Siewert Type II Esophageal Adenocarcinoma: Relationship Between Histology and Survival

NCT03416101 | Completed

• 1 other identifier: ADECC_2016
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Siewert Type II Adenocarcinoma of Esophagogastric Junction

Keywords

esophageal cancer; adenocarcinoma of the esophagus; esophageal surgery

Outcome Measures

Primary Outcomes (1)

• Survival

  5 year survival between intestinal and diffuse types (Lauren's classification) of Siewert type II adenocarcinoma after primary surgery,

  5 years

Secondary Outcomes (1)

• Frequency of gastric greater curvature lymph nodes metastases in Siewert II adenocarcinoma

  5 years

Interventions

Total Gastrectomy PROCEDURE

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.

Also known as: Distal Esophagectomy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

One hundred fifty four Siewert type II cases were enrolled: 124 men (80.5%), 30 women (19.5%), median age 65.5 (interquartile range 58-71); Intestinal type 91 (59%) and Diffuse type 63 (41%).

You may qualify if:

• Siewert type II adenocarcinoma \> 18 year submitted to primary surgery

You may not qualify if:

• Siewert type I adenocarcinoma. Siewert type III adenocarcinoma Squamous Carcinoma

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (2)

Department of Medical and Surgical Sciences University of Bologna

Bologna, Bo, 40138, Italy

Location

Sandro Mattioli - Alma Mater Studiorum-University

Bologna, BO, 40138, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Surgical specimen

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Sandro Mattioli - Alma M Studiorum-University, MD

  Department of Medical and Surgical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: January 30, 2018
• Study Start: January 1, 2007
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: January 30, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)