Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-01-04 @ 7:25 PM
Study NCT ID:
NCT02980861
Status:
UNKNOWN
Last Update Posted:
2016-12-06
First Post:
2016-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Versus Open 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-05', 'studyFirstSubmitDate': '2016-11-30', 'studyFirstSubmitQcDate': '2016-11-30', 'lastUpdatePostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of group Splenic Hilum (No.10) lymph nodes harvested', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'Early complication rate', 'timeFrame': '30 days', 'description': 'The early complication rate is defined as the event observed during operation'}, {'measure': 'Operative time', 'timeFrame': 'Intraoperative'}, {'measure': 'Operative blood loss', 'timeFrame': 'Intraoperative'}, {'measure': 'Time of splenic hilum lymph nodes dissection', 'timeFrame': 'Intraoperative'}, {'measure': 'Number of total lymph nodes harvested', 'timeFrame': '7 days'}, {'measure': 'Post-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': '3-year overall survival rate', 'timeFrame': '3 years'}, {'measure': 'Quality of life', 'timeFrame': '1 year', 'description': 'It will be assessed by questionnaire (WHO quality of life-100)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gastric Cancer', 'Splenic Hilum Lymph Nodes Dissection', 'Gastrectomy'], 'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '26940944', 'type': 'BACKGROUND', 'citation': 'Bian S, Xi H, Wu X, Cui J, Ma L, Chen R, Wei B, Chen L. The Role of No. 10 Lymphadenectomy for Advanced Proximal Gastric Cancer Patients Without Metastasis to No. 4sa and No. 4sb Lymph Nodes. J Gastrointest Surg. 2016 Jul;20(7):1295-304. doi: 10.1007/s11605-016-3113-3. Epub 2016 Mar 3.'}, {'pmid': '30380145', 'type': 'DERIVED', 'citation': 'Guo X, Peng Z, Lv X, Cui J, Zhang K, Li J, Jin N, Xi H, Wei B, Chen L. Randomized controlled trial comparing short-term outcomes of laparoscopic and open spleen-preserving splenic hilar lymphadenectomy for advanced proximal gastric cancer: An interim report. J Surg Oncol. 2018 Dec;118(8):1264-1270. doi: 10.1002/jso.25262. Epub 2018 Oct 31.'}]}, 'descriptionModule': {'briefSummary': 'Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The application of minimally invasive surgery for advanced gastric cancer is gaining popularity. The investigators aim to compare the safety and feasibility of LTG and OTG for advanced proximal gastric cancer.', 'detailedDescription': 'Total gastrectomy with D2 lymphadenectomy remains the standard surgical therapy for patients with advanced proximal gastric cancer. Although lymph nodes dissection along with the splenic hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines, however, complete removal of the No. 10 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 total gastrectomy (LTG) 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. Therefore,the investigators aim to investigate the safety and feasibility of LTG with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compare 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\n1. Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy;\n2. cT2-4aN0-3M0 at preoperative evaluation according to American Joint Committee On Cancer (AJCC) Cancer Staging Manual, 7th Edition.\n3. Eastern Cooperative Oncology Group (ECOG): 0 or 1;\n4. American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ;\n5. Written informed consent.\n\nExclusion Criteria:\n\n1. Pregnant or breast-feeding women;\n2. Severe mental disorder;\n3. Previous upper abdominal surgery (except laparoscopic cholecystectomy);\n4. Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection;\n5. Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging;\n6. Other malignant disease within the past 5 years;\n7. Previous neoadjuvant chemotherapy or radiotherapy;\n8. Contraindication to general anesthesia (severe cardiac and/or pulmonary disease);\n9. Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer.'}, 'identificationModule': {'nctId': 'NCT02980861', 'briefTitle': 'Laparoscopic Versus Open Gastrectomy With Splenic Hilum Lymph Nodes Dissection', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Laparoscopic Versus Open Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Z161100000516237'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laparoscopic total gastrectomy', 'description': 'Participants including in the laparoscopic total gastrectomy (LTG) group will undergo LTG with spleen-preserving splenic hilum lymph nodes dissection.', 'interventionNames': ['Procedure: Laparoscopic total gastrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open total gastrectomy', 'description': 'Participants 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 total gastrectomy', 'type': 'PROCEDURE', 'otherNames': ['LTG'], 'description': 'When the participants with advanced proximal gastric cancer are randomized in the laparoscopic totalgastrectomy (LATG) group, they will received LTG with spleen-preserving splenic hilum lymph nodes dissection.', 'armGroupLabels': ['Laparoscopic total gastrectomy']}, {'name': 'Open total gastrectomy', 'type': 'PROCEDURE', 'otherNames': ['OTG'], 'description': 'When the participants 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': '100853', 'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Lin Chen, Master', 'role': 'CONTACT', 'email': 'chenlinbj@sina.com', 'phone': '86-13801290395'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Hongqing Xi, Master', 'role': 'CONTACT', 'phone': '010-66938128'}], 'overallOfficials': [{'name': 'Lin Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'the Chinese PLA General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Lin Chen', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}