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Staging and Outcome Depending on Surgical Treatment in Adenocarcinomas of the Oesophagogastric Junction

Staging and Outcome Depending on Surgical Treatment in Adenocarcinomas of the Oesophagogastric Junction

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01766986
Enrollment
130
Registered
2013-01-11
Start date
2008-01-31
Completion date
2013-01-31
Last updated
2021-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Carcinoma

Brief 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. 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.

Interventions

None listed

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* One-hundred and thirty patients with Siewert types I and II AOG who did not have neoadjuvant treatment were included in the study

Exclusion criteria

* AOG type III * no surgical resection

Design outcomes

Primary

MeasureTime frameDescription
Overall Survival36 monthsOverall survival after surgery (months)

Participant flow

Participants by arm

ArmCount
Group 1
Patients with an adenocarcinoma of the oesophagogastricjunction (AOG) type I who underwent oesophagectomy and inwhom the final histological report confirmed an AOG type I
41
Group 2
Patients with an AOG staged as type I before surgerywho underwent oesophagectomy but the final histology showed AOG type II
51
Group 3
Patients with an AOG staged as typeII both before and after surgery who underwent extendedgastrectomy
38
Total130

Baseline characteristics

CharacteristicGroup 2Group 1Group 3Total
Age, Continuous62 years61 years63 years62 years
Sex: Female, Male
Female
3 Participants7 Participants5 Participants15 Participants
Sex: Female, Male
Male
48 Participants34 Participants33 Participants115 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 410 / 510 / 38
serious
Total, serious adverse events
0 / 410 / 510 / 38

Outcome results

Primary

Overall Survival

Overall survival after surgery (months)

Time frame: 36 months

ArmMeasureValue (NUMBER)
Group 1Overall Survival12 participants
Group 2Overall Survival11 participants
Group 3Overall Survival13 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026