Effect of Peritoneal Lavage on Surgery-induced Positive Peritoneal Cytology in Gastric Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Surgical manipulation and handling of a tumor may cause dissemination of cancer cells through peritoneal cavity after curative gastrectomy. Intra operative peritoneal lavage may have preventive effect on positive peritoneal cytology occurred during gastrectomy in patients with gastric cancer.

Detailed Description
-----------------
Peritoneal dissemination of gastric adenocarcinoma cells is the most frequent cause of death in patients with gastric cancer. Spreading of these cells occur by three routes: direct seeding via infiltration through gastric wall, via blood vessels and via perigastric lymphatic channels disturbed during lymph node dissection. Conversion of negative preoperative peritoneal cytology to positive cytology after curative gastrectomy has been shown by previous studies. Although extensive intra-operative peritoneal lavage (1 L of physiologic saline 10 times) has been shown to be an effective method to eliminate cancer cell dissemination during surgery, to cause significant improvement in survival after gastrectomy, widespread use of this approach has not existed most probably due to its time consuming technical difficulty. Therefore,intra-operative peritoneal lavage (1 L of physiologic saline 3 times) may be used more frequently during gastric surgery.If it is possible to show effectivity of intra-operative peritoneal lavage using a total of 3 L physiologic saline to eliminate cancer cell dissemination occurred before or after gastric surgery, use of this approach may gain acceptance to decrease risk of peritoneal metastasis.

Official Title
-----------------
Effect of Peritoneal Lavage on Surgery-induced Positive Peritoneal Cytology in Gastric Cancer Patients

Conditions
-----------------
Gastric Adenocarcinoma, Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: pre-gastrectomy peritoneal washing cytology
* Procedure: post-gastrectomy peritoneal washing cytology
* Procedure: post-lavage peritoneal washing cytology


Participation Criteria
=================
Eligibility Criteria
-----------------
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
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dissemination of cancer cells<br>conversion of negative result of pre-gastrectomy peritoneal washing cytology to positive cytology after gastrectomy | Procedure: pre-gastrectomy peritoneal washing cytology<br>* sampling of peritoneal washing fluid before gastrectomy<br>Procedure: post-gastrectomy peritoneal washing cytology<br>* sampling of peritoneal washing fluid after gastrectomy<br>|
| Experimental: elimination of cancer cells<br>elimination of peritoneal cancer cells occurred before (pre-gastrectomy peritoneal washing cytology) or after gastrectomy (post-gastrectomy peritoneal washing cytology) by intra operative peritoneal lavage ('post-lavage peritoneal washing cytology) | Procedure: pre-gastrectomy peritoneal washing cytology<br>* sampling of peritoneal washing fluid before gastrectomy<br>Procedure: post-gastrectomy peritoneal washing cytology<br>* sampling of peritoneal washing fluid after gastrectomy<br>Procedure: post-lavage peritoneal washing cytology<br>* sampling of peritoneal washing fluid after peritoneal lavage<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| elimination | rate of conversion of positive cytology results to negative cytology by peritoneal lavage during the surgery | at the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dissemination | rate of conversion of negative cytology results to positive cytology by surgery | at the operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peritoneal lavage, Dissemination, Gastrectomy, Cytology, Lavage