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

NCT03529968 | Completed

• 1 other identifier: ADECC2-2017
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Siewert Type I-II Adenocarcinoma of the Esophagus

Keywords

esophageal adenocarcinoma; staging; CT; PET-CT; EUS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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)

Procedure: esophagectomy

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.

Procedure: esophagectomy

Interventions

esophagectomy 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

Also known as: gastrectomy

Finnish Siewert I-II adenocarcinoma; Italian Siewert I-II adenocarcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

101 patients affected by Siewert type I (n=60) and type II (n=41) EAC, submitted to up front surgery (no neoadjuvant therapy) in the Thoracic Surgery divisions of the University of Bologna (Maria Cecilia Hospital n=54) and of the Helsinki University Hospital (n=47).

You may qualify if:

• Siewert type I-II adenocarcinoma \> 18 year submitted to primary surgery

You may not qualify if:

• Siewert type I-II adenocarcinoma submitted to neoadjuvant therapy.
• Siewert type III adenocarcinoma Squamous Carcinoma

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Department of Medical and Surgical Sciences University of Bologna

Bologna, Bo, 40138, Italy

Location

Related Publications (1)

• 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.

  PMID: 30496443 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Lymph nodes from surgical samples in patients submitted to surgical procedures for Siwert type I-II esophageal adenocarcinoma.

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus

Interventions

Esophagectomy; Gastrectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Sandro M Mattioli, MD

  Department of Medical and Surgical Sciences University of Bologna

  PRINCIPAL INVESTIGATOR

• Sandro M Mattioli, MD

  Department of Medical and Surgical Sciences

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 21, 2018
• Study Start: January 1, 2010
• Primary Completion: December 31, 2017
• Study Completion: January 1, 2018
• Last Updated: May 21, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)