Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-29 @ 10:01 PM
Study NCT ID:
NCT04384757
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-15
First Post:
2020-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Open and Laparoscopic Distal Gastrectomy for T4a 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005763', 'term': 'Gastroenterostomy'}], 'ancestors': [{'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2020-05-08', 'studyFirstSubmitQcDate': '2020-05-08', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-30', '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': 'hospital stay', 'timeFrame': '30 days after surgery', 'description': 'The number of days between surgery and discharge'}, {'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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastric cancer', 'laparoscopic gastrectomy', 'T4a stage'], 'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '41222957', 'type': 'DERIVED', 'citation': 'Dat TQ, Thong DQ, Nguyen DT, Hai NV, Phuoc TD, Anh NVT, Bac NH, Long VD. Laparoscopic vs Open Distal Gastrectomy With D2 Lymphadenectomy for Clinical T4a Gastric Cancer: The UMC-UPPERGI-01 Randomized Clinical Trial. JAMA Surg. 2025 Nov 12:e254929. doi: 10.1001/jamasurg.2025.4929. Online ahead of print.'}, {'pmid': '40316937', 'type': 'DERIVED', 'citation': 'Dat TQ, Thong DQ, Nguyen DT, Hai NV, Vuong NL, Bac NH, Long VD. Laparoscopic versus open distal gastrectomy with d2 lymphadenectomy in treatment of locally T4A gastric cancer: the protocol of a randomized controlled trial. BMC Surg. 2025 May 2;25(1):193. doi: 10.1186/s12893-025-02933-6.'}]}, 'descriptionModule': {'briefSummary': 'There are more than 75% of patients with gastric cancer who are diagnosed in advanced stage in Vietnam, most of cases in T4a. The purpose of this study is to compare the technical feasibility, early and long term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in T4A stage', 'detailedDescription': 'Gastric cancer poses a significant public health problem. It is one of the most common cancers in Vietnam . Despite recent advances in multimodality treatment and targeted therapy, surgery remains the first option of treament for this disease. For resectable gastric cancer, complete removal of macroscopic and microscopic lesions and/or combined resections and also regional or extended lymphadenectomy should represent in the world now. Since laparoscopic gastrectomy for early gastric cancer (EGC) was firstly reported in 1994 , this technique has become standard for treatment of EGC due to the many advantages of mininally invasive surgery and also in oncologic outcomes.\n\nLaparoscopic gastrectomy for advanced gastric cancer AGC was first applied by Uyama in 2000, and then, many surgeons have used it for treatment of AGC, especially in Japan, Korea and China. However, the real role of laparoscop for treament of (AGC) is still controversial in term of technical feasibility, safety and oncologic aspect.\n\nParagastric inflammatory strands may occur in T4a tumor so that laparoscopic technique is difficult to radically perform. Peritoneal seeding of malignant cells, intra- and postoperative complications, trocarts metastasis may risk during procedures. Despite, some studies have demonstrated the safety and the short-term benefits of LG for T4a gastric cancer, the number of these studies and sample sizes have been still inadequate to give good evidence for applying it. and long-term oncologic outcomes\n\nThere are more than 75% of patients with gastric cancer who are diagnosed in advanced stage in Vietnam, most of cases in T4a. The purpose of this study is to compare the technical feasibility, early and long term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in T4A stage.'}, '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 located at the middle or lower third of the stomach\n* Preoperative cancer stage (CT scan stage): cT4aN0M0, cT4aN1M0, cT4aN2M0, cT4aN3M0\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* Had another treatment methods, such as chemotherapy, immunotherapy, or radiotherapy\n* Pregnant patient\n* Combined resection\n* Total gastrectomy'}, 'identificationModule': {'nctId': 'NCT04384757', 'briefTitle': 'Comparison of Open and Laparoscopic Distal Gastrectomy for T4a Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Ho Chi Minh City (UMC)'}, 'officialTitle': 'Comparison of Laparoscopic Versus Open Distal Gastrectomy for T4a Gastric Cancer: a Prospective Randomized Control Trial', 'orgStudyIdInfo': {'id': 'UMC-UPPERGI-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Open distal gastrectomy', 'description': 'An incision of 15\\~20 cm length is made in the abdominal midline . Standard distal gastrectomy and omentectomy will be performed with D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, proper hepatic artery) . As a general rule, Billroth II method was used for gastric reconstruction for most cases', 'interventionNames': ['Procedure: Distal gastrectomy']}, {'type': 'EXPERIMENTAL', 'label': 'Laparoscopic distal gastrectomy', 'description': '5 trocar 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 the right gastroepiploic and the inferior pyloric artery were vascularized and cut at their origin from the gastroduodenal artery, just above the pancreatic head, 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 prepared and separately divided and then the left gastric artery was vascularized to remove group 7.\n\nThe dissection was continued upward along the proximal branches of splenic vessels to remove group 11p and along the lesser curvature to remove group 1,3.\n\nAs a general rule, Billroth II method was used for gastric reconstruction for most cases', 'interventionNames': ['Procedure: Distal gastrectomy']}], 'interventions': [{'name': 'Distal gastrectomy', 'type': 'PROCEDURE', 'description': 'Distal gastrectomy and standard D2 lymphadenectomy', 'armGroupLabels': ['Laparoscopic distal gastrectomy', 'Open distal gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700000', 'city': 'Ho Chi Minh City', 'state': 'Ho Chi Minh', 'country': 'Vietnam', 'facility': 'University Medical Center', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'overallOfficials': [{'name': 'Long D. Vo, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center, 215 Hong Bang street, Dist. 5, HCM city, VN'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Waiting for the results of this study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Ho Chi Minh City (UMC)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Head of GI Surgery Department', 'investigatorFullName': 'VoDuy Long', 'investigatorAffiliation': 'University Medical Center Ho Chi Minh City (UMC)'}}}}