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

March 26, 2016 updated by: Mustafa Hasbahceci, Bezmialem Vakif University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34093
        • bezmialem vakif university faculty of medicine dept of general surgery
      • Istanbul, Turkey, 34093
        • Mustafa Hasbahceci

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dissemination of cancer cells
conversion of negative result of pre-gastrectomy peritoneal washing cytology to positive cytology after gastrectomy
Procedure: pre-gastrectomy peritoneal washing cytology
sampling of peritoneal washing fluid before gastrectomy
Procedure: post-gastrectomy peritoneal washing cytology
sampling of peritoneal washing fluid after gastrectomy
Experimental: elimination of cancer cells
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
sampling of peritoneal washing fluid before gastrectomy
Procedure: post-gastrectomy peritoneal washing cytology
sampling of peritoneal washing fluid after gastrectomy
Procedure: post-lavage peritoneal washing cytology
sampling of peritoneal washing fluid after peritoneal lavage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
elimination
Time Frame: at the operation
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
Time Frame: at the operation
rate of conversion of negative cytology results to positive cytology by surgery
at the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 31, 2014

First Submitted That Met QC Criteria

November 6, 2014

First Posted (Estimate)

November 10, 2014

Study Record Updates

Last Update Posted (Estimate)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 26, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GastCancPerLav2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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