Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Siewert Type II Esophageal Adenocarcinoma: Relationship Between Histology and Survival (SiewertIIEAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416101
Recruitment Status : Completed
First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Sandro Mattioli, University of Bologna

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.

Condition or disease Intervention/treatment
Siewert Type II Adenocarcinoma of Esophagogastric Junction Procedure: Total Gastrectomy

Detailed 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 154 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Siewert Type II Esophageal Adenocarcinoma: on the Relationship Between Histology, Esophageal-gastric Intestinal Metaplasia and Gastric Greater Curvature Lymphatic Metastases, Survival
Actual Study Start Date : January 1, 2007
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.
    Other Name: Distal Esophagectomy


Primary Outcome Measures :
  1. Survival [ Time Frame: 5 years ]
    5 year survival between intestinal and diffuse types (Lauren's classification) of Siewert type II adenocarcinoma after primary surgery,


Secondary Outcome Measures :
  1. Frequency of gastric greater curvature lymph nodes metastases in Siewert II adenocarcinoma [ Time Frame: 5 years ]
    Frequency of gastric greater curvature lymph nodes metastases and survival


Biospecimen Retention:   Samples Without DNA
Surgical specimen


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%).
Criteria

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

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416101


Locations
Layout table for location information
Italy
Department of Medical and Surgical Sciences University of Bologna
Bologna, Bo, Italy, 40138
Sandro Mattioli - Alma Mater Studiorum-University
Bologna, BO, Italy, 40138
Sponsors and Collaborators
University of Bologna
Investigators
Layout table for investigator information
Principal Investigator: Sandro Mattioli - Alma M Studiorum-University, MD Department of Medical and Surgical Sciences
Layout table for additonal information
Responsible Party: Sandro Mattioli, Associate Professor, University of Bologna
ClinicalTrials.gov Identifier: NCT03416101    
Other Study ID Numbers: ADECC_2016
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sandro Mattioli, University of Bologna:
esophageal cancer
adenocarcinoma of the esophagus
esophageal surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms