Nodal Status in Adenocarcinoma of the Esophagus an Cardia

NCT01635595 | Completed

• 1 other identifier: Cardia AdCa UNIBO
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Adenocarcinoma of the Esophagus; Adenocarcinoma of the Gastric Cardia

Study Arms (2)

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.

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.

Procedure: Subtotal esophagectomy at the azygos vein, total gastrectomy

Interventions

Subtotal esophagectomy and gastric pull up PROCEDURE

Subtotal esophagectomy and gastric pull up and radical thoracic (2,3,4R,7,8,9)and abdominal (15,16,17,18,19,20) lymphadenectomy

Also known as: Esophagectomy

Patients with BIM

Subtotal esophagectomy at the azygos vein, total gastrectomy PROCEDURE

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.

Also known as: Esophagectomy, Gastrectomy

Patients without BIM

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• preoperative diagnosis of adenocarcinoma of the distal esophagus and cardia
• preoperative from local to locally advanced disease
• absence of neoadjuvant therapy

You may not qualify if:

• neoadjuvant therapy
• metastatic disease
• unfit for surgery

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

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, Italy

Location

Related Publications (2)

• 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.

  PMID: 11553218 BACKGROUND

• Mattioli 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.

  PMID: 17462405 RESULT

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus

Interventions

Esophagectomy; Gastrectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Sandro Mattioli, Prof.

  University of Bologna

  PRINCIPAL INVESTIGATOR

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: July 3, 2012
• First Posted: July 9, 2012
• Study Start: January 1, 2006
• Study Completion: December 1, 2011
• Last Updated: July 25, 2012

Record last verified: 2012-07

Locations

IT (1)