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Completed

NCT Number: NCT03416101

Siewert Type II Esophageal Adenocarcinoma: Relationship Between Histology and Survival

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sandro Mattioli - Alma Mater Studiorum-University, Bologna, BO, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

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.

Other names: Distal Esophagectomy

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study title

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

Acronym: SiewertIIEAC

Important dates

Study start
2007
Primary completion
2017
Study completion
2017
First posted
Jan 30, 2018
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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