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

NCT ID: NCT03529968

Last Updated: 2018-05-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 101 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-01
• Study Completion Date: 2018-01-01

Brief 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.

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.

Conditions

Siewert Type I-II Adenocarcinoma of the Esophagus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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)

esophagectomy

Intervention Type: PROCEDURE

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

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.

esophagectomy

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

gastrectomy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bologna

OTHER

Sponsor Role: lead

Responsible Party

Sandro Mattioli

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandro M Mattioli, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medical and Surgical Sciences University of Bologna

Sandro M Mattioli, MD

Role: STUDY_CHAIR

Department of Medical and Surgical Sciences

Locations

Department of Medical and Surgical Sciences University of Bologna

Bologna, Bo, Italy

Countries

Italy

References

Lopci E, Kauppi J, Lugaresi M, Mattioli B, Daddi N, Fortunato F, Rasanen J, Mattioli S. Siewert type I and II oesophageal adenocarcinoma: sensitivity/specificity of computed tomography, positron emission tomography and endoscopic ultrasound for assessment of lymph node metastases in groups of thoracic and abdominal lymph node stations. Interact Cardiovasc Thorac Surg. 2019 Apr 1;28(4):518-525. doi: 10.1093/icvts/ivy314.

Reference Type: DERIVED

PMID: 30496443 (View on PubMed)

Other Identifiers

ADECC2-2017

Identifier Type: -

Identifier Source: org_study_id