Adenocarcinoma of the EsophagusNCT01635595
Nodal Status in Adenocarcinoma of the Esophagus an Cardia
An observational study of Adenocarcinoma of the Esophagus and Adenocarcinoma of the Gastric Cardia, run by University of Bologna at 1 site in Italy.
Trial summary
Adenocarcinoma of the distal esophagus and cardia are grouped among the thoracic tumors according to the TNM 7th ed., however controversy is pending on the unique or dual pathogenesis (GERD or gastric-like cancerogenesis). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adenocarcinoma of the Esophagus, Adenocarcinoma of the Gastric Cardia
- What is being tested?
- Subtotal esophagectomy and gastric pull up and Subtotal esophagectomy at the azygos vein, total gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 194 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2006to Dec 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a preoperative diagnosis of adenocarcinoma of the distal esophagus and cardia who underwent surgery up to December 2011, which fully adhered to the pre and postoperative protocol, including endoscopic gastric mucosa sampling.
Who may be able to join
- preoperative diagnosis of adenocarcinoma of the distal esophagus and cardia
- preoperative from local to locally advanced disease
- absence of neoadjuvant therapy
Who cannot join
- neoadjuvant therapy
- metastatic disease
- unfit for surgery
Trial locations and contacts
1 site in 1 country.
Italy1 site
Division of Thoracic Surgery, Center for the Study and Therapy of Diseases of the Esophagus. Alma Mater Studiorum - University of Bologna, GVM Care & Research, Maria Cecilia Hospital
Cotignola, Ravenna, 48010
About this study
Official title: AdCa of the Esophagus and Cardia (ADEC): Relationship Between Nodal Metastasization and the Presence Absence of Intestinal Metaplasia in the Esophagus and Stomach
Adenocarcinoma of the distal esophagus and cardia are grouped among the thoracic tumors according to the TNM 7th ed., however controversy is pending on the unique or dual pathogenesis (GERD or gastric-like cancerogenesis). It has been shown that biological patterns differ according to the presence (+) or absence (-) of Barrett's epithelium (BIM) and gastric intestinal metaplasia (GIM) in the fundus and antrum. Lymphatic metastatic spreading may differ according to the type of tumor. The investigators retrospectively investigated the pathways of lymphatic spreading in 194 consecutive patients who received radical surgery for adenocarcinoma of the esophagus and cardia with or without BIM and GIM.
Read the detailed description
The assumption that adenocarcinoma of the esophagus and cardia (ADEC) originates only from the sequence intestinal metaplasia followed by dysplasia and cancer is controversial. It has been shown that biological patterns differ according to the presence (+) absence (-) of Barrett's epithelium (BIM) and of gastric intestinal metaplasia (GIM) in the fundus and antrum. Lymphatic metastatic spreading may differ according to the type of tumor.
Preoperatively patients underwent histological search for Barrett's esophagus (BIM) in mucosa surrounding (ADEC) and intestinal metaplasia in the gastric corpus and antrum mucosa (GIM). Patients in which BIM was documented underwent sub total esophagectomy and gastric pull up (group 1), others underwent esophagectomy at the azygos vein + total gastrectomy with Roux Y esophagojejunostomy (group 2). Radical lymphadenectomy was identical in both procedures except for the greater curvature station.
- Being tested
- Subtotal esophagectomy and gastric pull up, Subtotal esophagectomy at the azygos vein, total gastrectomy
- Medical subject headings
- Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subtotal esophagectomy and gastric pull upProcedure or surgery
Also called Esophagectomy
Subtotal esophagectomy and gastric pull up and radical thoracic (2,3,4R,7,8,9)and abdominal (15,16,17,18,19,20) lymphadenectomy
Subtotal esophagectomy at the azygos vein, total gastrectomyProcedure or surgery
Also called Esophagectomy, Gastrectomy
Subtotal esophagectomy at the azygos vein, total gastrectomy and esophagojejunostomy and radical thoracic (2,3,4R,7,8,9) abdominal (15,16,17,18,19,20) lymphadenectomy.
| Study group | Role | What they receive |
|---|---|---|
| Patients with BIM | Patients affected by adenocarcinoma of the distal esophagus and cardia with preoperative diagnosis of BIM underwent subtotal esophagectomy and gastric pull up. Receives: Procedure: Subtotal esophagectomy and gastric pull up | |
| Patients without BIM | Patients affected by adenocarcinoma of the distal esophagus and cardia without preoperative diagnosis of BIM underwent subtotal esophagectomy at the azygos vein, total gastrectomy and esophagojejunostomy. Receives: Procedure: Subtotal esophagectomy at the azygos vein, total gastrectomy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2012 (estimated)
- Study startJan 2006
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adenocarcinoma of the EsophagusStudies 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
- 194 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, Prof., Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635595
- Sponsor's protocol ID
- Cardia AdCa UNIBO
- Status last verified
- Jul 2012
- First submitted
- 3 Jul 2012
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Mattioli S, Di Simone MP, Ferruzzi L, D'Ovidio F, Pilotti V, Carella R, D'Errico A, Grigioni WF. Surgical therapy for adenocarcinoma of the cardia: modalities of recurrence and extension of resection. Dis Esophagus. 2001;14(2):104-9. doi: 10.1046/j.1442-2050.2001.00165.x.
PubMed 11553218Mattioli S, Ruffato A, Di Simone MP, Corti B, D'Errico A, Lugaresi ML, Mattioli B, D'Ovidio F. Immunopathological patterns of the stomach in adenocarcinoma of the esophagus, cardia, and gastric antrum: gastric profiles in Siewert type I and II tumors. Ann Thorac Surg. 2007 May;83(5):1814-9. doi: 10.1016/j.athoracsur.2007.01.016.
PubMed 17462405
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AdCa of the Esophagus and Cardia (ADEC): Relationship Between Nodal Metastasization and the Presence Absence of Intestinal Metaplasia in the Esophagus and Stomach
- ClinicalTrials.gov ID
- NCT01635595
- Acronym / sponsor ID
- Cardia AdCa UNIBO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Dec 2011 (actual)
- First posted
- 9 Jul 2012 (estimated)
- 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.
Adenocarcinoma of the distal esophagus and cardia are grouped among the thoracic tumors according to the TNM 7th ed., however controversy is pending on the unique or dual pathogenesis (GERD or gastric-like cancerogenesis). It has been shown that biological patterns differ according to the presence (+) or absence (-) of Barrett's epithelium (BIM) and gastric intestinal metaplasia (GIM) in the fundus and antrum. Lymphatic metastatic spreading may differ according to the type of tumor. The investigators retrospectively investigated the pathways of lymphatic spreading in 194 consecutive patients who received radical surgery for adenocarcinoma of the esophagus and cardia with or without BIM and GIM.
Detailed description
The assumption that adenocarcinoma of the esophagus and cardia (ADEC) originates only from the sequence intestinal metaplasia followed by dysplasia and cancer is controversial. It has been shown that biological patterns differ according to the presence (+) absence (-) of Barrett's epithelium (BIM) and of gastric intestinal metaplasia (GIM) in the fundus and antrum. Lymphatic metastatic spreading may differ according to the type of tumor.
Preoperatively patients underwent histological search for Barrett's esophagus (BIM) in mucosa surrounding (ADEC) and intestinal metaplasia in the gastric corpus and antrum mucosa (GIM). Patients in which BIM was documented underwent sub total esophagectomy and gastric pull up (group 1), others underwent esophagectomy at the azygos vein + total gastrectomy with Roux Y esophagojejunostomy (group 2). Radical lymphadenectomy was identical in both procedures except for the greater curvature station.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with BIM | – | Procedure: Subtotal esophagectomy and gastric pull upPatients affected by adenocarcinoma of the distal esophagus and cardia with preoperative diagnosis of BIM underwent subtotal esophagectomy and gastric pull up. |
| Patients without BIM | – | Procedure: Subtotal esophagectomy at the azygos vein, total gastrectomyPatients affected by adenocarcinoma of the distal esophagus and cardia without preoperative diagnosis of BIM underwent subtotal esophagectomy at the azygos vein, total gastrectomy and esophagojejunostomy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a preoperative diagnosis of adenocarcinoma of the distal esophagus and cardia who underwent surgery up to December 2011, which fully adhered to the pre and postoperative protocol, including endoscopic gastric mucosa sampling.
Key inclusion criteria (3 listed)
- preoperative diagnosis of adenocarcinoma of the distal esophagus and cardia
- preoperative from local to locally advanced disease
- absence of neoadjuvant therapy
Key exclusion criteria (3 listed)
- neoadjuvant therapy
- metastatic disease
- unfit for surgery
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 |
|---|---|---|
| Subtotal esophagectomy and gastric pull upAlso: EsophagectomySubtotal esophagectomy and gastric pull up and radical thoracic (2,3,4R,7,8,9)and abdominal (15,16,17,18,19,20) lymphadenectomy | Procedure or surgery | Patients with BIM |
| Subtotal esophagectomy at the azygos vein, total gastrectomyAlso: Esophagectomy, GastrectomySubtotal esophagectomy at the azygos vein, total gastrectomy and esophagojejunostomy and radical thoracic (2,3,4R,7,8,9) abdominal (15,16,17,18,19,20) lymphadenectomy. | Procedure or surgery | Patients without BIM |
Primary outcome
Not reported in the source record.
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 25 Jul 2012.
- Background: PubMed 11553218Mattioli S, Di Simone MP, Ferruzzi L, D'Ovidio F, Pilotti V, Carella R, D'Errico A, Grigioni WF. Surgical therapy for adenocarcinoma of the cardia: modalities of recurrence and extension of resection. Dis Esophagus. 2001;14(2):104-9. doi: 10.1046/j.1442-2050.2001.00165.x.
- Results publication: PubMed 17462405Mattioli S, Ruffato A, Di Simone MP, Corti B, D'Errico A, Lugaresi ML, Mattioli B, D'Ovidio F. Immunopathological patterns of the stomach in adenocarcinoma of the esophagus, cardia, and gastric antrum: gastric profiles in Siewert type I and II tumors. Ann Thorac Surg. 2007 May;83(5):1814-9. doi: 10.1016/j.athoracsur.2007.01.016.
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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, Prof. principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenocarcinoma of the Esophagus and Adenocarcinoma of the Gastric Cardia, run by University of Bologna at 1 site 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 3 inclusion and 3 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 25 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01635595, which also lists 2 linked publications.
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 25 Jul 2012.