Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT05493358
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2022-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Outcomes of Open Versus 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 472}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-04', 'studyFirstSubmitDate': '2022-08-04', 'studyFirstSubmitQcDate': '2022-08-05', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5 year overall survival by Kaplan Mayer', 'timeFrame': '5 year after surgery', 'description': 'The percentage of people in this study who are alive five years after surgery.'}, {'measure': '5 year disease-free survival by Kaplan Mayer', 'timeFrame': '5 year after surgery', 'description': 'The percentage of people in this study who are alive without recurrence/metastasis five years after surgery.'}], 'secondaryOutcomes': [{'measure': '1 year overall survival by Kaplan Mayer', 'timeFrame': '1 year after surgery', 'description': 'The percentage of people in this study who are alive one years after surgery.'}, {'measure': '3 year overall survival by Kaplan Mayer', 'timeFrame': '3 year after surgery', 'description': 'The percentage of people in this study who are alive one years after surgery.'}, {'measure': '1 year disease-free survival by Kaplan Mayer', 'timeFrame': '1 year after surgery', 'description': 'The percentage of people in this study who are alive without recurrence/metastasis one years after surgery.'}, {'measure': '3 year disease-free survival by Kaplan Mayer', 'timeFrame': '3 year after surgery', 'description': 'The percentage of people in this study who are alive without recurrence/metastasis one years after surgery.'}, {'measure': 'operative morbidity', 'timeFrame': '30 days after surgery', 'description': 'The overall rate of postoperative complications'}, {'measure': 'operative time', 'timeFrame': 'intraoperative', 'description': 'The duration of a surgical procedure in minutes.'}, {'measure': 'operative blood loss', 'timeFrame': 'intraoperative', 'description': 'The amount of blood lost during procedure'}, {'measure': 'time to flatus', 'timeFrame': '30 days after surgery or until mortality ]', 'description': 'Number of days from date of surgery until date of flatus'}, {'measure': 'Postoperative hospital length of stay', 'timeFrame': '30 days after surgery or until mortality', 'description': 'Number of days from date of surgery until date of discharge or mortality'}, {'measure': 'The percentage of complications with Clavien-Dindo', 'timeFrame': '30 days after surgery', 'description': 'The percentage of complication grade by Clavien-Dindo classification'}, {'measure': 'The percentage of pattern of recurrence/metastasis', 'timeFrame': '5 year after surgery', 'description': 'The percentage of pattern of recurrence/metastasis during follow up period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, '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 was to compare short- and long- term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in surgical T4A stage.', 'detailedDescription': 'Gastric cancer 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 worldwide now.\n\nLaparoscopic gastrectomy for locally advanced gastric cancer AGC have commonly used 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 for T4a stage.\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 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 was to compare short- and long- term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in surgical T4A stage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients with surgical T4a (sT4a) gastric adenocarcinoma at the lower or middle third of the stomach who underwent ODG or LDG plus lymphadenectomy between January 2013 and December 2020 at the Gastro-intestinal Surgical Department of the University Medical Center at Ho Chi Minh City, Vietnam', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with histologically confirmed adenocarcinoma of the stomach, surgical staging of sT4aN0-3M0 according to the 7th edition of the American Joint Committee on Cancer/Union Internationale Contre le Cancer (AJCC/UICC) staging system\n\nExclusion Criteria:\n\n* intraoperatively detected bulky lymph nodes\n* inadequate lymphadenectomy (D0, D1, D1+)\n* macroscopic residual tumor (R2)\n* an American Society of Anaesthesiology (ASA) score of \\> IV\n* concurrent cancer or history of previous other cancers\n* previous gastrectomy\n* neoadjuvant chemotherapy\n* complications such as bleeding or perforation required emergency gastrectomy.'}, 'identificationModule': {'nctId': 'NCT05493358', 'briefTitle': 'Long-term Outcomes of Open Versus Laparoscopic Distal Gastrectomy for T4a Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Ho Chi Minh City (UMC)'}, 'officialTitle': 'Long-term Outcomes of Open Versus Laparoscopic Distal Gastrectomy for T4a Gastric Cancer: a Propensity Score-matched Cohort Study', 'orgStudyIdInfo': {'id': '71/GCN-HĐĐĐ'}}, 'armsInterventionsModule': {'armGroups': [{'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 I, Billroth II or Roux en Y method was used for gastric reconstruction.'}, {'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 I, Billroth II or Roux en Y method was used for gastric reconstruction.', 'interventionNames': ['Procedure: Laparoscopic distal gastrectomy']}], 'interventions': [{'name': 'Laparoscopic distal gastrectomy', 'type': 'PROCEDURE', 'description': 'Distal gastrectomy and standard D2 lymphadenectomy', 'armGroupLabels': ['Laparoscopic distal gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700000', 'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'University Medical Center Ho Chi Minh City', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'overallOfficials': [{'name': 'Long D. Vo, MD PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center HCMC, Vietnam'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Ho Chi Minh City (UMC)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}