Effect of Peritoneal Lavage on Surgery-induced Positive Peritoneal Cytology in Gastric Cancer Patients
1 other identifier
interventional
34
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Oct 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 31, 2014
CompletedFirst Posted
Study publicly available on registry
November 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 29, 2016
March 1, 2016
1.2 years
October 31, 2014
March 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
elimination
rate of conversion of positive cytology results to negative cytology by peritoneal lavage during the surgery
at the operation
Secondary Outcomes (1)
dissemination
at the operation
Study Arms (2)
dissemination of cancer cells
EXPERIMENTALconversion of negative result of pre-gastrectomy peritoneal washing cytology to positive cytology after gastrectomy
elimination of cancer cells
EXPERIMENTALelimination 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)
Interventions
sampling of peritoneal washing fluid before gastrectomy
sampling of peritoneal washing fluid after gastrectomy
sampling of peritoneal washing fluid after peritoneal lavage
Eligibility Criteria
You may qualify if:
- Endoscopically proven gastric adenocarcinoma
- Standard gastrectomy and a D2 lymph node dissection;
- Desire to attend the study protocol
You may not qualify if:
- Metastatic or overt peritoneal disseminated cancer
- Undesired reaction to attend the study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Bezmialem Vakif University Faculty of Medicine Dept of General Surgery
Istanbul, 34093, Turkey (Türkiye)
Mustafa Hasbahceci
Istanbul, 34093, Turkey (Türkiye)
Related Publications (7)
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.
PMID: 23259786BACKGROUNDShimada 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.
PMID: 21682671BACKGROUNDYamamoto 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.
PMID: 16211228BACKGROUNDMisawa 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.
PMID: 24287077BACKGROUNDKuramoto 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.
PMID: 19638909BACKGROUNDMarutsuka 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.
PMID: 12576435BACKGROUNDShimada 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.
PMID: 12378344BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, general surgeon
Study Record Dates
First Submitted
October 31, 2014
First Posted
November 10, 2014
Study Start
October 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
March 29, 2016
Record last verified: 2016-03