Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT06202105
Status:
RECRUITING
Last Update Posted:
2025-01-01
First Post:
2023-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Laparoscopic and Open Total Gastrectomy for Locally Advanced Gastric Cancer
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2032-08-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-30', 'studyFirstSubmitDate': '2023-12-30', 'studyFirstSubmitQcDate': '2023-12-30', 'lastUpdatePostDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-08-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3 year overall survival by Kaplan Mayer', 'timeFrame': '3 year after surgery', 'description': 'The percentage of people in this study who are alive three years after surgery'}, {'measure': '3 year relapse-free survival by Kaplan Mayer', 'timeFrame': '3 year after surgery', 'description': 'The percentage of people in this study who are alive without recurrence three years after surgery.'}], 'secondaryOutcomes': [{'measure': 'operative morbidity', 'timeFrame': '30 days after surgery', 'description': 'The rate of postoperative bleeding and the rate of postoperative leakage'}, {'measure': 'operative mortality', 'timeFrame': '30 days after surgery', 'description': 'The rate of postoperative dead'}, {'measure': 'operative time', 'timeFrame': 'intraoperative', 'description': 'The duration of a surgical procedure in minutes.'}, {'measure': 'Resected lymph nodes', 'timeFrame': 'intraoperative', 'description': 'The number of lymph nodes harvested after surgery'}, {'measure': 'hospital stay', 'timeFrame': '30 days after surgery', 'description': 'The number of days between surgery and discharge'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'Evidence of implementation of laparoscopic total gastrectomy (LTG) for locally advanced gastric cancer (GC) remains inadequate. This study aimed to compare short- and mid-term outcomes of LTG versus open total gastrectomy (OTG) for cT2-4a GC.', 'detailedDescription': 'Gastric cancer (GC) is a significant public health issue worldwide. Surgical resection and lymphadenectomy is the first option for curative treatment of this disease. For tumors located in the middle and/or upper third of the stomach, open total gastrectomy (OTG) has long been the standard surgery.\n\nWhile the advantage of laparoscopic distal gastrectomy over open distal gastrectomy for not only early gastric cancer (EGC) but also locally advanced gastric cancer (AGC) had been proven, the use of laparoscopic total gastrectomy (LTG) for GC, particularly for AGC, has not been widely accepted due to technical challenges with lymphadenectomy at the distal pancreas and the splenic hilum as well as the complexity of the esophago-jejunal reconstruction. Recently, there has been advancement in laparoscopic techniques and improved surgical experience, a standard procedure of LTG has been established, leading to increase utilization of LTG, especially for EGC. Two large RCTs, KLASS-03 in Korea and CLASS-02 in China, provided good evidence for the advantages of LTG for EGC. However, for AGC, some prior studies have demonstrated the safety of LTG compared to OTG but lacked significant data for survival. Until now, there have been no completed RCTs to determine the short- and long-term outcomes of LTG for AGC.\n\nIn the research center, LTG has been accepted as a standard procedure for EGC since 2008 and for AGC since 2013. In Vietnam and other low-to-middle-income countries, most GC was diagnosed in an advanced stage. It is needed to have evidence of the feasibility, safety, and oncological results of LTG for locally advanced GC. Investigators performed this study to compare the technical feasibility, short- and long-term outcomes of LTG versus OTG for stage T2-4a GC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma\n* Age: 18 - 80 year old\n* Tumor required total gastrectomy for radical treatment\n* Preoperative cancer stage (CT scan stage): cT2-4aNanyM0\n* ASA score: ≤ 3\n* Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)\n\nExclusion Criteria:\n\n* Concurrent cancer or patient who was treated due to other cancer before the patient was diagnosed gastric cancer\n* Bulky lymph node andd/or Para-aortic lymph node metastasis\n* Combined esophagectomy due to invading to the esophagus\n* Pregnant patient'}, 'identificationModule': {'nctId': 'NCT06202105', 'acronym': 'LOTA', 'briefTitle': 'Comparison of Laparoscopic and Open Total Gastrectomy for Locally Advanced Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Ho Chi Minh City (UMC)'}, 'officialTitle': 'Comparison of Laparoscopic Versus Open Total Gastrectomy for Locally Advanced Gastric Cancer: a Prospective Randomized Control Trial', 'orgStudyIdInfo': {'id': 'LOTA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laparoscopic total gastrectomy', 'description': '5 trocars were used. The gastrocolic ligament was divided along the border of the transverse colon. ligating the left gastroepiploic vessels to remove group 4sb.\n\nThe right gastroepiploic vein was divided and right gastroepiploic and inferior pyloric artery were transected at their origin from the gastroduodenal artery to dissect group 6.\n\nThe dissection was continued along the hepatoduodenal ligament to removed group 5 and group 12a and along the common hepatic artery to remove group 8a and along the celiac axis to remove group 9.\n\nThe left gastric vein was divided and then the left gastric artery was vascularized to remove group 7.\n\nThe dissection was continued upward along the splenic artery and its branches to remove group 11p,d and/or along the splenic hilum to remove group 10.\n\nThe dissection was then conducted the right and left of the esophago-gastric junction to remove group 1,2.\n\nAs a general rule, Roux en Y method was used for esophagoo-jejunal reconstruction for all cases', 'interventionNames': ['Procedure: Laparoscopic gastrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open total gastrectomy', 'description': 'An incision of 15\\~20 cm length is made in the abdominal midline . Standard total gastrectomy and omentectomy will be performed with D2 lymph node dissection (around common hepatic artery, celiac artery, along splenic artery, proper hepatic artery, and/or the splenic hilum) . Roux-en Y esophagojejunal anastomosis is performed for reconstruction.', 'interventionNames': ['Procedure: Laparoscopic gastrectomy']}], 'interventions': [{'name': 'Laparoscopic gastrectomy', 'type': 'PROCEDURE', 'description': 'Gastrectomy with laparoscopic approach', 'armGroupLabels': ['Laparoscopic total gastrectomy', 'Open total gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '810000', 'city': 'Biên Hòa', 'state': 'Dong Nai', 'status': 'RECRUITING', 'country': 'Vietnam', 'contacts': [{'name': 'Nguyen Kim Kien', 'role': 'CONTACT', 'email': 'bsnguyenkimkien@gmail.com', 'phone': '0938770667'}], 'facility': 'Dong Nai General Hospital', 'geoPoint': {'lat': 10.94469, 'lon': 106.82432}}, {'zip': '100000', 'city': 'Hà Nội', 'status': 'NOT_YET_RECRUITING', 'country': 'Vietnam', 'contacts': [{'name': 'Pham Van Hiep, Ph.D', 'role': 'CONTACT', 'email': 'drphamvanhiep108@gmail.com'}], 'facility': '108 Military Central Hospital', 'geoPoint': {'lat': 20.47366, 'lon': 106.02292}}, {'zip': '700000', 'city': 'Ho Chi Minh City', 'status': 'RECRUITING', 'country': 'Vietnam', 'contacts': [{'name': 'Long D. Vo, MD.', 'role': 'CONTACT', 'email': 'long.vd@umc.edu.vn', 'phone': '+84918133915'}, {'name': 'L D.', 'role': 'CONTACT'}], 'facility': 'University Medical Center Ho Chi Minh City', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Ho Chi Minh City (UMC)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}