Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT05514769
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2022-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty Versus Esophagogastric Anastomosis for Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], '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'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2022-08-21', 'studyFirstSubmitQcDate': '2022-08-23', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastroesophagus reflux disease apprised by ph monitoring', 'timeFrame': '6 months', 'description': 'Ph monitoring by wireless or wire device'}, {'measure': 'Gastroesophagus reflux disease apprised by questionnaire', 'timeFrame': '6 months', 'description': 'PGSAS-45 questionnaire is adopted.'}], 'secondaryOutcomes': [{'measure': 'Surgical complications of proximal gastrectomy for gastric cancer', 'timeFrame': '1 year', 'description': 'Surgical complications include anastomotic leakage, anastomotic stricture, postoperative bleeding, pleural effusion, et al.'}, {'measure': 'Long-term outcome', 'timeFrame': '5 years', 'description': 'Total survival time after proximal gastrectomy for gastric cancer'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Proximal Gastric Adenocarcinoma', 'Gastric Cancer', 'Gastroesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'This research is designed to compare proximal gastrectomy anterior anastomosis with pyloroplasty with esophagogastric anastomosis for gastric cancer. Gastroesophageal reflux disease, postoperative quality of life, short term outcomes, and long term outcomes will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 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': 'NCT05514769', 'briefTitle': 'Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty Versus Esophagogastric Anastomosis for Gastric Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Nanchong Central Hospital'}, 'officialTitle': 'Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty Versus Esophagogastric Anastomosis for Gastric Cancer', 'orgStudyIdInfo': {'id': '20220720'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty (GAP)', 'description': 'The reconstruction including esophagogastric anastomosis and pyloroplasty for patients who underwent proximal gastrectomy . The anastomosis locate in the anterior of gastric stump.', 'interventionNames': ['Procedure: Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'The reconstruction including esophagogastric anastomosis and pyloroplasty for patients who underwent proximal gastrectomy . The anastomosis locate in the posterior or side of gastric stump.', 'interventionNames': ['Procedure: Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty']}], 'interventions': [{'name': 'Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty', 'type': 'PROCEDURE', 'description': 'The location of the anastomosis in the anterior of the gastric stump. Pyloroplasty is added in the procedure', 'armGroupLabels': ['Control', 'Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty (GAP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '637000', 'city': 'Nanchong', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yunhong Tian, PHD', 'role': 'CONTACT', 'email': 'drtianyunhong@126.com', 'phone': '13508087719'}], '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'}}}}