Siewert Type II Esophageal Adenocarcinoma: Relationship Between Histology and Survival

Siewert Type II Adenocarcinoma of Esophagogastric Junction Clinical Trial

— SiewertIIEAC  

Official title:

Siewert Type II Esophageal Adenocarcinoma: on the Relationship Between Histology, Esophageal-gastric Intestinal Metaplasia and Gastric Greater Curvature Lymphatic Metastases, Survival

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03416101
• Other study ID #: ADECC_2016
• Status: Completed
• Phase: N/A
• First received: January 23, 2018
• Last updated: January 23, 2018
• Start date: January 1, 2007
• Est. completion date: June 30, 2017

Study information

• Verified date: January 2018
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In Siewert type II adenocarcinoma, the relationship between adenocarcinoma sub types and survival, histologic/biologic patterns related to the presence/absence of gastric greater curvature metastases, were investigated.

Description:

In order to achieve further data on the biological patterns of intestinal and diffuse subtypes of esophageal adenocarcinoma (Lauren's classification), on the frequency of gastric greater curvature nodal stations and on the clinical relevance, in terms of prognosis and survival, of these parameters, a Siewert type II case series of Siewert type II adenocarcinomas, submitted to primary (no neoadjuvant therapy) surgical, studied, operated upon and followed up, were analysed. According to histologic patterns, cases were ordered in intestinal and diffuse adenocarcinoma sub types (Lauren's classification)and distinguished in Barret's, cardiopyloric, gastric types.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

Siewert type II adenocarcinoma > 18 year submitted to primary surgery

Exclusion Criteria: Siewert type II adenocarcinoma submitted to neoadjuvant therapy.

Siewert type I adenocarcinoma. Siewert type III adenocarcinoma Squamous Carcinoma

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Siewert Type II Adenocarcinoma of Esophagogastric Junction

Intervention

Procedure:
• Total Gastrectomy
The esophagus was resected at the arch level of the azygos vein, a frozen section of the resection margin was routinely performed to achieve a proximal clean resection margin. The surgical specimen was comprehensive of distal esophagus, stomach and omentum. Digestive tract continuity was established with Roux-en-Y esophagojejunostomy. Lymphadenectomy was extended to the thoracic stations R 2-4, 7-8-9, and L 4, numbered according to the Mountain's classification [39] (Suppl. File 2 Figure A) and to the abdominal stations 1-12, numbered according to the Japanese Research Society for Gastric Cancer (JRSGC) 1998 classification.

Locations

Country	Name	City	State
Italy	Department of Medical and Surgical Sciences University of Bologna	Bologna	Bo
Italy	Sandro Mattioli - Alma Mater Studiorum-University	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	5 year survival between intestinal and diffuse types (Lauren's classification) of Siewert type II adenocarcinoma after primary surgery,	5 years
Secondary	Frequency of gastric greater curvature lymph nodes metastases in Siewert II adenocarcinoma	Frequency of gastric greater curvature lymph nodes metastases and survival	5 years