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

Early Phase 1

Completed

• Conditions: Gastric Cancer; Gastric Adenocarcinoma
• Interventions: Procedure: pre-gastrectomy peritoneal washing cytology; Procedure: post-gastrectomy peritoneal washing cytology; Procedure: post-lavage peritoneal washing cytology

• Registration Number: NCT02287168
• Lead Sponsor: Bezmialem Vakif University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-31
• Study First Submitted QC: 2014-11-06
• Study First Posted: 2014-11-10
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-26
• Last Update Posted: 2016-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Endoscopically proven gastric adenocarcinoma
• Standard gastrectomy and a D2 lymph node dissection;
• Desire to attend the study protocol

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Exclusion Criteria

• Metastatic or overt peritoneal disseminated cancer
• Undesired reaction to attend the study protocol

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
elimination of cancer cells	pre-gastrectomy peritoneal washing cytology	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)
elimination of cancer cells	post-gastrectomy peritoneal washing cytology	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)
dissemination of cancer cells	pre-gastrectomy peritoneal washing cytology	conversion of negative result of pre-gastrectomy peritoneal washing cytology to positive cytology after gastrectomy
dissemination of cancer cells	post-gastrectomy peritoneal washing cytology	conversion of negative result of pre-gastrectomy peritoneal washing cytology to positive cytology after gastrectomy
elimination of cancer cells	post-lavage peritoneal washing cytology	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)

Primary Outcome Measures

Name	Time	Method
elimination	at the operation	rate of conversion of positive cytology results to negative cytology by peritoneal lavage during the surgery

Secondary Outcome Measures

Name	Time	Method
dissemination	at the operation	rate of conversion of negative cytology results to positive cytology by surgery

Trial Locations

Locations (2)

Bezmialem Vakif University Faculty of Medicine Dept of General Surgery; 🇹🇷 Istanbul, Turkey

Mustafa Hasbahceci; 🇹🇷 Istanbul, Turkey