Nodal Status in Adenocarcinoma of the Esophagus an Cardia

Adenocarcinoma of the Esophagus Clinical Trial

Official title:

AdCa of the Esophagus and Cardia (ADEC): Relationship Between Nodal Metastasization and the Presence Absence of Intestinal Metaplasia in the Esophagus and Stomach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635595
• Other study ID #: Cardia AdCa UNIBO
• Status: Completed
• Phase: N/A
• First received: July 3, 2012
• Last updated: July 24, 2012
• Start date: January 2006
• Est. completion date: December 2011

Study information

• Verified date: July 2012
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: National Bioethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• preoperative diagnosis of adenocarcinoma of the distal esophagus and cardia

• preoperative from local to locally advanced disease

• absence of neoadjuvant therapy

Exclusion Criteria:

• neoadjuvant therapy

• metastatic disease

• unfit for surgery

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Esophagus
• Adenocarcinoma of the Gastric Cardia
• Esophageal Neoplasms

Intervention

Procedure:
• Subtotal esophagectomy and gastric pull up
Subtotal esophagectomy and gastric pull up and radical thoracic (2,3,4R,7,8,9)and abdominal (15,16,17,18,19,20) lymphadenectomy
• Subtotal esophagectomy at the azygos vein, total gastrectomy
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.

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

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 — View Citation