Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-30 @ 9:53 AM
Study NCT ID:
NCT01043835
Status:
UNKNOWN
Last Update Posted:
2012-06-05
First Post:
2010-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Laparoscopic Versus Open Gastrectomy for Advanced Gastric Cancer:A Prospective Randomized Trial
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 328}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-04', 'studyFirstSubmitDate': '2010-01-06', 'studyFirstSubmitQcDate': '2010-01-06', 'lastUpdatePostDateStruct': {'date': '2012-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Complications, recurrence, quality of life measured by EORTC QLQ-C30 V 3.0 and EORTC QLQ-STO22', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stomach Neoplasm', 'Laparoscopy', 'gastrectomy'], 'conditions': ['Stomach Neoplasm', 'Laparoscopy', 'Gastrectomy', 'Complications']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the short- and long-term results between the laparoscopy-assisted gastrectomy and the open gastrectomy.', 'detailedDescription': 'Background: The use of laparoscopic surgery in the management of advanced gastric cancer (AGC) has not yet met with widespread acceptance and remains limited to only a few centers.\n\nIntervention: According to tumor pathological stage (JGCA, 2nd English ed), location of tumor, and patient clinical condition, a laparoscopy-assisted radical gastrectomy and open gastrectomy were performed. Laparoscopy-assisted radical gastrectomy consisted of the following procedures: 1) laparoscopic dissection of the lesser and greater omentum, ligation and division of the main vessels to mobilize the stomach under pneumoperitoneum, 2) laparoscopic D2 lymph node dissection, based on the Guidelines of the Japan Gastric Cancer Association and 3) resection of the distal two thirds (LADG), proximal third (LAPG), or total stomach (LATG), depending on the location of the tumor, followed by reconstruction by the Billroth I, Billroth Ⅱ, esophagogastrostomy, or Roux-en-Y method through a 3 to 5-cm-long minilaparotomy incision.\n\nFollow-up schedule: All patients were monitored postoperatively by physical examination, and blood tests including a test for serum carcinoembryonic antigen (CEA) at least every three months for the first year, every six months for the next two years, and every year for the fourth and fifth year, and thereafter by abdominal ultrasonography, CT, chest radiography, and gastroscopy at least once each year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pathologically proven gastric adenocarcinoma\n2. Age:older than 18 years old,younger than 80 years old\n3. Preoperative stage(CT, GFS stage):cT2N0M0, cT2N1M0, cT2N2M0, cT3N0M0, cT3N1M0,cT3N2M0\n4. ASA score:≤3\n5. Patients with an invasion of the gastric serosa exceeding 10 cm2 according to ultrasound examination or examination during surgery were excluded\n6. No history of other cancer\n7. No history of chemotherapy or radiotherapy\n8. Written informed consent\n\nExclusion Criteria:\n\n1. Concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient\n2. Patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy\n3. Patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy)\n4. ASA score:\\>3\n5. Contraindication of laparoscopy: severe cardiac disease, abdominal wall hernias, diaphragmatic hernias, uncorrected coagulopathies, portal hypertension, pregnancy\n6. Complicated case needed to get emergency operation\n7. Any accompanying surgical condition needed to be performed in same time'}, 'identificationModule': {'nctId': 'NCT01043835', 'briefTitle': 'Comparison of Laparoscopic Versus Open Gastrectomy for Advanced Gastric Cancer:A Prospective Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'Southwest Hospital, China'}, 'officialTitle': 'Prospective Randomized Trial of Laparoscopic Versus Open Gastrectomy for Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': '197691197392'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laparoscopy-assisted gastrectomy', 'interventionNames': ['Procedure: Laparoscopy-assisted gastrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open gastrectomy', 'interventionNames': ['Procedure: Open gastrectomy']}], 'interventions': [{'name': 'Laparoscopy-assisted gastrectomy', 'type': 'PROCEDURE', 'description': 'A 10-mm trocar for laparoscope was inserted below the umbilicus. Another 10-mm trocar was introduced in the left preaxillary line 2 cm below the costal margin as a major hand port，and a 5-mm trocar was placed at the contralateral site for traction. A 5-mm trocar was inserted in the left midclavicular line 2 cm above the umbilicus as an accessory port, and a 15-mm trocar also as an accessory port was placed at the contralateral site. The operator stood on the left side of the patient. Subtotal or total gastrectomy and D2 lymph node dissection will be performed basically. As a general rule, Billroth I, Billroth II or Roux-Y method was used for gastric reconstruction. Dissected stomach and lymph node are collected through additional 5 cm incision at a median superior abdominal incision.', 'armGroupLabels': ['Laparoscopy-assisted gastrectomy']}, {'name': 'Open gastrectomy', 'type': 'PROCEDURE', 'description': 'Approximately 15\\~20 cm length incision is made from falciform process to periumbilical area. Subtotal or total gastrectomy and D2 lymph node dissection will be performed basically. As a general rule, Billroth I, Billroth II or Roux-Y method was used for gastric reconstruction for all cases.', 'armGroupLabels': ['Open gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400038', 'city': 'Chongqing', 'state': 'Chong Qing', 'country': 'China', 'facility': 'Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery, Southwest Hospital', 'geoPoint': {'lat': 45.88029, 'lon': 127.13373}}, {'zip': '400038', 'city': 'Chongqing', 'state': 'Chong Qing', 'country': 'China', 'facility': 'Southwest Hospital, China', 'geoPoint': {'lat': 45.88029, 'lon': 127.13373}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yan Shi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery', 'investigatorFullName': 'Yan Shi', 'investigatorAffiliation': 'Southwest Hospital, China'}}}}