with resection of the distal esophagus, D-II lymphadenectomy plus dissection of the lower posterior mediastinum LN. The reconstruction included a jejunal loop with a J-pouch.
Histopathological analyses were performed by a senior specialist in gastrointestinal pathology. All removed LN were counted, identified according to their location and assessed separately. Standard histopathologic analysis of paraffin-embedded LN was performed by serial sections of 5 µm thickness and staining with hematoxylin-eosin and van Gieson.
The histopathological report including tumour type, stage and grade was determined according to the 7th edition of the TNM classification (8, 12). The percentage of positive lymph nodes in regard to excised lymph nodes was classified according the definition of Bogoevski et al. (13).
Postoperative follow-up was conducted at three months intervals for the first two years and at six-month intervals thereafter, and included physical examination, plain chest radiography, abdominal ultrasonography, endoscopy, endosonography, computed tomography of the chest and abdomen as well as PET-CT after January 2006 in selected patients. Further, studies of tumor markers (carcinoembryonic antigen and CA 19-9), and bone scanning were performed. Recurrence was diagnosed if proven by biopsy or unequivocal evidence of tumour masses with a tendency to grow during further follow-up and/or follow-up until death. Events considered were death, local recurrence, and distant metastasis. When no events were recorded, the patients were censored for the statistical evaluation at the last contact. Overall survival, defined as time from operation to death or last follow-up, and local recurrence-free survival, defined as time from operation to time of diagnosis of local tumour recurrence, were calculated.
Statistical analysis SPSS 17.0 for Windows was used for statistical analysis. Associations between categorical variables were assessed by χ2 test. The Mann-Whithney U and Kruskal-Wallis tests were used for analysis of continuous variables. The Kaplan-Meier method was used to analyse recurrence and death. Differences between patient groups were assessed using log-rank tests. Apart from patient's sex and age at surgery, those co-variates with a p-value <0.05 in univariable survival analysis (log rank test) were entered into multivariable Cox proportional-hazards analysis to assess the independent influence of these co-variates and shown as hazard ratio (HR) and 95 per cent c.i.. Because this analysis was intended to be explorative, no adjustment for multiple testing was carried out. Differences were considered to be statistically significant at P<0.05.
- Conditions
- Esophageal Carcinoma
- Medical subject headings
- Esophageal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival after surgery (months)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startJan 2008
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Esophageal CarcinomaStudies 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
- 130 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, University Hospital Hamburg-Eppendof, Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766986
- Sponsor's protocol ID
- AEGII-2012
- Status last verified
- Dec 2020
- First submitted
- 8 Jan 2013
- Last updated
- 6 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staging and Outcome Depending on Surgical Treatment in Adenocarcinomas of the Oesophagogastric Junction
- ClinicalTrials.gov ID
- NCT01766986
- Acronym / sponsor ID
- AEGII-2012
- Conditions
- Esophageal Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Posted 6 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Owing to controversial staging and classification of adenocarcinoma of the oesophagogastric junction (AOG) before surgery, the choice of appropriate surgical approach remains problematic.
In a retrospective study, preoperative staging of AOG and the impact of preoperative misclassification on outcome were analysed. Methods: Data from patients with AOG were analysed from a prospectively collected database with regard to surgical treatment, preoperative and postoperative staging, and outcome.
Detailed description
A prospective database of all patients with surgically resectable esophageal, cardia and gastric carcinomas was established in 1992 at the Department for General, Visceral and Thoracic Surgery at the University Hospital Hamburg-Eppendorf, Germany. Only patients without neoadjuvant therapy and histologically proven AEG type I and II were included into this study. The demographic, clinical, operative and postoperative courses of each patient were collected. Informed consent was obtained from all patients before including them in the prospective database which was approved by the Medical Ethical Committee of the chamber of physicians of Hamburg.
Preoperative examinations of patients included physical examination, routine blood tests, plain chest radiography, abdominal ultrasonography, endoscopy, endosonography (EUS), computed tomography (CT) of the chest and abdomen as well as positron emission tomography (PET)-CT after January 2006 and studies of tumor markers (CEA, CA 19-9), in selected patients. Tumour localization was defined according the Siewert classification (3) based upon endoscopy, endosonography and intraoperative assessment of the respective surgeon.
All patients undergoing a thoracoabdominal esophagectomy (TA) were operated with a right-sided thoracotomy, and a median inverse T-shaped laparotomy. Peritumoral resection included an en bloc subtotal esophageal resection with dissection of the right-sided paratracheal, aortopulmonary window, subcarinal and mediastinal lymph nodes (LN) and the azygos vein and a collar or high intrathoracically anastomosis. An extensive lymphadenectomy of the upper abdominal compartment (D-II lymphadenectomy, including the paracardial, the left gastric artery nodes along with the LN of the lesser and greater curvature of the stomach, the prepyloric LN, the celiac trunk, the common hepatic artery, the LN in the hepathoduodenal ligament and the LN at the splenic artery) was conducted.
The transhiatal esophagectomy (TH) consisted of an inversed T-shaped laparotomy, a wide peritumoral dissection of the distal esophagus, DII lymphadenectomy and a dissection of the LN of the posterior mediastinum extending as far as the carina of the trachea.
Extended gastrectomy (EG) consisted of an inversed T-shaped laparotomy, a gastrectomy with resection of the distal esophagus, D-II lymphadenectomy plus dissection of the lower posterior mediastinum LN. The reconstruction included a jejunal loop with a J-pouch.
Histopathological analyses were performed by a senior specialist in gastrointestinal pathology. All removed LN were counted, identified according to their location and assessed separately. Standard histopathologic analysis of paraffin-embedded LN was performed by serial sections of 5 µm thickness and staining with hematoxylin-eosin and van Gieson.
The histopathological report including tumour type, stage and grade was determined according to the 7th edition of the TNM classification (8, 12). The percentage of positive lymph nodes in regard to excised lymph nodes was classified according the definition of Bogoevski et al. (13).
Postoperative follow-up was conducted at three months intervals for the first two years and at six-month intervals thereafter, and included physical examination, plain chest radiography, abdominal ultrasonography, endoscopy, endosonography, computed tomography of the chest and abdomen as well as PET-CT after January 2006 in selected patients. Further, studies of tumor markers (carcinoembryonic antigen and CA 19-9), and bone scanning were performed. Recurrence was diagnosed if proven by biopsy or unequivocal evidence of tumour masses with a tendency to grow during further follow-up and/or follow-up until death. Events considered were death, local recurrence, and distant metastasis. When no events were recorded, the patients were censored for the statistical evaluation at the last contact. Overall survival, defined as time from operation to death or last follow-up, and local recurrence-free survival, defined as time from operation to time of diagnosis of local tumour recurrence, were calculated.
Statistical analysis SPSS 17.0 for Windows was used for statistical analysis. Associations between categorical variables were assessed by χ2 test. The Mann-Whithney U and Kruskal-Wallis tests were used for analysis of continuous variables. The Kaplan-Meier method was used to analyse recurrence and death. Differences between patient groups were assessed using log-rank tests. Apart from patient's sex and age at surgery, those co-variates with a p-value <0.05 in univariable survival analysis (log rank test) were entered into multivariable Cox proportional-hazards analysis to assess the independent influence of these co-variates and shown as hazard ratio (HR) and 95 per cent c.i.. Because this analysis was intended to be explorative, no adjustment for multiple testing was carried out. Differences were considered to be statistically significant at P<0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One-hundred and thirty patients with Siewert types I and II AOG who did not have neoadjuvant treatment were included in the study
Key inclusion criteria (1 listed)
- One-hundred and thirty patients with Siewert types I and II AOG who did not have neoadjuvant treatment were included in the study
Key exclusion criteria (2 listed)
- AOG type III
- no surgical resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival
Time frame: 36 months
Overall survival after surgery (months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Esophageal Carcinoma
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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
University Hospital Hamburg-Eppendof, Hamburg, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Carcinoma, run by Universitätsklinikum Hamburg-Eppendorf.
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 1 inclusion and 2 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 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 6 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 36 months). 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 6 Jan 2021.