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Nodal Status in Adenocarcinoma of the Esophagus an Cardia

NCT ID: NCT01635595

Last Updated: 2012-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

194 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Adenocarcinoma of the Esophagus Adenocarcinoma of the Gastric Cardia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Subtotal esophagectomy and gastric pull up

Intervention Type 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

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.

Subtotal esophagectomy at the azygos vein, total gastrectomy

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Esophagectomy Esophagectomy Gastrectomy

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bologna

OTHER

Sponsor Role lead

Responsible Party

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Sandro Mattioli

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandro Mattioli, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Bologna

Locations

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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

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 11553218 (View on PubMed)

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.

Reference Type RESULT
PMID: 17462405 (View on PubMed)

Other Identifiers

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Cardia AdCa UNIBO

Identifier Type: -

Identifier Source: org_study_id