ClinicalTrials.gg
CompletedNCT03416101SiewertIIEACUpdated Jan 30, 2018

Siewert Type II Esophageal Adenocarcinoma: Relationship Between Histology and Survival

An observational study in Siewert Type II Adenocarcinoma of Esophagogastric Junction, sponsored by University of Bologna. Completed at 2 sites in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-01-30.

Sponsored by University of Bologna · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
154
Ages
18 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 50 studies in Esophageal Neoplasms with a site in Italy — 17 open to participants now, 23 under way, 4 of them phase 3. Esophageal Neoplasms · Italy.

Enrollment
10th of 12
154 · median 2,000
Started
2007
the only one that year
Observational
12 of 50
4 open now
Registered
10th of 50
by date

Among the 50 studies in Esophageal Neoplasms with a site in Italy, this one is the 10th largest by enrollment of the 12 observational ones that give a count, is the only one that started in 2007, is one of 12 observational ones, and was the 10th registered.

Esophageal Neoplasms

1,873 studies on the registry are indexed under Esophageal Neoplasms; 502 are open to participants now.

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Open to participants now

17 of the 50 studies in Esophageal Neoplasms with a site in Italy are open now. Recruiting first, the newest first:

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All 17 open studies →

A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →

Who these studies take

Of the 388 Esophageal Neoplasms studies recruiting now, 246 (63%) set no upper age limit and 75 (19%) stop at 75 or younger; 20 take children under 18; 36 take healthy volunteers.

This study: 18 Years to 85 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Siewert Type II Adenocarcinoma of Esophagogastric Junction

Keywords

  • esophageal cancer
  • adenocarcinoma of the esophagus
  • esophageal surgery
04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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%).

Eligibility criteria

Inclusion Criteria:

Siewert type II adenocarcinoma > 18 year submitted to primary surgery

Exclusion Criteria: Siewert type II adenocarcinoma submitted to therapy.

Siewert type I adenocarcinoma. Siewert type III adenocarcinoma Squamous Carcinoma

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Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumor. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
154 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • ProcedureTotal 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.

    Also known as: Distal Esophagectomy

06

What researchers measure

Primary outcomes

  1. Survival

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

    Time frame: 5 years

Secondary outcomes

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

    Frequency of gastric greater curvature lymph nodes metastases and survival

    Time frame: 5 years

07

Study locations

2 sites
  • Department of Medical and Surgical Sciences University of Bologna
    Bologna, Bo 40138, Italy
  • Sandro Mattioli - Alma Mater Studiorum-University
    Bologna, BO 40138, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2007 to primary completion in Jun 2017, 125 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 23, 2018
First posted
Jan 30, 2018
StartActual
Jan 1, 2007
Primary completionActual
Jun 30, 2017
CompletionActual
Jun 30, 2017
Last update
Jan 30, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03416101
Responsible party
Sandro Mattioli (Associate Professor, University of Bologna) — Principal investigator
First posted
Jan 30, 2018
Start date
Jan 1, 2007
Primary completion
Jun 30, 2017
Completion
Jun 30, 2017
Last update
Jan 30, 2018

Study contacts

Sandro Mattioli - Alma M Studiorum-University, MD
principal investigator · Department of Medical and Surgical Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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