Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-27 @ 6:22 AM
Study NCT ID:
NCT01914692
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2013-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Somatostatin for Advanced Gastric Cancer After D2 Lymph Node Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013004', 'term': 'Somatostatin'}], 'ancestors': [{'id': 'D010905', 'term': 'Pituitary Hormone Release Inhibiting Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-31', 'studyFirstSubmitDate': '2013-07-30', 'studyFirstSubmitQcDate': '2013-07-31', 'lastUpdatePostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'postoperative pancreatitis', 'timeFrame': 'one year', 'description': 'number of patients'}], 'primaryOutcomes': [{'measure': 'fistula of pancreas', 'timeFrame': 'one year', 'description': 'number of patients'}], 'secondaryOutcomes': [{'measure': 'amount of bleeding', 'timeFrame': 'six months', 'description': 'amount of bleeding after the operation'}, {'measure': 'seroperitoneum', 'timeFrame': 'six months', 'description': 'seroperitoneum volum of patients'}, {'measure': 'infection of incisional wound', 'timeFrame': 'one year', 'description': 'number of patients'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gastric Cancer After D2 Lymph Node Dissection']}, 'descriptionModule': {'briefSummary': 'Gastric cancer radical surgery related complications are common.Somatostatin is a conventional medical therapy for bleeding.This study explore the effect of Somatostatin for Advanced Gastric Cancer After D2 Lymph Node dissection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. More than eighteen years old\n2. Gastric cancer diagnosed by pathological examination\n3. Be given informed consent\n4. Without diabetes/hyperthyroidism/Damages of functions of heart, liver and kidney/Systemic Infection/immunodeficiency\n\nExclusion Criteria:\n\n1. Contraindication of vascular puncture operation\n2. Patients who refused to take part in the programe\n3. Poor compliance of treatment\n4. Malnutrition,BMI\\<18\n5. with pancreatectomy'}, 'identificationModule': {'nctId': 'NCT01914692', 'briefTitle': 'Application of Somatostatin for Advanced Gastric Cancer After D2 Lymph Node Dissection', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'Application of Somatostatin for Advanced Gastric Cancer After D2 Lymph Node Dissection -a Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'nova-0426'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Somatostatin group', 'description': 'Patients with Advanced Gastric Cancer After D2 Lymph Node Dissection accept the Somatostatin medical therapy.', 'interventionNames': ['Drug: Somatostatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Blank group', 'description': 'Use the normal saline instead of somatostatin.'}], 'interventions': [{'name': 'Somatostatin', 'type': 'DRUG', 'description': 'Somatostatin is a kind of traditional medicines ,which is for the treatment of intestinal fistula，upper gastrointestinal hemorrhage.', 'armGroupLabels': ['Somatostatin group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Song Wu, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postgraduate', 'investigatorFullName': 'Wang Shaochuan', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}