Serum and Peritoneal CEA and CA 19-9 for Gastric Adenocarcinoma

Study Overview
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Brief Summary
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For preoperative staging and prediction of peritoneal dissemination of gastric adenocarcinoma, usage of serum and peritoneal levels of carcinoembryonic antigen (CEA) and CA 19-9 may be helpful. Additionally, the prognosis of the patients with gastric adenocarcinoma treated with gastrectrectomy may be associated with serum and peritoneal levels of tumor markers.

Detailed Description
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Clinical usage of tumor markers on preoperative staging and prediction of peritoneal dissemination of gastric adenocarcinoma is a controversial issue. It has been thought that there is a positive correlation between serum and peritoneal levels of carcinoembryonic antigen (CEA) and CA 19-9 and pathologic features of gastric tumors and peritoneal dissemination. In this study, it was aimed to evaluate the effect of serum and peritoneal CEA and CA 19-9 to predict TNM stages and peritoneal washing cytology in patients with gastric adenocarcinoma after curative gastrectomy, and to determine predictive value of these measurements to the development of recurrence and death.

Official Title
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Predictive Value of Serum and Peritoneal CEA and CA 19-9 for TNM Stage and Peritoneal Dissemination of Gastric Adenocarcinoma

Conditions
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Gastric Adenocarcinoma

Intervention / Treatment
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* Procedure: gastrectomy
* Procedure: sampling of peritoneal washing aspirate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Endoscopically proven gastric adenocarcinoma Standard gastrectomy and a D2 lymph node dissection; Desire to attend the study protocol Exclusion Criteria: Metastatic or overt peritoneal disseminated cancer Undesired reaction to attend the study protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| tumor marker<br>serum CEA and CA 19-9 levels in patients with curative gastrectomy preoperatively and peritoneal CEA and CA 19-9 levels in patients taken at the beginning of curative gastrectomy via sampling of peritoneal washing aspirate | Procedure: gastrectomy<br>* radical total/subtotal gastrectomy with D2 lymph node dissection<br>Procedure: sampling of peritoneal washing aspirate<br>* After thoroughly examination of the peritoneal cavity revealing the absence of peritoneal dissemination, the peritoneal cavity was washed with 200 ml of saline, and at least one third was aspirated from several regions of the peritoneal cavity, including near the primary tumor, the left and right subphrenic areas and the pouch of Douglas with suction tubes to a clean bottle and designated as the peritoneal sample for determination of peritoneal levels of CEA and CA 19-9.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNM stage | TNM stage based on the 7th American Joint Committee on Cancer/International Union Against Cancer tumor, node, metastasis system. | through pathologic report completion, an average of 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peritoneal washing cytology | detection of positive free peritoneal gastric adenocarcinoma cells. | through pathologic report completion, an average of 1 month | 
| recurrence/death | detection of recurrence or development of death | through follow-up period, an average of 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric adenocarcinoma, tumor markers, peritoneal cytology