Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-02 @ 11:48 AM
Study NCT ID:
NCT05360069
Status:
RECRUITING
Last Update Posted:
2025-05-20
First Post:
2022-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Linear Stapler Versus Circular Stapler in Esophagojejunostomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-17', 'studyFirstSubmitDate': '2022-03-11', 'studyFirstSubmitQcDate': '2022-05-02', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'hospitalization cost', 'timeFrame': '2 months', 'description': 'the cost in hospitalization'}], 'primaryOutcomes': [{'measure': 'Surgical complication', 'timeFrame': '6 months', 'description': 'All surgical complication after laparoscopic total gastrectomy'}], 'secondaryOutcomes': [{'measure': 'Operation duration', 'timeFrame': '1 day', 'description': 'operation time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laparoscopy', 'total gastrectomy', 'esophagojejunostomy', 'linear stapler', 'circular stapler'], 'conditions': ['Postoperative Complications', 'Operative Time', 'Hospital Costs']}, 'descriptionModule': {'briefSummary': 'With the development of stapler devices, various methods of esophagojejunostomy after laparoscopic total gastrectomy were evoluated. Which stapler is more advantageous has not been determined. At present, the most commonly used is linear stapler or Circular stapler in esophagojejunostomy. However, there is still a lack of reliable evidence for the selection of the two staplers. The purpose of this study is to explore the advantages of linear staper versus circular stapler in esophagojejunostomy for patients with gastric cancer who underwent total gastrectomy.', 'detailedDescription': 'With the development of stapler devices, various methods of esophagojejunostomy after laparoscopic total gastrectomy were evoluated. Which stapler is more advantageous has not been determined. At present, the most commonly used is linear stapler or Circular stapler in esophagojejunostomy. However, there is still a lack of reliable evidence for the selection of the two staplers. The purpose of this study is to explore the advantages of linear staper versus circular stapler in esophagojejunostomy for patients with Siewert classification type II and III gastric cancer who underwent total gastrectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages.\n2. Eastern Cooperative Oncology Group performance status of 0 or 1.\n3. Adequate organ function.\n\nExclusion Criteria:\n\n1. Patients had distant metastasis.\n2. oesophageal invasion of more than 3 cm.\n3. Borrmann type 4 or large (more than 8 cm) type 3 carcinoma.\n4. Previous chemotherapy or radiation therapy for any other malignancies.'}, 'identificationModule': {'nctId': 'NCT05360069', 'briefTitle': 'Linear Stapler Versus Circular Stapler in Esophagojejunostomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Nanchong Central Hospital'}, 'officialTitle': 'Linear Stapler Versus Circular Stapler in Esophagojejunostomy for Patients With Gastric Cancer Underwent Laparoscopic Total Gastrectomy', 'orgStudyIdInfo': {'id': '202101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Linear stapler group', 'description': 'Linear stapler is adopted in esophagojejunostomy.', 'interventionNames': ['Device: Linear stapler']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Circular stapler group', 'description': 'Circular stapler is adopted in esophagojejunostomy.', 'interventionNames': ['Device: Circular stapler']}], 'interventions': [{'name': 'Linear stapler', 'type': 'DEVICE', 'description': 'Linear stapler is adopted in esophagojejunostomy', 'armGroupLabels': ['Linear stapler group']}, {'name': 'Circular stapler', 'type': 'DEVICE', 'description': 'Circular stapler is adopted in esophagojejunostomy', 'armGroupLabels': ['Circular stapler group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '637000', 'city': 'Nanchong', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yunhong Tian, Doctor', 'role': 'CONTACT', 'email': 'drtianyunhong@126.com', 'phone': '+8613508087719'}], 'facility': 'Yunhong Tian', 'geoPoint': {'lat': 30.79508, 'lon': 106.08473}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanchong Central Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yunhong Tian', 'investigatorAffiliation': 'Nanchong Central Hospital'}}}}