Nodal Status in Adenocarcinoma of the Esophagus an Cardia

Sponsor

University of Bologna (Other)

Overall Status

Completed

CT.gov ID

NCT01635595

Collaborator

(none)

194

Enrollment

Location

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adenocarcinoma of the Esophagus Adenocarcinoma of the Gastric Cardia	Procedure: Subtotal esophagectomy and gastric pull up Procedure: Subtotal esophagectomy at the azygos vein, total gastrectomy

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 Design

Study Type:

Observational

Actual Enrollment :

194 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Study Start Date :

Jan 1, 2006

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Subtotal esophagectomy and gastric pull up and radical thoracic (2,3,4R,7,8,9)and abdominal (15,16,17,18,19,20) lymphadenectomy Other Names: Esophagectomy
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 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. Other Names: Esophagectomy Gastrectomy

Arm

Intervention/Treatment

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

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

Other Names:

Esophagectomy

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

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.

Other Names:

Esophagectomy

Gastrectomy

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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	48010

Sponsors and Collaborators

University of Bologna

Investigators

Principal Investigator: Sandro Mattioli, Prof., University of Bologna

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Sandro Mattioli, Associate Professor, University of Bologna

ClinicalTrials.gov Identifier:

NCT01635595

Other Study ID Numbers:

Cardia AdCa UNIBO

First Posted:

Jul 9, 2012

Last Update Posted:

Jul 25, 2012

Last Verified:

Jul 1, 2012

Additional relevant MeSH terms:

Adenocarcinoma

Esophageal Neoplasms

Study Results

No Results Posted as of Jul 25, 2012