Siewert Type I-II: CT, PET-CT, EUS Sensitivity/Specificity for the Assessment of Lymph Node Metastases

Siewert Type I-II Adenocarcinoma of the Esophagus Clinical Trial

— ADECC2-2017  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03529968
• Other study ID #: ADECC2-2017
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: January 1, 2018

Study information

• Verified date: May 2018
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In Siewert type I/II EAC, sensitivity/specificity of CT, PET-CT, EUS for assessment of N descriptor in defined groups of lymph nodes were investigated.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: January 1, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Siewert Type I-II Adenocarcinoma of the Esophagus

Intervention

Procedure:
• esophagectomy
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

Locations

Country	Name	City	State
Italy	Department of Medical and Surgical Sciences University of Bologna	Bologna	Bo

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Principal aim - sensitivity, specificity, accuracy	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