Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-06 @ 7:38 AM
Study NCT ID:
NCT02711033
Status:
UNKNOWN
Last Update Posted:
2017-04-10
First Post:
2016-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic-assisted Total Gastrectomy Versus Open Total Gastrectomy With Splenic Hilum Lymph Nodes Dissection
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-07', 'studyFirstSubmitDate': '2016-03-09', 'studyFirstSubmitQcDate': '2016-03-12', 'lastUpdatePostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early complication rate', 'timeFrame': '30 days', 'description': 'The early complication rate is defined as the event observed during operation and within 30 days after surgery.'}], 'secondaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'Intraoperative'}, {'measure': 'Time of splenic hilum lymph nodes dissection', 'timeFrame': 'Intraoperative'}, {'measure': 'Operative blood loss', 'timeFrame': 'Intraoperative', 'description': 'It will be assessed with the unit of "ml".'}, {'measure': 'Incision length', 'timeFrame': '7 days'}, {'measure': 'Number of total lymph nodes harvested', 'timeFrame': '7 days'}, {'measure': 'Number of group No.10 lymph nodes harvested', 'timeFrame': '7 days'}, {'measure': 'Number of lymph nodes posterior to splenic vessel', 'timeFrame': '7 days'}, {'measure': 'Poster-operative recovery course', 'timeFrame': '30 days', 'description': 'Time to first ambulation, flatus, liquid diet and duration of hospital stay are used to assess the postoperative recovery course.'}, {'measure': '3-year disease free survival rate', 'timeFrame': '3 years'}, {'measure': '5-year overall survival rate', 'timeFrame': '5 years'}, {'measure': 'Metastasis rate of lymph nodes posterior to splenic vessel', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastric Cancer', 'Splenic Hilum Lymph Nodes Dissection', 'Total Gastrectomy']}, 'descriptionModule': {'briefSummary': 'This study investigates the safety and feasibility of laparoscopic-assisted total gastrectomy with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compares the early results of this procedure with open total gastrectomy.', 'detailedDescription': 'For advanced proximal gastric cancer, total gastrectomy with D2 lymphadenectomy is the standard surgical therapy. Apparently, lymph nodes (LNs) dissection along the splenic artery (No.11) and the splenic hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines. Nevertheless, complete removal of the No. 10 and No. 11d LNs is technically challenging due to the tortuous splenic vessels and the high possibility of injury to the parenchyma of the spleen and pancreas. Recently, the application of minimally invasive surgery for advanced gastric cancer is gaining popularity. However, laparoscopic-assisted total gastrectomy (LATG) with standard D2 lymphadenectomy was still not widely performed, because pancreas- and spleen-preserving splenic hilum lymph node dissection were mainly challenging manipulations for laparoscopic surgeons. Herein, we aim to investigate the safety and feasibility of LATG with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compares the early results of this procedure with open total gastrectomy (OTG).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with advanced proximal gastric cancer （T2-T4a,N0-N3,M0）\n* Informed consent\n* Eastern Cooperative Oncology Group (ECOG): 0 ot 1\n* American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ\n\nExclusion Criteria:\n\n* Pregnancy or female in suckling period\n* Contraindication to general anesthesia (severe cardiac and/or pulmonary disease)\n* Severe mental disease\n* Emergency operation due to complication (bleeding, perforation or obstruction) caused by primary tumor\n* Body mass index (BMI) \\> 30 kg/m2'}, 'identificationModule': {'nctId': 'NCT02711033', 'briefTitle': 'Laparoscopic-assisted Total Gastrectomy Versus Open Total Gastrectomy With Splenic Hilum Lymph Nodes Dissection', 'organization': {'class': 'OTHER', 'fullName': 'Guangdong Provincial Hospital of Traditional Chinese Medicine'}, 'officialTitle': 'Laparoscopic-assisted Total Gastrectomy Versus Open Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'GDPHCM-GI-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laparoscopic-assisted total gastrectomy', 'description': 'Patients including in the laparoscopic-assisted total gastrectomy (LATG) group will undergo LATG with spleen-preserving splenic hilum lymph nodes dissection.', 'interventionNames': ['Procedure: Laparoscopic-assisted total gastrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open total gastrectomy', 'description': 'Patients who are included in the open total gastrectomy (OTG) group will OTG with spleen-preserving splenic hilum lymph nodes dissection.', 'interventionNames': ['Procedure: Open total gastrectomy']}], 'interventions': [{'name': 'Laparoscopic-assisted total gastrectomy', 'type': 'PROCEDURE', 'otherNames': ['LATG'], 'description': 'When patients with advanced proximal gastric cancer are randomized in the laparoscopic-assisted total gastrectomy (LATG) group, they will received LATG with spleen-preserving splenic hilum lymph nodes dissection.', 'armGroupLabels': ['Laparoscopic-assisted total gastrectomy']}, {'name': 'Open total gastrectomy', 'type': 'PROCEDURE', 'otherNames': ['OTG'], 'description': 'When patients with advanced proximal gastric cancer are randomized in the open total gastrectomy (OTG) group, they will received OTG with spleen-preserving splenic hilum lymph nodes dissection.', 'armGroupLabels': ['Open total gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Wang, M.D.,PH.D.', 'role': 'CONTACT', 'email': 'wangwei16400@163.com', 'phone': '+86-13922255515'}, {'name': 'Wenjun Xiong, M.D.', 'role': 'CONTACT', 'email': 'xiongwj1988@163.com', 'phone': '+86-15920553177'}, {'name': 'Wei Wang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jin Wan', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Wenjun Xiong', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Wei Wang, M.D., PH.D.', 'role': 'CONTACT', 'email': 'wangwei16400@163.com', 'phone': '+86-13922255515'}], 'overallOfficials': [{'name': 'Wei Wang, M.D., PH.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangdong Provincial Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., PhD.', 'investigatorFullName': 'Wei Wang', 'investigatorAffiliation': 'Guangdong Provincial Hospital of Traditional Chinese Medicine'}}}}