Siewert Type II Adenocarcinoma of Esophagogastric JunctionSiewertIIEACNCT03416101
Siewert Type II Esophageal Adenocarcinoma: Relationship Between Histology and Survival
An observational study of Siewert Type II Adenocarcinoma of Esophagogastric Junction, run by University of Bologna at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Siewert Type II Adenocarcinoma of Esophagogastric Junction
- What is being tested?
- Total Gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 154 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jan 2007to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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%).
Who may be able to join
- 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
- -
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Department of Medical and Surgical Sciences University of Bologna
Bologna, Bo, 40138
Sandro Mattioli - Alma Mater Studiorum-University
Bologna, BO, 40138
About this study
Official title: Siewert Type II Esophageal Adenocarcinoma: on the Relationship Between Histology, Esophageal-gastric Intestinal Metaplasia and Gastric Greater Curvature Lymphatic Metastases, 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.
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.
- Being tested
- Total Gastrectomy
- Keywords
- esophageal cancer, adenocarcinoma of the esophagus, esophageal surgery
- Medical subject headings
- Esophageal Neoplasms, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total GastrectomyProcedure or surgery
Also called Distal Esophagectomy
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
5 year survival between intestinal and diffuse types (Lauren's classification) of Siewert type II adenocarcinoma after primary surgery,
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start1 Jan 2007
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Siewert Type II Adenocarcinoma of Esophagogastric JunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandro Mattioli, University of Bologna
- Investigators
- Sandro Mattioli - Alma M Studiorum-University, MD, Principal investigator, Department of Medical and Surgical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416101
- Sponsor's protocol ID
- ADECC_2016
- Acronym
- SiewertIIEAC
- Status last verified
- Jan 2018
- First submitted
- 23 Jan 2018
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Siewert Type II Esophageal Adenocarcinoma: on the Relationship Between Histology, Esophageal-gastric Intestinal Metaplasia and Gastric Greater Curvature Lymphatic Metastases, Survival
- ClinicalTrials.gov ID
- NCT03416101
- Acronym / sponsor ID
- SiewertIIEAC / ADECC_2016
- Keywords
- esophageal cancer, adenocarcinoma of the esophagus, esophageal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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%).
Key inclusion criteria (4 listed)
- 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
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total GastrectomyAlso: Distal EsophagectomyThe 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. | Procedure or surgery | – |
Primary outcome
Survival
Time frame: 5 years
5 year survival between intestinal and diffuse types (Lauren's classification) of Siewert type II adenocarcinoma after primary surgery,
1 secondary outcome
Frequency of gastric greater curvature lymph nodes metastases in Siewert II adenocarcinoma
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandro Mattioli - Alma M Studiorum-University, MD principal investigator
Department of Medical and Surgical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Siewert Type II Adenocarcinoma of Esophagogastric Junction, run by University of Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.