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

Bezmialem Vakif University

Status and phase: Completed; Early Phase 1

Conditions: Gastric Cancer; Gastric Adenocarcinoma

Treatments: Procedure: post-lavage peritoneal washing cytology; Procedure: pre-gastrectomy peritoneal washing cytology; Procedure: post-gastrectomy peritoneal washing cytology

Study type: Interventional

Funder types: Other

Identifiers

NCT02287168

GastCancPerLav2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

dissemination of cancer cells

Experimental group

Description:

conversion of negative result of pre-gastrectomy peritoneal washing cytology to positive cytology after gastrectomy

Treatment:

Procedure: pre-gastrectomy peritoneal washing cytology

Procedure: post-gastrectomy peritoneal washing cytology

elimination of cancer cells

Experimental group

Description:

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)

Treatment:

Procedure: pre-gastrectomy peritoneal washing cytology

Procedure: post-lavage peritoneal washing cytology

Procedure: post-gastrectomy peritoneal washing cytology