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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02287168
Enrollment
34
Registered
2014-11-10
Start date
2014-10-31
Completion date
2015-12-31
Last updated
2016-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Adenocarcinoma, Gastric Cancer

Keywords

Peritoneal lavage, Dissemination, Gastrectomy, Cytology, Lavage

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.

Interventions

PROCEDUREpre-gastrectomy peritoneal washing cytology

sampling of peritoneal washing fluid before gastrectomy

PROCEDUREpost-gastrectomy peritoneal washing cytology

sampling of peritoneal washing fluid after gastrectomy

PROCEDUREpost-lavage peritoneal washing cytology

sampling of peritoneal washing fluid after peritoneal lavage

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
eliminationat the operationrate of conversion of positive cytology results to negative cytology by peritoneal lavage during the surgery

Secondary

MeasureTime frameDescription
disseminationat the operationrate of conversion of negative cytology results to positive cytology by surgery

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026