Effect of Peritoneal Lavage on Surgery-induced Positive Peritoneal Cytology in Gastric Cancer Patients
NCT ID: NCT02287168
Last Updated: 2016-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
34 participants
INTERVENTIONAL
2014-10-31
2015-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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dissemination of cancer cells
conversion of negative result of pre-gastrectomy peritoneal washing cytology to positive cytology after gastrectomy
pre-gastrectomy peritoneal washing cytology
sampling of peritoneal washing fluid before gastrectomy
post-gastrectomy peritoneal washing cytology
sampling of peritoneal washing fluid after gastrectomy
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)
pre-gastrectomy peritoneal washing cytology
sampling of peritoneal washing fluid before gastrectomy
post-gastrectomy peritoneal washing cytology
sampling of peritoneal washing fluid after gastrectomy
post-lavage peritoneal washing cytology
sampling of peritoneal washing fluid after peritoneal lavage
Interventions
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pre-gastrectomy peritoneal washing cytology
sampling of peritoneal washing fluid before gastrectomy
post-gastrectomy peritoneal washing cytology
sampling of peritoneal washing fluid after gastrectomy
post-lavage peritoneal washing cytology
sampling of peritoneal washing fluid after peritoneal lavage
Eligibility Criteria
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Inclusion Criteria
* Standard gastrectomy and a D2 lymph node dissection;
* Desire to attend the study protocol
Exclusion Criteria
* Undesired reaction to attend the study protocol
18 Years
80 Years
ALL
No
Sponsors
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Bezmialem Vakif University
OTHER
Responsible Party
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Mustafa Hasbahceci
MD, general surgeon
Locations
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Bezmialem Vakif University Faculty of Medicine Dept of General Surgery
Istanbul, , Turkey (Türkiye)
Mustafa Hasbahceci
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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GastCancPerLav2014
Identifier Type: -
Identifier Source: org_study_id
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