Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-04-21 @ 8:59 AM
Study NCT ID:
NCT02287168
Status:
COMPLETED
Last Update Posted:
2016-03-29
First Post:
2014-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Peritoneal Lavage on Surgery-induced Positive Peritoneal Cytology in Gastric Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-26', 'studyFirstSubmitDate': '2014-10-31', 'studyFirstSubmitQcDate': '2014-11-06', 'lastUpdatePostDateStruct': {'date': '2016-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'elimination', 'timeFrame': 'at the operation', 'description': 'rate of conversion of positive cytology results to negative cytology by peritoneal lavage during the surgery'}], 'secondaryOutcomes': [{'measure': 'dissemination', 'timeFrame': 'at the operation', 'description': 'rate of conversion of negative cytology results to positive cytology by surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peritoneal lavage', 'Dissemination', 'Gastrectomy', 'Cytology', 'Lavage'], 'conditions': ['Gastric Adenocarcinoma', 'Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '23259786', 'type': 'BACKGROUND', '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.'}, {'pmid': '21682671', 'type': 'BACKGROUND', '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.'}, {'pmid': '16211228', 'type': 'BACKGROUND', '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.'}, {'pmid': '24287077', 'type': 'BACKGROUND', '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.'}, {'pmid': '19638909', 'type': 'BACKGROUND', '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.'}, {'pmid': '12576435', 'type': 'BACKGROUND', '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.'}, {'pmid': '12378344', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAlthough 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Endoscopically proven gastric adenocarcinoma\n* Standard gastrectomy and a D2 lymph node dissection;\n* Desire to attend the study protocol\n\nExclusion Criteria:\n\n* Metastatic or overt peritoneal disseminated cancer\n* Undesired reaction to attend the study protocol'}, 'identificationModule': {'nctId': 'NCT02287168', 'briefTitle': 'Effect of Peritoneal Lavage on Surgery-induced Positive Peritoneal Cytology in Gastric Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Effect of Peritoneal Lavage on Surgery-induced Positive Peritoneal Cytology in Gastric Cancer Patients', 'orgStudyIdInfo': {'id': 'GastCancPerLav2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dissemination of cancer cells', 'description': 'conversion of negative result of pre-gastrectomy peritoneal washing cytology to positive cytology after gastrectomy', 'interventionNames': ['Procedure: pre-gastrectomy peritoneal washing cytology', 'Procedure: post-gastrectomy peritoneal washing cytology']}, {'type': 'EXPERIMENTAL', 'label': 'elimination of cancer cells', '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)", 'interventionNames': ['Procedure: pre-gastrectomy peritoneal washing cytology', 'Procedure: post-gastrectomy peritoneal washing cytology', 'Procedure: post-lavage peritoneal washing cytology']}], 'interventions': [{'name': 'pre-gastrectomy peritoneal washing cytology', 'type': 'PROCEDURE', 'description': 'sampling of peritoneal washing fluid before gastrectomy', 'armGroupLabels': ['dissemination of cancer cells', 'elimination of cancer cells']}, {'name': 'post-gastrectomy peritoneal washing cytology', 'type': 'PROCEDURE', 'description': 'sampling of peritoneal washing fluid after gastrectomy', 'armGroupLabels': ['dissemination of cancer cells', 'elimination of cancer cells']}, {'name': 'post-lavage peritoneal washing cytology', 'type': 'PROCEDURE', 'description': 'sampling of peritoneal washing fluid after peritoneal lavage', 'armGroupLabels': ['elimination of cancer cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bezmialem Vakif University Faculty of Medicine Dept of General Surgery', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34093', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Mustafa Hasbahceci', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, general surgeon', 'investigatorFullName': 'Mustafa Hasbahceci', 'investigatorAffiliation': 'Bezmialem Vakif University'}}}}