- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03529968
Siewert Type I-II: CT, PET-CT, EUS Sensitivity/Specificity for the Assessment of Lymph Node Metastases (ADECC2-2017)
Siewert Type I and II Esophageal Adenocarcinoma (EAC): CT, PET-CT, EUS Sensitivity / Specificity for the Assessment of Lymph Node Metastases (LNM) in Groups of Thoracic and Abdominal Lymph Nodal Stations
Study Overview
Status
Intervention / Treatment
Detailed Description
Esophageal adenocarcinoma (EAC) is a disease with poor overall prognosis and rising incidence in western countries. In patients without organ metastases, therapy is currently based on surgery with or without neoadjuvant therapy; indication for primary surgery is reserved to clinical TNM stages 0-IIa, whereas a multimodality approach is more suitable for clinical TNM stages IIb-III. The operation comprises the resection of distal esophagus and proximal or total gastrectomy. Two field lymphadenectomy is generally recommended, but the extent of lymphadenectomy is among the controversial issues, as extensive removal of nodes may cause significant morbidity and its effect on survival in addition to neoadjuvant therapy is not clear. Current guidelines are based on the 7th edition of AJCC & UICC TNM classification, which stages lymph node status (N) according to the number of metastatic nodes, but do not consider the specific anatomic stations of regional nodes. EAC subtypes are known to demonstrate different metastatic nodal patterns of spread. They may be classified with the Siewert's classification according to the position of the tumor with respect to the esophago-gastric junction (EGJ), or according to histologic parameters like the presence/absence of intestinal metaplasia in the esophagus and stomach. Siewert Type I EAC, which fairly corresponds to the Barret's like type according to the presence absence of intestinal metaplasia, spreads more likely to the thoracic nodal stations, while Siewert Type II and the pyloric like type, do spread more frequently to the perigastric and celiac stations. Therefore, an increasing interest is emerging for preoperative mapping of lymph nodes metastases in order to tailor surgery according to metastatic patterns.
The majority of studies aiming to assess the accuracy of N staging with clinical methods generally refer to the global evaluation of regional nodes according to the 7th edition of staging descriptors. Studies reporting specific data on the clinical staging assessment of specific thoracic and abdominal lymph nodal stations are few, diagnostic tests and results are not uniform, interpretation and comparison of data within reports is not immediate.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bo
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Bologna, Bo, Italy, 40138
- Department of Medical And Surgical Sciences University of Bologna
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Siewert type I-II adenocarcinoma > 18 year submitted to primary surgery
Exclusion Criteria:
- Siewert type I-II adenocarcinoma submitted to neoadjuvant therapy.
- Siewert type III adenocarcinoma Squamous Carcinoma
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Italian Siewert I-II adenocarcinoma
Patients with Siewert type I adenocarcinoma underwent subtotal esophagectomy and proximal gastrectomy with intrathoracic esophagogastric anastomosis.
Patients with Siewert type II adenocarcinoma underwent total gastrectomy and esophageal resection at the level of the azygos vein and Roux-en-Y esophagojejunostomy.
A right anterolateral thoracotomy and an upper midline laparotomy were performed as previously described.
Lymphadenectomy included chest stations classified according to the AJCC TNM 7th edition (L/R = left/right; 3, 4R, 7, 2R, 8 and 9 and abdominal stations classified according to the Japanese Classification of Gastric Carcinoma (stations 1-12)
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Subtotal esophagectomy and proximal gastrectomy with intrathoracic esophagogastric anastomosis.
Total gastrectomy and esophageal resection at the level of the azygos vein and Roux-en-Y esophagojejunostomy
Other Names:
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Finnish Siewert I-II adenocarcinoma
All Siewert type I/II patients underwent minimally invasive esophagectomy and reconstruction with gastric tube.
Laparoscopy and right-sided thoracoscopy in decubitus position were used as previously described.
Thoracic lymphadenectomy consisted of stations 7-9 (AJCC TNM 7th edition) and abdominal stations 1-3 and 7-11 according to the Japanese Classification of Gastric carcinoma.
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Subtotal esophagectomy and proximal gastrectomy with intrathoracic esophagogastric anastomosis.
Total gastrectomy and esophageal resection at the level of the azygos vein and Roux-en-Y esophagojejunostomy
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Principal aim - sensitivity, specificity, accuracy
Time Frame: 1 years
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The aim of this study was to evaluate sensitivity, specificity, accuracy of positron emission tomography integrated with CT (PET-CT), endoscopic ultrasound (EUS) and computed tomography (CT) for staging N descriptor in total (regional N) and in anatomical groups of thoracic and abdominal N stations. For each lymph nodal station thoracic and abdominal the outcome measures for CT, PET; EUS were: Sensitivity measured in percentage (number of lymph nodes true positive/number of lymph nodes positive in the test x 100); Specificity measured in percentage (number of lymph nodes true negative/number of lymph nodes negative in the test x 100). |
1 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sandro M Mattioli, MD, Department of Medical And Surgical Sciences University of Bologna
- Study Chair: Sandro M Mattioli, MD, Department of Medical and Surgical Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADECC2-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Siewert Type I-II Adenocarcinoma of the Esophagus
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