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

Primary Purpose

Gastric Adenocarcinoma, Gastric Cancer

Status
Completed
Phase
Early Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
pre-gastrectomy peritoneal washing cytology
post-gastrectomy peritoneal washing cytology
post-lavage peritoneal washing cytology
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma focused on measuring Peritoneal lavage, Dissemination, Gastrectomy, Cytology, Lavage

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bezmialem Vakif University Faculty of Medicine Dept of General Surgery
  • Mustafa Hasbahceci

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

dissemination of cancer cells

elimination of cancer cells

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

dissemination
rate of conversion of negative cytology results to positive cytology by surgery

Full Information

First Posted
October 31, 2014
Last Updated
March 26, 2016
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT02287168
Brief Title
Effect of Peritoneal Lavage on Surgery-induced Positive Peritoneal Cytology in Gastric Cancer Patients
Official Title
Effect of Peritoneal Lavage on Surgery-induced Positive Peritoneal Cytology in Gastric Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma, Gastric Cancer
Keywords
Peritoneal lavage, Dissemination, Gastrectomy, Cytology, Lavage

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dissemination of cancer cells
Arm Type
Experimental
Arm Description
conversion of negative result of pre-gastrectomy peritoneal washing cytology to positive cytology after gastrectomy
Arm Title
elimination of cancer cells
Arm Type
Experimental
Arm 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)
Intervention Type
Procedure
Intervention Name(s)
pre-gastrectomy peritoneal washing cytology
Intervention Description
sampling of peritoneal washing fluid before gastrectomy
Intervention Type
Procedure
Intervention Name(s)
post-gastrectomy peritoneal washing cytology
Intervention Description
sampling of peritoneal washing fluid after gastrectomy
Intervention Type
Procedure
Intervention Name(s)
post-lavage peritoneal washing cytology
Intervention Description
sampling of peritoneal washing fluid after peritoneal lavage
Primary Outcome Measure Information:
Title
elimination
Description
rate of conversion of positive cytology results to negative cytology by peritoneal lavage during the surgery
Time Frame
at the operation
Secondary Outcome Measure Information:
Title
dissemination
Description
rate of conversion of negative cytology results to positive cytology by surgery
Time Frame
at the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Bezmialem Vakif University Faculty of Medicine Dept of General Surgery
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Mustafa Hasbahceci
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
23259786
Citation
Yu XF, Ren ZG, Xue YW, Song HT, Wei YZ, Li CM. D2 lymphadenectomy can disseminate tumor cells into peritoneal cavity in patients with advanced gastric cancer. Neoplasma. 2013;60(2):174-81. doi: 10.4149/neo_2013_023.
Results Reference
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PubMed Identifier
21682671
Citation
Shimada S, Kuramoto M, Marutsuka T, Yagi Y, Baba H. Adopting extensive intra-operative peritoneal lavage (EIPL) as the standard prophylactic strategy for peritoneal recurrence. Rev Recent Clin Trials. 2011 Sep;6(3):266-70. doi: 10.2174/157488711796575603.
Results Reference
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PubMed Identifier
16211228
Citation
Yamamoto K, Shimada S, Hirota M, Yagi Y, Matsuda M, Baba H. EIPL (extensive intraoperative peritoneal lavage) therapy significantly reduces peritoneal recurrence after pancreatectomy in patients with pancreatic cancer. Int J Oncol. 2005 Nov;27(5):1321-8.
Results Reference
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PubMed Identifier
24287077
Citation
Misawa K, Mochizuki Y, Ohashi N, Matsui T, Nakayama H, Tsuboi K, Sakai M, Ito S, Morita S, Kodera Y. A randomized phase III trial exploring the prognostic value of extensive intraoperative peritoneal lavage in addition to standard treatment for resectable advanced gastric cancer: CCOG 1102 study. Jpn J Clin Oncol. 2014 Jan;44(1):101-3. doi: 10.1093/jjco/hyt157. Epub 2013 Nov 27.
Results Reference
background
PubMed Identifier
19638909
Citation
Kuramoto M, Shimada S, Ikeshima S, Matsuo A, Yagi Y, Matsuda M, Yonemura Y, Baba H. Extensive intraoperative peritoneal lavage as a standard prophylactic strategy for peritoneal recurrence in patients with gastric carcinoma. Ann Surg. 2009 Aug;250(2):242-6. doi: 10.1097/SLA.0b013e3181b0c80e.
Results Reference
background
PubMed Identifier
12576435
Citation
Marutsuka T, Shimada S, Shiomori K, Hayashi N, Yagi Y, Yamane T, Ogawa M. Mechanisms of peritoneal metastasis after operation for non-serosa-invasive gastric carcinoma: an ultrarapid detection system for intraperitoneal free cancer cells and a prophylactic strategy for peritoneal metastasis. Clin Cancer Res. 2003 Feb;9(2):678-85.
Results Reference
background
PubMed Identifier
12378344
Citation
Shimada S, Tanaka E, Marutsuka T, Honmyo U, Tokunaga H, Yagi Y, Aoki N, Ogawa M. Extensive intraoperative peritoneal lavage and chemotherapy for gastric cancer patients with peritoneal free cancer cells. Gastric Cancer. 2002;5(3):168-72. doi: 10.1007/s101200200029.
Results Reference
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Effect of Peritoneal Lavage on Surgery-induced Positive Peritoneal Cytology in Gastric Cancer Patients

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