Nodal Status in Adenocarcinoma of the Esophagus an Cardia

Completed

• Conditions: Adenocarcinoma of the Esophagus; Adenocarcinoma of the Gastric Cardia
• Interventions: Procedure: Subtotal esophagectomy and gastric pull up; Procedure: Subtotal esophagectomy at the azygos vein, total gastrectomy

• Registration Number: NCT01635595
• Lead Sponsor: University of Bologna

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.

Detailed Description

The assumption that adenocarcinoma of the esophagus and cardia (ADEC) originates only from the sequence intestinal metaplasia followed by dysplasia and cancer is controversial. It has been shown that biological patterns differ according to the presence (+) absence (-) of Barrett's epithelium (BIM) and of gastric intestinal metaplasia (GIM) in the fundus and antrum. Lymphatic metastatic spreading may differ according to the type of tumor.

Preoperatively patients underwent histological search for Barrett's esophagus (BIM) in mucosa surrounding (ADEC) and intestinal metaplasia in the gastric corpus and antrum mucosa (GIM). Patients in which BIM was documented underwent sub total esophagectomy and gastric pull up (group 1), others underwent esophagectomy at the azygos vein + total gastrectomy with Roux Y esophagojejunostomy (group 2). Radical lymphadenectomy was identical in both procedures except for the greater curvature station.

Study Timeline

• Study Start: 2006-01
• Study Completion: 2011-12
• Status Verified: 2012-07
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-06
• Study First Posted: 2012-07-09
• Last Update Submitted: 2012-07-24
• Last Update Posted: 2012-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

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

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Exclusion Criteria

• neoadjuvant therapy
• metastatic disease
• unfit for surgery

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with BIM	Subtotal esophagectomy and gastric pull up	Patients affected by adenocarcinoma of the distal esophagus and cardia with preoperative diagnosis of BIM underwent subtotal esophagectomy and gastric pull up.
Patients without BIM	Subtotal esophagectomy at the azygos vein, total gastrectomy	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.

Trial Locations

Locations (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, Italy