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Clinical Trials/NCT02287168
NCT02287168
Completed
Early Phase 1

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

Bezmialem Vakif University2 sites in 1 country34 target enrollmentOctober 2014

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Gastric Adenocarcinoma
Sponsor
Bezmialem Vakif University
Enrollment
34
Locations
2
Primary Endpoint
elimination
Status
Completed
Last Updated
10 years ago

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
December 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mustafa Hasbahceci

MD, general surgeon

Bezmialem Vakif University

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

Outcomes

Primary Outcomes

elimination

Time Frame: at the operation

rate of conversion of positive cytology results to negative cytology by peritoneal lavage during the surgery

Secondary Outcomes

  • dissemination(at the operation)

Study Sites (2)

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