Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT02302118
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2014-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Esophagogastrectomy Versus Extended Gastrectomy in AEG II
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Study Overview
Official Title:
Survival Benefit by Esophagogastrectomy Versus Extended Gastrectomy of Patients With Carcinoma of the Esophagogastric Junction
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AEG-II-EG
Brief Summary:
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: